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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: Normal Saline; Biological: CodaVax-RSV

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Johannesburg, South Africa
    • University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA)
• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 658510
      • Velocity
    • Omaha, Nebraska, United States, 68134
      • Velocity
  • Rhode Island
    • Providence, Rhode Island, United States, 02818
      • Velocity
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralizing antibody	Neutralizing antibody level	Screening, Days 29 and 57

Collaborators and Investigators

• Sponsor: Codagenix, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): August 27, 2025

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; RSV; respiratory infection; Live-attenuated vaccine; Codon-deoptimized
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: CDX-RSV-101P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No