PACTR202002606736841CompletedPhase 2
A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
Janssen Vaccines and Prevention B.V.0 sites1,056 target enrollmentStarted: November 6, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 1,056
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 Year(s) to 5 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •*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
Investigators
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