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Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)

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ClinicalTrials.gov Identifier: NCT02344407
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Results First Posted : August 1, 2017
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Ebola Virus
Interventions Biological: VSVG-ZEBOV
Biological: ChAd3-EBO Z
Biological: Placebo
Enrollment 1500

Recruitment Details  
Pre-assignment Details  
Arm/Group Title ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Hide Arm/Group Description

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: 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
Period Title: Overall Study
Started 500 500 500
Completed 492 491 494
Not Completed 8 9 6
Arm/Group Title ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline) Total
Hide Arm/Group Description

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: 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 Total of all reporting groups
Overall Number of Baseline Participants 500 500 500 1500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
30
(25 to 38)
29
(24 to 36)
30
(24 to 39)
30
(24 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
Female
185
  37.0%
187
  37.4%
177
  35.4%
549
  36.6%
Male
315
  63.0%
313
  62.6%
323
  64.6%
951
  63.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Liberia Number Analyzed 500 participants 500 participants 500 participants 1500 participants
500 500 500 1500
Contact past month with someone who had Ebola  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
1
   0.2%
5
   1.0%
5
   1.0%
11
   0.7%
Work involves contact with persons with Ebola  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
22
   4.4%
25
   5.0%
22
   4.4%
69
   4.6%
HIV Positive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
25
   5.0%
22
   4.4%
31
   6.2%
78
   5.2%
Syphilis positive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
30
   6.0%
22
   4.4%
25
   5.0%
77
   5.1%
IgG antibody level (EU/mL)  
Median (Inter-Quartile Range)
Unit of measure:  EU/mL
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
75
(44 to 135)
81
(49 to 141)
79
(50 to 148)
78
(47 to 139)
Positive antibody response  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 500 participants 500 participants 1500 participants
16
   3.2%
18
   3.6%
26
   5.2%
60
   4.0%
1.Primary Outcome
Title Serious Adverse Events.
Hide Description Number of Participants Experiencing Serious Adverse Events in First 30 Days
Time Frame One month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Participants Randomized
Arm/Group Title ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Hide Arm/Group Description:

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: 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
Overall Number of Participants Analyzed 500 500 500
Measure Type: Count of Participants
Unit of Measure: Participants
6
   1.2%
6
   1.2%
8
   1.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChAd3-EBO Z, Placebo (Saline)
Comments Each active vaccine is compared to the placebo group
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Chi-squared
Comments Bernards Exact Test Chi-square
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VSVG-ZEBOV, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Chi-squared
Comments Barnard Exact Test Chi-square
2.Primary Outcome
Title Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.
Hide Description Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry
Time Frame One month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with 1-month antibody data without elevated antibody levels at entry
Arm/Group Title ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Hide Arm/Group Description:

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: 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
Overall Number of Participants Analyzed 478 477 471
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
621
(565 to 682)
1000
(910 to 1099)
75
(69 to 80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChAd3-EBO Z, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Linear regression (analysis of covariance) adjusted for baseline antibody level
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VSVG-ZEBOV, Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance adjusting for baseline antibody level
Time Frame First 30 days after vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Hide Arm/Group Description

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: 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
All-Cause Mortality
ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/500 (0.00%)      0/500 (0.00%)      1/500 (0.20%)    
Show Serious Adverse Events Hide Serious Adverse Events
ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/500 (1.20%)      6/500 (1.20%)      8/500 (1.60%)    
Blood and lymphatic system disorders       
Anaemia  1  1/500 (0.20%)  1 0/500 (0.00%)  0 0/500 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea  1  1/500 (0.20%)  1 0/500 (0.00%)  0 0/500 (0.00%)  0
Infections and infestations       
Malaria  1  2/500 (0.40%)  2 6/500 (1.20%)  6 6/500 (1.20%)  6
Typhoid fever  1  1/500 (0.20%)  1 0/500 (0.00%)  0 0/500 (0.00%)  0
Pheumocystis jirovecii pheumonia  1  0/500 (0.00%)  0 0/500 (0.00%)  0 1/500 (0.20%)  1
Injury, poisoning and procedural complications       
Chest injury  1  1/500 (0.20%)  1 0/500 (0.00%)  0 0/500 (0.00%)  0
Reproductive system and breast disorders       
Vaginal haemorrhage  1  0/500 (0.00%)  0 0/500 (0.00%)  0 1/500 (0.20%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ChAd3-EBO Z VSVG-ZEBOV Placebo (Saline)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/500 (0.00%)      0/500 (0.00%)      0/500 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Greg Grandits
Organization: Division of Biostatistics, University of Minnesota
Phone: 612-626-9033
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02344407     History of Changes
Other Study ID Numbers: 999915071
15-I-N071 ( Other Identifier: NIH IRB Protocol ID number )
First Submitted: January 22, 2015
First Posted: January 26, 2015
Results First Submitted: May 25, 2017
Results First Posted: August 1, 2017
Last Update Posted: August 23, 2018