Clinical trial NCT04919109: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV
Live-attenuated vaccine
respiratory infection
Pediatric
Codon-deoptimized
Lead sponsor: Codagenix, Inc
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Number of participants reporting expected adverse reactions
timeFrame: Day 7
measure: Number of participants reporting expected adverse reactions
timeFrame: Day 36
measure: Number of participant reported adverse events
timeFrame: Days 57
measure: Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs)
timeFrame: Days 210
Secondary outcomes:
measure: Neutralizing antibody
timeFrame: Screening, Days 29 and 57
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Velocity
state: Nebraska
city: Omaha
country: United States
facility: Velocity
state: Nebraska
city: Providence
country: United States
facility: Velocity
state: Rhode Island
city: West Jordan
country: United States
facility: Velocity
state: Utah
city: Johannesburg
country: South Africa
facility: University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA)
Study officials:
References: