Intramuscular CodaVax-H1N1 in Healthy Adults

NCT05223179 | Completed Phase 1 FDA Drug

• 1 other identifier: CDX-FLU-103
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through the 2023 influenza season (Part B). Participants will be screened within 28 days of randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), or licenced injectable seasonal influenza vaccine (Flucelvax Quad). Each subsequent cohort will include a higher dose of CodaVax H1N1 than the previous cohort, in addition to placebo and the licensed injectable seasonal influenza vaccine. In Part B, 24 eligible participants will be enrolled into 1 of 2 sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.

Conditions

Influenza, Human

Keywords

Influenza, Human; Viral Vaccines; Vaccines, Live Attenuated

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events

  Percentage of participants with reactogenicity events

  Reactogenicity events from Day 1 to Day 7

• Safety and Tolerability by Assessing Percentage of Participants with Adverse Events

  Percentage of participants with adverse events

  Adverse events (AEs) from Day 1 to Day 29

• Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.

  Percentage of participants with MAAEs, NCIs, and SAEs.

  MAAEs, NCIs, SAEs from Day 1 to Day 181

Secondary Outcomes (1)

• Humoral Immunogenicity

  HAI assay titre against A/California/07/2009 and the current seasonal influenza vaccine H1N1 and H3N2 strains measured in samples collected on Days 1, 29, 91, and 181

Study Arms (3)

CODA-VAX H1N1

EXPERIMENTAL

Live Attenuated Vaccine administered by Intramuscular Injection

Biological: CODA-VAX H1N1

Flucelvax Quad

ACTIVE COMPARATOR

Licensed Injectable Seasonal Influenza Vaccine

Biological: Flucelvax Quad

Saline

PLACEBO COMPARATOR

Normal Sterile Saline for Intramuscular Injection

Other: Saline

Interventions

CODA-VAX H1N1 BIOLOGICAL

Intramuscular Live Attenuated Influenza H1N1 Vaccine

CODA-VAX H1N1

Flucelvax Quad BIOLOGICAL

Licensed Seasonal Injectable Influenza Vaccine

Flucelvax Quad

Saline OTHER

Saline

Saline

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
• In good health with no history, or current evidence, of clinically significant medical conditions
• Negative SARS-CoV-2 test predose on Day 1
• For all women, negative pregnancy test
• Agreement to comply with conditions to prevent the spread of genetically modified organisms (GMOs)

You may not qualify if:

• Pregnant or lactating women or women who plan to become pregnant through Day 29
• Inadequate venous access for repeated phlebotomy
• History of severe reaction to vaccination
• Receipt of any licenced or investigational influenza vaccine within 6 months before Day 1
• Receipt of any live vaccine within 30 days before Day 1
• Tattoo, skin reaction, or other condition at the injection site that would interfere with assessment of local reactogenicity

Sponsors & Collaborators

• Codagenix, Inc: lead

Study Sites (1)

Lis Gilmour, Senior Project Manager

Morayfield, Queensland, QLD 4556, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: April 11, 2022
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)