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NCT04919109 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
A Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by Codagenix.
- Active
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 5
- Study locations
NCT04919109: Active Phase 1 study of Respiratory Syncytial Virus Infections, sponsored by Codagenix.
NCT04919109 is a Phase 1 study of Respiratory Syncytial Virus Infections that is active but no longer recruiting, run by Codagenix. The registered enrollment target is 51 participants, below the 1,089-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919109, a Phase 1 study of Respiratory Syncytial Virus Infections, is active but no longer recruiting, sponsored by Codagenix.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to \< 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart. A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose. Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.
Primary Outcome
Reactogenicity Event Counts
Conditions Studied
Interventions
- BIOLOGICAL Normal Saline
- BIOLOGICAL CodaVax-RSV
Study Locations (5)
Nebraska
- Velocity - Lincoln
- Velocity - Omaha
Rhode Island
- Velocity - Providence
Utah
- Velocity - West Jordan
Other
- University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA) - Johannesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 1 |
What the registry record for NCT04919109 still lists
NCT04919109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,089-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT04919109 lists 5 locations in 4 states (Nebraska, Rhode Island, Utah).
Frequently Asked Questions
What is clinical trial NCT04919109 about?
NCT04919109 is a clinical study titled "Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children". This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged...
What is the current status of trial NCT04919109?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2023-03-28. Estimated completion is 2025-08-27.
What conditions does trial NCT04919109 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT04919109?
The interventions under investigation include: Normal Saline (BIOLOGICAL), CodaVax-RSV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04919109?
This trial is sponsored by Codagenix, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04919109 being conducted?
This trial has 5 study locations across Nebraska, Rhode Island, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04919109's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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