Partnership for Research on Ebola VACcinations (PREVAC)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02876328 |
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Recruitment Status :
Active, not recruiting
First Posted : August 23, 2016
Results First Posted : September 28, 2022
Last Update Posted : February 24, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ebola Virus Disease | Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Biological: rVSVΔG-ZEBOV-GP Biological: Placebo Biological: rVSV boost | Phase 2 |
The purpose of this study is to evaluate the safety and immunogenicity of two Ebola virus disease (EVD) vaccines, Ad26.ZEBOV (rHAd26) and rVSVΔG-ZEBOV-GP (rVSV), in children and adults. These vaccines will be studied using three different strategies: the rHAd26 vaccine plus a MVA-BN-Filo (MVA) boost, and the rVSV vaccine with or without boosting.
Participants will be randomized into five groups: the Ad26.ZEBOV vaccine with an MVA boost, the rVSV vaccine with or without boosting, or one of two placebo groups. At Day 0 (study entry), participants will receive the Ad26.ZEBOV vaccine, the rVSV vaccine, or placebo.
At Day 56, participants assigned to the rVSV vaccine without a boost and the two placebo groups will receive placebo. Those initially given the Ad26.ZEBOV vaccine will receive the MVA boost. Those assigned to the boosted rVSV group will receive the rVSV boost.
Additional study visits will occur on Days 7, 14, 28, and 63, and at Months 3, 6, 12, 24, 36, 48, and 60. Study visits may include blood collection and other assessments.
Some participants may take part in substudies, which will include blood or saliva collection.
After the Month 12 visit, during the long-term follow-up, the participants who received the placebo will be vaccinated with a single dose of rVSVΔG-ZEBOV-GP vaccine in Liberia and Mali and with the Ad26.ZEBOV/MVA-BN-Filo vaccine strategy in Guinea and Sierra Leone. The participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy will be offered a single dose of the Ad26.ZEBOV or MVA-BN-Filo vaccine in Guinea and Sierra Leone and a single dose of rVSVΔG-ZEBOV-GP in Liberia and Mali.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4789 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Partnership for Research on Ebola VACcinations (PREVAC) |
| Actual Study Start Date : | March 27, 2017 |
| Actual Primary Completion Date : | December 24, 2019 |
| Estimated Study Completion Date : | June 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
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Biological: Ad26.ZEBOV
0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Other Name: rHAd26 Biological: MVA-BN-Filo 0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Other Names:
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Placebo Comparator: Placebo (0.5 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
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Biological: Placebo
0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children |
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Experimental: rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
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Biological: rVSVΔG-ZEBOV-GP
1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Other Names:
Biological: Placebo 0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children |
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Experimental: rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
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Biological: rVSVΔG-ZEBOV-GP
1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Other Names:
Biological: rVSV boost 1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
Other Names:
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Placebo Comparator: Placebo (1 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
|
Biological: Placebo
0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children |
- Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response [ Time Frame: Measured through Month 12 ]Antibody responder at 12 months is defined as a participant who experiences a 4-fold increase in antibody level from baseline and for whom the antibody level at 12 months is greater than or equal to 200 EU/mL.
- Frequency of Serious Adverse Events (SAEs) [ Time Frame: Measured through Month 60 ]SAEs as defined in the protocol
- Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response [ Time Frame: Measured through Month 60 ]Antibodies to the Ebola virus glycoprotein will be measured with the Filovirus Animal Nonclinical Group (FANG) ELISA assay if available. Other assays may also be used.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Informed consent/assent
- Age greater than or equal to 1 year
- Planned residency in the area of the study site for the next 12 months
- Willingness to comply with the protocol requirements
Exclusion Criteria:
- Fever greater than 38º Celsius
- History of EVD (self-report)
- Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
- Positive HIV test for participants less than 18 years of age
- Reported current breast-feeding
- Prior vaccination against Ebola (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
- In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol
Inclusion Criteria for Revaccination Post 12 Month Visit:
- Participants who received the placebo
- Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
Temporary Exclusion Criteria for Revaccination Post 12 Month Visit:
- Fever greater than 38º Celsius
- Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
- Reported current breast-feeding (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after trial vaccination
Exclusion Criteria for Revaccination Post 12 Month Visit:
- EVD notified in the electronic case report form
- For minor participants: change in HIV status since enrollment (self-report)
- Previous Ebola vaccination outside of the study including incomplete vaccine strategies
- Known medical history or significant risk factors for a thrombotic and/or thrombocytopenic event (for participants who will receive the Ad26.ZEBOV or MVA-BN-Filo vaccine)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876328
| Guinea | |
| Centre national de formation et de recherche en santé rurale (Maferyniah) | |
| Conakry, Guinea | |
| Landreah | |
| Conakry, Guinea | |
| Liberia | |
| The Redemption Hospital | |
| Monrovia, Liberia | |
| Mali | |
| Centre pour le Développement des Vaccins (CVD) | |
| Bamako, Mali | |
| University Clinical Research Center (UCRC) | |
| Bamako, Mali | |
| Sierra Leone | |
| Mambolo Clinic | |
| Kapesseh, Sierra Leone | |
| Principal Investigator: | Yazdan Yazdanpannah | Institut National de la Santé Et de la Recherche Médicale, France | |
| Principal Investigator: | Abdoul Habib Beavogui | Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah | |
| Principal Investigator: | Mark Kieh | Redemption Hospital | |
| Principal Investigator: | Bailah Leigh | University of Sierra Leone | |
| Principal Investigator: | Stephen B. Kennedy | Redemption Hospital | |
| Principal Investigator: | Seydou Doumbia | University of Sciences, Techniques and Technologies of Bamako | |
| Principal Investigator: | Samba O. Sow | Centre pour le Developpement des Vaccins |
Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT02876328 |
| Other Study ID Numbers: |
C15-33 PREVACEBL3005 ( Other Identifier: LSHTM ) |
| First Posted: | August 23, 2016 Key Record Dates |
| Results First Posted: | September 28, 2022 |
| Last Update Posted: | February 24, 2023 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ebola Vaccine |
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Virus Diseases Hemorrhagic Fever, Ebola Infections Hemorrhagic Fevers, Viral RNA Virus Infections |
Filoviridae Infections Mononegavirales Infections Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic Antiviral Agents Anti-Infective Agents |