Project Title

A randomized controlled trial of two versus three doses of Rotarix™ vaccine for boosting and longevity of vaccine immune responses in Zambia.

EDCTP Project Call

Senior Fellowship (SF)

Project Objectives

Objective 1. Assess boosting and longevity of antibody responses between infants receiving two versus three doses of Rotarix™ vaccine and evaluate safety of third dose. Objective 2: Profile innate and adaptive cellular, cytokines and secretory antibodies responses to Rotarix™ vaccination and investigate influence of cytomegalovirus exposure Objective 3: Determine genotypes and phenotypes of HBGA profiles and assess association with Rotarix™ vaccine immunogenicity Objective 4: Profile changes in rotavirus specific antibody titres and non-immunological components in maternal breastmilk over time and determine association with infant vaccine response

Study Design

The proposed clinical trial is a phase IV or post licensure trial. It will have two arms and will be an open-label randomized controlled trial of two versus three doses of live, attenuated, oral Rotarix™ administered at 6 & 10 weeks (the standard of care arm) and at 6 & 10 weeks plus 9 months infants age (the experimental arm). The intervention in the experimental arm is an added third dose of Rotarix™ vaccine given at 9 months infant age

Project Summary

Rotavirus vaccines such as Rotarix™ are presently proven to be an effective and powerful tool for saving child lives from diarrhoea deaths especially in developing countries like Zambia which have high burden of diarrhoea. However, these vaccines show reduced immunogenicity, efficacy and effectiveness in developing countries compared to developed countries. Based on research findings in Zambia, vaccine induced responses also seem to wane in later infancy. The trial will assess the potential immunogenicity benefit and safety of an added third Rotarix dose to the regular two dose schedule in the national immunisation program in Zambia. The trial will profile immune responses associated with vaccination, longevity of these responses, and assess the influence of maternal and infant factors on these responses among Zambian infants at a peri-urban public health facility in Lusaka

Host Organisation

Sites

Results & Outcomes

Current Organisation

Centre for Infectious Disease Research in Zambia

Current Job Title

Chief Scientific Officer

Biography

Publications