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 range18 Years – 70 Years
SexALL
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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
✕. Pregnant or lactating female or plans to become pregnant or breastfeed starting from study vaccination through to study end.
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
✕. 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).