Trial no.:
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PACTR201610001813366 |
Date of Approval:
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06/10/2016 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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A Study to assess the Safety and Immunogenicity of the MAlaria Vaccine, R1, With Matrix-M1 Adjuvant |
Official scientific title |
A Phase Ib Randomised, Controlled, Single-blind Study to Assess the Safety, Immunogenicity of the Malaria Vaccine Candidate R21 With Matrix-M1 Adjuvant in West African Adult Volunteers |
Brief summary describing the background
and objectives of the trial
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A randomised, controlled, single-blind clinical trial to evaluate the safety and immunogenicity of the malaria vaccine candidate regime of three (3) doses of R21/Matrix-M1 compared with placebo, in healthy West African adult volunteers living in a malaria-endemic area.
The study will take place at the Centre National de Recherche et de Formation sur la Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B). Trial participants will be drawn from the Banfora Health Demographic system, which covers a total population of 30, 000.
Volunteers will be randomised to receive either three (3) doses of R21/ Matrix-M1 or placebo (normal saline) as control. Simple randomisation into the study groups will be done by an independent statistician based at the University of Oxford. A randomisation code list will be generated by the independent statistician and its use guided by a clear Standard Operating Procedure (SOP). Allocation concealment will be employed by use of opaque sealed envelopes. As this is a single-blind clinical trial design, the laboratory scientists will be blinded to vaccine allocation until the end of the study.
Each volunteer will be monitored for one hour (or longer if necessary) after each vaccination. Each volunteer will be visited at home daily for 6 days after each vaccination (Days 0, 28, and 56) by a field worker for assessment and recording of any solicited and unsolicited AEs in diary cards. If necessary the volunteer will continue to be seen regularly until any observed AEs have resolved or stabilised. Scheduled visits at the CNRFP will be on Days 0, 7, 28, 35, 56, 63, 84, and 140. All volunteers will be followed up to Day 140 post-first vaccination for adverse events. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
VAC 060 |
Disease(s) or condition(s) being studied |
Infections and Infestations |
Sub-Disease(s) or condition(s) being studied |
Malaria |
Purpose of the trial |
Prevention: Vaccines |
Anticipated trial start date |
15/08/2016 |
Actual trial start date |
26/08/2016 |
Anticipated date of last follow up |
31/05/2017 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
24 |
Actual target sample size (number of participants) |
24 |
Recruitment status |
Closed to recruitment,follow-up continuing |
Publication URL |
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