Ebola Virus Disease
Conditions
Keywords
Ebola Vaccine
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.
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
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
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
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
Sponsors
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)
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Serious Adverse Events (SAEs) | Measured through Month 60 | SAEs as defined in the protocol |
| Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | 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. |
Countries
Guinea, Liberia, Mali, Sierra Leone
Participant flow
Recruitment details
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.
Pre-assignment details
4789 participants were enrolled in the study, however, only 4786 participants are part of the data analysis.
Participants by arm
| Arm | Count |
|---|---|
| Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm | 396 |
| Placebo (0.5 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 221 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 395 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm | 197 |
| Placebo (1 mL) - Adults (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 191 |
| Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or the thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or the thigh | 403 |
| Placebo (0.5 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh | 179 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or the thigh | 407 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) Protocol Version 4.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh
rVSV boost: 1 mL at a nominal dose of 2x10\^7 pfu/mL administered by intramuscular (IM) injection into the upper arm or the thigh | 202 |
| Placebo (1 mL) - Children (v4.0) Protocol Version 4.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 210 |
| Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm | 187 |
| Placebo (0.5 mL) - Adults (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 99 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 177 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm
rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm | 99 |
| Placebo (1 mL) - Adults (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 100 |
| Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh | 227 |
| Placebo (0.5 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh | 107 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by a placebo boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh | 237 |
| rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Children (v3.0) Protocol Version 3.0
Participants will receive the rVSVΔG-ZEBOV-GP (rVSV) vaccine at Day 0 followed by an rVSV boost at Day 56.
rVSVΔG-ZEBOV-GP: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh
rVSV boost: 1 mL of a 1:2 diluted 2x10\^7 pfu/mL nominal dose administered by intramuscular (IM) injection into the upper arm or thigh | 108 |
| Placebo (1 mL) - Children (v3.0) Protocol Version 3.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 1 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh | 107 |
| Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm
MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm | 324 |
| Placebo (0.5 mL) - Adults (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm | 172 |
| Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v2.0) Protocol Version 2.0
Participants will receive the Ad26.ZEBOV (rHAd26) vaccine at Day 0 followed by an MVA-BN-Filo (MVA) boost at Day 56.
Ad26.ZEBOV: 0.5 mL at a dose of 5x10\^10 vp administered by intramuscular (IM) injection into the upper arm or thigh
MVA-BN-Filo: 0.5 mL at a dose of 1x10\^8 InfU administered by intramuscular (IM) injection into the upper arm or thigh | 34 |
| Placebo (0.5 mL) - Children (v2.0) Protocol Version 2.0
Participants will receive placebo at Day 0 followed by a placebo boost at Day 56.
Placebo: 0.5 mL sterile normal saline administered by intramuscular (IM) injection into the upper arm or thigh | 7 |
| Total | 4,786 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | 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 |
| Overall Study | 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 |
| Overall Study | 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 |
Baseline characteristics
| Characteristic | Placebo (1 mL) - Adults (v3.0) | rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + rVSV Boost (Diluted) - Adults (v3.0) | rVSVΔG-ZEBOV-GP (rVSV) Vaccine (Diluted) + Placebo Boost - Adults (v3.0) | Placebo (0.5 mL) - Adults (v3.0) | Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v3.0) | Placebo (1 mL) - Adults (v4.0) | rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Adults (v4.0) | rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Adults (v4.0) | Placebo (0.5 mL) - Adults (v4.0) | Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v4.0) | Total | Placebo (0.5 mL) - Adults (v2.0) | Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Adults (v2.0) | Placebo (1 mL) - Children (v3.0) | Placebo (0.5 mL) - Children (v2.0) | Placebo (0.5 mL) - Children (v3.0) | Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v3.0) | Placebo (1 mL) - Children (v4.0) | rVSVΔG-ZEBOV-GP (rVSV) Vaccine + rVSV Boost - Children (v4.0) | rVSVΔG-ZEBOV-GP (rVSV) Vaccine + Placebo Boost - Children (v4.0) | Placebo (0.5 mL) - Children (v4.0) | Ad26.ZEBOV (rHAd26) Vaccine + MVA-BN-Filo (MVA) Boost - Children (v4.0) | 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 - Children (v2.0) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Adults | 28 years | 28 years | 29 years | 31 years | 30 years | 26 years | 26 years | 27 years | 28 years | 27 years | 27 years | 27 years | 27 years | — | — | — | — | — | — | — | — | — | — | — | — |
