Phase 2 N=1,073 Randomized Triple-blind Prevention

Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults

Hemorrhagic Fever, Ebola

Bottom Line

View on ClinicalTrials.gov: NCT02564523 ↗

Enrolled (actual)

1,073

Serious AEs

2.4%

Results posted

Mar 2022

Primary outcome: Primary: Number of Participants With Adverse Events (Day 29) — 96; 17; 68; 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ad26.ZEBOV (Biological); MVA-BN-Filo (Biological); Placebo (Biological)
Age: Pediatric, Adult, Older Adult · 4+ yrs
Sex: All
Sponsor: Janssen Vaccines & Prevention B.V.
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (Day 29)	96; 17; 68; 17; 37; 6	—
PRIMARY Number of Participants With Adverse Events (AEs) (28-Day Interval)	74; 15; 22; 4; 18; 4	—
PRIMARY Number of Participants With Adverse Events (56-day Interval)	58; 13; 22; 4; 26; 4	—
PRIMARY Number of Participants With Adverse Events (84-day Interval)	34; 7	—
PRIMARY Number of Participants With Adverse Events Post-dose 3 (Day 393)	9; 3; 14; 0	—
PRIMARY Number of Participants With Serious Adverse Events	7; 1; 7; 0; 6; 0	—
PRIMARY Number of Participants With Immediate Reportable Events (IREs)	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Solicited Local Adverse Events (Day 8)	123; 16; 121; 20; 63; 11	—
PRIMARY Number of Participants With Solicited Local Adverse Events (28-day Interval)	126; 9; 26; 2; 29; 3	—
PRIMARY Number of Participants With Solicited Local Adverse Events Post-dose 2 (56-day Interval)	113; 16; 25; 2; 20; 3	—
PRIMARY Number of Participants With Solicited Local Adverse Events (84-day Interval)	57; 9	—
PRIMARY Number of Participants With Solicited Local Adverse Events (Day 372)	18; 1; 16; 3	—
PRIMARY Number of Participants With Solicited Systemic Adverse Events (Day 8)	146; 27; 140; 26; 75; 14	—
PRIMARY Number of Participants With Solicited Systemic Adverse Events (28-Day Interval)	121; 14; 32; 4; 27; 3	—
PRIMARY Number of Participants With Solicited Systemic Adverse Events (56-Day Interval)	121; 21; 26; 6; 25; 6	—
PRIMARY Number of Participants With Solicited Systemic Adverse Events (84-Day Interval)	64; 14	—
PRIMARY Number of Participants With Solicited Systemic Adverse Events (Day 372)	17; 2; 18; 4	—
SECONDARY Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay	3085; NA; 4207; NA; 6993; NA	—
SECONDARY Number of Participants With Serious Adverse Events Post-dose 3	0; 0; 0; 0	—

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.

Eligibility Criteria

Inclusion Criteria

Criteria for healthy adults and elderly participants:

Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the hemoglobin is above the age/gender specific limits
Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening and immediately prior to each study vaccination
A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening
Participant must pass the test of understanding (TOU)
Participant must be available and willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted Additional Inclusion Criteria HIV-infected Participants
Participant must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening
Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening and having a CD4 positive cell count of >350 cells/microliter. Also participant must be in an otherwise reasonable good medical condition Additional Inclusion Criteria Children Participants
Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents and older children, depending on local regulations and practice
Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive)
Pediatric participants must have received all routine immunizations appropriate for his or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules

Exclusion criteria

Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening
Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past
Having HIV type 1 or type 2 infection (for healthy adults/elderly/children)
Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds)
A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination
For HIV+ adults, no AIDS-defining illnesses

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02564523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.