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Nasal spray vaccine aims to shield children from RSV

NCT ID NCT04919109

Vaccine Sponsor: Codagenix, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental RSV vaccine called CodaVax-RSV, given as nose drops, in healthy children aged 6 months to 5 years. The study evaluates the vaccine's safety and the immune response it triggers. Some children receive the vaccine at different doses, while others get a placebo (saline nose drops). Participants are monitored closely for side effects and antibody levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a live attenuated vaccine against RSV called CodaVax-RSV, given as nose drops
What this could lead to
If successful, this could lead to a safe and effective vaccine to protect children from RSV, a common but potentially serious respiratory virus.
What could go wrong
This is an early Phase 1 trial with a small number of participants, so the vaccine may not prove safe or effective in larger studies. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

41 people

The number who actually took part.

Started

Mar 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 5 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at the time of informed consent: * Part A: 2 to 5 years, inclusive * Part B: 6 months to \< 2 years 2. RSV Status at Screening: * Part A: RSV-seropositive * Part B: RSV-seronegative 3. Good general health status 4. Product of normal full-term pregnancy (36 to 42 weeks gestation) Exclusion Criteria: 1. Household contact with any of the following groups of individuals for the period up to 14 days after each dose: * Pregnant women * Infants \< 6 months of age * With hospitalization for asthma or other chronic respiratory disease in the past 5 years * Immunocompromised individuals, which includes, but is not limited to, those with the following conditions: * AIDS * Receipt of chemotherapy within the past 6 months * Current receipt of immunosuppressive agents * Solid organ or bone marrow transplant 2. Enrolled in the same classroom at full-time day care with infants \< 6 months of age for 14 days after each dose 3. Household contact of another child enrolled into the study 4. Inadequate venous access for repeated phlebotomy 5. Height and weight ≤ 5th percentile for age and sex (according to CDC growth charts for children in Part A, according to World Health Organization Child Growth Standards for children in Part B)

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus infections

Contacts and locations

Locations

  • University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA)

    Johannesburg, South Africa

  • Velocity

    Lincoln, Nebraska, 658510, United States

  • Velocity

    Omaha, Nebraska, 68134, United States

  • Velocity

    Providence, Rhode Island, 02818, United States

  • Velocity

    West Jordan, Utah, 84088, United States

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