IDWeek 2013

SAN FRANCISCO – An investigational norovirus vaccine safely reduced the vomiting and diarrhea associated with norovirus genotype GII.4, the most common strain of the disease, in a randomized, double-blind, placebo-controlled trial.

Study subjects were randomized to receive either placebo or the bivalent vaccine, which also targets norovirus genotype GI.1 (the Norwalk strain), and they subsequently drank water containing a significant amount of the GII.4 strain of the virus. Infection with the challenge virus occurred in 52% of 56 subjects in the vaccine group and 60.4% of 53 subjects in the placebo group. Significantly fewer patients with infection in the vaccine group, compared with the placebo group, reported severe vomiting and/or diarrhea (0% vs. 8.3%), moderate or severe diarrhea or vomiting (6.0% vs. 18.8%), and vomiting and/or diarrhea of any severity (20.0% vs. 41.7%), Dr. David I. Bernstein reported during a press conference at an annual scientific meeting on infectious diseases.

Also, fewer subjects in the vaccine group shed norovirus at day 10 after the challenge (22.4% vs. 36.2%), according to Dr. Bernstein of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati.

Participants in this multicenter trial were adults aged 18-50 years who were injected twice, 28 days apart, with either placebo or the vaccine – a virus-like particle vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum. The virus challenge included 4,000 real-time polymerase chain reaction genome equivalents of a heterologous GII.4 norovirus. Subjects were isolated for 4 days as inpatients following the challenge, during which time they were monitored for infection.

"We are excited about the results," Dr. Bernstein said, noting that the findings with respect to the effect on severe symptoms are particularly encouraging because it is severe disease that is of the most concern.

Larger trials in a real-world setting are planned, he said.

Norovirus is the leading cause of acute gastroenteritis among both adults and children, and it is highly contagious. Significant outbreaks occur in many settings where people are in close quarters, including health care facilities, child care centers, cruise ships, and in the military, he said.

In fact, 19-21 million Americans are infected each year, and as many as 800 die from the infection. Children and older adults are particularly vulnerable to developing more serious illness.

"Until recently we accepted [norovirus] as a part of life, but this research gives us a glimmer as to a very different future," said Dr. Andrew T. Pavia of the University of Utah, Salt Lake City, the press conference moderator.

Indeed, one could envision a scenario in which this vaccine, if ultimately approved, could be used to help prevent norovirus among nursing home residents, members of the military, cruise ship passengers, and children in school settings, Dr. Bernstein said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

"This [research] is a good start," he said, adding that there is still a long way to go.

If this vaccine proves as safe and effective in the real world as in the challenge setting used in this trial, it would be a minimum of 5 years before a commercial vaccine was available, he estimated.

Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte Inc., the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.

SAN FRANCISCO – An investigational norovirus vaccine safely reduced the vomiting and diarrhea associated with norovirus genotype GII.4, the most common strain of the disease, in a randomized, double-blind, placebo-controlled trial.

Study subjects were randomized to receive either placebo or the bivalent vaccine, which also targets norovirus genotype GI.1 (the Norwalk strain), and they subsequently drank water containing a significant amount of the GII.4 strain of the virus. Infection with the challenge virus occurred in 52% of 56 subjects in the vaccine group and 60.4% of 53 subjects in the placebo group. Significantly fewer patients with infection in the vaccine group, compared with the placebo group, reported severe vomiting and/or diarrhea (0% vs. 8.3%), moderate or severe diarrhea or vomiting (6.0% vs. 18.8%), and vomiting and/or diarrhea of any severity (20.0% vs. 41.7%), Dr. David I. Bernstein reported during a press conference at an annual scientific meeting on infectious diseases.

Also, fewer subjects in the vaccine group shed norovirus at day 10 after the challenge (22.4% vs. 36.2%), according to Dr. Bernstein of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati.

Participants in this multicenter trial were adults aged 18-50 years who were injected twice, 28 days apart, with either placebo or the vaccine – a virus-like particle vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum. The virus challenge included 4,000 real-time polymerase chain reaction genome equivalents of a heterologous GII.4 norovirus. Subjects were isolated for 4 days as inpatients following the challenge, during which time they were monitored for infection.

