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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)

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ClinicalTrials.gov Identifier: NCT02509494
Recruitment Status : Active, not recruiting
First Posted : July 28, 2015
Last Update Posted : August 16, 2018
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.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Biological: MenACWY Biological: Placebo Phase 3

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, then boosted with the candidate vaccine MVA-BN-Filo and later the third vaccination using Ad26.ZEBOV will be administered 2 years post prime vaccination to participants in Stage 1 who consent to this. 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 976 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 then again from the day of the third vaccination until 28 days after the third vaccination, 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 (children and adolescents) or 24 months (adults) after the prime vaccination. Participants in Stage 1 will be followed up for safety and immunogenicity until 36 months after the prime vaccination or until 1 year after the third vaccination.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1023 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Actual Study Start Date : September 30, 2015
Estimated Primary Completion Date : August 2, 2019
Estimated Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
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). The third vaccination using Ad26.ZEBOV will be administered as a 0.5 mL IM injection (2 years post prime).
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 mL 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 for children
Ad26.ZEBOV will be administered as a 0.5 mL 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
MenACWY will be administered as a 0.5 mL IM injection on Day 1 (prime) and placebo on Day 57 (boost).
Biological: MenACWY
MenACWY is a 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
MenACWY 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 MenACWY.
Biological: MenACWY
MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.

Biological: Placebo
0.9% saline for injection.




Primary Outcome Measures :
  1. Stage 1: Number of Participants with Adverse Events [ Time Frame: From signing informed consent form (ICF) till 56 days after the boost vaccination (approximately 156 days) ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  2. Stage 2: Number of Participants with Adverse Events [ Time Frame: From signing ICF till 28 days post-prime and 28 days post-boost vaccination (approximately 79 days) ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  3. Stage 1: Number of participants with Serious Adverse Events [ Time Frame: From signing ICF till 36 months post prime (approximately up to 38 months) ]
    An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  4. Stage 2: Number of participants With Serious Adverse Events [ Time Frame: From signing ICF till 2 years post-prime in stage 2 (approximately up to 2 years and 1 month) ]
    An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  5. Stage 1 and 2: Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each vaccination ]
    Following local AEs: redness of skin, swelling/induration, pain/tenderness, and itching at the injection site will be noted in the participant diary. Following solicited systemic AEs: body temperature, vomiting, reduced activity, somnolence, fatigue, irritability/fussiness/crying/screaming, and loss of appetite for (preverbal children/infants) and body temperature, nausea/vomiting, fatigue/malaise, muscle pain, chills, joint pain and headache (young children, adolescents, and adults) will be noted in the participant diary.


Secondary Outcome Measures :
  1. Stage 1: Number of Participants with Adverse Events After the Third Vaccination [ Time Frame: From day of third vaccination till 28 days post third vaccination (approximately 28 days) ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  2. Stage 1 and 2: Serum Concentration of Antibodies Binding to EBOV GP Measured by an Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post-boost Vaccination [ Time Frame: At 21 days post-boost vaccination ]
    Serum concentration of antibodies binding to ebola virus (EBOV) glycoprotein (GP) measured by an enzyme-linked immunosorbent assay (ELISA) at 21 days post-boost vaccination.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
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 participants 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509494


Locations
Sierra Leone
Kambia, Sierra Leone
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.

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 )
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Device Product: No

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

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