Table 3. Vaccine trials recruiting in the most affected countries during the Ebola virus disease outbreak in west Africa.
Trial design | Research question (PICO model) | Registration number (declared status as of November, 2016) | |
---|---|---|---|
rVSV ZEBOV | |||
Ebola ça suffit! | Open label, cluster randomised, ring vaccination | Participants include contacts of confirmed EVD patients; intervention with immediate vaccination with rVSV ZEBOV; comparison with delayed (day 21) vaccination; outcome measured as safety and efficacy | Registered as PACTR201503001057193 (interim results available124) |
Ebola ça suffit! | Open label, single arm | Participants include adult front-line workers; intervention with immediate vaccination with rVSV ZEBOV; comparison with delayed (day 21) vaccination; outcome measured as safety and efficacy | Registered as PACTR201503001057193 (closed to recruitment, follow up complete125) |
STRIVE | Open label, randomised, with two substudies | Participants include adult front-line workers; intervention with immediate vaccination with vVSV ΔG ZEBOV; comparison with delayed (18–24 weeks) vaccination; outcomes measured as safety, efficacy, and immunogenicity | Registered as NCT02378753, PACTR201502001037220 (ongoing but not recruiting) |
Multiple | |||
PREVAC | Double-blind RCT | Participants include children and adults; intervention with immediate vaccination with rVSV-ZEBOV (with or without rVSV boost) or Ad26.ZEBOV + MVA-BN-Filo boost; comparison with placebo; outcomes measured as safety and immunogenicity | Registered as NCT02876328 (not yet open for recruitment) |
PREVAIL | Double-blind RCT | Participants include adults with Ebola virus infection; intervention with immediate vaccination with VSVG-ZEBOV or ChAd3-EBO Z; comparison with placebo; outcomes measured as safety and immunogenicity | Registered as NCT02344407 (ongoing, but not recruiting, no results available) |
Ad5-EBOV | |||
Ad5-EBOV | Double-blind RCT | Participants include healthy adults aged 18–50 years in Sierra Leone; intervention with high dose, or low dose immediate vaccination with Ad5-EBOV; comparison with placebo; outcome measured as safety and immunogenicity | Registered as NCT02575456, PACTR201509001259869 (completed, no results available) |
Ad26. ZEBOV + MVA-BN-Filo | |||
EBOVAC | Open label, single arm, followed by double-blind RCT | Participants include healthy adults and children in Sierra Leone; intervention with immediate vaccination with Ad26-ZEBOV and with MVA-BN-Filo boost; comparison with placebo (meningococcal vaccine during immediate vaccination) during the second stage of the RCT; outcome measured as safety, immunogenicity, and efficacy | Registered as NCT02509494, PACTR201506001147964 (recruiting) |
EVD=Ebola virus disease. PICO=participant, intervention, comparison, outcome. RCT=randomised controlled trial.