CompletedNCT02876328PREVACUpdated Jun 26, 2024Results posted

Partnership for Research on Ebola VACcinations

A Phase 2 interventional study of Ad26.ZEBOV and MVA-BN-Filo in Ebola Virus Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in 4 countries. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 4,789
Allocation: Randomized
Ages: 1 Year and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Ebola Virus Disease

Browse trials for

Hemorrhagic Fever, Ebola 104

Keywords

Ebola Vaccine

In context

Hemorrhagic Fever, Ebola

104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.

This study's enrollment of 4,789 is above the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.

Browse Hemorrhagic Fever, Ebola studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Year and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

/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

Exclusion Criteria:

Fever greater than 38º Celsius
History of EVD (self-report)
Pregnancy (a negative urine pregnancy test is required for females of , i.e., females who have experienced menarche or who are aged 14 years and older)
Positive 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 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)

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 4,789 participants (actual)

Study arms

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.
Biological: Ad26.ZEBOV · Biological: MVA-BN-Filo
Placebo comparator
Placebo (0.5 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Biological: Placebo
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.
Biological: rVSVΔG-ZEBOV-GP · Biological: Placebo
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.
Biological: rVSVΔG-ZEBOV-GP · Biological: rVSV boost
Placebo comparator
Placebo (1 mL)
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Biological: Placebo

Interventions

BiologicalAd26.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
Also known as: rHAd26
BiologicalMVA-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
Also known as: MVA, MVA-mBN226B
BiologicalrVSVΔG-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
Also known as: rVSV, V920
BiologicalPlacebo
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
BiologicalrVSV 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
Also known as: rVSVΔG-ZEBOV-GP, rVSV, V920

What researchers measure

Primary outcomes

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.
Time frame: Measured through Month 12

Secondary outcomes

Frequency of Serious Adverse Events (SAEs)
SAEs as defined in the protocol
Time frame: Measured through Month 60
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.
Time frame: Measured through Month 60

Results

Posted Sep 28, 2022

Participant flow

Healthy volunteers were enrolled at 6 sites in 4 countries: Guinea at 2 sites (Landreah and Maferinyah), Liberia (Redemption Hospital), Mali at 2 sites (Center for Vaccine Development and the University Clinical Research Center), and Sierra Leone (Mambolo). Total enrollment includes participants enrolled in all versions of the protocol, but only participants enrolled in version 4.0 of the protocol are included in the primary outcome analysis.

Participant flow — Overall Study
Milestone	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Title: Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)
Started	396	221	395	197	191	403	179	407	202	210	187	99	177	99	100	227	107	237	108	107	324	172	34	7
Completed	379	208	378	188	181	388	175	395	192	202	182	98	172	95	96	223	102	227	106	105	312	164	33	7
Not completed	17	13	17	9	10	15	4	12	10	8	5	1	5	4	4	4	5	10	2	2	12	8	1	0
Withdrew: Death	2	1	3	0	0	0	1	3	0	1	1	0	0	0	0	0	1	1	0	0	0	1	0	0
Withdrew: Withdrawal by subject	0	2	3	3	0	1	0	1	1	2	0	0	0	0	0	0	1	3	0	0	1	0	0	0
Withdrew: Missed 12 month visit	15	10	11	6	10	14	3	8	9	5	4	1	5	4	4	4	3	6	2	2	11	7	1	0

Outcome measures

PrimaryPercentage 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.

Time frame:: Measured through Month 12
Reported as:: Number · percentage of participants

Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response
percentage of participants	Protocol Version 4.0 Ad26/MVA	Protocol Version 4.0 rVSV	Protocol Version 4.0 rVSV Boost	Protocol Version 4.0 Pooled Placebo
Adults	40.9	75.7	81.1	2.7
Children	78.5	87.3	92.6	3.6

Statistical analysis

Protocol Version 4.0 Ad26/MVA vs Protocol Version 4.0 rVSV vs Protocol Version 4.0 rVSV Boost vs Protocol Version 4.0 Pooled Placebo · Cochran-Mantel-Haenszel · p = <.001 (Each active group is compared to placebo using a 2-sided .0167 significance level.)Analyses are stratified by site.

SecondaryFrequency of Serious Adverse Events (SAEs)

SAEs as defined in the protocol

Time frame:: Measured through Month 60

Results for this outcome have not been posted.

SecondaryNumber 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.

Time frame:: Measured through Month 60

Results for this outcome have not been posted.

