Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)

NCT02344407 | Completed Phase 2 Results DMC

• 2 other identifiers: 99991507115-I-N071
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ebola Virus

Keywords

Zaire Ebola Virus Disease

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Events.

  Number of Participants Experiencing Serious Adverse Events in First 30 Days

  One month

• Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.

  Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry

  One month

Study Arms (3)

2

EXPERIMENTAL

ChAd3-EBO Z

Biological: ChAd3-EBO Z

3

EXPERIMENTAL

VSVG-ZEBOV

Biological: VSVG-ZEBOV

1

PLACEBO COMPARATOR

Placebo (Saline)

Biological: Placebo

Interventions

VSVG-ZEBOV BIOLOGICAL

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)

3

ChAd3-EBO Z BIOLOGICAL

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.

2

Placebo BIOLOGICAL

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Liberian Ministry of Health and Social Welfare

Monrovia, Liberia

Location

Related Publications (8)

• Feldmann H, Geisbert TW. Ebola haemorrhagic fever. Lancet. 2011 Mar 5;377(9768):849-62. doi: 10.1016/S0140-6736(10)60667-8.

  PMID: 21084112 BACKGROUND

• Chertow DS, Kleine C, Edwards JK, Scaini R, Giuliani R, Sprecher A. Ebola virus disease in West Africa--clinical manifestations and management. N Engl J Med. 2014 Nov 27;371(22):2054-7. doi: 10.1056/NEJMp1413084. Epub 2014 Nov 5. No abstract available.

  PMID: 25372854 BACKGROUND

• Colloca S, Barnes E, Folgori A, Ammendola V, Capone S, Cirillo A, Siani L, Naddeo M, Grazioli F, Esposito ML, Ambrosio M, Sparacino A, Bartiromo M, Meola A, Smith K, Kurioka A, O'Hara GA, Ewer KJ, Anagnostou N, Bliss C, Hill AV, Traboni C, Klenerman P, Cortese R, Nicosia A. Vaccine vectors derived from a large collection of simian adenoviruses induce potent cellular immunity across multiple species. Sci Transl Med. 2012 Jan 4;4(115):115ra2. doi: 10.1126/scitranslmed.3002925.

  PMID: 22218691 BACKGROUND

• Simon JK, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller BG, Welebob C, Hanson ME, Grais RF. Immunogenicity of rVSVDeltaG-ZEBOV-GP Ebola vaccine (ERVEBO(R)) in African clinical trial participants by age, sex, and baseline GP-ELISA titer: A post hoc analysis of three Phase 2/3 trials. Vaccine. 2022 Nov 2;40(46):6599-6606. doi: 10.1016/j.vaccine.2022.09.037. Epub 2022 Oct 5.

  PMID: 36208978 DERIVED

• Antonello J, Grant-Klein RJ, Nichols R, Kennedy SB, Dubey S, Simon JK. Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis. Vaccine. 2020 Jun 26;38(31):4885-4891. doi: 10.1016/j.vaccine.2020.04.061. Epub 2020 Jun 1.

  PMID: 32499064 DERIVED

• Logue J, Tuznik K, Follmann D, Grandits G, Marchand J, Reilly C, Sarro YDS, Pettitt J, Stavale EJ, Fallah M, Olinger GG, Bolay FK, Hensley LE. Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay. J Virol Methods. 2018 May;255:84-90. doi: 10.1016/j.jviromet.2018.02.018. Epub 2018 Feb 23.

  PMID: 29481881 DERIVED

• Kennedy SB, Bolay F, Kieh M, Grandits G, Badio M, Ballou R, Eckes R, Feinberg M, Follmann D, Grund B, Gupta S, Hensley L, Higgs E, Janosko K, Johnson M, Kateh F, Logue J, Marchand J, Monath T, Nason M, Nyenswah T, Roman F, Stavale E, Wolfson J, Neaton JD, Lane HC; PREVAIL I Study Group. Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia. N Engl J Med. 2017 Oct 12;377(15):1438-1447. doi: 10.1056/NEJMoa1614067.

  PMID: 29020589 DERIVED

• Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.

  PMID: 28647166 DERIVED

Results Point of Contact

• Title: Greg Grandits
• Organization: Division of Biostatistics, University of Minnesota

grand001@umn.edu

612-626-9033

Study Officials

• H. Clifford Lane, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: January 26, 2015
• Study Start: January 20, 2015
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2020
• Last Updated: April 8, 2021
• Results First Posted: August 1, 2017

Record last verified: 2021-03

Locations

LI (1)