VAC52150EBL2002: Safety, Tolerability and Immunogenicity Study of 3 Prime-boost Regimens for Ebola vaccines Ad26.ZEBOV/MVA-BN-Filo in Healthy Adults, Children and Human Immunodeficiency Virus Positive (HIV+) Adults
- Conditions
- Ebola
- Registration Number
- PACTR202002606736841
- Lead Sponsor
- Janssen Vaccines and Prevention B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1056
For healthy adults and elderly participants:
*Must be healthy in the investigator’s clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination & vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if hemoglobin is above the age/gender specific limits
*Female participants of childbearing potential must use adequate birth control measures, must have a negative pregnancy test at screening & immediately prior to each study vaccination
*A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening
*Must pass the test of understanding (TOU)
*Must be available & willing to participate for the duration of the study visits and follow-up, provide verifiable identification, and have a means to be contacted
Additional Inclusion Criteria HIV-infected Participants
*Must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening
*Must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening & having a CD4 positive cell count of >350 cells/micoliter. Also participant must be in an otherwise reasonable good medical condition
Additional Inclusion Criteria Children Participants
*Parent/legal guardian must pass the TOU before signing the inform consent form. Informed assent must be obtained from adolescents & older children, depending on local regulations and practice.
*Pediatric participant's age on the day of randomization must be within one of the 2 age strata: 12-17 years or 4-11 years (all ages inclusive)
*Pediatric participants must have received all routine immunizations appropriate for his/her age as reported by parent(s)/legal guardian, according to local routine vaccination schedule
*Diagnosed with Ebola virus disease or previously exposed to Ebola virus including travel to epidemic Ebola areas less than 1 month prior to screening
*Having received any candidate Ebola vaccine or any experimental candidate Ad26- or MVA-based vaccine in the past
*Having HIV type 1 or type 2 infection (for healthy adults/elderly/children)
*Pediatric participants with weight-per-height below 10th percentile according to the Centers for Disease Control and Prevention (CDC) growth charts (4- to 11-year-olds)
*A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination or up to 1 month after the boost vaccination (whichever takes longer) or within at least 3 months after the third vaccination
*For HIV+ adults, no AIDS-defining illnesses
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants With Adverse Events;Number of Participants With Serious Adverse Events;Number of Participants with Solicited Local and Systemic Adverse Events
- Secondary Outcome Measures
Name Time Method Antibody levels against the EBOV GP measured by an enzyme-linked immunosorbent assay (ELISA);Number of Participants With Adverse Events as a Measure of Safety and Tolerability of a Third Vaccination With Ad26.ZEBOV