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Trial record 5 of 16 for:    Liberia

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 : September 1, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    ChAd3-EBO Z   VSVG-ZEBOV   Placebo (Saline)
STARTED   500   500   500 
COMPLETED   492   491   494 
NOT COMPLETED   8   9   6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   ChAd3-EBO Z   VSVG-ZEBOV   Placebo (Saline)   Total 
Overall Participants Analyzed 
[Units: Participants]
 500   500   500   1500 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 30 
 (25 to 38) 
 29 
 (24 to 36) 
 30 
 (24 to 39) 
 30 
 (24 to 38) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
       
Liberia   500   500   500   1500 
Contact past month with someone who had Ebola 
[Units: Participants]
Count of Participants
 1   5   5   11 
Work involves contact with persons with Ebola 
[Units: Participants]
Count of Participants
 22   25   22   69 
HIV Positive 
[Units: Participants]
Count of Participants
 25   22   31   78 
Syphilis positive 
[Units: Participants]
Count of Participants
 30   22   25   77 
IgG antibody level (EU/mL) 
[Units: EU/mL]
Median (Inter-Quartile Range)
 75 
 (44 to 135) 
 81 
 (49 to 141) 
 79 
 (50 to 148) 
 78 
 (47 to 139) 
Positive antibody response 
[Units: Participants]
Count of Participants
 16   18   26   60 


  Outcome Measures

1.  Primary:   Serious Adverse Events.   [ Time Frame: One month ]

2.  Primary:   Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.   [ Time Frame: One month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: grand001@umn.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: September 1, 2017