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Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study

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: NCT05284097
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : October 14, 2022
Sponsor:
Collaborators:
University of Sierra Leone
Janssen Vaccines & Prevention B.V.
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
This is a Phase 2, open-label, study evaluating the safety and immunogenicity of the 2-dose vaccination regimen, Ad26.ZEBOV, MVA-BN-Filo, in adults and children originally enrolled in the control arm of the EBOVAC-Salone study

Condition or disease Intervention/treatment Phase
Virus Diseases Hemorrhagic Fever, Ebola Infections Hemorrhagic Fevers, Viral RNA Virus Infections Filoviridae Infections Mononegavirales Infections Vaccines Immunologic Factors Physiological Effects of Drugs Ebola Drug: Ad26.ZEBOV, MVA-BN-Filo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2, Open-label, Study to Evaluate the Safety and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV, MVA-BN-Filo in Adults and Children Originally Enrolled in the Control Arm of the EBOVAC-Salone Study
Actual Study Start Date : September 19, 2022
Estimated Primary Completion Date : February 17, 2023
Estimated Study Completion Date : February 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Study Intervention

Subjects will receive the following study vaccines as a 0.5 mL IM injection into the deltoid:

  • Ad26.ZEBOV at a dose of 5x10^10 vp on Day 1
  • MVA-BN-Filo at a dose of 1x10^8 Inf U on Day 57
Drug: Ad26.ZEBOV, MVA-BN-Filo

Ad26.ZEBOV - is an adenovirus serotype 26 vector expressing the glycoprotein (GP) of the Ebola virus (EBOV) Mayinga variant

MVA-BN-Filo - is a Modified Vaccinia Ankara (MVA) - Bavarian Nordic (BN) vector expressing the GPs of EBOV, Sudan virus (SUDV) and Marburg virus (MARV) and the nucleoprotein of Tai Forest virus

Other Name: VAC52150




Primary Outcome Measures :
  1. Incidence of solicited adverse events in children aged 4-11 years. [ Time Frame: From the day of Dose 1 vaccination (Day 1) to 7 days post-Dose 1 vaccination ]
    Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically

  2. Incidence of solicited adverse events in children aged 4-11 years. [ Time Frame: From the day of Dose 2 vaccination (Day 56 days post-Dose 1) to 7 days post-Dose 2 vaccination ]
    Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically

  3. Incidence of unsolicited serious adverse events [ Time Frame: From the day of Dose 1 vaccination through 28 days post-Dose 2 vaccination (approximately 84 days) ]
    Number and percentage of participants with any untoward medical event

  4. Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP) [ Time Frame: At Day 1 (Dose 1 vaccination) ]
    Proportion of participants with detectable EBOV-specific T cell subsets of interest

  5. Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP) [ Time Frame: At Day 57 (56 days post-Dose 1 vaccination) ]
    Proportion of participants with detectable EBOV-specific T cell subsets of interest

  6. Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP) [ Time Frame: At Day 78 (21 days post-Dose 2 vaccination) ]
    Proportion of participants with detectable EBOV-specific T cell subsets of interest


Secondary Outcome Measures :
  1. Vaccine induced humoral immune responses to EBOV GP [ Time Frame: At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 vaccination) ]
    EBOV GP antibody concentration measured by ELISA


Other Outcome Measures:
  1. Vaccine induced humoral immune response to EBOV GP [ Time Frame: At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 vaccination) ]
    EBOV GP antibody concentration measured by LUMINEX assay



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:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Must have been enrolled in the control arm and received at least the first vaccination (Dose 1) in EBOVAC-Salone.
  2. Must consent to participate, or their parent/guardian must consent for their child to participate, in the VAC52150EBL2012 study.Children aged 7 years and older will be asked to give positive assent for their participation in the study.
  3. Must be willing/able to adhere to the prohibitions and restrictions specified in the protocol, or the parent/guardian must be willing/able to ensure that their child adheres to the prohibitions and restrictions specified in the protocol
  4. Must be healthy in the investigator's clinical judgement (and the parent/guardian's judgement) on the basis of medical history, physical examination, vital signs, and a haematological assessment (i.e., full blood count) performed at screening.
  5. Female subjects of childbearing potential, who have started their menstrual periods and/or are ≥12 years of age at the time of screening must use adequate birth control measures consistent with local regulations regarding the use of birth control for subjects participating in clinical studies from at least 14 days before vaccination until the end of the study, with a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test at screening and immediately prior to the vaccination, which shall occur no earlier than 14 days after the screening visit.
  6. Must be willing to participate for the duration of the study visits, or the parent/guardian must be available and willing to have their child participate for the duration of the study visits.
  7. Must have, or the parent/guardian must have, the means to be contacted.
  8. Must pass the Test of Understanding (TOU), or the parent/guardian must pass the TOU.

Exclusion Criteria:

  1. Participants in the EBOVAC-Salone trial who received at least 1 dose of the Ebola vaccine regimen.
  2. Subjects who have received any candidate or other Ebola vaccine.
  3. Subjects who have a known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccine, e.g., polysorbate 80, ethylenediaminetetraacetic acid, or L-histidine for Ad26.ZEBOV vaccine), including known allergy to chicken or egg proteins and aminoglycosides (gentamicin).
  4. Subjects who have a known history of any thrombotic disorder, thrombocytopaenia, thrombotic thrombocytopaenia syndrome (TTS), or heparin-induced thrombocytopaenia and thrombosis (HITT).
  5. Subjects with presence of acute illness (this does not include minor illnesses such as mild diarrhoea or mild upper respiratory tract infection) or axillary temperature ≥38° C on Day 1. Participants with such symptoms will be excluded from enrolment at that time but may be rescheduled for enrolment at a later date within the screening window.
  6. Subjects with a clinically significant history of skin disorder (e.g., psoriasis, contact dermatitis), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the investigator or other delegated individual.
  7. Women who are known to be pregnant or planning to become pregnant while enrolled in the study.
  8. Subjects who have received a blood transfusion or other blood products within 8 weeks prior to vaccination day.
  9. Subjects who have been vaccinated with live-attenuated vaccines within 30 days before the study vaccination, or with an inactivated vaccine within 15 days before the study vaccination.
  10. Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the vaccination and observation.
  11. Subjects with any other finding which, in the opinion of the investigator or other delegated individual, would increase the risk of an adverse outcome from participation in the study.

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): NCT05284097


Contacts
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Contact: Julie Foster, MSc +442076127898 julie.foster@lshtm.ac.uk

Locations
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Sierra Leone
EBOVAC Kambia 1 clinic Recruiting
Kambia, Sierra Leone
Principal Investigator: Bailah Leigh, MD         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Sierra Leone
Janssen Vaccines & Prevention B.V.
Investigators
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Study Chair: Deborah Watson-Jones, PhD London School of Hygiene and Tropical Medicine
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT05284097    
Other Study ID Numbers: VAC52150EBL2012
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The clinical trials results will be published in an open access, peer-reviewed journal, which will include, as feasible, the study protocol. A summary of the study results will be included within the trial resignation record in PACTR and ClinicalTrials.gov
Supporting Materials: Study Protocol
Time Frame: within 12 months of the study completion date
Access Criteria: open

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London School of Hygiene and Tropical Medicine:
Ad26.ZEBOV
MVA-BN-Filo
vaccination
children
adults
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Fever
Disease Attributes
Pathologic Processes
Body Temperature Changes