"We are excited about the results," Dr. Bernstein said, noting that the findings with respect to the effect on severe symptoms are particularly encouraging because it is severe disease that is of the most concern.

Larger trials in a real-world setting are planned, he said.

Norovirus is the leading cause of acute gastroenteritis among both adults and children, and it is highly contagious. Significant outbreaks occur in many settings where people are in close quarters, including health care facilities, child care centers, cruise ships, and in the military, he said.

In fact, 19-21 million Americans are infected each year, and as many as 800 die from the infection. Children and older adults are particularly vulnerable to developing more serious illness.

"Until recently we accepted [norovirus] as a part of life, but this research gives us a glimmer as to a very different future," said Dr. Andrew T. Pavia of the University of Utah, Salt Lake City, the press conference moderator.

Indeed, one could envision a scenario in which this vaccine, if ultimately approved, could be used to help prevent norovirus among nursing home residents, members of the military, cruise ship passengers, and children in school settings, Dr. Bernstein said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

"This [research] is a good start," he said, adding that there is still a long way to go.

If this vaccine proves as safe and effective in the real world as in the challenge setting used in this trial, it would be a minimum of 5 years before a commercial vaccine was available, he estimated.

Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte Inc., the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.

SAN FRANCISCO – An investigational norovirus vaccine safely reduced the vomiting and diarrhea associated with norovirus genotype GII.4, the most common strain of the disease, in a randomized, double-blind, placebo-controlled trial.

Study subjects were randomized to receive either placebo or the bivalent vaccine, which also targets norovirus genotype GI.1 (the Norwalk strain), and they subsequently drank water containing a significant amount of the GII.4 strain of the virus. Infection with the challenge virus occurred in 52% of 56 subjects in the vaccine group and 60.4% of 53 subjects in the placebo group. Significantly fewer patients with infection in the vaccine group, compared with the placebo group, reported severe vomiting and/or diarrhea (0% vs. 8.3%), moderate or severe diarrhea or vomiting (6.0% vs. 18.8%), and vomiting and/or diarrhea of any severity (20.0% vs. 41.7%), Dr. David I. Bernstein reported during a press conference at an annual scientific meeting on infectious diseases.

Also, fewer subjects in the vaccine group shed norovirus at day 10 after the challenge (22.4% vs. 36.2%), according to Dr. Bernstein of Cincinnati Children’s Hospital Medical Center and the University of Cincinnati.

Participants in this multicenter trial were adults aged 18-50 years who were injected twice, 28 days apart, with either placebo or the vaccine – a virus-like particle vaccine adjuvanted with monophosphoryl lipid A (MPL) and alum. The virus challenge included 4,000 real-time polymerase chain reaction genome equivalents of a heterologous GII.4 norovirus. Subjects were isolated for 4 days as inpatients following the challenge, during which time they were monitored for infection.

"We are excited about the results," Dr. Bernstein said, noting that the findings with respect to the effect on severe symptoms are particularly encouraging because it is severe disease that is of the most concern.

Larger trials in a real-world setting are planned, he said.

Norovirus is the leading cause of acute gastroenteritis among both adults and children, and it is highly contagious. Significant outbreaks occur in many settings where people are in close quarters, including health care facilities, child care centers, cruise ships, and in the military, he said.

In fact, 19-21 million Americans are infected each year, and as many as 800 die from the infection. Children and older adults are particularly vulnerable to developing more serious illness.

"Until recently we accepted [norovirus] as a part of life, but this research gives us a glimmer as to a very different future," said Dr. Andrew T. Pavia of the University of Utah, Salt Lake City, the press conference moderator.

Indeed, one could envision a scenario in which this vaccine, if ultimately approved, could be used to help prevent norovirus among nursing home residents, members of the military, cruise ship passengers, and children in school settings, Dr. Bernstein said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

"This [research] is a good start," he said, adding that there is still a long way to go.

If this vaccine proves as safe and effective in the real world as in the challenge setting used in this trial, it would be a minimum of 5 years before a commercial vaccine was available, he estimated.

Dr. Bernstein reporting serving as an investigator for and receiving research support from LigoCyte Inc., the maker of the investigational vaccine. He also receives royalties for a different norovirus vaccine.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Universal glove and gown precautions in the intensive care unit setting reduced acquisition of methicillin-resistant Staphylococcus aureus by nearly 40% in a cluster randomized trial.

This "very meaningful reduction" was significantly greater than the 15% reduction in the relative risk of acquiring MRSA in a control group that received usual care, Dr. Anthony D. Harris reported at IDWeek 2013, an annual scientific meeting on infectious diseases.

Although the primary composite outcome of MRSA or vancomycin-resistant enterococcus acquisition was not met in the study (the Benefits of Universal Glove and Gown, or BUGG study), this was because no difference was seen in the rate of VRE acquisition in the intervention and control groups – possibly because of variations in the biology of MRSA and VRE, explained Dr. Harris of the University of Maryland, Baltimore.

©Anton Gvozdikov/Fotolia.com

Overall, the relative risk reduction from baseline was 20.8% in the intervention group, compared with 14.4% for the composite outcome in the control group, but the relative risk reduction for MRSA was 40.2% vs. 15.0%, and for VRE it was 10.5% vs. 17.3% in the groups, respectively, Dr. Harris said.

Furthermore, no adverse events associated with universal glove and gown use occurred, and the precautions were associated with an increase in hand hygiene compliance (78.9% vs. 62.9% in the intervention and control groups, respectively).

The findings were reported during a "featured abstract" presentation at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

They were published simultaneously online Oct. 4 in JAMA (JAMA 2013 Oct. 4 [doi: 10.1001/jama.2013.277815]).

A total of 26,180 patients from 20 medical and surgical ICUs and 20 U.S. hospitals were included in the 9-month study, which was conducted between Jan. 4, 2012, and Oct. 4, 2012, and a total of 92,241 swabs were collected on admission and discharge to test for the primary outcome. In the intervention groups, health care workers were required to wear gloves and gown for all patient contact. Usual care was provided in the control arm.

Prior smaller studies showed that universal glove and gown precautions in the ICU setting could lead to decreased antibiotic resistant bacterial transmission, but numerous studies have also suggested that such precautions might have certain adverse events, Dr. Harris said.

"What we did find consistent with the literature is that health care workers seem to go into rooms less often when patients are on contact precautions ... you see about 1 visit less per hour in the intervention arm than in the control arm," he said, noting that visits dropped from about 5 to 4 per hour.

However, this did not translate to an increase in adverse events.

"Basically, we found no difference in the adverse event rate," he added, noting that, in fact, the trend was toward an increased adverse event rate in the control group (74.4 vs. 58.7 events per 1,000 patient-days in the control vs. intervention group, respectively).

While the findings are noteworthy given that antibiotic resistance is associated with considerable morbidity, mortality, and cost, and that MRSA is a primary cause of health care–associated infections that are linked to poor outcomes, they require replication before definitive conclusions can be reached, Dr. Harris said.

This study was supported by grants from the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Harris reported serving as a consultant for Premier, Cubist, and Sanogiene. He is an editor for UpToDate Online. Several other authors reported financial ties to drug and medical device companies. Detailed disclosures are provided with the full text of the JAMA article.

SAN FRANCISCO – Compared with standard dose inactivated influenza vaccine, high-dose influenza vaccine produced non-inferior hemagglutination inhibition titer responses for all A/H1N1, A/H3N2, and B influenza strains among frail elderly long-term care residents in a recent randomized study conducted during the 2011-2012 and 2012-2013 influenza seasons.

The high-dose vaccine produced superior titer responses for all strains except A/H1N1 during the 2012-2013 season, Dr. Richard K. Zimmerman reported during an annual scientific meeting on infectious diseases.

lisafx/istockphoto.com

Geometric mean titers were similar in the groups at baseline for both the 2011-2012 and 2012-2013 seasons. At day 30 during the 2011-2012 season, the geometric mean titers in the standard vs. high-dose group, respectively, were 27.9 vs. 67.7 for A/California/07/2009; 9.3 vs. 23.1 for A/Perth/16/2010; and 14.0 vs. 24.8 for B/Brisbane/60/2008. At day 30 during the 2012-2013 season, titers were 51.6 vs. 45.6 for A/California/07/2009; 13.4 vs.25.0 for A/Victoria/63/2011; and 18.7 vs. 25.6 for B/Wisconsin/1/2010, said Dr. Zimmerman, who is professor of family medicine at the University of Pittsburgh, Pa.

