A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent C… (NCT06803342) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Sudan Ebolavirus Vaccine in Healthy Adults
United States200 participantsStarted 2025-06-26
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 informed consent prior to any trial procedure including optional consent for retention of blood samples for potential future testing and assay development. As part of the informed consent process, the participant must complete a Test of Understanding (ToU) about the study and answer at least 90% of the questions correctly at least once in three attempts;
. Male or non-pregnant female 18 to 70 (inclusive) years of age at time of consent;
. Is capable of understanding and agrees to comply with planned trial procedures and to be available for all clinic follow-up for all planned trial visits;
. Able to provide proof of identity to the satisfaction of the trial clinician completing the enrollment process; has a means to be contacted and to contact the investigator during the trial;
. Agree not to receive any vaccine within 3 months of trial vaccination (prior and after) trial;
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 determine the percentage of vaccinated participants who develop SAEs, AEs, and AESI from cAd3-Sudan Vaccine and placebo
. Agree not to donate bone marrow, blood, or blood products until 3 months after the trial vaccination;
. In good general health without clinically significant medical conditions, based on medical history, physical examination, vital signs, and clinical laboratory results as deemed acceptable by PI;
. Clinical laboratory results within 28 days prior to vaccination within the testing laboratory reference ranges (or deemed not clinically significant by the PI) for the following parameters: White blood cells (WBC), Complete blood count (CBC), Red blood cells (RBC), Hemoglobin (HGB), total lymphocyte count, coagulation tests to include prothrombin time in terms of INR, fibrinogen, protein C, d-dimer, and chemistry tests to include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine. A laboratory result that is outside the reference range and is deemed not clinically significant by the PI will not exclude the participant;
Exclusion criteria
. Participant is female and is breastfeeding or plans to become pregnant or breastfeed from trial vaccination through 24 weeks post-vaccination
. Has any medical disease or condition that, in the opinion of the investigator, precludes trial participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that would place the Participant at an unacceptable risk of injury, render the Participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the Participant's successful completion of the trial; (Chronic conditions that are well-controlled and medically stable, i.e. no relevant change in treatment for medical reasons occurred in the last 6 months, are allowed at the discretion of the PI, e.g. hypertension, asthma, thyroid disease) Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders) and any infection requiring IV antibiotics or hospitalization within 90 days prior to screening.
. History of Guillain-Barré syndrome
. History of allergy to any component of the vaccine
. Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV, Human T-cell leukemia virus (HTLV), Syphilis);
. Known prior exposure to Sudan Ebolavirus or prior diagnosis of Sudan Ebolavirus Disease, determined from the participant's reported medical history
. History of or active status of any of the following clinically significant conditions:
. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain;