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Immune Response to a Delayed Second Dose of Oral Cholera Vaccine

NCT05453253 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2023-03-07

No results posted yet for this study

Summary

Immune response to a delayed second dose of oral cholera vaccine

A randomized, controlled, non-inferiority immunogenicity trial in Conakry, The Republic of Guinea

Conditions

  • Cholera
  • Vibrio Cholerae Infection

Interventions

BIOLOGICAL

Delayed second dose of oral cholera vaccine, Euvichol-Plus

The intervention arms (6 and 12 months) will modify the recommended interval for administration of the second vaccine dose, which will be extended to 6 and 12 months according to the intervention arm.

BIOLOGICAL

Oral cholera vaccine, Euvichol-Plus, according to manufacturer notice

Euvichol-Plus, a WHO prequalified oral cholera vaccine, contains modified killed whole cell vaccine of formalin killed Vibrio cholerae strains of O1 Inaba, O1 Ogawa and O139. In the control arm, participants will receive the Euvichol-Plus following the manufacturer recommendations: two doses administered orally 14 days apart for individuals aged ≥1 year.

Sponsors & Collaborators

  • Ministry of Health, Guinea

    collaborator OTHER_GOV

  • Massachusetts General Hospital

    collaborator OTHER

  • Médecins Sans Frontières, Belgium

    collaborator OTHER

  • Epicentre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2024-02-01
Completion
2024-07-01

Countries

  • Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453253 on ClinicalTrials.gov