NCT03435874

Safety and Immunogenicity of ChAd63 RH5 and MVA RH5 in Adults, Young Children and Infants Living in Tanzania

Completed Phase 1 Last updated 4 September 2019

What this trial tests

Phase 1 trial testing ChAd63 RH5 in Malaria,Falciparum in 63 participants. Completed in 11 July 2019.

Timeline

12 April 2018

Primary endpoint
11 July 2019

11 July 2019

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	63
Start date	12 April 2018
Primary completion	11 July 2019
Estimated completion	11 July 2019
Sites	1 location across Tanzania

Drugs / interventions tested

• ChAd63 RH5 — full drug profile →
• MVA RH5 — full drug profile →
• Rabies Vaccine — full drug profile →

Conditions studied

• Malaria,Falciparum — all drugs for Malaria,Falciparum →

Sponsor

University of Oxford

Who can join

Adults 6 Months to 35, any sex, with Malaria,Falciparum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a dose-escalation, age de-escalation randomised double-blind controlled Phase Ib trial to assess the safety, tolerability and immunogenicity of ChAd63-RH5 administered with MVA-RH5 in a heterologous prime-boost regimen. Adults (18-35 years), young children (1-6 years) and infants (6-11 months) will be enrolled in the study. Safety data will be collected for each of the vaccination regimens. The humoral and cellular immune responses generated by each of these regimens will be assessed.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reduced blood-stage malaria growth and immune correlates in humans following RH5 vaccination.
   Minassian AM, Silk SE, Barrett JR, Nielsen CM, et al · · 2021 · cited 117× · PMID 34223402 · DOI 10.1016/j.medj.2021.03.014
2. The RH5-CyRPA-Ripr Complex as a Malaria Vaccine Target.
   Ragotte RJ, Higgins MK, Draper SJ. · · 2020 · cited 58× · PMID 32359873 · DOI 10.1016/j.pt.2020.04.003
3. Superior antibody immunogenicity of a viral-vectored RH5 blood-stage malaria vaccine in Tanzanian infants as compared to adults.
   Silk SE, Kalinga WF, Mtaka IM, Lilolime NS, et al · · 2023 · cited 30× · PMID 37572659 · DOI 10.1016/j.medj.2023.07.003
4. A Critical Review on Human Malaria and Schistosomiasis Vaccines: Current State, Recent Advancements, and Developments.
   Siddiqui AJ, Bhardwaj J, Saxena J, Jahan S, et al · · 2023 · cited 16× · PMID 37112704 · DOI 10.3390/vaccines11040792
5. Malaria therapeutics: are we close enough?
   Tripathi H, Bhalerao P, Singh S, Arya H, et al · · 2023 · cited 12× · PMID 37060004 · DOI 10.1186/s13071-023-05755-8
6. Assessment of precision in growth inhibition assay (GIA) using human anti-PfRH5 antibodies.
   Miura K, Diouf A, Fay MP, Barrett JR, et al · · 2023 · cited 11× · PMID 37208733 · DOI 10.1186/s12936-023-04591-6
7. Antibodies from malaria-exposed Malians generally interact additively or synergistically with human vaccine-induced RH5 antibodies.
   Willcox AC, Huber AS, Diouf A, Barrett JR, et al · · 2021 · cited 11× · PMID 34337556 · DOI 10.1016/j.xcrm.2021.100326
8. Superior antibody immunogenicity of a RH5 blood-stage malaria vaccine in Tanzanian infants as compared to adults
   Silk SE, Kalinga WF, Mtaka IM, Lilolime NS, et al · · 2023 · cited 1× · DOI 10.1101/2023.04.17.23288686