A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study in which healthy adult volunteers will be given either an experimental
      Malaria vaccine or a saline control vaccine.

      Each volunteer will receive three vaccinations in total. Volunteers will be randomly
      allocated to one of two groups:

      Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will
      receive a saline solution on days 0, 28, and 56.
    

Detailed description: 
      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.

      Community sensitisation will be undertaken to engage the community with the study and recruit
      volunteers for participation in the study. The CNRFP study team will hold local community
      meetings and explain the study to the potentially eligible adult volunteers. During these
      meetings the investigators will explain the following: the need for a vaccine; the current
      status of vaccine development (including the fact that this is likely to be a prolonged
      process); the study screening and informed consent procedure; risks of vaccination and the
      unproven benefits of vaccination. It will be stressed that these are experimental vaccine
      regimens and cannot be guaranteed to provide protection, and that it will therefore still be
      necessary to seek treatment for possible malaria even after vaccination and they should
      continue to use other protective measures such as bed nets. It will be explained that to aid
      identification, a photograph of the volunteer will be taken if they are eligible to be
      enrolled in the trial.

      After this meeting, based on the list of adults of suitable age for participation in the
      trial drawn from the DSS database, volunteers will be asked to participate in a public
      lottery that is made to randomly select participants who will be invited for a screening
      visit. All proposed volunteers thus selected will be invited to the Banfora clinical trials
      centre for the screening visit.

      The Volunteer Information Sheet (VIS) will contain detailed information about the study and
      will be distributed to the proposed volunteers. The investigators will endeavour to ensure
      that all volunteers fully understand the risks. Any volunteer who appears to have less than
      complete understanding will be considered unable to give consent. If unable to sign, the
      volunteer will be asked to thumbprint the consent form in the presence of an impartial
      witness who will be present during the screening procedures and will countersign the consent
      form. Fully consented volunteers will undergo the full screening procedures. This consists of
      medical history, physical examination, and blood sampling for screening tests.

      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.
    

Intervention name(s): R21/Matrix-M1; Saline
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention