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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

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ClinicalTrials.gov Identifier: NCT02564523
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
EBOVAC2 Consortium
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE November 6, 2015
Actual Primary Completion Date February 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • Number of Participants With Adverse Events [ Time Frame: Up to 42 +/-3 days post-last vaccination ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to Day 365 +/- 1 month) ]
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Number of Participants With Adverse Events [ Time Frame: Up to 42 +/-3 days post-boost visit ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to Day 365 +/- 1 month) ]
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]
Change History Complete list of historical versions of study NCT02564523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • Antibody levels against the EBOV GP measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At 21 days post boost vaccination ]
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability of a Third Vaccination With Ad26.ZEBOV [ Time Frame: Up to 28 Days after third vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Immune responses to study vaccine regimens as measured by a virus neutralization assay against ebola virus glycoprotein (EBOV GP) [ Time Frame: At Day 1 (prime vaccination) and Day 14 (Groups 2 and 3, in healthy adults and elderly). At boost vaccination on Day 29, 57, 85 (Group 1, 2 and 3) and, Days 7 and 21 post-boost follow-up; At Days 180 (± 15 days) and 365 (± 1 month) long-term follow-up ]
  • Antibody levels against the EBOV GP Protein measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Day 1 (prime vaccination) and Day 14 (Groups 2 and 3, in healthy adults and elderly). At boost vaccination on Day 29, 57, 85 (Group 1, 2 and 3) and, Days 7 and 21 post-boost follow-up; At Days 180 (± 15 days) and 365 (± 1 month) long-term follow-up ]
  • Number of interferon gamma-producing T cells measured by an enzyme-linked immunospot (ELISpot) assay [ Time Frame: At Day 1 (prime vaccination) and Day 14 (Groups 2 and 3, in healthy adults and elderly). At boost vaccination on Day 29, 57, 85 (Group 1, 2 and 3) and, Days 7 and 21 post-boost follow-up; At Days 180 (± 15 days) and 365 (± 1 month) long-term follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.
Detailed Description This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, Phase 2 study evaluating the safety, tolerability and immunogenicity of 3 heterologous prime-boost regimens using Ad26.ZEBOV as prime and MVA-BN-Filo as boost vaccination, administered at 28-, 56- and 84-day (Group 1, 2 and 3 as above) intervals, in healthy adults and elderly participants. A 28- and 56-day (Groups 1 and 2, as above) schedule will be evaluated in HIV-infected participants and in healthy children in 2 age strata. The study consists of a screening phase of up to 8 weeks, a vaccination phase in which participants will be vaccinated at baseline (Day 1) followed by a boost vaccination on Day 29, 57 or 85, a post-vaccination phase and long-term follow-up phase until Day 365. Participants in Cohort 1 substudy (Group 1 and 2) who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination). All participants within a cohort will be followed in a blinded manner by the site until the last subject in that cohort has completed the study. This study will be conducted in Africa and the enrollment will take place sequentially in three cohorts: the first cohort will consist of healthy participants (18 - 70 years); the second cohort (2a) will include HIV-infected participants (18 to 50 years) and healthy children 12 to 17 years (cohort 2b); the third cohort will include children aged 4 to 11 years inclusive will be enrolled. Within each cohort, participants will be randomized in a 5:1 ratio to receive active vaccine versus placebo. Safety evaluations will include assessments of adverse events, an electrocardiogram (ECG) for adult participants at screening, physical examination, vital signs (blood pressure, pulse/heart rate, body temperature), clinical laboratory and pregnancy testing. An independent data monitoring committee (IDMC) will be established to monitor data on a regular basis to ensure the continuing safety of the participants enrolled in the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hemorrhagic Fever, Ebola
Intervention  ICMJE
  • Biological: Ad26.ZEBOV
    One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
  • Biological: MVA-BN-Filo
    One 0.5 mL IM injection of (1x10*8 infectious units)
  • Biological: Placebo
    One 0.5 mL IM injection of 0.9% saline
Study Arms  ICMJE
  • Experimental: Group 1
    Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 29) or placebo (Day 1/Day 29) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
    • Biological: Placebo
  • Experimental: Group 2
    Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 57) or placebo (Day 1/Day 57) followed by a subset of participants who received Ad26.ZEBOV and MVA-BN-Filo (at selected sites) will receive Ad26.ZEBOV as third vaccination and who received placebo will receive placebo as third vaccination (at least 1 year post prime vaccination).
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
    • Biological: Placebo
  • Experimental: Group 3
    Participants will receive Ad26.ZEBOV, MVA-BN-Filo (Day 1/Day 85) or placebo (Day 1/Day 85)
    Interventions:
    • Biological: Ad26.ZEBOV
    • Biological: MVA-BN-Filo
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
1075
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
1188
Actual Study Completion Date  ICMJE February 12, 2019
Actual Primary Completion Date February 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Criteria for healthy adults and elderly participants:

  • Participant must be healthy in the investigator's clinical judgment on the basis of clinical laboratory tests, medical history, ECG, physical examination and vital signs performed at screening. Participants with hemoglobin values outside the local laboratory reference ranges may be included if the 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 and 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
  • Participant must pass the test of understanding (TOU)
  • Participant must be available and 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
  • Participant must be between 18 to 50 years of age and must have a documented HIV-infection for at least 6 months prior to screening
  • Participant must be on a stable 3 drug regimen of Highly Active Antiretroviral Therapy for at least 4 weeks prior to screening and having a CD4 positive cell count of >350 cells/microliter. 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 and 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 or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Côte D'Ivoire,   Burkina Faso,   Kenya,   Uganda
Removed Location Countries Ghana,   Rwanda,   Tanzania
 
Administrative Information
NCT Number  ICMJE NCT02564523
Other Study ID Numbers  ICMJE CR107249
VAC52150EBL2002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE EBOVAC2 Consortium
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP