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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02598388
• Date of registration: 04/11/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
• Scientific title: A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
• Date of first enrolment: December 10, 2015
• Target sample size: 578
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02598388
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Kenya, Mozambique, Nigeria, Tanzania, Uganda, United States

Contacts

• Name: Janssen Vaccines & Prevention B.V. Clinical Trial
• Affiliation: Janssen Vaccines & Prevention B.V.

Key inclusion & exclusion 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 ß-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 <350 cells/mcL must also be on a stable
HAART regimen for 4 weeks prior to Screening

Exclusion Criteria:

- Has received any candidate Ebola vaccine

- Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to
epidemic Ebola areas less than 1 month prior to Screening

- Has received any experimental candidate Ad26- or MVA-based vaccine in the past or
received any other investigational drug or investigational vaccine or used an invasive
investigational medical device within 3 months prior to Screening

- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines
or vaccine products

- Presence of significant conditions (eg, history of seizure disorders, (auto)immune
disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis
treatment, other systemic infections) or clinically significant findings during
screening of medical history, ECG (only in participants >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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hemorrhagic Fever, Ebola

Intervention(s)

Biological: Ad26.ZEBOV

Biological: Placebo

Biological: MVA-BN-Filo

Primary Outcome(s)

Ebola Virus Glycoprotein (EBOV GP)-specific Antibody Concentrations Measured by an Ezyme-linked Immunosorbent Assay (ELISA) [Time Frame: Up to day 21 after dose 2 vaccination]

Number of Participants with Solicited Local and Systemic Adverse Events [Time Frame: Up to 7 days after each study vaccination]

Number of Participants With Serious Adverse Events [Time Frame: Continuous throughout the duration of the study (up to 1 year post dose 2 visit +/- 1 month)]

Number of Participants With Adverse Events [Time Frame: Up to Day 42 post-dose 2 visit]

Secondary Outcome(s)

Comparison of Safety and Tolerability of Ad26.ZEBOV/MVA-BN-Filo and MVA-BN- Filo/Ad26.ZEBOV Regimens Between Healthy and HIV-Infected Adults [Time Frame: Up to 1 year post dose 2]

Secondary ID(s)

VAC52150EBL2003

CR108062

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Walter Reed Army Institute of Research (WRAIR)