Phase 2 N=574 Randomized Triple-blind Prevention

Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

Hemorrhagic Fever, Ebola

Bottom Line

View on ClinicalTrials.gov: NCT02598388 ↗

Enrolled (actual)

574

Serious AEs

1.7%

Results posted

Feb 2022

Primary outcome: Primary: Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events — 33; 10; 32; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ad26.ZEBOV (Biological); MVA-BN-Filo (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Vaccines & Prevention B.V.
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events	33; 10; 32; 3	—
PRIMARY Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events	83; 21; 78; 15	—
PRIMARY Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs)	1; 1; 3; 1	—
PRIMARY Part 2 (Group 1): Number of Participants With SAEs	1; 1; 2; 0	—
PRIMARY Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs)	0; 0; 0; 0	—
PRIMARY Part 2 (Group 1): Number of Participants With IREs	0; 0; 0; 0	—
PRIMARY Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination	46; 5; 34; 3; 71; 10	—
PRIMARY Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination	44; 4; 33; 0	—
PRIMARY Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination	82; 7; 64; 7	—
PRIMARY Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination	39; 10; 37; 7; 109; 24	—
PRIMARY Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination	45; 8; 35; 4	—
PRIMARY Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination	83; 20; 80; 10	—
PRIMARY Part 1, Part 2 (Group 2): 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 (ELISA)	5733; 40; 2325; NA	—
PRIMARY Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA	6037; NA; 2939; NA	—
SECONDARY Number of Participants With Adverse Events	33; 32; 83; 78; 56; 47	—

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.

Eligibility Criteria

Inclusion Criteria

Participant must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening
Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants >50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin [beta-hCG] pregnancy test at Screening and a negative urine [beta-hCG] pregnancy test immediately prior to each study vaccine administration
A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to dose 1 vaccination until at least 3 months after the dose 2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening
Participant must pass the test of understanding (TOU)
Additional Inclusion Criteria for HIV-infected participants a) participants must have a positive HIV-1 and/or -2 serology test within 6 months of screening, including the day of screening; b) participants must have a Screening CD4+ cell count >200 cells/microliter (mcL); c) in part 1, all participants must be on a stable highly active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part 2 participants with screening CD4+ cell count 50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02598388). 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.