A total of 56 and 113 elderly adults participated during 2011-2012 and 2012-2013 study periods, respectively; 34 subjects participated during both time periods. The participants, who had a mean age of 86.7 years, provided venous blood samples for hemagglutination inhibition titers at baseline and were randomly assigned to either the high-dose or standard-dose vaccination group. A follow-up blood sample was obtained and evaluated 1 month after vaccination. No serious adverse events related to vaccination were reported during the study.

The noninferiority and superiority tests were performed separately for the two influenza seasons, because the vaccine formulations for those seasons contained different A/H3N2 and B strains; the A/H1N1 strains were the same during both seasons, which may explain the lack of superiority in titer response for A/H1N1 during the 2012-2013 season, since 34 patients received the vaccine in 2011-2012, as well, Dr. Zimmerman explained.

"We may have been seeing the effects of the prior vaccination," he said.

The findings of this study are of particular interest because more than 90% of influenza cases reported each year occur in patients aged 65 years and older, and each year, between 3,000 and 49,000 influenza-associated deaths occur; the risk of death increases with increasing age, Dr. Zimmerman said at the conference, which are the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

When infected with influenza, mortality among those aged 85 years and older is 16-fold higher than the rate among those aged 65-69 years.

Influenza also results in an estimated 226,000 hospitalizations annually, and hospitalization rates among older adults have increased over the past 2 decades, he said, adding that more effective vaccine options are needed for frail older adults.

The high-dose vaccine was approved in 2009 for use in adults aged 65 years and older, but the phase III study that led to the approval was conducted in healthy adults over age 65 years, leaving questions about the applicability of the findings in the frail elderly long-term-care resident population.

Those included in the current study were also over 65 years of age, but were a frail population in need of assistance in two or more instrumental activities of daily living or at least one activity of daily living, Dr. Zimmerman said.

Though limited by the small sample size, the single-blind study design, and the fact that the study was conducted over two different influenza seasons during which two of the three strains tested changed from year 1 to year 2, the findings suggest that the high-dose vaccine is safe and immunogenic in the frail elderly population. How the titer responses seen in this study correlate with clinical outcomes in this population requires further study, he concluded.

This study was funded by an investigator initiated grant from Sanofi Pasteur. Dr. Zimmerman reported serving as a research grant investigator funded by Merck, MedImmune, and Sanofi Pasteur.

SAN FRANCISCO – Compared with standard dose inactivated influenza vaccine, high-dose influenza vaccine produced non-inferior hemagglutination inhibition titer responses for all A/H1N1, A/H3N2, and B influenza strains among frail elderly long-term care residents in a recent randomized study conducted during the 2011-2012 and 2012-2013 influenza seasons.

The high-dose vaccine produced superior titer responses for all strains except A/H1N1 during the 2012-2013 season, Dr. Richard K. Zimmerman reported during an annual scientific meeting on infectious diseases.

lisafx/istockphoto.com

Geometric mean titers were similar in the groups at baseline for both the 2011-2012 and 2012-2013 seasons. At day 30 during the 2011-2012 season, the geometric mean titers in the standard vs. high-dose group, respectively, were 27.9 vs. 67.7 for A/California/07/2009; 9.3 vs. 23.1 for A/Perth/16/2010; and 14.0 vs. 24.8 for B/Brisbane/60/2008. At day 30 during the 2012-2013 season, titers were 51.6 vs. 45.6 for A/California/07/2009; 13.4 vs.25.0 for A/Victoria/63/2011; and 18.7 vs. 25.6 for B/Wisconsin/1/2010, said Dr. Zimmerman, who is professor of family medicine at the University of Pittsburgh, Pa.

A total of 56 and 113 elderly adults participated during 2011-2012 and 2012-2013 study periods, respectively; 34 subjects participated during both time periods. The participants, who had a mean age of 86.7 years, provided venous blood samples for hemagglutination inhibition titers at baseline and were randomly assigned to either the high-dose or standard-dose vaccination group. A follow-up blood sample was obtained and evaluated 1 month after vaccination. No serious adverse events related to vaccination were reported during the study.

The noninferiority and superiority tests were performed separately for the two influenza seasons, because the vaccine formulations for those seasons contained different A/H3N2 and B strains; the A/H1N1 strains were the same during both seasons, which may explain the lack of superiority in titer response for A/H1N1 during the 2012-2013 season, since 34 patients received the vaccine in 2011-2012, as well, Dr. Zimmerman explained.

"We may have been seeing the effects of the prior vaccination," he said.

The findings of this study are of particular interest because more than 90% of influenza cases reported each year occur in patients aged 65 years and older, and each year, between 3,000 and 49,000 influenza-associated deaths occur; the risk of death increases with increasing age, Dr. Zimmerman said at the conference, which are the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

When infected with influenza, mortality among those aged 85 years and older is 16-fold higher than the rate among those aged 65-69 years.

Influenza also results in an estimated 226,000 hospitalizations annually, and hospitalization rates among older adults have increased over the past 2 decades, he said, adding that more effective vaccine options are needed for frail older adults.

The high-dose vaccine was approved in 2009 for use in adults aged 65 years and older, but the phase III study that led to the approval was conducted in healthy adults over age 65 years, leaving questions about the applicability of the findings in the frail elderly long-term-care resident population.

Those included in the current study were also over 65 years of age, but were a frail population in need of assistance in two or more instrumental activities of daily living or at least one activity of daily living, Dr. Zimmerman said.

Though limited by the small sample size, the single-blind study design, and the fact that the study was conducted over two different influenza seasons during which two of the three strains tested changed from year 1 to year 2, the findings suggest that the high-dose vaccine is safe and immunogenic in the frail elderly population. How the titer responses seen in this study correlate with clinical outcomes in this population requires further study, he concluded.

This study was funded by an investigator initiated grant from Sanofi Pasteur. Dr. Zimmerman reported serving as a research grant investigator funded by Merck, MedImmune, and Sanofi Pasteur.

SAN FRANCISCO – Compared with standard dose inactivated influenza vaccine, high-dose influenza vaccine produced non-inferior hemagglutination inhibition titer responses for all A/H1N1, A/H3N2, and B influenza strains among frail elderly long-term care residents in a recent randomized study conducted during the 2011-2012 and 2012-2013 influenza seasons.

The high-dose vaccine produced superior titer responses for all strains except A/H1N1 during the 2012-2013 season, Dr. Richard K. Zimmerman reported during an annual scientific meeting on infectious diseases.

lisafx/istockphoto.com

Geometric mean titers were similar in the groups at baseline for both the 2011-2012 and 2012-2013 seasons. At day 30 during the 2011-2012 season, the geometric mean titers in the standard vs. high-dose group, respectively, were 27.9 vs. 67.7 for A/California/07/2009; 9.3 vs. 23.1 for A/Perth/16/2010; and 14.0 vs. 24.8 for B/Brisbane/60/2008. At day 30 during the 2012-2013 season, titers were 51.6 vs. 45.6 for A/California/07/2009; 13.4 vs.25.0 for A/Victoria/63/2011; and 18.7 vs. 25.6 for B/Wisconsin/1/2010, said Dr. Zimmerman, who is professor of family medicine at the University of Pittsburgh, Pa.

A total of 56 and 113 elderly adults participated during 2011-2012 and 2012-2013 study periods, respectively; 34 subjects participated during both time periods. The participants, who had a mean age of 86.7 years, provided venous blood samples for hemagglutination inhibition titers at baseline and were randomly assigned to either the high-dose or standard-dose vaccination group. A follow-up blood sample was obtained and evaluated 1 month after vaccination. No serious adverse events related to vaccination were reported during the study.

