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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919109
• Other study ID #: CDX-RSV-101P
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2023
• Est. completion date: June 27, 2025

Study information

• Verified date: May 2024
• Source: Codagenix, Inc
• Contact: Lasmy Tea
• Phone: +1-631-227-3932
• Email: tea[@]codagenix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: June 27, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

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

Locations

Country	Name	City	State
South Africa	University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA)	Johannesburg
United States	Velocity	Lincoln	Nebraska
United States	Velocity	Omaha	Nebraska
United States	Velocity	Providence	Rhode Island
United States	Velocity	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Codagenix, Inc

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting expected adverse reactions	Reactogenicity Event Counts	Day 7
Primary	Number of participants reporting expected adverse reactions	Reactogenicity Event Counts	Day 36
Primary	Number of participant reported adverse events	Adverse event counts	Days 57
Primary	Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)	counts	Days 210
Secondary	Neutralizing antibody	Neutralizing antibody level	Screening, Days 29 and 57