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Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 (EBOVAC-Salone)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Janssen Vaccines & Prevention B.V.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Ministry of Health and Sanitation of Sierra Leone
College of Medicine and Allied Health Sciences (COMAHS)
University of Oxford
Institut National de la Santé Et de la Recherche Médicale, France
Grameen Foundation
World Vision of Ireland
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02509494
First received: June 24, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen.

Condition Intervention Phase
Healthy
Biological: Ad26.ZEBOV
Biological: MVA-BN-Filo
Biological: Menveo
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola

Resource links provided by NLM:


Further study details as provided by Janssen Vaccines & Prevention B.V.:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: Up to 56 days post boost vaccination in stage 1; Up to 28 days after each vaccination in stage 2 ]
  • Number of participants With Serious Adverse Events [ Time Frame: up to 3 years post prime in stage 1; up to Day 360 in stage 2 ]
  • Number of Participants with Solicited local and systemic adverse events [ Time Frame: Up to 7 days after each vaccination ]
  • Serum concentration of antibodies binding to EBOV GP [ Time Frame: up to 3 years in stage 1; up to Day 360 in stage 2 ]
    Blood samples will be collected from all subjects from Stage 1 and 2 to assess humoral immune responses to the vaccines over time


Estimated Enrollment: 1019
Actual Study Start Date: September 30, 2015
Estimated Study Completion Date: May 12, 2019
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1: Active vaccination
Ad26.ZEBOV will be administered as a 0.5 milliliter (mL) intramuscular (IM) injection (prime); MVA-BN-Filo will be administered as a 0.5 mL IM injection (boost).
Biological: Ad26.ZEBOV
Ebola Zaire vaccine, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.
Biological: MVA-BN-Filo
MVA‐BN‐Filo‐ is a live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).
Experimental: Stage 2: Active vaccination
Ad26.ZEBOV will be administered as a 0.5 milliliter (mL) intramuscular (IM) injection (prime); MVA-BN-Filo will be administered as a 0.5 mL IM injection (boost). Children aged less than 2 years at randomization will receive a third vaccination at 3 months post boost with Placebo.
Biological: Ad26.ZEBOV
Ebola Zaire vaccine, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.
Biological: MVA-BN-Filo
MVA‐BN‐Filo‐ is a live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).
Active Comparator: Stage 2: Control vaccination
Menveo will be administered as a 0.5 mL IM injection on Day 1 (prime) and placebo on Day 57 (boost).
Biological: Menveo
Menveo WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
Biological: Placebo
0.9% saline for injection
Active Comparator: Stage 2: Control vaccination for children
Menveo will be administered as a 0.5 mL IM injection on Day 1 (prime) and placebo on Day 57 (boost). Children aged less than 2 years at randomization will receive a third vaccination at 3 months post boost with Menveo.
Biological: Menveo
Menveo WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
Biological: Placebo
0.9% saline for injection

Detailed Description:
This is staged Phase 3 study to gather information on the safety and immunogenicity of a heterologous prime-boost regimen. In this regimen, Ad26.ZEBOV will be administered as a prime vaccination and later boosted with the candidate vaccine MVA-BN-Filo. The study will take place in Sierra Leone and will consist of a screening phase, an active phase (vaccination) and a follow-up phase. The active phase of the study will be conducted initially in two stages. In the first stage approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity of the prime-boost regimen. In stage 2 a larger group of approximately 688 individuals will be vaccinated to further evaluate the safety and immunogenicity of the prime-boost regimen across different age groups. In this stage, children aged 1 year or older, adolescents and adults will be included. Solicited local and systemic adverse events will be collected until 7 days after the prime and boost vaccination. Unsolicited adverse events will be collected from signing of the informed consent form (ICF) onwards until 56 days after the boost vaccination in Stage 1 and until 28 days after the prime vaccination in Stage 2, and then again until 28 days after the boost vaccination. Serious adverse events will be collected from signing of the ICF onwards until 12 and 36 months after the prime vaccination in Stage 2 and Stage 1, respectively. These data will be reviewed by an independent data monitoring committee (IDMC) to assess whether initiation of vaccination in the next stage or age group can be provided. Safety evaluations will include assessment of adverse events, which will be monitored throughout the study. Participants in Stage 2 will be followed up for safety and immunogenicity until 12 months after the prime vaccination. Participants in Stage 1 will be followed up for safety and immunogenicity until 36 months after the prime vaccination.
  Eligibility

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria Stage 1 and 2:

  • Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available
  • Participant Stage 1 must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months
  • Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before prime vaccination
  • Female subjects of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
  • Participant must pass the test of understanding (TOU)

Additional Inclusion criteria Stage 2:

  • One year or older at screening (children of enrolled parents are eligible)
  • Parent/legal guardian (for children) must pass the TOU before signing the ICF
  • Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness

Exclusion Criteria:

  • Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of >= 38 degree Celsius (fever)
  • Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
  • Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
  • Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before prime vaccination
  • Treated with an immunosuppressive drug at the time of screening

Additional exclusion criteria:

- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02509494

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Sierra Leone
Recruiting
Kambia, Sierra Leone
Recruiting
Rokupr, Sierra Leone
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
London School of Hygiene and Tropical Medicine
Ministry of Health and Sanitation of Sierra Leone
College of Medicine and Allied Health Sciences (COMAHS)
University of Oxford
Institut National de la Santé Et de la Recherche Médicale, France
Grameen Foundation
World Vision of Ireland
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
  More Information

Additional Information:
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02509494     History of Changes
Other Study ID Numbers: CR107372
VAC52150EBL3001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
115854 EBOVAC1 ( Other Grant/Funding Number: The Trial is financed within the IMI-2 Ebola program )
Study First Received: June 24, 2015
Last Updated: March 21, 2017

Keywords provided by Janssen Vaccines & Prevention B.V.:
Vaccine
Ebola
Ebola virus disease
EVD
Hemorrhagic fever
Sierra Leone
Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Safety
Immunogenicity
Modified Vaccinia Virus Ankara ‐ Bavarian Nordic Filo‐vector
(MVA‐BN Filo)

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 23, 2017