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Partnership for Research on Ebola VACcinations (PREVAC)

Primary Purpose

Ebola Virus Disease

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ad26.ZEBOV

MVA-BN-Filo

rVSVΔG-ZEBOV-GP

Placebo

rVSV boost

About this trial

This is an interventional prevention trial for Ebola Virus Disease focused on measuring Ebola Vaccine

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Centre national de formation et de recherche en santé rurale (Maferyniah)
Landreah
The Redemption Hospital
Centre pour le Développement des Vaccins (CVD)
University Clinical Research Center (UCRC)
Mambolo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost

Placebo (0.5 mL)

rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost

rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost

Placebo (1 mL)

Arm Description

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Outcomes

Primary Outcome Measures

Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response

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.

Secondary Outcome Measures

Frequency of Serious Adverse Events (SAEs)

SAEs as defined in the protocol

Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response

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.

Full Information

NCT ID

NCT02876328

First Posted

August 16, 2016

Last Updated

February 22, 2023

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Partnership for Research on Ebola Virus in Liberia (PREVAIL), Institut National de la Santé Et de la Recherche Médicale, France, London School of Hygiene and Tropical Medicine, European and Developing Countries Clinical Trials Partnership (EDCTP)

1. Study Identification

Unique Protocol Identification Number

NCT02876328

Brief Title

Partnership for Research on Ebola VACcinations

Acronym

PREVAC

Official Title

Partnership for Research on Ebola VACcinations (PREVAC)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 27, 2017 (Actual)

Primary Completion Date

December 24, 2019 (Actual)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ebola Virus Disease

Keywords

Ebola Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4789 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ad26.ZEBOV (rHAd26) vaccine + MVA-BN-Filo (MVA) boost

Arm Type

Experimental

Arm Description

Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.

Arm Title

Placebo (0.5 mL)

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Arm Title

rVSVΔG-ZEBOV-GP (rVSV) vaccine + placebo boost

Arm Type

Experimental

Arm Description

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.

Arm Title

rVSVΔG-ZEBOV-GP (rVSV) vaccine + rVSV boost

Arm Type

Experimental

Arm Description

Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.

Arm Title

Placebo (1 mL)

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.

Intervention Type

Biological

Intervention Name(s)

Ad26.ZEBOV

Other Intervention Name(s)

rHAd26

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

MVA-BN-Filo

Other Intervention Name(s)

MVA, MVA-mBN226B

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

rVSVΔG-ZEBOV-GP

Other Intervention Name(s)

rVSV, V920

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

rVSV boost

Other Intervention Name(s)

rVSVΔG-ZEBOV-GP, rVSV, V920

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response

Description

Time Frame

Measured through Month 12

Secondary Outcome Measure Information:

Title

Frequency of Serious Adverse Events (SAEs)

Description

SAEs as defined in the protocol

Time Frame

Measured through Month 60

Title

Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response

Description

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.

Time Frame

Measured through Month 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: