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All Profiles
Call Senior Fellowship (SF)
Programme EDCTP2
Start Date 2018-04-01
End Date 2022-03-31
Project Code TMA2016SF1511
Status Active

Title

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

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

Host Organisation

Institution Country
Centre for Infectious Disease Research in Zambia (CIDRZ) Zambia

Participants

Name Institution Country
Roma Chilengi Centre for Infectious Disease Research in Zambia Zambia

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

Sites

CIDRZ George Clinical Research Site, Lusaka Zambia

Phd Study

Title University Start Date End Date
Profile of innate and adaptive immune responses to rotavirus vaccination and the influence of host genetics and cytomegalovirus in Zambian infants University of London - London School of Hygiene and Tropical Medicine 2018-09-24 2022-09-23

Students Supervised

Type Name Title University Start Date End Date
PhD Natasha Makabilo Laban Miss University of London - London School of Hygiene and Tropical Medicine 2018 2022
MSc Adriace Chauwa Mr University of Zambia 2019 2021

Results & Outcomes

Participants in follow up period. Primary outcome assessment in progress.

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