Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016
Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. 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 118 papers.
What it found
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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.
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.
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
Who cites it
118 citing papers in PubMed, 194 citations in OpenAlex.
- Evaluation of the Safety, Genetic Stability, and Immunogenicity of an Attenuated Shigella Live Vector Expressing Enterotoxigenic Escherichia coli Antigens, Vaccine Strain CVD 1208S-122.The Journal of infectious diseases · 2026Trial
- Safety and immunogenicity of PanChol, a single-dose live-attenuated oral cholera vaccine: results from a phase 1a, double-blind, randomised, placebo-controlled trial.The Lancet. Infectious diseases · 2026Trial
- The case for evaluation of double mutant heat-labile toxin as an adjuvant to improve oral cholera vaccine immunogenicity.Frontiers in immunology · 2026Trial
- A Phase 2a randomized, single-center, double-blind, placebo-controlled study to evaluate the safety and preliminary efficacy of oral iOWH032 against cholera diarrhea in a controlled human infection model.PLoS neglected tropical diseases · 2021Trial
- An emm-type specific qPCR to track bacterial load during experimental human Streptococcus pyogenes pharyngitis.BMC infectious diseases · 2021Trial
- Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years.The American journal of tropical medicine and hygiene · 2020Trial
- Trial
- 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.PLoS neglected tropical diseases · 2018Trial
- Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator.Clinical and vaccine immunology : CVI · 2017Trial
- The Live Attenuated Cholera Vaccine CVD 103-HgR Primes Responses to the Toxin-Coregulated Pilus Antigen TcpA in Subjects Challenged with Wild-Type Vibrio cholerae.Clinical and vaccine immunology : CVI · 2017Trial
- Is India ready for controlled human infection studies? A narrative review of stakeholders' perceptions & regulatory preparedness.Dialogues in health · 2026Review
- Two decades of cholera in Dhaka, Bangladesh: Epidemiology, seasonal patterns, and environmental risk, insights from 2004-2024.PLoS neglected tropical diseases · 2026Article
- Review
- Advances in vaccine development through the controlled human infection models for hookworm and schistosomiasis.PLoS neglected tropical diseases · 2026Review
- Manufacture of Clostridioides difficile Spores for Experimental Infection of Human Volunteers.The Journal of infectious diseases · 2026Article
- Proceedings of the inaugural symposium on dengue human challenge studies "Challenging the norm: Accelerating dengue countermeasures through human studies".PLoS neglected tropical diseases · 2026Article
- Vaccine Treatment and Evaluation Units: Why Support a "Ready Base" of Clinical Trial Sites?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- De-risking vaccine development: lessons, challenges, and prospects.NPJ vaccines · 2025Review
58 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
16 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundNo licensed cholera vaccine is presently available in the United States. Cholera vaccines available in other countries require 2 spaced doses. A single-dose cholera vaccine that can rapidly protect short-notice travelers to high-risk areas and help control explosive outbreaks where logistics render 2-dose immunization regimens impractical would be a major advance.PXVX0200, based on live attenuated Vibrio cholerae O1 classical Inaba vaccine strain CVD 103-HgR, elicits seroconversion of vibriocidal antibodies (a correlate of protection) within 10 days of a single oral dose. We investigated the protection conferred by this vaccine in a human cholera challenge model.
methodsConsenting healthy adult volunteers, 18-45 years old, were randomly allocated 1:1 to receive 1 oral dose of vaccine (approximately 5 × 10(8) colony-forming units [CFU]) or placebo in double-blind fashion. Volunteers ingested approximately 1 × 10(5) CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961 10 days or 3 months after vaccination and were observed on an inpatient research ward for stool output measurement and management of hydration.
resultsThe vaccine was well tolerated, with no difference in adverse event frequency among 95 vaccinees vs 102 placebo recipients. The primary endpoint, moderate (≥3.0 L) to severe (≥5.0 L) diarrheal purge, occurred in 39 of 66 (59.1%) placebo controls but only 2 of 35 (5.7%) vaccinees at 10 days (vaccine efficacy, 90.3%; P < .0001) and 4 of 33 (12.1%) vaccinees at 3 months (vaccine efficacy, 79.5%; P < .0001).
conclusionsThe significant vaccine efficacy documented 10 days and 3 months after 1 oral dose of PXVX0200 supports further development as a single-dose cholera vaccine. CLINICAL TRIALS REGISTRATION: NCT01895855.
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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.