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

Sponsor
Codagenix, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04919109
Collaborator
(none)
36
Enrollment
2
Arms
11.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a Phase 1, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety of and immune response to CodaVax-RSV in 36 healthy children. They will be vaccinated in summer to early autumn 2021 and followed through the 2021-22 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 18 children aged 6 months to < 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled. Children will receive 2 doses of the vaccine 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CodaVax-RSV
  • Biological: Normal Saline
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Feb 22, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants reporting expected adverse reactions [Day 7]

    Reactogenicity Event Counts

  2. Number of participants reporting expected adverse reactions [Day 36]

    Reactogenicity Event Counts

  3. Number of participant reported adverse events [Days 57]

    Adverse event counts

  4. Number of participants with Medically attended AEs (MAAEs), new-onset chronic illnesses (NCIs), and serious AEs (SAEs) [Days 210]

    counts

Secondary Outcome Measures

  1. Neutralizing antibody [Screening, Days 29 and 57]

    Neutralizing antibody level

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age at the time of informed consent:

  • Part A: 2 to 5 years, inclusive

  • Part B: 6 months to < 2 years

  1. RSV Status at Screening:

  • Part A: RSV-seropositive

  • Part B: RSV-seronegative

  1. Good general health status

  2. 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

  1. Enrolled in the same classroom at full-time day care with infants < 6 months of age for 14 days after each dose

  2. Household contact of another child enrolled into the study

  3. Inadequate venous access for repeated phlebotomy

  4. 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Codagenix, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Codagenix, Inc
ClinicalTrials.gov Identifier:
NCT04919109
Other Study ID Numbers:
  • CDX-RSV-101P
First Posted:
Jun 9, 2021
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Codagenix, Inc
RSV
Live-attenuated vaccine
respiratory infection
Pediatric
Codon-deoptimized
Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Sep 21, 2021