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EBOVAC-Salone Extension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820739
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
University of Sierra Leone
Janssen Vaccines & Prevention B.V.
Institut National de la Santé Et de la Recherche Médicale, France
Universiteit Antwerpen
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study evaluating the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in participants who were exposed to these vaccines in the VAC52150EBL3001 trial (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494). No investigational vaccine will be administered during this study. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit.

Condition or disease Intervention/treatment
Ebola Virus Disease Other: Follow-up Other: Blood sample collection

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Study Type : Observational
Estimated Enrollment : 630 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study to Evaluate the Long-term Safety and Immunogenicity of the Candidate Ebola Vaccines Ad26.ZEBOV and MVA-BN®-Filo in Adults and Children
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Group/Cohort Intervention/treatment
Cohort 1
Subjects who received an Ebola vaccine prime vaccination in EBOVAC-Salone are eligible for enrolment in this study. Adults are defined as participants 18 years of age or older at the time of prime vaccination, and children are defined as participants aged 1 to 17 years at the time of prime vaccination in EBOVAC-Salone.
Other: Follow-up
No investigational vaccine will be administered during this study

Other: Blood sample collection
Blood sampling to assess vaccine-induced immune responses will be conducted only in cohort 1 in a subsample consisting of approximately 102 adults and 165 children (55 from each of the three paediatric age groups that were enrolled in EBOVAC-Salone: 12-17 year olds, 4-11 year olds, and 1-3 year olds).

Cohort 2 (offspring)
Infants conceived by a female participant in EBOVAC-Salone during the 3 months following vaccination with Ad26.ZEBOV or during the 28 days following vaccination with MVA-BN®-Filo.
Other: Follow-up
No investigational vaccine will be administered during this study




Primary Outcome Measures :
  1. Number of Serious Adverse Events in subjects who received an Ebola vaccine prime vaccination in the EBOVAC-Salone trial. [ Time Frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination ]
    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.

  2. Binding antibody responses against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA). [ Time Frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination ]
    Serum Concentration of Antibodies Binding to EBOV GP measured by Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).

  3. Number of Serious Adverse Events, in infants conceived by an EBOVAC-Salone trial female participant during the 3-month period following vaccination with Ad26.ZEBOV or during the 28 day period following vaccination with MVA-BN®-Filo. [ Time Frame: From birth to their fifth birthday ]
    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.


Secondary Outcome Measures :
  1. Neutralising antibody responses directed against EBOV GP as measured by a pseudovirion neutralisation assay (psVNA) [ Time Frame: At years 2, 3 and 4 post-prime in children and years 3, 4 and 5 post-prime in adults ]
    psVNA: pseudovirion neutralising antibody reactivity against the EBOV GP defined as the serum titre that is able to inhibit viral infection by 50% (IC50 titer).

  2. Effect of previous infection with malaria, determined using validated ELISA and bead based assays, on the persistence of the humoral immune response to vaccination. [ Time Frame: Up to approximately 5 years in adults and 4 years in children from prime vaccination ]
    Serum concentration of malaria specific antibodies, determined using validated ELISA and bead based assays. The bead based assays will allow the inclusion of antigens associated with short term humoral immune responses and thus assessment of intra study exposure to malaria.


Biospecimen Retention:   Samples Without DNA
Blood serum


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.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will be open to subjects who were exposed to Ad26.ZEBOV and/or MVA-BN®-Filo in the EBOVAC-Salone study.

The study population will consist of two cohorts:

  • Cohort 1: subjects who received an Ebola vaccine prime vaccination in EBOVAC-Salone are eligible for enrolment in this study. Adults are defined as participants 18 years of age or older at the time of prime vaccination, and children are defined as participants aged 1 to 17 years at the time of prime vaccination.
  • Cohort 2 (offspring) will consist of infants conceived by a female participant in EBOVAC-Salone during the 3 months following vaccination with Ad26.ZEBOV or during the 28 days following vaccination with MVA-BN®-Filo.
Criteria

Inclusion Criteria:

  1. Must be a participant, or former participant, of the EBOVAC-Salone study, and received Ebola vaccine prime vaccination.

    or Must be an infant conceived by a female participant of EBOVAC-Salone during the 3-month period following vaccination with Ad26.ZEBOV or the 28 day period following vaccination with MVA-BN®-Filo.

  2. Must consent to participate in the EBOVAC-Salone Extension study by signing (or thumbprinting, if illiterate) an ICF, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. If a potential participant cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved in the conduct of the study. If the potential participant is under 18 years of age, they and their parent/guardian will be informed about the study and the parent/guardian will be asked to give consent. Children aged 7 years and older will be asked to give positive assent for their participation in the study and the assent procedure must be witnessed by an adult, literate parent/guardian/third party not involved in the conduct of the study, and documented.
  3. Must confirm that he/she will return to the study site for each yearly visit.

Exclusion Criteria:

  1. Participants in the EBOVAC-Salone study who were allocated to the control arm receiving the WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine
  2. Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study, or unlikely to complete follow up

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): NCT03820739


Contacts
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Contact: Deborah Watson-Jones, PhD +44 (0)20 7927 ext 2958 Deborah.Watson-Jones@lshtm.ac.uk
Contact: Daniela Manno, MD +44 (0)20 7927 ext 2092 daniela.manno@lshtm.ac.uk

Locations
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Sierra Leone
EBOVAC Rokupr clinic Recruiting
Rokupr, Kambia, Sierra Leone
Contact: Bailah Leigh, MD, Specialist Obs/Gyn       bailahleigh@yahoo.co.uk   
Contact: David Ishola, FWACP, MRCPS(Glasg), FFPH       david.ishola@lshtm.ac.uk   
EBOVAC Kambia 1 clinic Recruiting
Kambia, Sierra Leone
Contact: Bailah Leigh, MD, Specialist Obs/Gyn       bailahleigh@yahoo.co.uk   
Contact: David Ishola, FWACP, MRCPS(Glasg), FFPH       david.ishola@lshtm.ac.uk   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Sierra Leone
Janssen Vaccines & Prevention B.V.
Institut National de la Santé Et de la Recherche Médicale, France
Universiteit Antwerpen
Investigators
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Principal Investigator: Deborah Watson-Jones, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Bailah Leigh, MD University of Sierra Leone
Additional Information:
Publications of Results:
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03820739    
Other Study ID Numbers: VAC52150EBL3005
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections