NCT02325050

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

A Phase 1, Randomized, Placebo-Controlled, Observer-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous and Homologous Prime-Boost Regimens Using MVA-BN-Filo® and Ad26.ZEBOV Administered in Different Doses, Sequences and Schedules in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · 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 and homologous prime-boost vaccine regimens in healthy adult participants.

Detailed description

This study consists of 3 parts: the first and third part with standard doses and the second part with higher doses. All parts are randomized, placebo-controlled, observer-blind to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8). The total duration of the study will be about 1 year for participants who wiil receive boost vaccine and about 3 months for participants who will receive placebo and 2 year for participants who will receive a 3rd dose. Safety will be monitored during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN-Filo	One 0.5 milliliter (ml) intramuscular (IM) injection of 1\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]).
BIOLOGICAL	Ad26. ZEBOV	One 0.5 mL IM injection of 5\*10\^10 viral particles (vp).
BIOLOGICAL	MVA-BN-Filo	One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4\*10\^8, (50%Tissue Culture Infectious Dose \[TCID50\]).
BIOLOGICAL	Ad26. ZEBOV	One 0.5 mL IM injection of 1\*10\^11 viral particles (vp).
OTHER	Placebo	One 0.5 mL IM injection of 0.9% saline.

Timeline

• Start date: 2015-01-08
• Primary completion: 2015-07-02
• Completion: 2017-05-08
• First posted: 2014-12-24
• Last updated: 2017-06-14

Locations

1 site across 1 country: United States