Nasal spray vaccine aims to protect kids from two breathing viruses
NCT ID NCT06546423
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tested two experimental nasal spray vaccines in 24 children aged 2 to 5 years. The vaccines target two viruses that can cause breathing problems: human metapneumovirus (HMPV) and parainfluenza virus type 3 (HPIV3). The main goal was to see if the vaccines are safe and trigger an immune response. Children received a single dose of one of the two vaccines or a placebo, and were monitored for 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Jun 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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24 to 59 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * ≥24 months of age and \<60 months of age at the time of inoculation * HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation * Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer \>1:8 * Pre-inoculation serum sample for HPIV3-neutralizing antibody specimen is obtained no more than 42 days prior to inoculation * In good health based on review of the medical record, history, and physical examination at the time of inoculation * Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger * Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age * Expected to be available for the duration of the study * Parent/guardian is willing and able to provide written informed consent Exclusion Criteria: * \<24 months of age and \>60 months of age at the time of inoculation. * Born at less than 34 weeks gestation * Maternal history of a positive HIV test before or during pregnancy. * Evidence of chronic disease * Known or suspected infection or impairment of immunological functions * Bone marrow/solid organ transplant recipient * Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities * Suspected or documented developmental disorder, delay, or other developmental problem * Cardiac abnormality requiring treatment * Lung disease or reactive airway disease * More than one episode of medically diagnosed wheezing in the first year of life * Wheezing episode or received bronchodilator therapy or racemic epinephrine within the past 12 months * Wheezing episode or received bronchodilator therapy after the age of 12 months * Previous receipt of supplemental oxygen therapy in a home setting * Previous receipt of an investigational HPIV3 or HMPV vaccine * Previous receipt or planned administration of human immunoglobulin within the past 6 months. Receipt of licensed monoclonal antibody products for passive prophylaxis against RSV (e.g., nirsevimab) within the past 6 months is not a cause for exclusion * Previous receipt of any blood products within the past 6 months. * Previous anaphylactic reaction * Previous vaccine-associated adverse reaction that was Grade 3 or above. * Known hypersensitivity to any study product component * Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation * Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to: * a person who is HIV-infected * a person who has cancer and has received chemotherapy within the 12 months prior to enrollment * a person living with a solid organ or bone marrow transplant * Attends a daycare facility that does not separate children by age and contains a child \<12 months of age at the date of inoculation through the 10th day after inoculation * Receipt of any of the following prior to enrollment: * inactivated influenza vaccine within 3 days prior, or * any other inactivated vaccine, messenger RNA (mRNA) vaccine, or live-attenuated rotavirus vaccine within the 14 days prior, or * any live vaccine, other than rotavirus vaccine, within the 28 days prior, or * another investigational vaccine or investigational drug within 28 days prior, or * salicylate (aspirin) or salicylate-containing products within the past 28 days * Scheduled administration of any of the following after planned inoculation: * inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or * any live vaccine other than rotavirus within the 28 days after, or * any salicylate or salicylate-containing products within the 28 days after, or * another investigational vaccine or investigational drug in the 56 days after * Receipt of any of the following medications within 3 days prior to study enrollment: * systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or * intranasal medications, or * other prescription medications except the permitted concomitant medications listed below * Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents * Any of the following events at the time of enrollment: * fever (temporal or rectal temperature of ≥100.4°F), or * upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis), or * nasal congestion significant enough to interfere with successful inoculation, or * otitis media, or * contact with a person diagnosed with COVID-19 disease or active SARS-CoV-2 infection within the preceding 10 days
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CIR - Rangos, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205, United States
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CIR South
Columbia, Maryland, 21045, United States
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University of Rochester Medical Center
Rochester, New York, 14642, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.