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Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04919109
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : May 31, 2024
Sponsor:
Information provided by (Responsible Party):
Codagenix, Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: CodaVax-RSV Biological: Normal Saline Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
Actual Study Start Date : March 28, 2023
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : June 27, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo comparator
Administered as nose drops
 Biological: Normal Saline
Placebo comparator
Experimental: Experimental: CodaVax-RSV 10^6 PFU
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
 Biological: CodaVax-RSV
live attenuated vaccine against RSV
Experimental: Experimental: CodaVax-RSV 10^5 PFU
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
 Biological: CodaVax-RSV
live attenuated vaccine against RSV
Experimental: Experimental: CodaVax-RSV 10^4 PFU
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
 Biological: CodaVax-RSV
live attenuated vaccine against RSV
Experimental: Experimental: CodaVax-RSV 10^3 PFU
Respiratory syncytial virus live attenuated vaccine against RSV administered as nose drops
 Biological: CodaVax-RSV
live attenuated vaccine against RSV


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants reporting expected adverse reactions [ Time Frame: Day 7 ]
    Reactogenicity Event Counts

  2. Number of participants reporting expected adverse reactions [ Time Frame: Day 36 ]
    Reactogenicity Event Counts

  3. Number of participant reported adverse events [ Time Frame: Days 57 ]
    Adverse event counts

  4. Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs) [ Time Frame: Days 210 ]
    counts


Secondary Outcome Measures :
  1. Neutralizing antibody [ Time Frame: Screening, Days 29 and 57 ]
    Neutralizing antibody level


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age at the time of informed consent:

    • Part A: 2 to 5 years, inclusive
    • Part B: 6 months to < 2 years

  2. RSV Status at Screening:

    • Part A: RSV-seropositive
    • Part B: RSV-seronegative
  3. Good general health status
  4. Product of normal full-term pregnancy (36 to 42 weeks gestation)

Exclusion Criteria:

  1. 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
  2. Enrolled in the same classroom at full-time day care with infants < 6 months of age for 14 days after each dose
  3. Household contact of another child enrolled into the study
  4. Inadequate venous access for repeated phlebotomy
  5. 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919109


Contacts
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Contact: Lasmy Tea +1-631-227-3932 tea@codagenix.com

Locations
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United States, Nebraska
Velocity Recruiting
Lincoln, Nebraska, United States, 658510
Velocity Recruiting
Omaha, Nebraska, United States, 68134
United States, Rhode Island
Velocity Recruiting
Providence, Rhode Island, United States, 02818
United States, Utah
Velocity Recruiting
West Jordan, Utah, United States, 84088
South Africa
University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA) Recruiting
Johannesburg, South Africa
Sponsors and Collaborators
Codagenix, Inc
More Information
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Responsible Party: Codagenix, Inc
ClinicalTrials.gov Identifier: NCT04919109    
Other Study ID Numbers: CDX-RSV-101P
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: May 31, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Codagenix, Inc:
RSV
Live-attenuated vaccine
respiratory infection
Pediatric
Codon-deoptimized
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Infections
Virus Diseases
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections