Trial Outcomes & Findings for Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) (NCT NCT02344407)
NCT ID: NCT02344407
Last Updated: 2021-04-08
Results Overview
Number of Participants Experiencing Serious Adverse Events in First 30 Days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1500 participants
Primary outcome timeframe
One month
Results posted on
2021-04-08
Participant Flow
Participant milestones
| Measure |
ChAd3-EBO Z
ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
|
VSVG-ZEBOV
VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
|
Placebo (Saline)
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
500
|
500
|
500
|
|
Overall Study
COMPLETED
|
492
|
491
|
494
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
Baseline characteristics by cohort
| Measure |
ChAd3-EBO Z
n=500 Participants
ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
|
VSVG-ZEBOV
n=500 Participants
VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
|
Placebo (Saline)
n=500 Participants
Placebo
|
Total
n=1500 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
29 years
n=7 Participants
|
30 years
n=5 Participants
|
30 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
549 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
315 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
951 Participants
n=4 Participants
|
|
Region of Enrollment
Liberia
|
500 participants
n=5 Participants
|
500 participants
n=7 Participants
|
500 participants
n=5 Participants
|
1500 participants
n=4 Participants
|
|
Contact past month with someone who had Ebola
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Work involves contact with persons with Ebola
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
HIV Positive
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Syphilis positive
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
IgG antibody level (EU/mL)
|
75 EU/mL
n=5 Participants
|
81 EU/mL
n=7 Participants
|
79 EU/mL
n=5 Participants
|
78 EU/mL
n=4 Participants
|
|
Positive antibody response
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: All Participants Randomized
Number of Participants Experiencing Serious Adverse Events in First 30 Days
Outcome measures
| Measure |
ChAd3-EBO Z
n=500 Participants
ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
|
VSVG-ZEBOV
n=500 Participants
VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
|
Placebo (Saline)
n=500 Participants
Placebo
|
|---|---|---|---|
|
Serious Adverse Events.
|
6 Participants
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: Participants with 1-month antibody data without elevated antibody levels at entry
Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry
Outcome measures
| Measure |
ChAd3-EBO Z
n=478 Participants
ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
|
VSVG-ZEBOV
n=477 Participants
VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
|
Placebo (Saline)
n=471 Participants
Placebo
|
|---|---|---|---|
|
Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.
|
621 EU/mL
Interval 565.0 to 682.0
|
1000 EU/mL
Interval 910.0 to 1099.0
|
75 EU/mL
Interval 69.0 to 80.0
|
Adverse Events
ChAd3-EBO Z
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
VSVG-ZEBOV
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Saline)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ChAd3-EBO Z
n=500 participants at risk
ChAd3-EBO Z
ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
|
VSVG-ZEBOV
n=500 participants at risk
VSVG-ZEBOV
VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
|
Placebo (Saline)
n=500 participants at risk
Placebo
|
|---|---|---|---|
|
Infections and infestations
Malaria
|
0.40%
2/500 • Number of events 2 • First 30 days after vaccination
|
1.2%
6/500 • Number of events 6 • First 30 days after vaccination
|
1.2%
6/500 • Number of events 6 • First 30 days after vaccination
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/500 • Number of events 1 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/500 • Number of events 1 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
|
Infections and infestations
Typhoid fever
|
0.20%
1/500 • Number of events 1 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/500 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
0.20%
1/500 • Number of events 1 • First 30 days after vaccination
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.20%
1/500 • Number of events 1 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
|
Infections and infestations
Pheumocystis jirovecii pheumonia
|
0.00%
0/500 • First 30 days after vaccination
|
0.00%
0/500 • First 30 days after vaccination
|
0.20%
1/500 • Number of events 1 • First 30 days after vaccination
|
Other adverse events
Adverse event data not reported
Additional Information
Greg Grandits
Division of Biostatistics, University of Minnesota
Phone: 612-626-9033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place