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

NCT06962904 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB# STUDY00008061
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotavirus Infections

Keywords

Rotavirus; Vaccine; Safety; Immunogenicity; Infection; CDC-9; Inactivated; Microneedle patch (MNP)

Outcome Measures

Primary Outcomes (6)

• Any unsolicited adverse events

  The number of vaccine-related unsolicited adverse events following each vaccination. Unsolicited AEs will be collected continuously from vaccination on Day 1 through 28 days after the last vaccination (Day 85)

  Up to Day 29 following each vaccination or placebo

• Any serious adverse events

  The number vaccine-related serious adverse events from vaccination until end of the study. SAEs will be collected from Day 1 (after study product administration) through the last study visit (Day 237)

  Up to end of the study (Day 237)

• Any solicited site reactions from vaccination

  The subject will be provided with a memory aid, thermometer and ruler and will be instructed to record the presence of solicited local injection site symptoms and oral temperature through the 7 days after each vaccine

  Up to Day 8 following vaccination or placebo

• Any solicited systemic reactions from vaccination

  The subject will be provided with a memory aid, thermometer and ruler and will be instructed to record the presence of solicited systemic symptoms and oral temperature through the 7 days after each vaccine

  Up to Day 8 following vaccination or placebo

• Any new-onset medical conditions (NOMC)

  The number of new-onset medical conditions (NOMC) from first vaccination until end of the study

  Day 1 vaccination or placebo through end of the study (Day 237)

• Any medically attended adverse events (MAAEs) from first vaccination until end of the study

  The number of medically attended adverse events (MAAES)

  From Day 1 vaccination or placebo through the end of the study (Day 237)

Secondary Outcomes (3)

• Percentage of Subjects with Rotavirus IgG or Neutralizing Antibody Seroconversion

  Baseline (Day 0) to 4 weeks post 3rd vaccination (Day 85)

• Geometric Mean Titer (GMT) of rotavirus Immunoglobulin G (IgG) and Neutralizing Antibody Titer

  4 weeks post 3rd vaccination (Day 85)

• Geometric Mean Fold Rise (GMFR) of rotavirus Immunoglobulin G (IgG) and Neutralizing Antibody Titer

  4 weeks post 3rd vaccination (Day 85)

Other Outcomes (7)

• Percentage of Subjects with Rotavirus Immunoglobulin A (IgA) Seroresponses

  Baseline (Day 0) to 4 weeks post 3rd vaccination (Day 85)

• Geometric mean titer (GMT) of Rotavirus Immunoglobulin A (IgA)

  4 weeks post 3rd vaccination (Day 85)

• Geometric mean fold rise (GMFR) in rotavirus IgA antibody

  From baseline (Day 0) to 4 weeks post 3rd vaccination (Day 85)

Study Arms (2)

3.75 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)

EXPERIMENTAL

20 healthy adults will be administered 3.75 µg of IRV via a single microneedle patch at days 1, 29 and 57

Biological: 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV); Other: Placebo

7.5 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)

EXPERIMENTAL

20 healthy adults will be administered 7.5 µg of IRV via two microneedle patches at days 1, 29 and 57

Biological: 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV); Other: Placebo

Interventions

3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) BIOLOGICAL

CDC-9 IRV dissolving MNP for intradermal administration is comprised of a single human rotavirus strain for protection against rotavirus infection

3.75 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)

7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) BIOLOGICAL

CDC-9 IRV dissolving MNP for intradermal administration is comprised of a single human rotavirus strain for protection against rotavirus infection

7.5 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)

Placebo OTHER

Placebo MNP (containing sucrose, sorbitol, maltodextrin, methylcellulose, HEPES, sodium chloride, and calcium chloride) administered intradermally

3.75 µg CDC-9 Inactivated Rotavirus Vaccine (IRV); 7.5 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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
• Note: These criteria are applicable to females in a heterosexual relationship and childbearing potential (i.e., the criteria do not apply to subjects in a same sex relationship). ¹Note of childbearing potential: post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure® placement). ²True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). ³Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, and hormonal contraception products (e.g., birth control pills, patches, injections, implants, vaginal rings, or other insertable hormonal birth control products). ⁴Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination.
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
• 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.
• ⁵Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.
• Male subjects of childbearing potential agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination.
• Oral temperature is less than or equal to 100.4°F (38.0°C).
• Pulse no greater than 100 beats per minute.

You may not qualify if:

• 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.
• ⁷Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
• 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).
• Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.⁸
• ⁸Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
• Received immunoglobulins and/or any blood or blood products within 6 months before the study.
• Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration.
• Received or plans to receive a licensed, live vaccine within 4 weeks before the first dose until 4 weeks after the last study vaccination.
• Received or plans to receive a licensed, inactivated vaccine within 2 weeks before the first dose until 4 weeks after the last study vaccination.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: collaborator
• Micron Biomedical, Inc: collaborator
• Centers for Disease Control and Prevention: lead
• Emory-Children's Center: collaborator

Study Sites (1)

Emory Children's Center - Vaccine Research Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Rotavirus Infections; Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Christina Rostad, MD

  Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

  PRINCIPAL INVESTIGATOR

• Lauren Nolan, PA-C

  Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 8, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): October 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)