Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in … (NCT05284097) | Clinical Trial Compass
CompletedPhase 2
Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study
Sierra Leone133 participantsStarted 2022-09-19
Plain-language 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
Who can participate
Age range
4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of solicited adverse events in children aged 4-11 years.
Timeframe: From the day of Dose 1 vaccination (Day 1) to 7 days post-Dose 1 vaccination
2
Incidence of solicited adverse events in children aged 4-11 years.
Timeframe: From the day of Dose 2 vaccination (Day 56 days post-Dose 1) to 7 days post-Dose 2 vaccination
3
Incidence of unsolicited serious adverse events
Timeframe: From the day of Dose 1 vaccination through 28 days post-Dose 2 vaccination (approximately 84 days)
4
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Timeframe: At Day 1 (Dose 1 vaccination)
5
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Timeframe: At Day 57 (56 days post-Dose 1 vaccination)
6
Vaccine-induced cellular immune responses to the Ebola virus glycoprotein (EBOV GP)
Timeframe: At Day 78 (21 days post-Dose 2 vaccination)
Trial details
NCT IDNCT05284097
SponsorLondon School of Hygiene and Tropical Medicine
. 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.
Exclusion criteria
. 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.