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Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa

NCT04658914 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2025-05-15

No results posted yet for this study

Summary

Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world. This study will assess protection against rotavirus infection and investigate immune correlates of protection following vaccination with a novel trivalent VP8 subunit rotavirus vaccine used alone or in combination with oral rotavirus vaccine.

Conditions

Interventions

BIOLOGICAL

Rotarix

Live-attenuated oral human rotavirus vaccine (Rotarix) manufactured by GlaxoSmithKline containing at least 10\^6 CCID50(median cell culture infective doses) of G1P\[8\] rotavirus, RIX4414 strain produced in Vero cells. This vaccine is an oral suspension with a single dose (1.5ml) administered using an oral applicator.

BIOLOGICAL

Trivalent P2-VP8

Trivalent P2-VP8 subunit vaccine manufactured by SK Chemicals containing 90ug of each VP8 antigen derived from P\[4\] (DS-1), P\[6\] (1076), and P\[8\] (Wa) rotavirus strains fused to the P2 epitope from tetanus toxoid and adsorbed to aluminium hydroxide. A single dose (0.5ml) of this vaccine is administered intramuscularly through injection.

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • PATH

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Imperial College London

    collaborator OTHER

  • Centre for Infectious Disease Research in Zambia

    lead OTHER

Principal Investigators

  • Roma Chilengi, MD · Centre for Infectious Disease Research in Zambia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-08-30
Completion
2023-01-30

Countries

  • Zambia

Study Locations

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Diseases
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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 NCT04658914 on ClinicalTrials.gov