CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults

Inclusion 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 beavailable for all study visits.

3. Subject is between the ages of 18 to 45 years, inclusive, on the day of signinginformed 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, physicalexamination, 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 asoutlined in the protocol.

8. Women of childbearing potential¹ must agree to use or have practiced trueabstinence² or use at least one acceptable primary form of contraception.³,⁴ Note: These criteria are applicable to females in a heterosexual relationship andchildbearing potential (i.e., the criteria do not apply to subjects in a same sexrelationship). ¹Note of childbearing potential: post-menopausal females (defined ashaving a history of amenorrhea for at least one year) or a documented status asbeing surgically sterile (hysterectomy, bilateral oophorectomy, tuballigation/salpingectomy, or Essure® placement). ²True abstinence is 100% of time nosexual intercourse (male's penis enters the female's vagina). ³Acceptable forms ofprimary contraception include monogamous relationship with a vasectomized partnerwho has been vasectomized for 180 days or more prior to the subject's firstvaccination, intrauterine devices, and hormonal contraception products (e.g., birthcontrol pills, patches, injections, implants, vaginal rings, or other insertablehormonal birth control products). ⁴Must use at least one acceptable primary form ofcontraception for at least 30 days prior to the first vaccination and at least oneacceptable primary form of contraception for 60 days after the last vaccination.

9. Women of childbearing potential must have a negative urine or serum pregnancy testwithin 24 hours prior to each vaccination.

10. Male subjects of childbearing potential⁵: use of condoms to ensure effectivecontraception with a female partner of childbearing potential OR female partners useat least one acceptable primary form of contraception from first vaccination until 60 days after the last vaccination.

⁵Biological males who are post-pubertal and considered fertile until permanentlysterile by bilateral orchiectomy or vasectomy.

11. Male subjects of childbearing potential agree to refrain from sperm donation fromthe 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 140 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.

Exclusion Criteria:

1. Subject has an acute illness with fever (temperature ≥100.4°F) within 72 hours priorto vaccine administration or >3 looser-than-normal stools, any vomiting, or other GIillness within 7 days prior to vaccine administration.

2. Positive pregnancy test either at screening or just prior to each vaccineadministration.

3. Female subject who is breastfeeding or plans to breastfeed from the time of thefirst vaccination through 60 days after the last vaccination.

4. Has any medical disease or condition that, in the opinion of the site PI orappropriate sub-investigator, precludes study participation.⁶

⁶Including acute, subacute, intermittent, or chronic medical disease or conditionthat would place the subject at an unacceptable risk of injury, render the subjectunable to meet the requirements of the protocol, or may interfere with theevaluation of responses or the subject's successful completion of this trial.Chronic medical conditions which are stable, with no escalation in medication dosesor new medications administered in the preceding 3 months, will not be consideredexclusionary.

5. Presence of self-reported or medically documented significant medical or psychiatriccondition(s) as determined by the investigator.

6. Has a positive test result for hepatitis B surface antigen, hepatitis C virusantibody, or HIV types 1 or 2 antibodies at screening.

7. Currently enrolled in or plans to participate in another clinical trial with aninvestigational agent⁷ that will be received during the study-reporting period.

⁷Including licensed or unlicensed vaccine, drug, biologic, device, blood product, ormedication.

8. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis,generalized urticaria, angioedema, other significant reaction) to any vaccinecomponent, any previous licensed or unlicensed vaccines, or other components of thestudy product including sorbitol, maltodextrin, HEPES, sodium chloride, sucrose,methylcellulose, calcium chloride, medical adhesive (acrylated urethane, medicaltape, high-impact polystyrene (HIPS), stainless steel).

9. Chronic use (more than 14 continuous days) of any medications that may be associatedwith impaired immune responsiveness.⁸

⁸Including, but not limited to, systemic corticosteroids exceeding 10 mg/day ofprednisone equivalent, allergy injections, immunoglobulin, interferon,immunomodulators, cytotoxic drugs, or other similar or toxic drugs during thepreceding 6-month period prior to vaccine administration (Day 1). The use of lowdose topical, ophthalmic, inhaled, and intranasal steroid preparations will bepermitted.

10. Received immunoglobulins and/or any blood or blood products within 6 months beforethe study.

11. Has a history of alcohol abuse or other recreational drug (excluding cannabis) usewithin 6 months before the first vaccine administration.

12. Received or plans to receive a licensed, live vaccine within 4 weeks before thefirst dose until 4 weeks after the last study vaccination.

13. Received or plans to receive a licensed, inactivated vaccine within 2 weeks beforethe first dose until 4 weeks after the last study vaccination.

14. Subject has previously received a rotavirus vaccine or has had a diagnosis ofrotavirus disease within the past 10 years.

15. Subject has a prior clinically significant history of or active/ongoinggastrointestinal disease including hospitalization for gastroenteritis or priordiagnosis of intussusception.

16. Subject has an active skin condition (e.g., eczema or other chronic dermatitis) oran open lesion (e.g., laceration, abrasion), scar, tattoo, or rash in the areas ofthe planned MNP administration, which will interfere with the assessment ofreactogenicity.

17. Subject or immediate family members have a history of keloid formation.