Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-boost Regimens of the Candidate Prophylactic Vaccines for

Brief 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 adults, healthy adolescents, children and young children.

Detailed Summary: This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in children. The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a post-vaccination phase and long-term follow-up phase until Day 365. All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study. This study will be conducted in Africa and the enrollment will take place sequentially in four cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive and in the fourth cohort young children aged 1 to 3 years will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.
Sponsor: Janssen Vaccines & Prevention B.V.

Current Primary Outcome:

  • Number of Participants With Adverse Events [ Time Frame: Up to 42 +/-3 days post-last vaccination ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to Day 365 +/- 1 month) ]
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]


Original Primary Outcome:

  • Number of Participants With Adverse Events [ Time Frame: Up to 42 +/-3 days post-boost visit ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to Day 365 +/- 1 month) ]
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]


Current Secondary Outcome: Antibody levels against the EBOV GP measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Up to 365 days postprime Vaccination ]

Original Secondary Outcome:

  • Immune responses to study vaccine regimens as measured by a virus neutralization assay against ebola virus glycoprotein (EBOV GP) [ Time Frame: At Day 1 (prime vaccination) and Day 14 (Groups 2 and 3, in healthy adults and elderly). At boost vaccination on Day 29, 57, 85 (Group 1, 2 and 3) and, Days 7 and 21 post-boost follow-up; At Days 180 (± 15 days) and 365 (± 1 month) long-term follow-up ]
  • Antibody levels against the EBOV GP Protein measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Day 1 (prime vaccination) and Day 14 (Groups 2 and 3, in healthy adults and elderly). At boost vaccination on Day 29, 57, 85 (Group 1, 2 and 3) and, Days 7 and 21 post-boost follow-up; At Days 180 (± 15 days) and 365 (± 1 month) long-term follow-up ]
  • Number of interferon gamma-producing T cells measured by an enzyme-linked immunospot (ELISpot) assay [ Time Frame: At Day 1 (prime vaccination) and Day 14 (Groups 2 and 3, in healthy adults and elderly). At boost vaccination on Day 29, 57, 85 (Group 1, 2 and 3) and, Days 7 and 21 post-boost follow-up; At Days 180 (± 15 days) and 365 (± 1 month) long-term follow-up ]


Information By: Janssen Vaccines & Prevention B.V.

Dates:
Date Received: September 29, 2015
Date Started: November 6, 2015
Date Completion: June 18, 2019
Last Updated: March 28, 2017
Last Verified: March 2017