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

Trial Summary

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 data supports the effectiveness of the treatment CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) for rotavirus infection?

Research shows that using a microneedle patch for the inactivated rotavirus vaccine (IRV) can trigger a strong immune response, similar to or better than traditional injections, and can protect against rotavirus infection and diarrhea in animal studies. This method also uses a smaller vaccine dose, making it a promising option for safer and more effective vaccination. ^{1 2 3 4 5}

Is the rotavirus vaccine patch safe for humans?

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. While specific human safety data for this patch isn't available, similar microneedle patches for other vaccines have been well-tolerated in clinical trials. ^{1 2 5 6 7}

How is the Rotavirus Vaccine Patch treatment different from other treatments for rotavirus infection?

The Rotavirus Vaccine Patch uses a microneedle patch to deliver an inactivated rotavirus vaccine through the skin, which is different from the traditional oral vaccines. This method can potentially reduce the vaccine dose needed and avoid the rare but severe side effect of intussusception associated with live oral vaccines. ^{1 2 7 8 9}

What is the purpose of this trial?

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.

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)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Skin Vaccination against Rotavirus Using Microneedles: Proof of Concept in Gnotobiotic Piglets. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Dose sparing and enhanced immunogenicity of inactivated rotavirus vaccine administered by skin vaccination using a microneedle patch. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Inactivated rotavirus vaccines: a priority for accelerated vaccine development. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Inactivated rotavirus vaccine by parenteral administration induces mucosal immunity in mice. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Acceptability of an inactivated influenza vaccine delivered by microneedle patch: Results from a phase I clinical trial of safety, reactogenicity, and immunogenicity. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Inactivated polio vaccination using a microneedle patch is immunogenic in the rhesus macaque. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Inactivated rotavirus vaccine induces protective immunity in gnotobiotic piglets. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Intussusception after rotavirus vaccines reported to US VAERS, 2006-2012. [2013]