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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201608001734218
• Date of registration: 01/08/2016
• Prospective Registration: No
• 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: 30/11/2015
• Target sample size: 575
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1734
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a computer software program,Central randomization by computer software
• Phase: Phase-2

Countries of recruitment

Kenya, Mozambique, Nigeria, Tanzania, Uganda

Contacts

• Name: Melissa van Alst
• Affiliation: Janssen Clinical Registry

• Name: Melissa van Alst
• Affiliation: Janssen Clinical Registry

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: 13 Year(s)
Age maximum: 18 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola
Ebola Vaccine

Ebola Vaccine

Ebola

Intervention(s)

Part 2 Group 2 African Participants Placebo

Part 1 US Participants MVA BN Filo Ad26 ZEBOV

Part 2 Group 1 African Participants Ad26 ZEBOV MVA BN Filo

Part 1 US Participants Placebo

Part 2 Group 1 African Participants Placebo

Part 2 Group 2 African Participants MVA BN Filo Ad26 ZEBOV

Primary Outcome(s)

Ebola Virus Glycoprotein (EBOV GP)-specific Antibody Concentrations measured by an enzyme-linked immunosorbent assay (ELISA)

Number of Participants with Adverse Events

Number of Participants with Serious Adverse Events

Number of Participants with Solicited Local and Systemic Adverse Events

Secondary Outcome(s)

Comparison of Safety and Tolerability of Ad26.ZEBOV/MVABN-Filo and MVA-BNFilo/Ad26.ZEBOV Regimens Between Healthy and HIV-Infected Adults

Secondary ID(s)

VAC52150EBL2003

Source(s) of Monetary Support

Janssen Vaccines & Prevention B.V

U.S. Military HIV Research Program (MHRP), Walter Reed Army Institute of Research (WRAIR)

Ethics review

Status: Approved
Approval date: 28/04/2016
Contact:

[e-mail]

Makarere University School of Public Health Higher Degrees Research and ethics Committee

00256414532207

[e-mail]

Status: Approved
Approval date: 25/05/2016
Contact:

[e-mail]

KEMRI Scientific and Ethics Review Unit

002540202722541

[e-mail]

Status: Approved
Approval date: 26/06/2016
Contact:

[e-mail]

National Health Research Ethics Committee of Nigeria NHREC

00234095238367

[e-mail]

Status: Approved
Approval date: 21/07/2016
Contact:

[e-mail]

National Bioethics Committee for Health CNBS

0025821427131

[e-mail]

Status: Approved
Approval date: 23/08/2016
Contact:

[e-mail]

Uganda National Council for Science and Technology

00256414705500

[e-mail]

Status: Approved
Approval date: 15/09/2016
Contact:

[e-mail]

National Institute for Medical Research

00255222121400

[e-mail]

Status: Approved
Approval date: 20/10/2016
Contact:

[e-mail]

Mbeya Medical Research and Ethics Committee

[phone]

[e-mail]