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Clinical Trial Summary

The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.


Clinical Trial Description

This is staged Phase 3 study to gather information on the safety and immunogenicity of a heterologous prime-boost regimen. In this regimen, Ad26.ZEBOV will be administered as a prime vaccination, then boosted with the candidate vaccine MVA-BN-Filo and later the third vaccination using Ad26.ZEBOV will be administered 2 years post prime vaccination to participants in Stage 1 who consent to this. The study will take place in Sierra Leone and will consist of a screening phase, an active phase (vaccination) and a follow-up phase. The active phase of the study will be conducted initially in two stages. In the first stage approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity of the prime-boost regimen. In stage 2 a larger group of approximately 976 individuals will be vaccinated to further evaluate the safety and immunogenicity of the prime-boost regimen across different age groups. In this stage, children aged 1 year or older, adolescents and adults will be included. Solicited local and systemic adverse events will be collected until 7 days after the prime and boost vaccination. Unsolicited adverse events will be collected from signing of the informed consent form (ICF) onwards until 56 days after the boost vaccination in Stage 1 and then again from the day of the third vaccination until 28 days after the third vaccination, and until 28 days after the prime vaccination in Stage 2, and then again until 28 days after the boost vaccination. Serious adverse events will be collected from signing of the ICF onwards until 12 and 36 months after the prime vaccination in Stage 2 and Stage 1, respectively. These data will be reviewed by an independent data monitoring committee (IDMC) to assess whether initiation of vaccination in the next stage or age group can be provided. Safety evaluations will include assessment of adverse events, which will be monitored throughout the study. Participants in Stage 2 will be followed up for safety and immunogenicity until 12 months (children and adolescents) or 24 months (adults) after the prime vaccination. Participants in Stage 1 will be followed up for safety and immunogenicity until 36 months after the prime vaccination or until 1 year after the third vaccination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02509494
Study type Interventional
Source Janssen Vaccines & Prevention B.V.
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 30, 2015
Completion date August 2, 2019

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