Trial reportVaccine2018
A randomized, observer-blinded, equivalence trial comparing two variations of Euvichol®, a bivalent killed whole-cell oral cholera vaccine, in healthy adults and children in the Philippines.
Trial report in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02502331 (A Randomized, Observer Blinded, Controlled Trial to Evaluate the Safety and Immunogenicity of a New Formulation of Euvichol®), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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 Randomized, Observer Blinded, Controlled Trial to Evaluate the Safety and Immunogenicity of a New Formulation of Euvichol® (Killed Bivalent Whole Cell Oral Cholera Vaccine Manufactured by EuBiologics Co. Ltd.) in Healthy Individuals
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Oral killed cholera vaccines for preventing cholera.The Cochrane database of systematic reviews · 2024Pooled it
- Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial.The Lancet regional health. Southeast Asia · 2023Article
- Correlates of Protection for Cholera.The Journal of infectious diseases · 2021Article
- Generation and Characterization of Monoclonal Antibodies to the Ogawa Lipopolysaccharide ofJournal of microbiology and biotechnology · 2020Article
- Vaccines against gastroenteritis, current progress and challenges.Gut microbes · 2020Review
- An overview of VaxchoraHuman vaccines & immunotherapeutics · 2020Article
- Combating Cholera.F1000Research · 2019Review
- Immunogenicity of a bivalent killed thimerosal-free oral cholera vaccine, Euvichol, in an animal model.Clinical and experimental vaccine research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo contribute to the global demand for oral cholera vaccine (OCV), the production of Euvichol® was scaled up with elimination of thimerosal. To demonstrate the equivalence of the variations, a study was carried out in the Philippines.
methodsHealthy male and female adults and children in Manila were randomized to receive two doses of Euvichol® two weeks apart from either the 100L (Comparator) or the 600L (Test) variation. Primary and secondary immunogenicity endpoints were respectively geometric mean titer (GMT) of vibriocidal antibodies (two weeks post second dose) and seroconversion rate (two weeks after each dose) against O1 Inaba, Ogawa, and O139 serogroups. The GMT of vibriocidal antibodies against O1 Inaba, Ogawa, and O139 two weeks post first dose was also measured. To show the equivalence of two variations of Euvichol®, the ratio of GMT and the difference of seroconversion rate between Test and Comparator vaccines were tested with equivalence margin of [0.5, 2.0] for GMT ratio and of 15% for seroconversion rate, respectively. Safety assessment included solicited reactogenicity within 6 days after each dose and unsolicited and serious adverse events.
resultsA total of 442 participants were enrolled. For the overall population, equivalence between Test and Comparator was demonstrated for vibriocidal antibody response against O1 Inaba and Ogawa serotypes and O139 serogroup in both modified intention-to-treat (mITT) and per protocol analysis, since the 95% confidence intervals (CI) of GMT to any serotypes were within the lower and upper boundary [0.5, 2.0]. Seroconversion rates after two doses also showed equivalence for O1 Inaba, Ogawa, and O139. The vaccine was safe and well tolerated, similarly between the two groups.
conclusionThe study results support the equivalence of the 600L Euvichol® to the 100L formulation in healthy children and adults. The 600L Euvichol® is safe and immunogenic in adults and children. ClinicalTrials.gov registration number: NCT02502331.
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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.