Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
1 other identifier
interventional
51
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2023
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 9, 2021
CompletedStudy Start
First participant enrolled
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2025
CompletedFebruary 6, 2025
February 1, 2025
2.1 years
May 26, 2021
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of participants reporting expected adverse reactions
Reactogenicity Event Counts
Day 7
Number of participants reporting expected adverse reactions
Reactogenicity Event Counts
Day 36
Number of participant reported adverse events
Adverse event counts
Days 57
Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)
counts
Days 210
Secondary Outcomes (1)
Neutralizing antibody
Screening, Days 29 and 57
Study Arms (5)
Placebo comparator
PLACEBO COMPARATORAdministered as nose drops
Experimental: CodaVax-RSV 10^6 PFU
EXPERIMENTALRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Experimental: CodaVax-RSV 10^5 PFU
EXPERIMENTALRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Experimental: CodaVax-RSV 10^4 PFU
EXPERIMENTALRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Experimental: CodaVax-RSV 10^3 PFU
EXPERIMENTALRespiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
Interventions
live attenuated vaccine against RSV
Eligibility Criteria
You may qualify if:
- Age at the time of informed consent:
- Part A: 2 to 5 years, inclusive
- Part B: 6 months to \< 2 years
- RSV Status at Screening:
- Part A: RSV-seropositive
- Part B: RSV-seronegative
- Good general health status
- Product of normal full-term pregnancy (36 to 42 weeks gestation)
You may not qualify if:
- 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
- Enrolled in the same classroom at full-time day care with infants \< 6 months of age for 14 days after each dose
- Household contact of another child enrolled into the study
- Inadequate venous access for repeated phlebotomy
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Codagenix, Inclead
Study Sites (5)
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
University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA)
Johannesburg, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 9, 2021
Study Start
March 28, 2023
Primary Completion
April 30, 2025
Study Completion
August 27, 2025
Last Updated
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share