The noninferiority and superiority tests were performed separately for the two influenza seasons, because the vaccine formulations for those seasons contained different A/H3N2 and B strains; the A/H1N1 strains were the same during both seasons, which may explain the lack of superiority in titer response for A/H1N1 during the 2012-2013 season, since 34 patients received the vaccine in 2011-2012, as well, Dr. Zimmerman explained.

"We may have been seeing the effects of the prior vaccination," he said.

The findings of this study are of particular interest because more than 90% of influenza cases reported each year occur in patients aged 65 years and older, and each year, between 3,000 and 49,000 influenza-associated deaths occur; the risk of death increases with increasing age, Dr. Zimmerman said at the conference, which are the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

When infected with influenza, mortality among those aged 85 years and older is 16-fold higher than the rate among those aged 65-69 years.

Influenza also results in an estimated 226,000 hospitalizations annually, and hospitalization rates among older adults have increased over the past 2 decades, he said, adding that more effective vaccine options are needed for frail older adults.

The high-dose vaccine was approved in 2009 for use in adults aged 65 years and older, but the phase III study that led to the approval was conducted in healthy adults over age 65 years, leaving questions about the applicability of the findings in the frail elderly long-term-care resident population.

Those included in the current study were also over 65 years of age, but were a frail population in need of assistance in two or more instrumental activities of daily living or at least one activity of daily living, Dr. Zimmerman said.

Though limited by the small sample size, the single-blind study design, and the fact that the study was conducted over two different influenza seasons during which two of the three strains tested changed from year 1 to year 2, the findings suggest that the high-dose vaccine is safe and immunogenic in the frail elderly population. How the titer responses seen in this study correlate with clinical outcomes in this population requires further study, he concluded.

This study was funded by an investigator initiated grant from Sanofi Pasteur. Dr. Zimmerman reported serving as a research grant investigator funded by Merck, MedImmune, and Sanofi Pasteur.

SAN FRANCISCO – Fecal microbiota transplantation via a pill appears to be as effective as other delivery methods, according to Dr. Thomas Louie.

Typically, fecal microbiota transplantation (FMT) using feces from healthy donors is delivered by enema, colonoscopy, or nasogastric tube to rebalance the bacteria in the gastrointestinal system of patients with recurrent Clostridium difficile infection, but Dr. Louie of the University of Calgary (Alta.) has developed a pill formulation that had 100% efficacy at 3-months’ follow-up in the first 32 patients he treated. Some of those patients have been followed for up to 3 years, and they remain C. difficile free.

Courtesy CDC/Dr. Gilda Jones

The findings were reported at an annual scientific meeting on infectious diseases.

"I’m happy to report that we’ve basically had no recurrences in any of [the 32 patients]," Dr. Louie said during a press conference, noting that one patient who required treatment with antibiotics after FMT developed what Dr. Louie said may be a mild recurrence associated with the antibiotic use.

He has been performing FMT via the enema route since 1996and has treated numerous patients with a very high success rate. He said he came up with the idea for a pill formulation when he encountered a patient who failed to respond to FMT enema on two occasions because of an inability to retain the high-volume treatment for her C. difficile infection, and who was unable to undergo nasogastric delivery because of esophageal varices.

Using freshly passed fecal matter donated, in most cases, by patients’ family members, Dr. Louie said he concentrates the fecal bacteria using a serial centrifugation process that results in pelleted fecal microbes in the sediment of the last centrifugation, and encapsulates the product inside three layers of gelatin capsule to ensure delivery into the small intestine.

The first few patients took 10 pills daily over a period of 4 days with a successful outcome, but the technique has been refined to the ingestion of a "one-shot deal" involving ingestion of 12-34 freshly prepared pills at a single visit.

Patients come in on an empty stomach, take their pills, go home, and wait about an hour and a half, and have some lunch.

"And that’s the end of their C. diff.," he said.

While the dosing isn’t an exact science, it does appear that some patients require fewer pills. For example, a 6-year-old heart transplant patient who had had multiple C. difficile recurrences over a 9-month period was successfully treated with 12 pills, Dr. Louie said.

An analysis of stool following FMT in the treated patients demonstrated that healthy bacteria were significantly increased, while Enterobacteriaceae and Veillonella bacteria were significantly decreased.