Adverse events

Collected over 12 months for the Primary Outcome. Adverse events will be collected through the end of the study (60 months). A full summary will be provided when the study is complete.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	2/396 (0.5%)	14/396 (3.5%)	296/396 (74.7%)
Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0)	1/412 (0.2%)	5/412 (1.2%)	291/412 (70.6%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	3/395 (0.8%)	6/395 (1.5%)	320/395 (81%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	0/197 (0%)	1/197 (0.5%)	155/197 (78.7%)
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	0/403 (0%)	5/403 (1.2%)	341/403 (84.6%)
Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0)	2/389 (0.5%)	8/389 (2.1%)	298/389 (76.6%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	3/407 (0.7%)	9/407 (2.2%)	350/407 (86%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	0/202 (0%)	3/202 (1.5%)	179/202 (88.6%)
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	1/187 (0.5%)	12/187 (6.4%)	142/187 (75.9%)
Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0)	0/199 (0%)	6/199 (3%)	151/199 (75.9%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	0/177 (0%)	6/177 (3.4%)	148/177 (83.6%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	0/99 (0%)	2/99 (2%)	80/99 (80.8%)
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	0/227 (0%)	4/227 (1.8%)	167/227 (73.6%)
Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0)	1/214 (0.5%)	7/214 (3.3%)	143/214 (66.8%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	1/237 (0.4%)	6/237 (2.5%)	186/237 (78.5%)
rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	0/108 (0%)	1/108 (0.9%)	84/108 (77.8%)
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	0/324 (0%)	6/324 (1.9%)	232/324 (71.6%)
Placebo (0.5 mL) - Adults (v2.0)	1/172 (0.6%)	5/172 (2.9%)	97/172 (56.4%)
Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	0/34 (0%)	1/34 (2.9%)	23/34 (67.6%)
Placebo (0.5 mL) - Children (v2.0)	0/7 (0%)	0/7 (0%)	4/7 (57.1%)

Most frequent serious events

Showing 10 of 74

Most frequent serious events
Event	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)
APPENDICITISInfections and infestations	6/396	2/412	1/395	0/197	1/403	2/389	1/407	0/202	1/187	0/199	2/177	0/99	1/227	2/214	1/237	1/108	1/324	0/172	1/34	0/7
COMPARTMENT SYNDROME; HUMERUS FRACTUREGeneral disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	0/187	0/199	0/177	1/99	0/227	0/214	0/237	0/108	0/324	0/172	0/34	0/7
UTERINE LEIOMYOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	1/187	0/199	0/177	1/99	0/227	0/214	0/237	0/108	0/324	0/172	0/34	0/7
CEREBROVASCULAR ACCIDENTNervous system disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	1/187	0/199	0/177	0/99	0/227	0/214	0/237	0/108	0/324	1/172	0/34	0/7
DIABETES MELLITUSMetabolism and nutrition disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	0/187	0/199	0/177	0/99	0/227	0/214	0/237	0/108	0/324	1/172	0/34	0/7
DIARRHOEAGastrointestinal disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	0/187	0/199	0/177	0/99	0/227	0/214	0/237	0/108	0/324	1/172	0/34	0/7
INGUINAL HERNIAGastrointestinal disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	1/187	0/199	0/177	0/99	0/227	0/214	0/237	0/108	0/324	1/172	0/34	0/7
SKIN ULCERSkin and subcutaneous tissue disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	0/187	0/199	0/177	0/99	0/227	0/214	0/237	0/108	0/324	1/172	0/34	0/7
DIABETES MELLITUS; URINARY TRACT INFECTIONGeneral disorders	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	0/187	0/199	1/177	0/99	0/227	0/214	0/237	0/108	0/324	0/172	0/34	0/7
HEAD INJURY; JAW FRACTUREInjury, poisoning and procedural complications	0/396	0/412	0/395	0/197	0/403	0/389	0/407	0/202	0/187	0/199	1/177	0/99	0/227	0/214	0/237	0/108	0/324	0/172	0/34	0/7

