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 July 2016 by Crucell Holland BV
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):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT02509494
First received: June 24, 2015
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
The purpose of this study is the evaluation of the safety and immunogenicity, during the implementation of Stages 1-2, 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Crucell Holland BV:

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 ] [ Designated as safety issue: Yes ]
  • Number of participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to Day 360 ± 1 month) ] [ Designated as safety issue: Yes ]
  • Number of Participants with Solicited local and systemic adverse events [ Time Frame: Up to 7 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Serum concentration of antibodies binding to EBOV GP [ Time Frame: Up to Day 360 (± 1 month) ] [ Designated as safety issue: No ]
    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: 728
Study Start Date: September 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: October 2017 (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 into either shoulder muscle in the upper arm as the prime vaccination; MVA-BN-Filo will be administered as a 0.5 mL IM injection into either shoulder muscle in the upper arm as the boost vaccination.
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 into either shoulder muscle in the upper arm as the prime vaccination; MVA-BN-Filo will be administered as a 0.5 mL IM injection into either shoulder muscle in the upper arm as the boost vaccination.
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 into either deltoid in the upper arm as the prime vaccination on Day 1 and placebo as boost on Day 57.
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 into either deltoid in the upper arm as the prime vaccination on Day 1. Children younger than 2 years of age will receive a second dose of Menveo as boost on Day 57 .
Biological: Menveo
Menveo WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.

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, the immune system will be primed with the candidate vaccine Ad26.ZEBOV 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. Safety data will be collected in stage 1 and 2, seven days after the initial vaccination and boost vaccination. 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. For Stages 1 and 2, the follow-up will be 360 days after prime vaccination.
  Eligibility

Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
Crucell Holland BV
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: Crucell Holland BV Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT02509494     History of Changes
Other Study ID Numbers: CR107372  VAC52150EBL3001  115854 EBOVAC1 
Study First Received: June 24, 2015
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration
Sierra Leone: Ministry of Health and Sanitation

Keywords provided by Crucell Holland BV:
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 July 21, 2016