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

• ClinicalTrials.gov Identifier: NCT04919109
• Recruitment Status: Recruiting
• First Posted: June 9, 2021
• Last Update Posted: May 31, 2024
• Sponsor: Codagenix, Inc
• Information provided by (Responsible Party): Codagenix, Inc

Tracking Information

• First Submitted Date: May 26, 2021
• First Posted Date: June 9, 2021
• Last Update Posted Date: May 31, 2024
• Actual Study Start Date: March 28, 2023
• Estimated Primary Completion Date: April 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2021)

• Number of participants reporting expected adverse reactions [ Time Frame: Day 7 ]
  Reactogenicity Event Counts
• Number of participants reporting expected adverse reactions [ Time Frame: Day 36 ]
  Reactogenicity Event Counts
• Number of participant reported adverse events [ Time Frame: Days 57 ]
  Adverse event counts
• Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs) [ Time Frame: Days 210 ]
  counts

Original Primary Outcome Measures (submitted: June 2, 2021)

• Severity of reported Events [ Time Frame: Day 7 ]
  Reactogenicity Event Counts
• Severity of reported Events [ Time Frame: Day 36 ]
  Reactogenicity Event Counts
• Adverse Events [ Time Frame: Days 57 ]
  Adverse event counts
• Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs) [ Time Frame: Days 210 ]
  counts

Current Secondary Outcome Measures (submitted: June 2, 2021)

Neutralizing antibody [ Time Frame: Screening, Days 29 and 57 ]

Neutralizing antibody level

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
• Official Title: Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Respiratory Syncytial Virus Infections

Intervention

• Biological: CodaVax-RSV
  live attenuated vaccine against RSV
• Biological: Normal Saline
  Placebo comparator

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 16, 2022): 51
• Original Estimated Enrollment (submitted: June 2, 2021): 36
• Estimated Study Completion Date: June 27, 2025
• Estimated Primary Completion Date: April 30, 2025 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 5 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: South Africa, United States

Administrative Information

• NCT Number: NCT04919109
• Other Study ID Numbers: CDX-RSV-101P
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Codagenix, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Codagenix, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Codagenix, Inc
• Verification Date: May 2024