| Age, Continuous Children | — | — | — | — | — | — | — | — | — | — | 10 years | — | — | 12 years | 14 years | 12 years | 12 years | 8 years | 8 years | 9 years | 8 years | 8 years | 12 years | 12 years | 14 years |
| Age, Customized 12-17 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 929 Participants | 0 Participants | 0 Participants | 54 Participants | 7 Participants | 58 Participants | 126 Participants | 63 Participants | 66 Participants | 138 Participants | 61 Participants | 139 Participants | 127 Participants | 56 Participants | 34 Participants |
| Age, Customized 1-4 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 549 Participants | 0 Participants | 0 Participants | 12 Participants | 0 Participants | 12 Participants | 25 Participants | 77 Participants | 71 Participants | 123 Participants | 59 Participants | 137 Participants | 24 Participants | 9 Participants | 0 Participants |
| Age, Customized 5-11 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 750 Participants | 0 Participants | 0 Participants | 41 Participants | 0 Participants | 37 Participants | 76 Participants | 70 Participants | 65 Participants | 146 Participants | 59 Participants | 127 Participants | 86 Participants | 43 Participants | 0 Participants |
| Age, Customized Adults >18 years | 100 Participants | 99 Participants | 177 Participants | 99 Participants | 187 Participants | 191 Participants | 197 Participants | 395 Participants | 221 Participants | 396 Participants | 2558 Participants | 172 Participants | 324 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Geometric Mean Ebola IgG Concentration (Version 4.0) Adults | — | — | — | — | — | 87 EU/mL STANDARD_DEVIATION 2.8 | 91 EU/mL STANDARD_DEVIATION 2.7 | 87 EU/mL STANDARD_DEVIATION 2.7 | 92 EU/mL STANDARD_DEVIATION 2.8 | 85 EU/mL STANDARD_DEVIATION 2.7 | 88 EU/mL STANDARD_DEVIATION 2.7 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Geometric Mean Ebola IgG Concentration (Version 4.0) Children | — | — | — | — | — | — | — | — | — | — | 66 EU/mL STANDARD_DEVIATION 3 | — | — | — | — | — | — | 73 EU/mL STANDARD_DEVIATION 3.1 | 67 EU/mL STANDARD_DEVIATION 3.1 | 67 EU/mL STANDARD_DEVIATION 3 | 66 EU/mL STANDARD_DEVIATION 2.8 | 63 EU/mL STANDARD_DEVIATION 3 | — | — | — |
| HIV Positive Adults | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 5 Participants | 3 Participants | 2 Participants | 13 Participants | 1 Participants | 6 Participants | 54 Participants | 8 Participants | 6 Participants | — | — | — | — | — | — | — | — | — | — | — | — |
| HIV Positive Children | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Median Ebola IgG Concentration (Version 4.0) Adults | — | — | — | — | — | 94 EU/mL | 94 EU/mL | 92 EU/mL | 99 EU/mL | 94 EU/mL | 95 EU/mL | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Median Ebola IgG Concentration (Version 4.0) Children | — | — | — | — | — | — | — | — | — | — | 70 EU/mL | — | — | — | — | — | — | 78 EU/mL | 69 EU/mL | 74 EU/mL | 68 EU/mL | 67 EU/mL | — | — | — |
| Number of Participants with Ebola IgG Concentration >= 200 EU/mL (Version 4.0) Adults | — | — | — | — | — | 30 Participants | 32 Participants | 58 Participants | 38 Participants | 50 Participants | 208 Participants | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Number of Participants with Ebola IgG Concentration >= 200 EU/mL (Version 4.0) Children | — | — | — | — | — | — | — | — | — | — | 163 Participants | — | — | — | — | — | — | 32 Participants | 19 Participants | 47 Participants | 22 Participants | 43 Participants | — | — | — |
| Number of Participants with Ebola IgG Concentration < 66.96 EU/mL (Version 4) Adults | — | — | — | — | — | 68 Participants | 66 Participants | 144 Participants | 78 Participants | 142 Participants | 498 Participants | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Number of Participants with Ebola IgG Concentration < 66.96 EU/mL (Version 4) Children | — | — | — | — | — | — | — | — | — | — | 670 Participants | — | — | — | — | — | — | 101 Participants | 97 Participants | 187 Participants | 87 Participants | 198 Participants | — | — | — |
| Number of Participants with Results for Ebola IgG Concentration (Version 4) Adults | — | — | — | — | — | 189 Participants | 197 Participants | 388 Participants | 220 Participants | 394 Participants | 1388 Participants | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Number of Participants with Results for Ebola IgG Concentration (Version 4) Children | — | — | — | — | — | — | — | — | — | — | 1385 Participants | — | — | — | — | — | — | 209 Participants | 200 Participants | 401 Participants | 177 Participants | 398 Participants | — | — | — |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Region of Enrollment Guinea | 76 Participants | 77 Participants | 141 Participants | 80 Participants | 144 Participants | 63 Participants | 66 Participants | 130 Participants | 72 Participants | 121 Participants | 1212 Participants | 84 Participants | 158 Participants | 77 Participants | 4 Participants | 72 Participants | 160 Participants | 79 Participants | 77 Participants | 156 Participants | 71 Participants | 163 Participants | 163 Participants | 76 Participants | 17 Participants |
