The purpose of this study is to assess the safety, immunogenicity and efficacy of the candidate malaria vaccines ChAdOx1 LS2 and MVA LS2. Healthy adult volunteers will be recruited and vaccinated in Oxford.
This is an open label, dose-escalation, first in human, partially blinded, phase I/IIa controlled human malaria infection (CHMI) study. The study will assess the safety, immunogenicity and protective efficacy of the novel malaria vaccine candidates ChAdOx1 LS2 and MVA LS2 in healthy UK adults. Healthy, malaria naive adults, aged between 18 and 45 years, will be recruited and vaccinated in Oxford. A total of between 23 and 31 volunteers will be recruited across four groups: Group 1 volunteers will receive a low dose ChAdOx1 LS2 vaccination on day 0. Group 2 volunteers will receive a high dose ChAdOx1 LS2 vaccination on day 0 and a dose of MVA LS2 on day 56, followed by a CHMI on day 77. Volunteers exhibiting sterile protection will undergo a repeat CHMI 5-7 months later. Control Group A will not receive any vaccinations and will undergo CHMI on day 77. Control Group B will not receive any vaccinations and will undergo CHMI during the repeat challenge.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
18
A viral vectored vaccine, using a chimpanzee adenovirus as a vector encoding malaria liver-stage dual antigen LS2 (LSA1 and LSAP2) fused with the transmembrane domain from shark invariant chain.
Modified vaccinia Ankara vector encoding liver-stage dual antigen LS2 (LSA1 ad LSAP2) fused to the C-terminal end of the leader sequence of tPA.
CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom
The safety and tolerability of ChAdOx1 LS2 administered alone and with MVA LS2 in a prime-boost vaccination regimen in healthy malaria-naive volunteers assessed by the frequency and severity of adverse events.
The number of participants who experience adverse events and the severity of any adverse events.
Time frame: 31 - 40 weeks
The efficacy of ChAdOx2 LS2 and MVA LS2 administered in a prime-boost vaccination regimen against malaria sporozoite challenge, in healthy malaria-naive volunteers.
The occurrence of Plasmodium falciparum parasitemia, assessed by blood slide and polymerase chain reaction (PCR).
Time frame: 90 days
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