A Phase I trial to evaluate the safety and immunogenicity of WRSs2 and WRSs3; two live oral candidate vaccines against Shigella sonnei
•Shigella is a significant cause of morbidity and mortality among children in the developing world and travelers to endemic areas.•There are no licensed vaccines against Shigella.•The study showed the safety and immunogenicity of two live-attenuated, oral S. sonnei vaccines.•Future research will eva...
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| Published in | Vaccine Vol. 36; no. 32; pp. 4880 - 4889 |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier Ltd
06.08.2018
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0264-410X 1873-2518 1873-2518 |
| DOI | 10.1016/j.vaccine.2018.06.063 |
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| Abstract | •Shigella is a significant cause of morbidity and mortality among children in the developing world and travelers to endemic areas.•There are no licensed vaccines against Shigella.•The study showed the safety and immunogenicity of two live-attenuated, oral S. sonnei vaccines.•Future research will evaluate the efficacy of the vaccines against S. sonnei infection in a human challenge model.
Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity.
Healthy adults 18–45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 103 CFU to 107 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples.
Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 107 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding.
S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. |
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| AbstractList | Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity.Healthy adults 18–45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 103 CFU to 107 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples.Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 107 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding.S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity. Healthy adults 18-45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 10 CFU to 10 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples. Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 10 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding. S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity.Healthy adults 18–45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 10³ CFU to 10⁷ CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples.Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 10⁷ CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding.S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. •Shigella is a significant cause of morbidity and mortality among children in the developing world and travelers to endemic areas.•There are no licensed vaccines against Shigella.•The study showed the safety and immunogenicity of two live-attenuated, oral S. sonnei vaccines.•Future research will evaluate the efficacy of the vaccines against S. sonnei infection in a human challenge model. Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity. Healthy adults 18–45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 103 CFU to 107 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples. Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 107 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding. S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. Highlights•Shigella is a significant cause of morbidity and mortality among children in the developing world and travelers to endemic areas. •There are no licensed vaccines against Shigella. •The study showed the safety and immunogenicity of two live-attenuated, oral S. sonnei vaccines. •Future research will evaluate the efficacy of the vaccines against S. sonnei infection in a human challenge model. Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity. Healthy adults 18-45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 103 CFU to 107 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples. Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 107 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding. S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine.Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity. Healthy adults 18-45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 103 CFU to 107 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples. Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 107 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding. S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. Effective vaccines are needed to combat diarrheal diseases due to Shigella . Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally by the lack of spreading ability, as well as the loss of enterotoxin and acyl transferase genes, were tested for safety and immunogenicity. Healthy adults 18–45 years of age, assigned to 5 cohorts of 18 subjects each (WRSs2 (n = 8), WRSs3 (n = 8) or placebo (n = 2)) were housed in an inpatient facility and administered a single oral dose of study agent 5 min after ingestion of oral bicarbonate. Ascending dosages of vaccine (from 10 3 CFU to 10 7 CFU) were evaluated. On day 8, treatment with ciprofloxacin (500 mg BID for 3 days) was initiated and subjects were discharged home 2 days after completing antibiotics. Subjects returned for outpatient visits on day 14, 28 and 56 post-vaccination for monitoring and collection of stool and blood samples. Both WRSs2 and WRSs3 were generally well tolerated and safe over the entire dose range. Among the 80 vaccinees, 11 subjects developed diarrhea, 8 of which were mild and did not affect daily activities. At the 10 7 CFU dose, moderate diarrhea occurred in one WRSs2 subject while at the same dose of WRSs3, 2 subjects had moderate or severe diarrhea. Vaccinees mounted dose-dependent mucosal and systemic immune responses that appeared to correlate with fecal shedding. S. sonnei vaccine candidates WRSs2 and WRSs3 are safe and immunogenic over a wide dose range. Future steps will be to select the most promising candidate and move to human challenge models for efficacy of the vaccine. |
