A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
NCT02325050 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2017-06-14
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.
Conditions
- Healthy
Interventions
- 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.
Sponsors & Collaborators
-
Janssen Vaccines & Prevention B.V.
lead INDUSTRY
Principal Investigators
-
Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-08
- Primary Completion
- 2015-07-02
- Completion
- 2017-05-08
Countries
- United States
Study Locations
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