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Virus Therapy

Nasal Vaccine for Respiratory Syncytial Virus

Phase 1
Recruiting
Research Sponsored by Codagenix, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Current receipt of immunosuppressive agents
Inadequate venous access for repeated phlebotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, days 29 and 57

Summary

This trial will evaluate the safety and immune response of a nasal vaccine given to children aged 2-5 and 6 months to <2 to protect against RSV; they'll be monitored monthly for 1 yr.

Who is the study for?
This trial is for healthy children who had a full-term birth. Kids aged 2-5 with RSV antibodies and those 6 months to under 2 years without these antibodies can join. They shouldn't be in close contact with certain vulnerable individuals or have conditions affecting their immune system.
What is being tested?
The study tests CodaVax-RSV, a vaccine given as nose drops to prevent Respiratory Syncytial Virus (RSV). Children will get either the vaccine at different doses or a placebo, across two shots spaced by 28 days. Their health will be monitored over the RSV season.
What are the potential side effects?
Possible side effects are not detailed but parents/guardians will record any symptoms like fever after vaccination. The safety of the vaccine is closely watched, especially when dose levels increase.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that weakens my immune system.
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I have poor vein access for blood draws.
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I have had a solid organ or bone marrow transplant.
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I have been hospitalized for asthma or another lung condition in the last 5 years.
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I have received chemotherapy in the last 6 months.
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My child is younger than 6 months old.
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I have AIDS.
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My height and weight are in the bottom 5% for my age and sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, days 29 and 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, days 29 and 57 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participant reported adverse events
Number of participants reporting expected adverse reactions
Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)
Secondary study objectives
Neutralizing antibody

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: CodaVax-RSV 10^6 PFUExperimental Treatment1 Intervention
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Group II: Experimental: CodaVax-RSV 10^5 PFUExperimental Treatment1 Intervention
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Group III: Experimental: CodaVax-RSV 10^4 PFUExperimental Treatment1 Intervention
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Group IV: Experimental: CodaVax-RSV 10^3 PFUExperimental Treatment1 Intervention
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Group V: Placebo comparatorPlacebo Group1 Intervention
Administered as nose drops
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CodaVax-RSV
2020
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Codagenix, IncLead Sponsor
7 Previous Clinical Trials
331 Total Patients Enrolled

Media Library

CodaVax-RSV (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04919109 — Phase 1
Respiratory Syncytial Virus Infection Research Study Groups: Experimental: CodaVax-RSV 10^3 PFU, Experimental: CodaVax-RSV 10^5 PFU, Experimental: CodaVax-RSV 10^4 PFU, Placebo comparator, Experimental: CodaVax-RSV 10^6 PFU
Respiratory Syncytial Virus Infection Clinical Trial 2023: CodaVax-RSV Highlights & Side Effects. Trial Name: NCT04919109 — Phase 1
CodaVax-RSV (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919109 — Phase 1
~10 spots leftby Apr 2025
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