A 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 Adults
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 2/7/2018 |
Start Date: | August 2016 |
End Date: | January 2018 |
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.
Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
Inclusion Criteria:
- Body mass index (BMI) of greater than or equal to (>=) 18.5 and less than (<) 35.0
kilogram per square meter (kg/m^2)
- Healthy on the basis of physical examination, medical history, and the investigator's
clinical judgment
- All women of childbearing potential must have a negative serum (beta-human chorionic
gonadotropin [beta-hCG]) pregnancy test at screening, have a negative urine beta-hCG
pregnancy test immediately prior to each study vaccine administration
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction from the start of screening onwards until at least 3 months after the
last vaccination
- Participant must be available and willing to participate for the duration of the study
visits and follow-up
Exclusion Criteria:
- Has been vaccinated with a candidate filovirus vaccine
- Has received any Ad26- or MVA-based candidate vaccines in the past
- Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV),
Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or
TAFV, including participants who traveled to epidemic filovirus areas in West Africa
during the last 2 years (that is, since the start of the last Ebolavirus outbreak)
should be excluded from the study
- Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface
antigen and hepatitis C antibody, respectively
- Acute illness (this does not include minor illnesses such as diarrhea or mild upper
respiratory tract infection) or body temperature greater than or equal to (>=) 38.0
degree Celsius on Day 1
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