NCT02313077

A Safety and Immunogenicity Study of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.

Detailed description

This first-in-human study consists of 2 parts: 1) The main study, which is randomized, placebo-controlled, observer-blind; 2) A sub-study, which is open-label, uncontrolled, non-randomized study evaluating the safety, tolerability, and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different sequences and schedules to healthy adult participants. The study consists of a Screening period (up to 28 days in the main study and up to 56 days in the sub-study), a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29 or 57, and a post-boost follow-up until all participants have had their 21-day post-boost visit (Day 36, 50 or Day 78). The total duration of the study will be about 1 year for participants who received vaccine and about 3 months for participants who received placebo. Safety will be monitored during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN-filo	One 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose \[TCID50\]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).
BIOLOGICAL	Ad26. ZEBOV	One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).
OTHER	Placebo	One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).

Timeline

• Start date: 2014-12-17
• Primary completion: 2015-04-17
• Completion: 2016-03-15
• First posted: 2014-12-09
• Last updated: 2017-04-14

Locations

1 site across 1 country: United Kingdom