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

NCT05284097 | Completed Phase 2

• 1 other identifier: VAC52150EBL2012
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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

Conditions

Virus Diseases; Hemorrhagic Fever, Ebola; Infections; Hemorrhagic Fevers, Viral; RNA Virus Infections; Filoviridae Infections; Mononegavirales Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs; Ebola

Keywords

Ad26.ZEBOV; MVA-BN-Filo; vaccination; children; adults

Outcome Measures

Primary Outcomes (6)

• Incidence of solicited adverse events in children aged 4-11 years.

  Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically

  From the day of Dose 1 vaccination (Day 1) to 7 days post-Dose 1 vaccination

• Incidence of solicited adverse events in children aged 4-11 years.

  Number and percentage of participants aged 4-11 years with solicited adverse events at the local injection site and systemically

  From the day of Dose 2 vaccination (Day 56 days post-Dose 1) to 7 days post-Dose 2 vaccination

• Incidence of unsolicited serious adverse events

  Number and percentage of participants with any untoward medical event

  From the day of Dose 1 vaccination through 28 days post-Dose 2 vaccination (approximately 84 days)

• Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)

  Proportion of participants with detectable EBOV-specific T cell subsets of interest

  At Day 1 (Dose 1 vaccination)

• Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)

  Proportion of participants with detectable EBOV-specific T cell subsets of interest

  At Day 57 (56 days post-Dose 1 vaccination)

• Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)

  Proportion of participants with detectable EBOV-specific T cell subsets of interest

  At Day 78 (21 days post-Dose 2 vaccination)

Secondary Outcomes (1)

• Vaccine induced humoral immune responses to EBOV GP

  At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 vaccination)

Other Outcomes (1)

• Vaccine induced humoral immune response to EBOV GP

  At Day 1 (Dose 1 vaccination), Day 57 (56 days post-Dose 1 vaccination), and Day 78 (21 days post-Dose 2 vaccination)

Study Arms (1)

Study Intervention

EXPERIMENTAL

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

Interventions

Ad26.ZEBOV, MVA-BN-Filo DRUG

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

Also known as: VAC52150

Study Intervention

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have been enrolled in the control arm and received at least the first vaccination (Dose 1) in EBOVAC-Salone.
• 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.
• 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
• 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.
• 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.
• 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.
• Must have, or the parent/guardian must have, the means to be contacted.
• Must pass the Test of Understanding (TOU), or the parent/guardian must pass the TOU.

You may not qualify if:

• Participants in the EBOVAC-Salone trial who received at least 1 dose of the Ebola vaccine regimen.
• Subjects who have received any candidate or other Ebola vaccine.
• 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).
• Subjects who have a known history of any thrombotic disorder, thrombocytopaenia, thrombotic thrombocytopaenia syndrome (TTS), or heparin-induced thrombocytopaenia and thrombosis (HITT).
• 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.
• 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.
• Women who are known to be pregnant or planning to become pregnant while enrolled in the study.
• Subjects who have received a blood transfusion or other blood products within 8 weeks prior to vaccination day.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Sierra Leone: collaborator
• Janssen Vaccines & Prevention B.V.: collaborator

Study Sites (1)

EBOVAC Kambia 1 clinic

Kambia, Sierra Leone

Location

MeSH Terms

Conditions

Virus Diseases; Hemorrhagic Fever, Ebola; Infections; Hemorrhagic Fevers, Viral; RNA Virus Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Deborah Watson-Jones, PhD

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 17, 2022
• Study Start: September 19, 2022
• Primary Completion: March 2, 2023
• Study Completion: October 31, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 12 months of the study completion date
• Access Criteria: open

Locations

SI (1)