Rotavirus Vaccine Patch for Rotavirus Infection

Overseen By Christina Rostad, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Centers for Disease Control and Prevention

Must not be taking: Systemic corticosteroids, Immunomodulators

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 88

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rotavirus vaccine delivered through a microneedle patch to determine its safety and ability to trigger an immune response in healthy adults. The study divides participants into two groups, one receiving a lower dose and the other a higher dose, over three appointments. It seeks individuals who are healthy, not currently ill, and have not recently had rotavirus or this type of vaccine. Participants will assist researchers in evaluating whether this patch could offer a new method of protection against rotavirus infections. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that affect the immune system, you might need to stop them, as chronic use of such medications is an exclusion criterion.

What prior data suggests that this vaccine patch is safe?

Research has shown that the CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch is safe and effective in animal studies. These studies found that the vaccine helps the body fight the virus by triggering a strong immune response. Although results from human trials are not yet available, its current testing in people indicates it has passed important safety checks. This vaccine is administered through a microneedle patch, offering a new and less invasive method compared to traditional shots. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the CDC-9 Inactivated Rotavirus Vaccine (IRV) because it uses a microneedle patch for delivery, which is different from the traditional oral vaccines like Rotarix or RotaTeq. This patch method could make vaccination easier and less invasive, especially for those afraid of needles or with difficulty swallowing pills. Additionally, the microneedle patch targets the skin's immune cells directly, potentially enhancing the immune response and offering better protection against rotavirus.

What evidence suggests that this vaccine patch might be an effective treatment for rotavirus?

Research has shown that the CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) performed well in animal studies. These studies found that the vaccine generated a strong immune response in animals like mice and piglets without major safety issues. Additionally, when used with other vaccines in animals, it did not affect their efficacy. It also enhanced gut immunity, which is crucial for combating rotavirus. Although this is early data, it provides a promising basis for further human testing. In this trial, participants will receive either a 3.75 µg or a 7.5 µg dose of the IRV via microneedle patches to evaluate its effectiveness and safety in humans. ^{1 4 5 6 7}

Who Is on the Research Team?

Christina Rostad, MD

Principal Investigator

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

Lauren Nolan, PA-C

Principal Investigator

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

Are You a Good Fit for This Trial?

Healthy adults aged 18-45 can join this trial. They must be in good health, have a BMI of 18.0 to 35.9, and agree to use contraception or practice abstinence if applicable. Participants should not plan to donate blood/plasma during the study and must consent to all procedures.

Inclusion Criteria

I agree not to donate sperm during the trial.

Body Mass Index 18.0 to 35.9 kg/m² at the time of screening

In good health as determined by vital signs, medical history, physical examination, and the judgment of the investigator

Exclusion Criteria

Positive pregnancy test either at screening or just prior to each vaccine administration

Has any medical disease or condition that precludes study participation

Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 doses of the CDC-9 Inactivated Rotavirus Vaccine (IRV) or placebo via microneedle patch on Days 1, 29, and 57

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including adverse events and antibody responses, for approximately 6 months after the third dose

28 weeks

Multiple visits (in-person) on Days 85 and 237

What Are the Treatments Tested in This Trial?

Interventions

• CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP)

Trial Overview The trial is testing two doses (3.75 µg and 7.5 µg) of an inactivated rotavirus vaccine delivered via a microneedle patch against a placebo, given as a series of three shots, to see if it's safe and how the immune system responds.

How Is the Trial Designed?

Group I: 7.5 µg CDC-9 Inactivated Rotavirus Vaccine (IRV) Experimental Treatment 2 Interventions

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

Group II: 3.75 µg CDC-9 Inactivated Rotavirus Vaccine (IRV) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Centers for Disease Control and Prevention

Lead Sponsor

Trials

902

Recruited

25,020,000+

Emory-Children's Center

Collaborator

Trials

5

Recruited

5,001,000+

Micron Biomedical, Inc

Industry Sponsor

Trials

2

Recruited

310+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

The candidate inactivated rotavirus vaccine (IRV) demonstrated strong immunogenicity in gnotobiotic piglets, inducing high levels of rotavirus-specific IgG and neutralizing antibodies after three doses.

The IRV provided effective protection against rotavirus infection, as evidenced by reduced shedding of the virus after an oral challenge, supporting its potential as a viable alternative vaccine for infants in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inactivated rotavirus vaccine induces protective immunity in gnotobiotic piglets. Wang, Y., Azevedo, M., Saif, LJ., et al.[2010]

Citations

1. trialx.com trialx.com/clinical-trials/listings/299834/cdc-9-inactivated-rotavirus-vaccine-irv-microneedle-patch-mnp-in-healthy-adults/

CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle ... IRV MNP has been shown to be safe and immunogenic in animal studies. A rotavirus vaccine with greater efficacy and stronger immunogenic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06485258

NCT06485258 | CDC-9 Inactivated Rotavirus Vaccine (IRV ... When given in combination with inactivated polio vaccine in mice it did not impair immune responses to either rotavirus or poliovirus serotypes 1, 2, and 3.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8885742/

Microneedle patch as a new platform to effectively deliver ... We conclude that IRV-IPV dMNP did not interfere with each other in triggering an immunologic response and were highly immunogenic in rats.

4. withpower.com withpower.com/trial/phase-1-rotavirus-infections-4-2025-4e268

Rotavirus Vaccine Patch for Rotavirus Infection The rotavirus vaccine patch has been tested in animals like mice and piglets, showing it can trigger a strong immune response without reported safety issues.

5. nature.com nature.com/articles/s41598-017-18973-9

Inactivated rotavirus vaccine by parenteral administration ... Our study is the first to show that parenterally administered IRV can induce mucosal immunity in the gut, in addition to strong serum antibody response.

6. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2025.2555700?scroll=top&needAccess=true

The safety and immunogenicity of inactivated rotavirus ... In particular, IRV (CDC-9, G1P[8]) MNPs were found to be safe, have dose-sparing effect, and induce potent immunogenicity including mucosal immunity in animals.

7. ctv.veeva.com ctv.veeva.com/study/cdc-9-inactivated-rotavirus-vaccine-irv-microneedle-patch-mnp-phase-1-clinical-trial-in-healthy

CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch ... To improve the safety and efficacy of oral rotavirus vaccines, CDC ... IRV MNP has been shown to be safe and immunogenic in animal studies.