NCT03203421

A Safety and Efficacy Study of ChAdOx1 LS2 and MVA LS2

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 LS2	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.
BIOLOGICAL	MVA LS2	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.

Timeline

• Start date: 2017-07-03
• Primary completion: 2017-12-20
• Completion: 2017-12-20
• First posted: 2017-06-29
• Last updated: 2018-06-13

Locations

1 site across 1 country: United Kingdom