Last updated on June 2017

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


Brief description of study

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 participants and healthy children in 2 age strata.

Detailed Study Description

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 adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in healthy children in 2 age strata. 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. Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). 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 three 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 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.

Clinical Study Identifier: NCT02564523

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Centre MURAZ

Centre MURAZ
Bobodioulasso, Burkina Faso
  Connect »

Centre National de Recherche et ...

Centre National de Recherche et de Formation sur le Paludisme (CNRFP)
Ouagadougou, Burkina Faso
  Connect »

Centre Hospitalier Universitaire de Treichville

Centre Hospitalier Universitaire de Treichville
Abidjan, Côte D'Ivoire
  Connect »

Centre Medical SAPH Toupah

Centre Medical SAPH Toupah
Toupah/Ousrou, Côte D'Ivoire
  Connect »

Univeristy of Nairobi - KAVI ...

Univeristy of Nairobi - KAVI Institute of Clinical Research
Nairobi, Kenya
  Connect »

Medical Research Council-Uganda Virus Research ...

Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS (MRC/UVRI)
Entebbe, Uganda
  Connect »

Makerere University - Walter Reed ...

Makerere University - Walter Reed Project
Kampala, Uganda
  Connect »