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Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon

NCT05130398 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-04-20

No results posted yet for this study

Summary

LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector.

The study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination.

The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

rVSVΔG-ZEBOV-GP, V920

The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.

DIETARY_SUPPLEMENT

Fibre and equilibrate breakfast and lunch

Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.

DIAGNOSTIC_TEST

Active detection and treatment of pathogens

Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.

COMBINATION_PRODUCT

Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens

Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days and diagnostic and treatment of childhood infections Active detection and treatment of pathogens every month for 12 months

BIOLOGICAL

Chikenpox or Varicella vaccine (VARILRIX)

The active comparator vaccine, a Varicella vaccine (VARILRIX®)

OTHER

Placebo

About 30 children do not receive diet, nor active pathogen detection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2021-09-08
Completion
2022-08-09
FDA Drug
Yes

Countries

  • Gabon

Study Locations

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Entities

Companies

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 NCT05130398 on ClinicalTrials.gov