EDCTP Alumni Network

Fostering excellence and collaboration in the next generation of researchers

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

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.

Current Organisation

Centre for Infectious Disease Research in Zambia

Current Job Title

Chief Scientific Officer

Awards

2018 Development of a live attenuated rotavirus vaccine as a human infection challenge model MRC/UK-GCRF
2018 Characterisation of host immune responses to Salmonella Typhi in an endemic setting – A Comparison of Natural Typhoid Infection with Controlled Human Infection MRC/UK-GCRF
2018 Measurement of Shigella-specific antibodies in the first two years of life in Zambian children to refine correlates of protection and determine the optimal window for vaccination MRC/UK-GCRF
2018 An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC®, ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants. PATH-USA
2018 A Phase 1 age descending placebo controlled clinical trial to examine the safety, tolerability, and immunogenicity of an oral inactivated ETEC Vaccine (ETVAX®) with dmLT adjuvant in healthy adults and children in Zambia. EDCTP
2020 ROTA-biotic-measuring the impact of rotavirus vaccines on paediatric antibiotic usage. Wellcome Trust
2020 Early clinical development of an oral Shigella vaccine through phase II study in Africa. EDCTP
2020 A Phase 3 double-blind, randomized, active comparator-controlled, group-sequential, multinational trial to assess the safety, immunogenicity, and efficacy of a trivalent P2-VP8 subunit rotavirus vaccine in prevention of severe rotavirus gastroenteritis in healthy infants MRC/UK
2020 Creating awareness for Human Infection Studies in Zambia. Wellcome Trust
2019 Phase 3 development of the first ETEC vaccine-ETVAX. EDCTP

Students Supervised

Type Name Title University Start Date End Date
PhD Natasha Makabilo Laban Ms University of London - London School of Hygiene and Tropical Medicine 2018 2022
MSc Adriace Chauwa Mr University of Zambia 2019 2021
PhD John Mwaba Mr University of Zambia 2017 2020
PhD Katayi Kazimbaya Mrs University of Zambia 2016 2019

Memberships

Role Committee/board Start Date End Date
Chair Data Safety Monitoring Board 2017 2019
Chair Data Safety Monitoring Board 2018 2020
Member Scientific Committee- Vaccines Against ETEC and Shigella 2017 2022
Member WHO Advisory Committee on Enteric Vaccines 2016 2018

Education

Institution Degree Year
University of London - London School of Hygiene and Tropical Medicine, United Kingdom Master of Science 2018-08-22
University of London - London School of Hygiene and Tropical Medicine, United Kingdom Post Graduate Diploma
University of Zambia, Zambia Bachelor of Medicine and Surgery
University of Zambia, Zambia Bachelor of Science

Areas Of Specialisation

Diarrhoeal Diseases (DDs)

Publications

Authors:
Evelyn Muleba Kunda-Ng'andu , author
Michelo Simuyandi , author
Melissa Kapulu , author
Masuzyo Chirwa-Chobe , author
Hope Mwanyungwi-Chinganya , author
Stanley Mwale , author
Roma Chilengi , author
Anjali Sharma , author
Date:
2021-09-14
Journal:
Wellcome Open Research
Content:
Authors:
Katayi Mwila Kazimbaya , author
Laxmi Yeruva , editor
Caroline C. Chisenga , author
Michelo Simuyandi , author
Cynthia Mubanga Phiri , author
Natasha Makabilo Laban , author
Samuel Bosomprah , author
Sallie R. Permar , author
Sody Munsaka , author
Roma Chilengi , author
Date:
2020-11-10
Journal:
PLOS ONE
Content:
Identifiers:
Authors:
Aybüke Koyuncu , author
Pradeep Dudeja , editor
Michelo Simuyandi , author
Samuel Bosomprah , author
Roma Chilengi , author
Date:
2020-10-02
Journal:
PLOS ONE
Content:
Identifiers:
Authors:
Wilbroad Mutale , author
Imelda K. Moise , editor
Samuel Bosomprah , author
Perfect Shankalala , author
Oliver Mweemba , author
Roma Chilengi , author
Sharon Kapambwe , author
Charles Chishimba , author
Mulenga Mukanu , author
Daniel Chibutu , author
Douglas Heimburger , author
Date:
2018-08-23
Journal:
PLOS ONE
Content:
Identifiers:
Authors:
Evelyn Muleba Kunda-Ng'andu , author
Michelo Simuyandi , author
Melissa Kapulu , author
Masuzyo Chirwa-Chobe , author
Hope Mwanyungwi-Chinganya , author
Stanley Mwale , author
Roma Chilengi , author
Anjali Sharma , author
Date:
2021-02-12
Journal:
Content:
Identifiers:
Authors:
Roma Chilengi , author
Michelo Simuyandi , author
Mwelwa Chibuye , author
Masuzyo Chirwa , author
Nsofwa Sukwa , author
Natasha Laban , author
Caroline Chisenga , author
Suwilanji Silwamba , author
Nicholas Grassly , author
Samuel Bosomprah , author
Date:
2020-10-01
Journal:
Vaccine
Content:
Identifiers:
Authors:
R. Chilengi , author
K. Mwila- Kazimbaya , author
M. Chirwa , author
N. Sukwa , author
C. Chipeta , author
R.M. Velu , author
N. Katanekwa , author
S. Babji , author
G. Kang , author
M.M. McNeal , author
N. Meyer , author
G. Gompana , author
S. Hazra , author
Y. Tang , author
J. Flores , author
N. Bhat , author
N. Rathi , author
Date:
2021-06-01
Journal:
Vaccine
Content:
Identifiers:
Authors:
Katayi Mwila-Kazimbaya , author
Miren Iturriza-Gómara , editor
Miguel Pugliese Garcia , author
Samuel Bosomprah , author
Natasha Makabilo Laban , author
Caroline Cleopatra Chisenga , author
Sallie Robey Permar , author
Michelo Simuyandi , author
Sody Munsaka , author
Roma Chilengi , author
Date:
2017-12-28
Journal:
PLOS ONE
Content:
Identifiers:
Authors:
Natasha Makabilo Laban , author
Samuel Bosomprah , author
Kalo Musukuma-Chifulo , author
Michelo Simuyandi , author
Shilpa Iyer , author
Harriet Ng'ombe , author
Mutinta Muchimba , author
Adriace Chauwa , author
Sekayi Tigere , author
Caroline Cleopatra Chisenga , author
Mwelwa Chibuye , author
Obvious Nchimunya Chilyabanyama , author
Martin Goodier , author
Roma Chilengi , author
Date:
2021-05-06
Journal:
Content:
Identifiers:

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