CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) Phase 1 Clinical Trial in Healthy Adults

Eligibility Criteria

• 1. Provides written informed consent prior to any study procedures being performed.
• 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
• 3. Subject is between the ages of 18 to 45 years, inclusive, on the day of signing informed consent.
• 4. Agrees to collection of venous blood per protocol.
• 5. Body Mass Index 18.0 to 35.9 kg/m² at the time of screening.
• 6. Subject is in good health as determined by vital signs, medical history, physical examination, and the judgment of the investigator.
• 7. 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.
• 8. 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
• 9. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
• 10. Male subjects of childbearing potential⁵: use of condoms to ensure effective contraception with a female partner of childbearing potential OR female partners use at least one acceptable primary form of contraception from first vaccination until 60 days after the last vaccination.
• 11. Male subjects of childbearing potential agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination.
• 12. Oral temperature is less than or equal to 100.4°F (38.0°C).
• 13. Pulse no greater than 100 beats per minute.
• 14. Systolic BP is 85 to 145 mmHg, inclusive.
• 15. Must agree to have samples stored for secondary research.
• 16. The subject must agree to refrain from donating blood or plasma during the study.
• 1. 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.
• 2. Positive pregnancy test either at screening or just prior to each vaccine administration.
• 3. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
• 4. Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.⁶
• 5. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
• 6. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
• 7. Currently enrolled in or plans to participate in another clinical trial with an investigational agent⁷ that will be received during the study-reporting period.
• 8. 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).
• 9. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.⁸
• 10. Received immunoglobulins and/or any blood or blood products within 6 months before the study.
• 11. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration.
• 12. Received or plans to receive a licensed, live vaccine within 4 weeks before the first dose until 4 weeks after the last study vaccination.
• 13. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before the first dose until 4 weeks after the last study vaccination.
• 14. Subject has previously received a rotavirus vaccine or has had a diagnosis of rotavirus disease within the past 10 years.
• 15. Subject has a prior clinically significant history of or active/ongoing gastrointestinal disease including hospitalization for gastroenteritis or prior diagnosis of intussusception.
• 16. Subject has an active skin condition (e.g., eczema or other chronic dermatitis) or an open lesion (e.g., laceration, abrasion), scar, tattoo, or rash in the areas of the planned MNP administration, which will interfere with the assessment of reactogenicity.
• 17. Subject or immediate family members have a history of keloid formation.