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

July 14, 2026 updated by: Codagenix, Inc

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codagenix, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

June 26, 2025

Study Completion (Actual)

July 8, 2026

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)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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