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A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
Details
| Lead sponsor | Janssen Vaccines & Prevention B.V. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 72 |
| Start date | 2016-08 |
| Completion | 2018-01 |
Conditions
- Healthy
Interventions
- Ad26.Filo
- MVA-BN-Filo
- Ad26.ZEBOV
- Placebo
- MVA-BN-Filo
Primary outcomes
- Number of Participants With Adverse events (AEs) — Up to 28 days after the last vaccination
- Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events) — One Week after each study vaccine administration
- Number of Participants With Serious Adverse Events — Up to the end of long-term follow-up (Day 360)
Countries
United States