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

Phase 2 Completed 16 enrolled University of Oxford

Non-randomizedParallel-groupOpen-labelPrevention

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

Timeline

Start: 2019-07-18
Primary completion: 2022-07-07
Completion: 2022-07-07

Outcome

Missed primary endpoint

registry analysis (other test); Groups 1, 2 and 3 Volunteers Completing CHMI; p = 0.14; Wilcoxon (Mann-Whitney); NCT04009096 ↗

paper No other vaccine or regimen impacted parasite growth. PMID 35664997 ↗

Publications

Hou MM, Barrett JR, Themistocleous Y, Rawlinson TA, Diouf A, Martinez FJ, Nielsen CM, Lias AM, King LDW, Edwards NJ, Greenwood NM, Kingham L, Poulton ID, Khozoee B, Goh C, Mac Lochlainn DJ, Salkeld J, Guilotte-Blisnick M, Huon C, Mohring F, Reimer JM, Chauhan VS, Mukherjee P, Biswas S, Taylor IJ, Lawrie AM, Cho JS, Nugent FL, Long CA, Moon RW, Miura K, Silk SE, Chitnis CE, Minassian AM, Draper SJ. Impact of a blood-stage vaccine on Plasmodium vivax malaria. medRxiv [Preprint]. 2022 May 30:2022.05.27.22275375. doi: 10.1101/2022.05.27.22275375.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ChAd63 PvDBP	Vaccine	5e+10 unknown	—
Subject	MVA PvDBP	Vaccine	2e+08 unknown	—