NCT04009096

VAC071: A Study to Assess Efficacy of the ChAd63/MVA PvDBP Vaccines

A Phase IIa Challenge Study to Assess Efficacy of the Plasmodium Vivax Malaria Vaccine Candidates ChAd63 PvDBP and MVA PvDBP in Healthy Adults Living in the UK

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, Phase IIa, controlled human malaria infection (CHMI) study aimed to assess whether the new vivax malaria vaccines ChAd63 PvDBP and MVA PvDBP can protect against malaria infection. The participants will receive one or two doses of ChAd63 PvDBP followed by one dose of MVA PvDBP 8 weeks later. Approximately 4 weeks after the second vacccination, the volunteers will be challenged (deliberately infected) with malaria by intravenous injection blood-stage

Detailed description

Volunteers will be recruited and vaccinated at the CCVTM, Oxford. There will be two groups vaccinated in the trial, with an optional third group included if fewer than 6 volunteers complete group 2. Up to 19 volunteers will be included in total. These will be compared to a matched number of infectivity controls, receiving no vaccination, who will be recruited as part of a separate study (VAC069 - NCT03797989).

Conditions

• Malaria, Vivax

Interventions

Type	Name	Description
BIOLOGICAL	ChAd63 PvDBP and MVA PvDBP	one dose of 5 x 10\^10 vp ChAd63 PvDBP and one dose of 2 x 10\^8 pfu MVA PvDBP 8 weeks later, in a heterologous prime-boost regimen.

Timeline

• Start date: 2019-07-18
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2019-07-05
• Last updated: 2024-04-12
• Results posted: 2024-04-12

Locations

1 site across 1 country: United Kingdom