Safety, immunogenicity and risk–benefit analysis of rVSV-ΔG-ZEBOV-GP (V920) Ebola vaccine in Phase I–III clinical trials across regions

Abstract

To evaluate the risk–benefits balance of the rVSV-ΔG-ZEBOV-GP vaccine. We performed a systematic review to summarize data on safety, immunogenicity and efficacy. About 17,600 adults and 234 children received 11 different doses of the V920 vaccine ranging from 3000 to 100 million and 20 million plaque-forming units, respectively, during Phase I–III clinical trials. Cases of severe but transient arthritis were reported in about six and 0.08% of vaccinees in high-income countries (HICs) and low–middle-income countries (LMICs), respectively. The 20 million plaque-forming units dose yielded GP-specific antibody titres which peaked at day 28 with a pooled geometric mean titres of 2557.7 (95% CI: 1665.5–3934.2) versus 1156.9 (95% CI: 832.5–1649.2) but with similar seroconversion rates at 96% (95% CI: 87–100) versus 100% (95% CI: 90–100) for HICs and LMICs, respectively. Data from stringent Phase I–II clinical trials in LMICs and HICs and from the ring efficacy trials yielded a good risk–benefit balance of the V920 vaccine in adults, but also in children and pregnant and lactating women and HIV-infected people.