Malaria Clinical Trial
Official title:
A Phase I/II Study to Assess the Safety, Immunogenicity and Protective Efficacy of Novel Malaria Vaccine Candidates ChAdOx1 LS2 and MVA LS2 in Healthy UK Adults
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.
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