Plasmodium Falciparum Malaria Clinical Trial
Official title:
A Phase I/IIa Sporozoite Challenge Study to Assess the Safety and Protective Efficacy of the Combination Malaria Vaccine Candidate Regimen of RTS,S/AS01B + ChAd63 and MVA Encoding ME-TRAP and Also RTS,S/AS01B Alone.
This is a clinical trial in which healthy volunteers will be administered experimental
malaria vaccines. One group of volunteers will receive vaccination with the leading malaria
vaccine candidate, RTS,S/AS01. This vaccine schedule will consist of 3 doses of RTS,S/AS01
with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints).
Another group will receive a vaccination schedule composed of the same dosage and timing
regimen of RTS,S, but they will also receive vaccination with ChAd63 ME-TRAP, 2 weeks after
the first RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week
timepoints).
The study will assess the safety of the vaccinations, and the immune responses to
vaccination. Immune responses are measured by tests on blood samples. Volunteers will be
infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition,
a group of volunteers not receiving vaccines will also be infected with malaria by the same
method. These infection experiments will be used to assess vaccine efficacy: how well the
vaccines act to prevent malaria disease. A further single volunteer may also be infected
with malaria; this volunteer participated in a previous trial where they received vaccines
and was completely protected against malaria disease after infection by mosquito bite.
The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). The ChAd63
ME-TRAP and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from
viruses which are modified so that they can not multiply. The viruses have extra DNA in them
so that after injection, the body makes malaria proteins (but malaria does not develop), so
that the immune system builds a response to malaria without having been infected by it.
Healthy volunteers will be recruited in England at three research sites: in Oxford, London
and Southampton.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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