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InfluenzaPhase 1NCT03926416

Safety Study of Live Attenuated Influenza Vaccine, CodaVax

A Phase 1 study testing CodaVax-H1N1 and Fluzone quadrivalent in people with Influenza, run by Codagenix, Inc at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
CodaVax-H1N1 and Fluzone quadrivalent
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
1 siteAustralia
Study dates
21 Feb 2017to 14 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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
  • All tissues and materials used to collect respiratory secretions are to be sealed in a primary container and placed within a secondary container so that it is not accessible to children or animals for 7 days until it is returned to the study site for disposal, for 7 days within vaccination
  • Adequate venous access in the left or right arms to allow collection of a number of blood samples
  • No birthmarks, tattoos, wounds or other skin conditions which could reasonably obscure IM injection site reactions
  • Able to communicate effectively with study personnel and considered reliable, willing and cooperative in terms of compliance with the protocol requirements
  • Participant does not intend to start or change an existing physical conditioning regimen prior to or during the study period
  • Participant has voluntarily given written informed consent to participate in the study (prior study entry)
  • Participant is available for the duration of the study

Who cannot join

  • 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®)
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  • 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
  • Participant is seropositive to Human Immunodeficiency Virus (HIV-1 or HIV-2), Hepatitis C Virus (HCV) or HBV.
  • Body temperature (oral) ≥38.0ºC or acute illness within 5 days prior to vaccination
  • Any skin marking, tattoo or blemish precluding injection site inspection.
  • Any other significant finding that, in the opinion of the Investigator, would increase the risk of the individual having an adverse outcome from participating in this study
  • Participant is a member of the team or is related or in a dependent relationship with a member of the study team, as defined as the Sponsor or study site personnel

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Q-Pharm

    Herston, Queensland, 4006

Other trials in Australia

About this study

Official title: A Randomised, Double-Blind, Double-Dummy, Active and Placebo Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of the CodaVax Influenza Vaccine

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.

Read the detailed description

This randomized, double-blind, placebo and active controlled Phase I study is intended to study the effects of a live-attenuated vaccine against influenza A H1N1. Part 1 of this study will enroll 75 participants at a single site. Participants will be randomized in a 2:2:1 ratio to receive one dose each of either CodaVax-H1N1, FluZone quadrivalent, or placebo. This study is conducted during the influenza "off season" in Australia. Part 2 of the study will enroll an 50 additional participants randomized to receive either CodaVax-H1N1 at a higher dose or placebo (40:10).

Conditions
Influenza
Being tested
CodaVax-H1N1, Fluzone quadrivalent
Keywords
vaccines, live-attenuated vaccine, influenza vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CodaVax-H1N1Biological

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

  • Fluzone quadrivalentBiological

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

Study groups in NCT03926416
Study groupRoleWhat they receive
CodaVax-H1N1, low doseExperimentalParticipants will receive a single dose of either CodaVax (5 x 10^3 PFU in 200 uL) and an intramuscular injection of placebo
Receives: Biological: CodaVax-H1N1
FluzoneActive comparatorParticipants will receive an intranasal (IN) dose of placebo and an intramuscular (IM) dose of QuadriFlu- Tetravalent Influenza Vaccine (TIV) (Fluzone®)
Receives: Biological: Fluzone quadrivalent
CodaVax-H1N1, high doseExperimentalParticipants will receive a single intranasal (IN) dose of CodaVax-H1N1 (1 x 10^5 PFU in 500 uL)
Receives: Biological: CodaVax-H1N1
PlaceboPlacebo comparatorLeibovitz's L-15 medium (IN) or saline (IM)
Receives: Biological: CodaVax-H1N1; Biological: Fluzone quadrivalent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of volunteers that experience adverse events

    Measured: 6 days

  2. Incidence of Adverse Events (AE)

    Number of subjects with AEs

    Measured: 30 days

  3. Incidence of Serious Adverse Events (SAE)

    Number of subjects with SAEs

    Measured: Days 1-168

Secondary outcomes (6)

  1. Haemagglutination Inhibition Test (HAI) titre

    The percentage of subjects achieving a (HAI) antibody titre ≥ 1:40 determined 30 days post-vaccination as compared to baseline (Day 0, pre-vaccination)

    Measured: 30 days post-vaccination

  2. Rate of Seroconversion

    The rate of seroconversion, defined as the percentage of subjects with either a pre-vaccination HAI titre < 1:10 and a post vaccination HAI titre > 1:40 or a pre-vaccination HAI titre > or = to 1:10 and a minimum four-fold rise in post-vaccination HAI antibody titre, determined 30 days postvaccination

    Measured: 30 days post-vaccination

  3. Cal/09 HAI antibodies

    Geometric mean titres (GMT) of anti-A/California/07/2009 (H1N1) HAI serum antibodies 30 days after each vaccination, by treatment group

    Measured: 30 days post-vaccination

  4. Mich/15 HAI antibodies

    Geometric mean titres (GMT) of anti-A/Michigan/45/2015 (H1N1) antibodies (HAI)

    • Geometric mean fold increase (GMFI) of anti-A/California/07/2009 (H1N1) HAI serum antibodies determined 30 days after each vaccination relative to baseline
    • Geometric mean fold increase (GMFI) of anti-A/Michigan/45/2015 (H1N1) HAI serum antibodies determined 30 days after each vaccination relative to baseline

    Measured: 30 days post-vaccination

  5. Increase in anti-Cal/09 antibodies

    Geometric mean fold increase (GMFI) of anti-A/California/07/2009 (H1N1) HAI serum antibodies determined 30 days after each vaccination relative to baseline

    Measured: 30 days post-vaccination

  6. Increase in anti-Mich/15 antibodies

    Geometric mean fold increase (GMFI) of anti-A/Michigan/45/2015 (H1N1) HAI serum antibodies determined 30 days after each vaccination relative to baseline

    Measured: 30 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start21 Feb 2017
  3. Primary completion29 May 2018
  4. Study completion14 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926416
Sponsor's protocol ID
CODA01-001
Status last verified
Apr 2019
First submitted
18 Apr 2019
Last updated
23 Jul 2020
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CodaVax-H1N1 and Fluzone quadrivalent in people with Influenza, run by Codagenix, Inc at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with solicited local and/or systemic reactions after each vaccination, for each treatment group (time frame: 6 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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