| Author | Baughman, Holly El-Khorazaty, Jill Suvarnapunya, Akamol E. Baqar, Shahida Alexander, William Dickey, Michelle McNeal, Monica Kaminski, Robert W. Frenck, Robert W Barnoy, Shoshana Hoeper, Amy Venkatesan, Malabi M. |
| AuthorAffiliation | a Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States b Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States c The Emmes Corporation, Rockville, MD, USA d Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States |
| AuthorAffiliation_xml | – name: c The Emmes Corporation, Rockville, MD, USA – name: b Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States – name: d Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States – name: a Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States |
| Author_xml | – sequence: 1 givenname: Robert W surname: Frenck fullname: Frenck, Robert W email: robert.frenck@cchmc.org organization: Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States – sequence: 2 givenname: Shahida surname: Baqar fullname: Baqar, Shahida organization: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States – sequence: 3 givenname: William surname: Alexander fullname: Alexander, William organization: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States – sequence: 4 givenname: Michelle surname: Dickey fullname: Dickey, Michelle organization: Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States – sequence: 5 givenname: Monica surname: McNeal fullname: McNeal, Monica organization: Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States – sequence: 6 givenname: Jill surname: El-Khorazaty fullname: El-Khorazaty, Jill organization: The Emmes Corporation, Rockville, MD, USA – sequence: 7 givenname: Holly surname: Baughman fullname: Baughman, Holly organization: The Emmes Corporation, Rockville, MD, USA – sequence: 8 givenname: Amy surname: Hoeper fullname: Hoeper, Amy organization: Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, United States – sequence: 9 givenname: Shoshana surname: Barnoy fullname: Barnoy, Shoshana organization: Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States – sequence: 10 givenname: Akamol E. surname: Suvarnapunya fullname: Suvarnapunya, Akamol E. organization: Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States – sequence: 11 givenname: Robert W. surname: Kaminski fullname: Kaminski, Robert W. organization: Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States – sequence: 12 givenname: Malabi M. surname: Venkatesan fullname: Venkatesan, Malabi M. organization: Department of Enteric Infections, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, United States |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30037478$$D View this record in MEDLINE/PubMed |
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| Copyright | 2018 Elsevier Ltd Elsevier Ltd Copyright © 2018 Elsevier Ltd. All rights reserved. 2018. Elsevier Ltd |
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| Keywords | Phase I study Shigella sonnei WRSs2/3 Live vaccines |
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| References | Coster (b0120) 1999; 67 Clemens (b0130) 2004; 189 Hartman, Venkatesan (b0015) 1998; 66 Orr (b0025) 2005; 73 Dharmasena (b0095) 2013; 303 Jeong (b0040) 2013; 31 Barnoy (b0030) 2011; 29 Kotloff (b0005) 1999; 77 Chang (b0010) 2016; 16 Pitisuttithum (b0075) 2016; 23 Riddle (b0100) 2016; 23 van der Put (b0110) 2016; 27 Guerrero (b0125) 1994; 13 Venkatesan, Ranallo (b0085) 2006; 5 Turbyfill, Kaminski, Oaks (b0055) 2008; 26 Mani, Wierzba, Walker (b0115) 2016; 34 Picking (b0060) 1996; 8 Kaminski, Oaks (b0090) 2009; 8 Mills, Buysse, Oaks (b0045) 1988; 56 Tribble (b0080) 2010; 28 Barnoy (b0035) 2010; 28 Kaminski (b0065) 2014; 21 Kotloff (b0020) 2002; 70 Rossi (b0105) 2014; 289 Riddle (b0050) 2011; 29 Bodhidatta (b0070) 2012; 30 Mills (10.1016/j.vaccine.2018.06.063_b0045) 1988; 56 Barnoy (10.1016/j.vaccine.2018.06.063_b0030) 2011; 29 Riddle (10.1016/j.vaccine.2018.06.063_b0100) 2016; 23 Coster (10.1016/j.vaccine.2018.06.063_b0120) 1999; 67 Jeong (10.1016/j.vaccine.2018.06.063_b0040) 2013; 31 Bodhidatta (10.1016/j.vaccine.2018.06.063_b0070) 2012; 30 Mani (10.1016/j.vaccine.2018.06.063_b0115) 2016; 34 Hartman (10.1016/j.vaccine.2018.06.063_b0015) 1998; 66 Dharmasena (10.1016/j.vaccine.2018.06.063_b0095) 2013; 303 Kotloff (10.1016/j.vaccine.2018.06.063_b0020) 2002; 70 van der Put (10.1016/j.vaccine.2018.06.063_b0110) 2016; 27 Rossi (10.1016/j.vaccine.2018.06.063_b0105) 2014; 289 Kaminski (10.1016/j.vaccine.2018.06.063_b0065) 2014; 21 Kaminski (10.1016/j.vaccine.2018.06.063_b0090) 2009; 8 Tribble (10.1016/j.vaccine.2018.06.063_b0080) 2010; 28 Orr (10.1016/j.vaccine.2018.06.063_b0025) 2005; 73 Chang (10.1016/j.vaccine.2018.06.063_b0010) 2016; 16 Riddle (10.1016/j.vaccine.2018.06.063_b0050) 2011; 29 Picking (10.1016/j.vaccine.2018.06.063_b0060) 1996; 8 Kotloff (10.1016/j.vaccine.2018.06.063_b0005) 1999; 77 Turbyfill (10.1016/j.vaccine.2018.06.063_b0055) 2008; 26 Venkatesan (10.1016/j.vaccine.2018.06.063_b0085) 2006; 5 Barnoy (10.1016/j.vaccine.2018.06.063_b0035) 2010; 28 Pitisuttithum (10.1016/j.vaccine.2018.06.063_b0075) 2016; 23 Clemens (10.1016/j.vaccine.2018.06.063_b0130) 2004; 189 Guerrero (10.1016/j.vaccine.2018.06.063_b0125) 1994; 13 |
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| Snippet | •Shigella is a significant cause of morbidity and mortality among children in the developing world and travelers to endemic areas.•There are no licensed... Highlights•Shigella is a significant cause of morbidity and mortality among children in the developing world and travelers to endemic areas. •There are no... Effective vaccines are needed to combat diarrheal diseases due to Shigella. Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated principally... Effective vaccines are needed to combat diarrheal diseases due to Shigella . Two live oral S. sonnei vaccine candidates, WRSs2 and WRSs3, attenuated... |
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| Title | A Phase I trial to evaluate the safety and immunogenicity of WRSs2 and WRSs3; two live oral candidate vaccines against Shigella sonnei |
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