Dr. Tom Moore of the University of Kansas in Wichita who moderated the press conference, said in an interview that while none of the methods for delivering FMT have been compared in head-to-head studies, the available evidence suggests they all are highly effective, and the choice depends on patient and physician preference.

Certainly there is a "yuck factor" involved in this treatment for both patients and clinicians. For patients, the pill formulation may seem more palatable; clinicians charged with assembling the capsules may feel otherwise, he said.

But he, along with Dr. Ravi Kamepalli, an infectious disease specialist in group practice in Lima, Ohio, who presented patient satisfaction data for FMT via nasogastric delivery, said clinicians just "need to get over it."

FMT is a life-altering, if not lifesaving procedure for many patients, Dr. Kamepalli said.

In a survey, 28 patients who underwent FMT via nasogastric delivery rated overall satisfaction at 9.6 on a 1-10 scale, and rated ease and likelihood of recommending the procedure to a family member or friend at 9.9 each.

The patients, who had a mean age of 67 years, were surveyed 3 months after the procedure.

To date, Dr. Kamepalli has treated 40 patients with a 98% success rate, he said.

IDWeek is the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The investigators reported having no relevant financial disclosures.

SAN FRANCISCO – Fecal microbiota transplantation via a pill appears to be as effective as other delivery methods, according to Dr. Thomas Louie.

Typically, fecal microbiota transplantation (FMT) using feces from healthy donors is delivered by enema, colonoscopy, or nasogastric tube to rebalance the bacteria in the gastrointestinal system of patients with recurrent Clostridium difficile infection, but Dr. Louie of the University of Calgary (Alta.) has developed a pill formulation that had 100% efficacy at 3-months’ follow-up in the first 32 patients he treated. Some of those patients have been followed for up to 3 years, and they remain C. difficile free.

Courtesy CDC/Dr. Gilda Jones

The findings were reported at an annual scientific meeting on infectious diseases.

"I’m happy to report that we’ve basically had no recurrences in any of [the 32 patients]," Dr. Louie said during a press conference, noting that one patient who required treatment with antibiotics after FMT developed what Dr. Louie said may be a mild recurrence associated with the antibiotic use.

He has been performing FMT via the enema route since 1996and has treated numerous patients with a very high success rate. He said he came up with the idea for a pill formulation when he encountered a patient who failed to respond to FMT enema on two occasions because of an inability to retain the high-volume treatment for her C. difficile infection, and who was unable to undergo nasogastric delivery because of esophageal varices.

Using freshly passed fecal matter donated, in most cases, by patients’ family members, Dr. Louie said he concentrates the fecal bacteria using a serial centrifugation process that results in pelleted fecal microbes in the sediment of the last centrifugation, and encapsulates the product inside three layers of gelatin capsule to ensure delivery into the small intestine.

The first few patients took 10 pills daily over a period of 4 days with a successful outcome, but the technique has been refined to the ingestion of a "one-shot deal" involving ingestion of 12-34 freshly prepared pills at a single visit.

Patients come in on an empty stomach, take their pills, go home, and wait about an hour and a half, and have some lunch.

"And that’s the end of their C. diff.," he said.

While the dosing isn’t an exact science, it does appear that some patients require fewer pills. For example, a 6-year-old heart transplant patient who had had multiple C. difficile recurrences over a 9-month period was successfully treated with 12 pills, Dr. Louie said.

An analysis of stool following FMT in the treated patients demonstrated that healthy bacteria were significantly increased, while Enterobacteriaceae and Veillonella bacteria were significantly decreased.

Dr. Tom Moore of the University of Kansas in Wichita who moderated the press conference, said in an interview that while none of the methods for delivering FMT have been compared in head-to-head studies, the available evidence suggests they all are highly effective, and the choice depends on patient and physician preference.

Certainly there is a "yuck factor" involved in this treatment for both patients and clinicians. For patients, the pill formulation may seem more palatable; clinicians charged with assembling the capsules may feel otherwise, he said.

But he, along with Dr. Ravi Kamepalli, an infectious disease specialist in group practice in Lima, Ohio, who presented patient satisfaction data for FMT via nasogastric delivery, said clinicians just "need to get over it."

