Evidence map›Paper›PMID 29624592›Full record

Trial reportPLoS neglected tropical diseases2018

Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers.

Kamrul Islam, Motaher Hossain, Meagan Kelly, Leslie M Mayo Smith, Richelle C Charles, Taufiqur Rahman Bhuiyan, Pavol Kováč, Peng Xu, Regina C LaRocque, Stephen B Calderwood and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01895855 (A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.8field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01895855 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

TypeinterventionalSponsorBavarian NordicRan2013 to 2014Enrolled197ConditionsCholeraArmsPXVX0200, placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 36 citations in OpenAlex.

  1. Trial
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  6. InactivatedJournal of microbiology and biotechnology · 2022
    Article
  7. Virus-like Particle Display ofACS infectious diseases · 2022
    Article
  8. Article
  9. Article
  10. Systemic, Mucosal, and Memory Immune Responses following Cholera.Tropical medicine and infectious disease · 2021
    Review
  11. Dissecting serotype-specific contributions to live oral cholera vaccine efficacy.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  12. Article
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  15. Article
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  19. Frontiers in cellular and infection microbiology · 2019
    Review
  20. (Patho-)Physiology of NaFrontiers in physiology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 9 institutions in 2 countries.

Kamrul IslamDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.ORCID 0000-0001-5557-4368
Motaher HossainDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Meagan KellyDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Leslie M Mayo SmithDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Richelle C CharlesDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.ORCID 0000-0002-8881-1849
Taufiqur Rahman BhuiyanInfectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Pavol KováčNational Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), Laboratory of Bioorganic Chemistry (LBC), National Institutes of Health, Bethesda, Maryland, United States of America.ORCID 0000-0001-5044-3449
Peng XuNational Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), Laboratory of Bioorganic Chemistry (LBC), National Institutes of Health, Bethesda, Maryland, United States of America.
Regina C LaRocqueDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Stephen B CalderwoodDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Jakub K SimonMerck & Co., Inc., Kenilworth, New Jersey, United States of America.
Wilbur H ChenCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Douglas HaneyPaxVax, Inc., Redwood City, California, United States of America.
Michael LockPaxVax, Inc., Redwood City, California, United States of America.
Caroline E LyonVaccine Testing Center, Department of Medicine University of Vermont College of Medicine, Burlington, Vermont, United States of America.
Beth D KirkpatrickVaccine Testing Center, Department of Medicine University of Vermont College of Medicine, Burlington, Vermont, United States of America.
Mitchell CohenCincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States of America.ORCID 0000-0002-4412-350X
Myron M LevineCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.
Marc GurwithPaxVax, Inc., Redwood City, California, United States of America.
Jason B HarrisDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Firdausi QadriInfectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Edward T RyanDivision of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.
Harvard University · USInternational Centre for Diarrhoeal Disease Research · BDPaxVax (United States) · USMassachusetts General Hospital · USNational Institutes of Health · USUniversity of Maryland, Baltimore · USUniversity of Vermont · USCincinnati Children's Hospital Medical Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

Pilot & Feasibility ProgramP30DK043351 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI RAYMOND T CHUNG · 1991 to 2026
$35.3M
VERMONT IMMUNOBIOLOIGY/ INFECTIOUS DISEASES CENTERP20RR021905 · NCRR · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HUSTON, CHRISTOPHER D · 2006 to 2011
$14.5M
Reactions And Immunochemistry Of CarbohydratesZIADK059701 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI KOVAC, PAVOL · 2009 to 2019
$9.5M
Vermont Immunology/Infectious Diseases CenterP30GM118228 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI BUDD, RALPH C · 2016 to 2021
$6.8M
Training program in vaccine development and public healthD43TW005572 · FIC · MASSACHUSETTS GENERAL HOSPITAL · PI QADRI, FIRDAUSI, RYAN, EDWARD T. · 2000 to 2025
$5.4M
O-Specific Polysaccharide Responses and CholeraR37AI106878 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI Edward T. Ryan · 2020 to 2026
$5.1M
O-Specific Polysaccharide Responses and CholeraR01AI106878 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI RYAN, EDWARD T. · 2014 to 2018
$3.7M
High-throughput proteomic study of protective immunity in human cholera infectionK08AI089721 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI CHARLES, RICHELLE C · 2010 to 2014
$684k
Humoral and adaptive immune responses study in Vibrio cholerae infectionK43TW010362 · FIC · INTERNATIONAL CTR/DIARRHOEAL DIS RES · PI BHUIYAN, MD TAUFIQUR RAHMAN · 2016 to 2020
$359k
FIC NIH HHS D43 TW005572FIC NIH HHS K43 TW010362NCRR NIH HHS P20 RR021905NIAID NIH HHS K08 AI089721NIAID NIH HHS R01 AI106878NIAID NIH HHS R37 AI106878NIDDK NIH HHS P30 DK043351NIGMS NIH HHS P30 GM118228NIH HHS D43 TW005572NIH HHS K08 AI089721NIH HHS R01 AI106878
6 · The paper itself

Abstract

backgroundCholera is an acute voluminous dehydrating diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and occasionally O139. A growing body of evidence indicates that immune responses targeting the O-specific polysaccharide (OSP) of V. cholerae are involved in mediating protection against cholera. We therefore assessed whether antibody responses against OSP occur after vaccination with live attenuated oral cholera vaccine CVD 103-HgR, and whether such responses correlate with protection against cholera. METHODOLOGY: We assessed adult North American volunteers (n = 46) who were vaccinated with 5 × 108 colony-forming units (CFU) of oral cholera vaccine CVD 103-HgR and then orally challenged with approximately 1 × 105 CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961, either 10 or 90 days post-vaccination. PRINCIPAL

findingsVaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination. There was significant correlation between anti-OSP and vibriocidal antibody responses. IgM and IgA anti-OSP responses on day 10 following vaccination were associated with lower post-challenge stool volume (r = -0.44, P = 0.002; r = -0.36, P = 0.01; respectively), and none of 27 vaccinees who developed a ≥1.5 fold increase in any antibody isotype targeting OSP on day 10 following vaccination compared to baseline developed moderate or severe cholera following experimental challenge, while 5 of 19 who did not develop such anti-OSP responses did (P = 0.01).

conclusionOral vaccination with live attenuated cholera vaccine CVD 103-HgR induces antibodies that target V. cholerae OSP, and these anti-OSP responses correlate with protection against diarrhea following experimental challenge with V. cholerae O1.

trial registrationClinicalTrials.gov NCT01895855.

Indexed as

Administration, OralAdultAntibodies, BacterialAntibody FormationCholeraCholera VaccinesDouble-Blind MethodFemaleHumansImmunoglobulin AImmunoglobulin GImmunoglobulin MMaleO AntigensUnited StatesVaccinationAntibodies, Bacterialcholera vaccine CVD 103-HgRCholera VaccinesImmunoglobulin AImmunoglobulin GImmunoglobulin MO Antigens

Identifiers

PMID29624592
PMCPMC5906022
OpenAlexW2796374194

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.