Safety Study of Live Attenuated Influenza Vaccine, CodaVax

NCT03926416 | Completed Phase 1 FDA Drug

• 1 other identifier: CODA01-001
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to assess the safety, tolerability, and immunogenicity of the CodaVax-H1N1 influenza vaccine as compared to active and placebo controls when administered to healthy adults.

Conditions

Influenza

Keywords

vaccines; live-attenuated vaccine; influenza vaccine

Outcome Measures

Primary Outcomes (3)

• Number of subjects with solicited local and/or systemic reactions after each vaccination, for each treatment group

  Number of volunteers that experience adverse events

  6 days

• Incidence of Adverse Events (AE)

  Number of subjects with AEs

  30 days

• Incidence of Serious Adverse Events (SAE)

  Number of subjects with SAEs

  Days 1-168

Secondary Outcomes (6)

• Haemagglutination Inhibition Test (HAI) titre

  30 days post-vaccination

• Rate of Seroconversion

  30 days post-vaccination

• Cal/09 HAI antibodies

  30 days post-vaccination

• Mich/15 HAI antibodies

  30 days post-vaccination

• Increase in anti-Cal/09 antibodies

  30 days post-vaccination

Study Arms (4)

CodaVax-H1N1, low dose

EXPERIMENTAL

Participants will receive a single dose of either CodaVax (5 x 10\^3 PFU in 200 uL) and an intramuscular injection of placebo

Biological: CodaVax-H1N1

Fluzone

ACTIVE COMPARATOR

Participants will receive an intranasal (IN) dose of placebo and an intramuscular (IM) dose of QuadriFlu- Tetravalent Influenza Vaccine (TIV) (Fluzone®)

Biological: Fluzone quadrivalent

CodaVax-H1N1, high dose

EXPERIMENTAL

Participants will receive a single intranasal (IN) dose of CodaVax-H1N1 (1 x 10\^5 PFU in 500 uL)

Biological: CodaVax-H1N1

Placebo

PLACEBO COMPARATOR

Leibovitz's L-15 medium (IN) or saline (IM)

Biological: CodaVax-H1N1; Biological: Fluzone quadrivalent

Interventions

CodaVax-H1N1 BIOLOGICAL

Live-attenuated vaccine against influenza A H1N1, A/California/07/2009

CodaVax-H1N1, high dose; CodaVax-H1N1, low dose; Placebo

Fluzone quadrivalent BIOLOGICAL

Fluzone® (QuadriFlu - TIV), inactivated, quadrivalent influenza vaccine

Fluzone; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In good health, in the opinion of the Medical Investigator (with or without the Sponsor), with no significant medical history and no clinically significant abnormal findings at screening. Particular attention will be paid to:
• A drug history identifying any known drug allergies and the presence of drug abuse;
• Any chronic use of medication(s); and
• Thorough review of body systems
• Women of child bearing potential (WOCBP) must use highly effective, double contraception from the Screening Visit and up to the Follow-up visit (Day 30 ± 2 days). Double contraception is defined as a condom AND one other form of the following:
• Established hormonal contraception (with approved oral, injected or depot regimen) for at least 2 months prior to screening
• Depot or injectable birth control
• Intrauterine device or intrauterine system in place for at least 2 months prior to screening
• Documented evidence of surgical sterilization at least 6 months prior to screening visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men (with appropriate post-vasectomy documentation of the absence of sperm in semen) provided the male partner is a sole partner; Males must not donate sperm for at least 70 days post-dose of the last study treatment. Male partners of female participants and female partners of male participants must also use contraception, if they are of childbearing potential.
• Women of childbearing potential must have a negative serum pregnancy test at Screening and Day 30. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by FSH level meets the requirement of post-menopausal women if in doubt. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant abstinence for the duration of the study and 1 month after the last study treatment is acceptable.
• Must be willing to comply with the following conditions to prevent the spread of GMOs according the OGTR Licence (DIR 144):
• Hygiene measures intended to prevent interpersonal transmission of study drug must be implemented, including but not limited to frequent handwashing with soap or hand disinfectant, respiratory hygiene and cough etiquette within 7 days following vaccination
• Blood, tissue or organs must not be donated within 7 days of vaccination
• Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days of vaccination
• Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days of vaccination

You may not qualify if:

• Immunodeficiency (including HIV) or autoimmune disorder, or participant is currently taking drugs or was undergoing a form of treatment within 6 weeks prior to study entry that affects the immune system. (Treatment of asthma with low dose corticosteroids equivalent to prednisone \<10 mg/day, is permitted).
• Participant is not to have had Guillain-Barre Syndrome
• Received blood or blood products in the 3 months prior to screening
• Received another vaccine within 30 days before screening
• Received another influenza vaccine within 2 years prior to screening
• Participated in another clinical study (involving an investigational product or device) within 60 days before screening (including studies for FluMist®)
• Suffered previous anaphylactic reaction to foods, vaccines, drugs or hymenoptera stings, or has a history of severe allergic reactions (e.g. clinically severe urticaria, asthma)
• Participants with active asthma currently managed by ad lib with inhalers
• Participants with a known egg allergy
• If female, pregnant, planning to become pregnant, or lactating
• Participant has a history of, or current evidence at the time of screening of abuse of alcohol or any drug substance, licit or illicit, or current alcohol consumption is \> 4 standard drinks (or equivalent) per day
• History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
• Current or history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder
• Clinically significant abnormal laboratory value at screening as determined by the Investigator
• Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety pathology parameters

Sponsors & Collaborators

• Codagenix, Inc: lead

Study Sites (1)

Q-Pharm

Herston, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Griffin, MD

  Q-Pharm Pty Limited

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 24, 2019
• Study Start: February 21, 2017
• Primary Completion: May 29, 2018
• Study Completion: September 14, 2018
• Last Updated: July 23, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)