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

PHASE2CompletedINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

April 15, 2021

Primary Completion Date

August 30, 2022

Study Completion Date

January 30, 2023

Conditions
DiarrheaDiarrhea Rotavirus
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.

Trial Locations (1)

10101

Chawama first level hospital, Lusaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical Research Council

OTHER_GOV

collaborator

PATH

OTHER

collaborator

University of Liverpool

OTHER

collaborator

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

OTHER_GOV

collaborator

Imperial College London

OTHER

lead

Centre for Infectious Disease Research in Zambia

OTHER