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Pooled Placebo (0.5 mL or 1 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Pooled Placebo (0.5 mL or 1 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Pooled Placebo (0.5 mL or 1 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Pooled Placebo (0.5 mL or 1 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)
PyrexiaGeneral disorders	156/396	135/412	180/395	87/197	261/403	192/389	278/407	145/202	55/187	52/199	69/177	34/99	88/227	68/214	114/237	45/108	66/324	24/172	8/34	1/7
HeadacheNervous system disorders	215/396	218/412	250/395	116/197	169/403	150/389	217/407	97/202	110/187	114/199	114/177	66/99	103/227	93/214	124/237	56/108	163/324	71/172	17/34	2/7
FatigueGeneral disorders	91/396	84/412	113/395	61/197	82/403	66/389	111/407	44/202	67/187	69/199	74/177	37/99	55/227	25/214	60/237	31/108	68/324	39/172	5/34	2/7
MyalgiaMusculoskeletal and connective tissue disorders	105/396	92/412	138/395	68/197	62/403	38/389	78/407	32/202	56/187	54/199	61/177	33/99	34/227	24/214	50/237	25/108	76/324	23/172	6/34	1/7
ArthralgiaMusculoskeletal and connective tissue disorders	79/396	63/412	94/395	45/197	28/403	18/389	38/407	14/202	52/187	48/199	57/177	29/99	24/227	15/214	31/237	12/108	66/324	22/172	4/34	0/7
Decreased appetiteMetabolism and nutrition disorders	55/396	54/412	77/395	32/197	94/403	80/389	120/407	59/202	37/187	39/199	53/177	24/99	52/227	31/214	58/237	26/108	47/324	21/172	6/34	0/7
ChillsGeneral disorders	51/396	48/412	81/395	37/197	72/403	59/389	80/407	34/202	21/187	21/199	31/177	14/99	37/227	21/214	36/237	12/108	40/324	16/172	3/34	2/7
DizzinessNervous system disorders	44/396	46/412	60/395	15/197	38/403	27/389	55/407	19/202	26/187	35/199	33/177	16/99	9/227	17/214	21/237	9/108	38/324	17/172	2/34	2/7
Abdominal painGastrointestinal disorders	70/396	77/412	80/395	39/197	92/403	69/389	97/407	44/202	41/187	36/199	38/177	17/99	53/227	48/214	56/237	24/108	43/324	23/172	7/34	1/7
CryingGeneral disorders	—	—	—	—	26/137	15/136	27/123	14/71	—	—	—	—	1/25	1/24	5/24	1/9	—	—	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Adults	27 (21 to 40)	28 (20 to 38)	27 (20 to 39)	26 (20 to 35)	26 (21 to 38)	—	—	—	—	—	30 (23 to 44)	31 (23 to 40)	29 (22 to 39)	28 (22 to 43)	28 (22 to 39)	—	—	—	—	—	27 (22 to 37)	27 (22 to 37)	—	—	27 (21 to 39)
Children	—	—	—	—	—	8 (4 to 13)	8 (4 to 13)	9 (4 to 12)	8 (3 to 13)	8 (4 to 13)	—	—	—	—	—	12 (8 to 15)	12 (8 to 15)	12 (8 to 15)	12 (7 to 15)	12 (7 to 14)	—	—	14 (13 to 16)	14 (12 to 15)	10 (5 to 14)

Age, Customized
Age, Customized(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
1-4 years	0	0	0	0	0	137	59	123	71	77	0	0	0	0	0	25	12	24	9	12	0	0	0	0	549
5-11 years	0	0	0	0	0	127	59	146	65	70	0	0	0	0	0	76	37	86	43	41	0	0	0	0	750
12-17 years	0	0	0	0	0	139	61	138	66	63	0	0	0	0	0	126	58	127	56	54	0	0	34	7	929
Adults >18 years	396	221	395	197	191	0	0	0	0	0	187	99	177	99	100	0	0	0	0	0	324	172	0	0	2558

Sex: Female, Male
Sex: Female, Male(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Adults — Female	171	106	182	87	81	—	—	—	—	—	99	45	75	43	49	—	—	—	—	—	120	60	—	—	1118
Adults — Male	225	115	213	110	110	—	—	—	—	—	88	54	102	56	51	—	—	—	—	—	204	112	—	—	1440
Children — Female	—	—	—	—	—	186	87	185	85	95	—	—	—	—	—	122	48	117	55	53	—	—	19	5	1057
Children — Male	—	—	—	—	—	217	92	222	117	115	—	—	—	—	—	105	59	120	53	54	—	—	15	2	1171

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Count of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	0

Region of Enrollment
Region of Enrollment(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Guinea	121	72	130	66	63	—	—	—	—	—	144	80	141	77	76	—	—	—	—	—	158	84	—	—	1212
Liberia	73	43	70	35	38	—	—	—	—	—	43	19	36	22	24	—	—	—	—	—	166	88	—	—	657
Mali	81	48	84	41	38	—	—	—	—	—	0	0	0	0	0	—	—	—	—	—	0	0	—	—	292
Sierra Leone	121	58	111	55	52	—	—	—	—	—	0	0	0	0	0	—	—	—	—	—	0	0	—	—	397

Region of Enrollment
Region of Enrollment(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Guinea	—	—	—	—	—	163	71	156	77	79	—	—	—	—	—	160	72	163	76	77	—	—	17	4	1115
Liberia	—	—	—	—	—	64	25	66	33	30	—	—	—	—	—	67	35	74	32	30	—	—	17	3	476
Mali	—	—	—	—	—	95	40	94	46	51	—	—	—	—	—	0	0	0	0	0	—	—	0	0	326
Sierra Leone	—	—	—	—	—	81	43	91	46	50	—	—	—	—	—	0	0	0	0	0	—	—	0	0	311

HIV Positive
HIV Positive(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Adults	6	1	13	2	3	—	—	—	—	—	5	2	4	2	2	—	—	—	—	—	6	8	—	—	54
Children	—	—	—	—	—	0	0	0	0	0	—	—	—	—	—	0	0	0	0	0	—	—	0	0	0

Number of Participants with Results for Ebola IgG Concentration (Version 4)
Number of Participants with Results for Ebola IgG Concentration (Version 4)(Participants)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0)	Placebo (0.5 mL) - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0)	Placebo (1 mL) - Adults (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0)	Placebo (0.5 mL) - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0)	Placebo (1 mL) - Children (v4.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0)	Placebo (0.5 mL) - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0)	Placebo (1 mL) - Adults (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0)	Placebo (0.5 mL) - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0)	rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0)	Placebo (1 mL) - Children (v3.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0)	Placebo (0.5 mL) - Adults (v2.0)	Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0)	Placebo (0.5 mL) - Children (v2.0)	Total
Adults	394	220	388	197	189	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	1388
Children	—	—	—	—	—	398	177	401	200	209	—	—	—	—	—	—	—	—	—	—	—	—	—	—	1385

4 further baseline measures are reported on the registry.

Study locations

6 sites

Centre national de formation et de recherche en santé rurale (Maferyniah)
Conakry, Guinea
Landreah
Conakry, Guinea
The Redemption Hospital
Monrovia, Liberia
Centre pour le Développement des Vaccins (CVD)
Bamako, Mali
University Clinical Research Center (UCRC)
Bamako, Mali
Mambolo Clinic
Kapesseh, Sierra Leone

References and documents

Publications

Badio M, Lhomme E, Kieh M, Beavogui AH, Kennedy SB, Doumbia S, Leigh B, Sow SO, Diallo A, Fusco D, Kirchoff M, Termote M, Vatrinet R, Wentworth D, Esperou H, Lane HC, Pierson J, Watson-Jones D, Roy C, D'Ortenzio E, Greenwood B, Chene G, Richert L, Neaton JD, Yazdanpanah Y; PREVAC study team. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. Trials. 2021 Jan 23;22(1):86. doi: 10.1186/s13063-021-05035-9. Erratum In: Trials. 2021 Sep 1;22(1):583. doi: 10.1186/s13063-021-05572-3. PubMed 33485369 ↗
PREVAC Study Team; Kieh M, Richert L, Beavogui AH, Grund B, Leigh B, D'Ortenzio E, Doumbia S, Lhomme E, Sow S, Vatrinet R, Roy C, Kennedy SB, Faye S, Lees S, Millimouno NP, Camara AM, Samai M, Deen GF, Doumbia M, Esperou H, Pierson J, Watson-Jones D, Diallo A, Wentworth D, McLean C, Simon J, Wiedemann A, Dighero-Kemp B, Hensley L, Lane HC, Levy Y, Piot P, Greenwood B, Chene G, Neaton J, Yazdanpanah Y. Randomized Trial of Vaccines for Zaire Ebola Virus Disease. N Engl J Med. 2022 Dec 29;387(26):2411-2424. doi: 10.1056/NEJMoa2200072. Epub 2022 Dec 14. PubMed 36516078 ↗

Study documents

Study protocol ↗ · Mar 10, 2018
Statistical analysis plan ↗ · Apr 10, 2020
Informed consent form ↗ · Mar 20, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Dec 2019, 32 months.

Results were first posted in Sep 2022, 2 years 9 months after primary completion.

Of 13 phase 2 interventional studies under Hemorrhagic Fever, Ebola, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 32 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 16, 2016
First posted: Aug 23, 2016
StartActual: Mar 27, 2017
Primary completionActual: Dec 24, 2019
CompletionActual: Dec 20, 2023
Results first posted: Sep 28, 2022
Last update: Jun 26, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02876328
Lead 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)
Responsible party: Sponsor
First posted: Aug 23, 2016
Start date: Mar 27, 2017
Primary completion: Dec 24, 2019
Completion: Dec 20, 2023
Results posted: Sep 28, 2022
Last update: Jun 26, 2024

Study contacts

Yazdan Yazdanpannah

principal investigator · Institut National de la Santé Et de la Recherche Médicale, France

Abdoul Habib Beavogui

principal investigator · Centre de Formation et de Recherche en Santé Rurale de Mafèrinyah

Mark Kieh

principal investigator · Redemption Hospital

Bailah Leigh

principal investigator · University of Sierra Leone

Stephen B. Kennedy

principal investigator · Redemption Hospital

Seydou Doumbia

principal investigator · University of Sciences, Techniques and Technologies of Bamako

Samba O. Sow

principal investigator · Centre pour le Developpement des Vaccins

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Recombinant zaire ebolavirus KIKWIT-95 envelope glycoprotein modified vesicular stomatitis virus

Other studies in this condition

Hemorrhagic Fever, Ebola →

Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID) →

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