| Region of Enrollment Liberia | 24 Participants | 22 Participants | 36 Participants | 19 Participants | 43 Participants | 38 Participants | 35 Participants | 70 Participants | 43 Participants | 73 Participants | 476 Participants | 88 Participants | 166 Participants | 30 Participants | 3 Participants | 35 Participants | 67 Participants | 30 Participants | 33 Participants | 66 Participants | 25 Participants | 64 Participants | 74 Participants | 32 Participants | 17 Participants |
| Region of Enrollment Mali | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 38 Participants | 41 Participants | 84 Participants | 48 Participants | 81 Participants | 292 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 51 Participants | 46 Participants | 94 Participants | 40 Participants | 95 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Sierra Leone | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 52 Participants | 55 Participants | 111 Participants | 58 Participants | 121 Participants | 311 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 50 Participants | 46 Participants | 91 Participants | 43 Participants | 81 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Adults Female | 49 Participants | 43 Participants | 75 Participants | 45 Participants | 99 Participants | 81 Participants | 87 Participants | 182 Participants | 106 Participants | 171 Participants | 1118 Participants | 60 Participants | 120 Participants | — | — | — | — | — | — | — | — | — | — | — | — |
| Sex: Female, Male Adults Male | 51 Participants | 56 Participants | 102 Participants | 54 Participants | 88 Participants | 110 Participants | 110 Participants | 213 Participants | 115 Participants | 225 Participants | 1440 Participants | 112 Participants | 204 Participants | — | — | — | — | — | — | — | — | — | — | — | — |
| Sex: Female, Male Children Female | — | — | — | — | — | — | — | — | — | — | 1057 Participants | — | — | 53 Participants | 5 Participants | 48 Participants | 122 Participants | 95 Participants | 85 Participants | 185 Participants | 87 Participants | 186 Participants | 117 Participants | 55 Participants | 19 Participants |
| Sex: Female, Male Children Male | — | — | — | — | — | — | — | — | — | — | 1171 Participants | — | — | 54 Participants | 2 Participants | 59 Participants | 105 Participants | 115 Participants | 117 Participants | 222 Participants | 92 Participants | 217 Participants | 120 Participants | 53 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 396 | 1 / 412 | 3 / 395 | 0 / 197 | 0 / 403 | 2 / 389 | 3 / 407 | 0 / 202 | 1 / 187 | 0 / 199 | 0 / 177 | 0 / 99 | 0 / 227 | 1 / 214 | 1 / 237 | 0 / 108 | 0 / 324 | 1 / 172 | 0 / 34 | 0 / 7 |
| other Total, other adverse events | 296 / 396 | 291 / 412 | 320 / 395 | 155 / 197 | 341 / 403 | 298 / 389 | 350 / 407 | 179 / 202 | 142 / 187 | 151 / 199 | 148 / 177 | 80 / 99 | 167 / 227 | 143 / 214 | 186 / 237 | 84 / 108 | 232 / 324 | 97 / 172 | 23 / 34 | 4 / 7 |
| serious Total, serious adverse events | 14 / 396 | 5 / 412 | 6 / 395 | 1 / 197 | 5 / 403 | 8 / 389 | 9 / 407 | 3 / 202 | 12 / 187 | 6 / 199 | 6 / 177 | 2 / 99 | 4 / 227 | 7 / 214 | 6 / 237 | 1 / 108 | 6 / 324 | 5 / 172 | 1 / 34 | 0 / 7 |
Outcome results
Primary
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
Population: The analysis population only includes participants from version 4.0 of the protocol. Adults and children are analyzed separately.~Participants with a missing baseline or 12-month antibody result are excluded. Participants with elevated antibody levels at baseline were not excluded. The placebo group is pooled. Percentages of participants that do not yield whole numbers are the result of rounding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Protocol Version 4.0 Ad26/MVA | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Adults | 40.9 percentage of participants |
| Protocol Version 4.0 Ad26/MVA | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Children | 78.5 percentage of participants |
| Protocol Version 4.0 rVSV | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Children | 87.3 percentage of participants |
| Protocol Version 4.0 rVSV | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Adults | 75.7 percentage of participants |
| Protocol Version 4.0 rVSV Boost | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Adults | 81.1 percentage of participants |
| Protocol Version 4.0 rVSV Boost | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Children | 92.6 percentage of participants |
| Protocol Version 4.0 Pooled Placebo | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Adults | 2.7 percentage of participants |
| Protocol Version 4.0 Pooled Placebo | Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response | Children | 3.6 percentage of participants |
Comparison: Analysis applies to both adults and children.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Frequency of Serious Adverse Events (SAEs)
SAEs as defined in the protocol
Time frame: Measured through Month 60
Secondary
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