RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study to Evaluate the Safety and Immunogenicity of CDC-9 Inactivated Rotavirus Vaccine for Intradermal Administration by Microneedle Patch in Healthy Adults

Quick Facts

Study Start:2025-07-09

Study Completion:2027-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06962904

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Christina Rostad, MD

CONTACT

404-727-4044

Christina.rostad@emory.edu

Principal Investigator

Christina Rostad, MD

PRINCIPAL_INVESTIGATOR

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

Lauren Nolan, PA-C

STUDY_CHAIR

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

Study Locations (Sites)

Emory Children's Center - Vaccine Research Clinic

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Centers for Disease Control and Prevention

Christina Rostad, MD, PRINCIPAL_INVESTIGATOR, Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
Lauren Nolan, PA-C, STUDY_CHAIR, Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-09

Study Completion Date2027-07-15

Study Record Updates

Study Start Date2025-07-09

Study Completion Date2027-07-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Rotavirus Infections