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Virus Therapy

Vaccines for Respiratory Infections in Children

Phase 1

Recruiting

Led By Ruth Karron, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥24 months of age and <60 months of age at the time of inoculation

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

Must not have

Cardiac abnormality requiring treatment

Wheezing episode or received bronchodilator therapy after the age of 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through day 180

Awards & highlights

Summary

"This trial is testing two vaccines for viruses that can cause breathing problems in children. Children aged 24 to 60 months will receive either a vaccine or a placebo. The study aims to see if the

Who is the study for?

This trial is for HPIV3-seropositive children aged 24 to less than 60 months who may have had breathing issues due to certain viruses. The study excludes those not meeting the age requirement or with conditions that could interfere with vaccine assessment.

What is being tested?

The trial tests two experimental nasal spray vaccines against respiratory viruses in young children. It aims to assess safety and how well these vaccines work, involving daily check-ins, physical exams, blood samples, and nasal swabs over six months.

What are the potential side effects?

Potential side effects are not specified but may include typical vaccine reactions such as a runny nose, sore throat, or fever following administration. Close monitoring will identify any unexpected reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 5 years old.

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My growth is normal for my age and my height and weight are above the 3rd percentile.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving treatment for a heart condition.

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I have had wheezing or used a bronchodilator since turning 1 year old.

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My child goes to a daycare where kids are not separated by age and there's a child under 1 year old.

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I was born before reaching 34 weeks of pregnancy.

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I have an infection or my immune system is not working properly.

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I have received a bone marrow or organ transplant.

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I do not have major birth defects like cleft palate or genetic abnormalities.

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I have a lung condition or asthma.

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I had more than one wheezing episode in my first year.

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I have had wheezing or taken medication for it in the last year.

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I have used supplemental oxygen at home before.

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I have not received any blood products in the last 6 months.

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I have had a severe reaction to a vaccine before.

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I live with someone who is immunocompromised.

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I am either younger than 2 years or older than 5 years.

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I currently have a fever, cold symptoms, or have been in close contact with someone with COVID-19 in the last 10 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 through day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of vaccinees shedding of vaccine virus

Secondary study objectives

Number of MAAEs and SAEs

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: B/HPIV3/HMPV-F-B365 vaccineActive Control1 Intervention

A single dose of intranasal B/HPIV3/HMPV-F-B365 will be administered by a Vax300 VaxINator atomization device.

Group II: B/HPIV3/HMPV-PreF-A vaccineActive Control1 Intervention

A single dose of intranasal B/HPIV3/HMPV-PreF-A will be administered by a Vax300 VaxINator atomization device.

Group III: PlaceboPlacebo Group1 Intervention

A single dose of intranasal Lactated Ringer's Solution for Injection will be administered by a Vax300 VaxINator atomization device.

0 / 18Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,302 Previous Clinical Trials

5,501,417 Total Patients Enrolled

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Johns Hopkins Bloomberg School of Public HealthOTHER

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Vanderbilt University Medical CenterOTHER

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~17 spots leftby Jun 2025

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