This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.
Who can participate
Age range
18 Years – 45 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
. Provides written informed consent prior to any study procedures being performed.
. Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
. Subject is between the ages of 18 to 45 years, inclusive, on the day of signing informed consent.
. Agrees to collection of venous blood per protocol.
. Body Mass Index 18.0 to 35.9 kg/m² at the time of screening.
. Subject is in good health as determined by vital signs, medical history, physical examination, and the judgment of the investigator.
. Clinical screening laboratory evaluations (white blood cell (WBCs), hemoglobin (Hgb), platelets (plts), absolute neutrophil count (ANC), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin (T. Bili), lipase, and creatinine (Cr)) are within acceptable normal reference ranges as outlined in the protocol.
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
Any unsolicited adverse events
Timeframe: Up to Day 29 following each vaccination or placebo
2
Any serious adverse events
Timeframe: Up to end of the study (Day 237)
3
Any solicited site reactions from vaccination
Timeframe: Up to Day 8 following vaccination or placebo
4
Any solicited systemic reactions from vaccination
Timeframe: Up to Day 8 following vaccination or placebo
5
Any new-onset medical conditions (NOMC)
Timeframe: Day 1 vaccination or placebo through end of the study (Day 237)
6
Any medically attended adverse events (MAAEs) from first vaccination until end of the study
Timeframe: From Day 1 vaccination or placebo through the end of the study (Day 237)
. Women of childbearing potential¹ must agree to use or have practiced true abstinence² or use at least one acceptable primary form of contraception.³,⁴
Exclusion criteria
. Subject has an acute illness with fever (temperature ≥100.4°F) within 72 hours prior to vaccine administration or \>3 looser-than-normal stools, any vomiting, or other GI illness within 7 days prior to vaccine administration.
. Positive pregnancy test either at screening or just prior to each vaccine administration.
. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
. Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.⁶
. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
. Currently enrolled in or plans to participate in another clinical trial with an investigational agent⁷ that will be received during the study-reporting period.
. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any vaccine component, any previous licensed or unlicensed vaccines, or other components of the study product including sorbitol, maltodextrin, HEPES, sodium chloride, sucrose, methylcellulose, calcium chloride, medical adhesive (acrylated urethane, medical tape, high-impact polystyrene (HIPS), stainless steel).