FMT is a life-altering, if not lifesaving procedure for many patients, Dr. Kamepalli said.

In a survey, 28 patients who underwent FMT via nasogastric delivery rated overall satisfaction at 9.6 on a 1-10 scale, and rated ease and likelihood of recommending the procedure to a family member or friend at 9.9 each.

The patients, who had a mean age of 67 years, were surveyed 3 months after the procedure.

To date, Dr. Kamepalli has treated 40 patients with a 98% success rate, he said.

IDWeek is the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The investigators reported having no relevant financial disclosures.

SAN FRANCISCO – Fecal microbiota transplantation via a pill appears to be as effective as other delivery methods, according to Dr. Thomas Louie.

Typically, fecal microbiota transplantation (FMT) using feces from healthy donors is delivered by enema, colonoscopy, or nasogastric tube to rebalance the bacteria in the gastrointestinal system of patients with recurrent Clostridium difficile infection, but Dr. Louie of the University of Calgary (Alta.) has developed a pill formulation that had 100% efficacy at 3-months’ follow-up in the first 32 patients he treated. Some of those patients have been followed for up to 3 years, and they remain C. difficile free.

Courtesy CDC/Dr. Gilda Jones

The findings were reported at an annual scientific meeting on infectious diseases.

"I’m happy to report that we’ve basically had no recurrences in any of [the 32 patients]," Dr. Louie said during a press conference, noting that one patient who required treatment with antibiotics after FMT developed what Dr. Louie said may be a mild recurrence associated with the antibiotic use.

He has been performing FMT via the enema route since 1996and has treated numerous patients with a very high success rate. He said he came up with the idea for a pill formulation when he encountered a patient who failed to respond to FMT enema on two occasions because of an inability to retain the high-volume treatment for her C. difficile infection, and who was unable to undergo nasogastric delivery because of esophageal varices.

Using freshly passed fecal matter donated, in most cases, by patients’ family members, Dr. Louie said he concentrates the fecal bacteria using a serial centrifugation process that results in pelleted fecal microbes in the sediment of the last centrifugation, and encapsulates the product inside three layers of gelatin capsule to ensure delivery into the small intestine.

The first few patients took 10 pills daily over a period of 4 days with a successful outcome, but the technique has been refined to the ingestion of a "one-shot deal" involving ingestion of 12-34 freshly prepared pills at a single visit.

Patients come in on an empty stomach, take their pills, go home, and wait about an hour and a half, and have some lunch.

"And that’s the end of their C. diff.," he said.

While the dosing isn’t an exact science, it does appear that some patients require fewer pills. For example, a 6-year-old heart transplant patient who had had multiple C. difficile recurrences over a 9-month period was successfully treated with 12 pills, Dr. Louie said.

An analysis of stool following FMT in the treated patients demonstrated that healthy bacteria were significantly increased, while Enterobacteriaceae and Veillonella bacteria were significantly decreased.

Dr. Tom Moore of the University of Kansas in Wichita who moderated the press conference, said in an interview that while none of the methods for delivering FMT have been compared in head-to-head studies, the available evidence suggests they all are highly effective, and the choice depends on patient and physician preference.

Certainly there is a "yuck factor" involved in this treatment for both patients and clinicians. For patients, the pill formulation may seem more palatable; clinicians charged with assembling the capsules may feel otherwise, he said.

But he, along with Dr. Ravi Kamepalli, an infectious disease specialist in group practice in Lima, Ohio, who presented patient satisfaction data for FMT via nasogastric delivery, said clinicians just "need to get over it."

FMT is a life-altering, if not lifesaving procedure for many patients, Dr. Kamepalli said.

In a survey, 28 patients who underwent FMT via nasogastric delivery rated overall satisfaction at 9.6 on a 1-10 scale, and rated ease and likelihood of recommending the procedure to a family member or friend at 9.9 each.

The patients, who had a mean age of 67 years, were surveyed 3 months after the procedure.

To date, Dr. Kamepalli has treated 40 patients with a 98% success rate, he said.

IDWeek is the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

The investigators reported having no relevant financial disclosures.