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Rotavirus InfectionsPhase 1NCT06962904

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

A Phase 1 study testing 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) and 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) in people with Rotavirus Infections, run by Centers for Disease Control and Prevention at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Rotavirus Infections
What is being tested?
3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) and 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
7 Jul 2025to 6 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.
  • Systolic BP is 85 to 140 mmHg, inclusive.
  • Must agree to have samples stored for secondary research.
  • The subject must agree to refrain from donating blood or plasma during the study.

Who cannot join

  • 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
  • ⁶Including acute, subacute, intermittent, or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. Chronic medical conditions which are stable, with no escalation in medication doses or new medications administered in the preceding 3 months, will not be considered exclusionary.
  • Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
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  • 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.
  • Subject has previously received a rotavirus vaccine or has had a diagnosis of rotavirus disease within the past 10 years.
  • Subject has a prior clinically significant history of or active/ongoing gastrointestinal disease including hospitalization for gastroenteritis or prior diagnosis of intussusception.
  • 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.
  • Subject or immediate family members have a history of keloid formation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory Children's Center - Vaccine Research Clinic

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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

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.

Read the detailed description

Rotavirus remains an important cause of gastroenteritis and accounted for 19% of diarrhea-related deaths worldwide in 2019, the majority of which were in low and lower-middle income countries. Although live-attenuated vaccines for rotavirus are available for infants, the immunogenicity and vaccine effectiveness in low- and middle-income countries, where morbidity is highest, is suboptimal. Developing rotavirus vaccination strategies with improved immunogenicity could be advantageous in resource-limited settings.

To improve the safety and efficacy of oral rotavirus vaccines, CDC scientists have developed a human rotavirus strain CDC-9 (G1P[8]^9) that grows to high titer in Vero cells and shows structural stability during manufacturing process. The strain is a single gene natural reassortant with the VP3 gene derived naturally from a G2P[4] virus and the other 10 genes from a G1P[8] virus, the most common genotype throughout the world. Purified CDC-9 particles when inactivated by heat and administered to the skin using a MNP induced strong serum antibody response, and showed dose sparing effect in mice and rats. This inactivated rotavirus vaccine (IRV) also induced intestinal immunity in mice and prevented fecal shedding in gnotobiotic pigs, thus established the proof of concept for skin vaccination using a MNP against rotavirus. 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. IRV MNP has been shown to be safe and immunogenic in animal studies.

A rotavirus vaccine with greater efficacy and stronger immunogenic response could further reduce infant mortality and morbidity, and a parenterally administered rotavirus vaccine could minimize interactions from co-administration with polio vaccination. Given the lower immunogenicity and vaccine efficacy of the oral rotavirus vaccines currently licensed by the US and in developing countries and approved for use by the WHO, the IRV presents an opportunity to further prevent rotavirus-associated gastroenteritis in infants.

This will be a Phase 1, randomized, observer blinded, dose escalating, placebo-controlled clinical trial in which healthy adults (18 to 45 years of age) will receive inactivated rotavirus vaccine (IRV) or placebo administered through intradermal inoculation by MNP to determine the safety, reactogenicity, and immunogenicity. Two cohorts, each consisting of 25 individuals (20 vaccine recipients and 5 placebo recipients) will receive 3 intradermal doses by MNP four weeks apart. One cohort will receive 3.75 μg and the other 7.5 μg.

Subjects will receive a total of 3 doses by IRV MNPs or placebo MNPs. These will be administered at Days 1, 29, and 57. Subjects will be monitored for approximately 6 months after the third-dose vaccination. They will be followed for solicited (local and systemic) adverse events (AEs) through 7 days after each dose of vaccine. Unsolicited AEs will be collected through Day 85. Immunogenicity labs will be obtained before each study product dose, 7 days after each dose, 28 days after each dose, 35 days after the first dose, and at the end of study visit (durability of response). Serious adverse events (SAEs), new-onset chronic medical conditions (NOCMCs), and medically attended adverse events (MAAEs) will be followed from study product administration on Day 1 through end of study visit on Day 237. There is no expected overlap with standard-of-care clinical appointments or procedures.

Being tested
3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV), 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV), Placebo
Keywords
Rotavirus, Vaccine, Safety, Immunogenicity, Infection, CDC-9, Inactivated, Microneedle patch (MNP)
Medical subject headings
Rotavirus Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

  • PlaceboOther

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

Study groups in NCT06962904
Study groupRoleWhat they receive
3.75 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)Experimental20 healthy adults will be administered 3.75 µg of IRV via a single microneedle patch at days 1, 29 and 57
Receives: Biological: 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV); Other: Placebo
7.5 µg CDC-9 Inactivated Rotavirus Vaccine (IRV)Experimental20 healthy adults will be administered 7.5 µg of IRV via two microneedle patches at days 1, 29 and 57
Receives: Biological: 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to Day 29 following each vaccination or placebo

  2. 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)

    Measured: Up to end of the study (Day 237)

  3. 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

    Measured: Up to Day 8 following vaccination or placebo

  4. 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

    Measured: Up to Day 8 following vaccination or placebo

  5. Any new-onset medical conditions (NOMC)

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

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

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

    The number of medically attended adverse events (MAAES)

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

Secondary outcomes (3)

  1. Percentage of Subjects with Rotavirus IgG or Neutralizing Antibody Seroconversion

    Seroconversion defined as a four-fold increase in antibody titers between baseline to 4 weeks post 3rd vaccination

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

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

    Measured from sera to be collected from both cohorts on Day 85

    Measured: 4 weeks post 3rd vaccination (Day 85)

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

    Measured from sera to be collected from both cohorts on Day 85

    Measured: 4 weeks post 3rd vaccination (Day 85)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2025
  2. Study start7 Jul 2025
  3. Primary completion6 Oct 2026 (estimated)
  4. Study completion6 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06962904
Sponsor's protocol ID
IRB# STUDY00008061
Status last verified
Mar 2026
First submitted
21 Apr 2025
Last updated
5 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) and 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) in people with Rotavirus Infections, run by Centers for Disease Control and Prevention at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any unsolicited adverse events (time frame: Up to Day 29 following each vaccination or placebo). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06962904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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