Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers (NCT05313139) | Clinical Trial Compass
CompletedNot Applicable
Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers
Democratic Republic of the Congo133 participantsStarted 2021-12-13
Plain-language summary
During the previous Ebola virus disease (EVD) outbreaks, the institute National de Recherche Biomédicale (INRB) and other institutional's staff in Democratic Republic of the Congo (DRC) got vaccinated with the rVSV-ZEBOV vaccine. However, the longevity of Ebola virus (EBOV)-specific immune responses after vaccination has not been studied extensively (only 1-2 years) nor comprehensively (only humoral), despite the wide use of this vaccine. With the re-emergence of Ebola in North-Kivu from a previously vaccinated individual, and the new planned vaccination campaign (considering homologous booster doses for previously vaccinated HCW) in light of the new outbreak in Beni, assessing the persistence and quality of vaccine-induced anti-EBOV immune responses is pertinent and timely.
Who can participate
Age range
18 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:
* Subject is willing and able to give informed consent for participation in the study
* Subject can be contacted by phone, email or physical address
* Subject is aged 18 years or above
* Subject must have a ID card (or other identification document)
For vaccinated group:
\- Subject must be receiving the rVSV-ZEBOV vaccine (first or second dose) at time of inclusion OR has received a first rVSV-ZEBOV vaccine dose prior to inclusion of which vaccination date and brand is known
For unvaccinated group (controls):
Subject must NOT have received the rVSV-ZEBOV vaccine nor had any prior close contact with EBOV patients
Exclusion Criteria:
* Subject was previously diagnosed with EVD
* Subject has any contraindication to venipuncture, as determined by clinical judgement
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
EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units
Timeframe: Day 0
2
EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units
Timeframe: Day 7
3
EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units