Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
Kenya, Uganda125 participantsStarted 2024-07-15
Plain-language summary
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
Who can participate
Age range
18 Years – 70 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
. Able and willing to complete and provide written informed consent prior to any study procedure; including injection site photograph consent, completing an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions correctly at least once in 3 attempts, and including optional consent for retention of blood samples for potential future testing and assay development. Note: Participants can be enrolled even if they do not provide optional consent for retention of blood samples for potential future testing and assay development.
. Able to read and write the language used in diary card.
. Male or non-pregnant female 18 to 70 years of age (inclusive) at time of informed consent.
. Is capable of understanding and agrees to comply with planned study procedures and to be available for all clinic follow-up for all planned study visits.
. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
. Has a means to be contacted and to contact the investigator during the study.
. Agree not to receive any vaccine within 28 days from study vaccination (prior and after), with the exception of an emergency use authorization or authorized non-adenoviral vectored COVID-19 vaccine, which may be given within 14 days of study vaccination.
. Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination.
Exclusion criteria
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
To evaluate the safety and tolerability of cAd3-Sudan Ebolavirus vaccine through the assessment of SAEs, solicited AEs, unsolicited AEs, AESI, MAAE, and AE
. Pregnant or lactating female or plans to become pregnant or breastfeed starting from study vaccination through to study end.
. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that:
. Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV 1 and 2, syphilis).
. Known history of prior exposure to SUDV or prior diagnosis of SUVD.
. Current diagnosis of COVID-19 by Reverse Transcription Polymerase Chain Reaction (RT-PCR) or antigenic testing or current signs and symptoms of COVID-19. Participants may be enrolled 14 days post resolution of all signs and symptoms of COVID-19 or of testing positive for COVID-19 in asymptomatic participants.
. History of or active status of any of the following clinically significant conditions:
. Has a clinically significant acute illness (this does not include minor illnesses) or temperature ≥38.0°Celsius (≥100.4° Fahrenheit) within 24 hours of the planned dose of study vaccine. Re-evaluation of eligibility may be performed at resolution of all signs and symptoms, and randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor (as appropriate).