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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) )

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE January 26, 2015
Results First Submitted Date  ICMJE May 25, 2017
Results First Posted Date  ICMJE August 1, 2017
Last Update Posted Date August 23, 2018
Study Start Date  ICMJE January 20, 2015
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • Serious Adverse Events. [ Time Frame: One month ]
    Number of Participants Experiencing Serious Adverse Events in First 30 Days
  • Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody. [ Time Frame: One month ]
    Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • Adverse events. [ Time Frame: One month ]
  • Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody. [ Time Frame: One month ]
Change History Complete list of historical versions of study NCT02344407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
Official Title  ICMJE Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
Brief Summary

Background:

- Ebola virus disease (EVD) affects many people in Liberia and other countries in West Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting, diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause Ebola.

Objectives:

- To study the safety and efficacy of two Ebola vaccines.

Eligibility:

- Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never had Ebola.

Design:

  • Participants will give information including birthdate, gender, occupation, and location of home. They will give contact information for themselves and 2 alternate contacts. They will give a history of their contact with people with Ebola. Some participants may have a physical. They may have blood taken.
  • Participants will be injected with either an Ebola vaccine or a placebo with a needle in the upper arm. The placebo is a salt solution.
  • Participants will have blood taken.
  • Participants will be watched for 30 minutes.
  • Participants will return to the clinic 1 week and 1 month after they get the shot. They will have blood taken.
  • After that, participants will be contacted monthly to discuss how they are feeling. They may be contacted by phone, may visit the clinic, or may have a home visit.
  • The study ends 8-12 months after participants get the shot. If one of the vaccines works against Ebola and does not have many side effects, participants can get the vaccine if they did not get it in the study.
Detailed Description

Ebola virus disease (EVD) in West Africa is spreading rapidly, and there is a critical need for a vaccine to prevent EVD. There are two candidate Ebola virus vaccines, the chimpanzee adenovirus 3 (ChAd3-EBO Z)-based vaccine and the Vesicular Stomatitis virus (VSVdeltaG-ZEBOV)-based vaccine. This study will evaluate both of these vaccines in a randomized, double-blind, controlled, 3-arm study in Liberia. Each vaccine will be compared against the same active control. Because there are limited data on the safety of these vaccines, the initial phase (phase 2) of the study will include the collection of more detailed data on safety and will define the immune response elicited by each vaccine in the first 600 volunteers. With the decline in new cases of Ebola virus infection the phase 3 component was no longer deemed to be feasible and, following safety, ethical and FDA approve/concurrence, the study was amended to a more robust, 1,500 person phase 2 design.

With the amendment to only a phasae 3 study the endpoint reverted to the phase 2 endpoint of safety and immunogenicity.

Participants aged 18 year and older will be enrolled at health clinics in Monrovia, Liberia over 4 months. A single dose of the assigned agent will be administered. Participants in phase 2 will undergo blood draw and assessment of adverse events (AEs) and signs and symptoms of Ebola infection at 1 week and 1 month after vaccination, and monthly assessment of AEs and signs and symptoms of Ebola thereafter. Participants in phase 3 will undergo monthly assessment of AEs and signs and symptoms of Ebola infection after vaccination. All participants will be followed for 8 to 12 months.

This clinical trial to evaluate vaccine efficacy will provide an accurate assessment of the benefits and risks associated with each candidate vaccine and inform policy on wider scale vaccination in other countries.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Ebola Virus
Intervention  ICMJE
  • Biological: 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)
  • Biological: 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.
  • Biological: Placebo
Study Arms  ICMJE
  • Experimental: 2
    ChAd3-EBO Z
    Intervention: Biological: ChAd3-EBO Z
  • Experimental: 3
    VSVG-ZEBOV
    Intervention: Biological: VSVG-ZEBOV
  • Placebo Comparator: 1
    Placebo (Saline)
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 17, 2016)
1500
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2015)
28170
Estimated Study Completion Date  ICMJE June 1, 2020
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

The inclusion criteria for the study are broad reflecting the target population that would eventually receive an efficacious vaccine.

  • Informed consent
  • Age greater than or equal to 18 years
  • Likely to be in the surrounding area of the vaccination center for at least one year.

EXCLUSION CRITERIA:

  • Fever greater than or equal to 38.0 degrees Celsius
  • History of EVD (self-report)
  • Current pregnancy (a negative urine pregnancy test is required for women of child-bearing potential)
  • Breast-feeding an infant
  • Any condition which would limit the ability of the participant to meet the requirements of the study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Liberia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02344407
Other Study ID Numbers  ICMJE 999915071
15-I-N071 ( Other Identifier: NIH IRB Protocol ID number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H. Clifford Lane, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP