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

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ClinicalTrials.gov Identifier: NCT02598388
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 5, 2015
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE December 10, 2015
Actual Primary Completion Date December 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Number of Participants With Adverse Events [ Time Frame: Up to Day 42 post-boost visit ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to 1 year post boost visit +/- 1 month) ]
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]
  • Antibody levels against the ebola virus glycoprotein (EBOV GP) measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Up to day 21 after boost vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02598388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2016)
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 boost ]
The comparison will be made on the basis of treatment emergent adverse events as well as comparison of the solicited local and systemic adverse events for tolerability.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Immune Responses to study vaccine regimens as measured by a virus neutralization assay against ebola virus glycoprotein (EBOV GP) [ Time Frame: Day 21, 42, Month 6 and 1 year post boost ]
  • Number of interferon-gamma producing T Cells measured by an enzyme-linked immunospot (ELISpot) assay [ Time Frame: Day 21, 42, Month 6 and 1 year post boost ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Immunogenicity Study of 2 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
Official Title  ICMJE 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
Brief 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 heterologous prime-boost regimens in healthy and in HIV-infected adults.
Detailed Description This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, 2-part, Phase 2 study Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In part 1, prime vaccination with MVA-Bn-Filo will be followed by boost vaccination with Ad26 14 days later in the US. In part 2, two regimens will be investigated. The first regimen will be Ad26 prime vaccination followed by MVA-BN-Filo boost 28 days later and the second regimen will be MVA-BN-Filo prime vaccination followed by MVA-BN-Filo boost 14 days later in Africa. The study consists of a Screening phase of up to 8 weeks (starting from the moment the participants signs the ICF), a Vaccination Phase, in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 15 or 29, and a post-boost follow-up phase of maximum 1 year post-boost vaccination. Upon completion of 6-month post boost visit those participants who received active vaccine will enter long-term follow-up until the 1 year post boost vaccination visit to assess long-term safety and immunogenicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hemorrhagic Fever, Ebola
Intervention  ICMJE
  • Biological: Ad26.ZEBOV
    One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).
  • Biological: MVA-BN-Filo
    One 0.5 mL IM injection of (1x10*8 infectious units).
  • Biological: Placebo
    One 0.5 mL IM injection of 0.9 percent (%) saline.
Study Arms  ICMJE
  • Experimental: Part 1 (US Participants)
    Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
    • Biological: Placebo
  • Experimental: Part 2 Group 1 (African Participants)
    Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 29.
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
    • Biological: Placebo
  • Experimental: Part 2 Group 2 (African Participants)
    Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
578
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2015)
575
Actual Study Completion Date  ICMJE December 12, 2018
Actual Primary Completion Date December 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 prime vaccination until at least 3 months after the boost 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya,   Mozambique,   Nigeria,   Tanzania,   Uganda,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02598388
Other Study ID Numbers  ICMJE CR108062
VAC52150EBL2003 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Walter Reed Army Institute of Research (WRAIR)
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP