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InfluenzaPhase 1NCT04146623

Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray

A Phase 1 study testing CodaVax-H1N1 influenza vaccine 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 live-attenuated CodaVax-H1N1 influenza vaccine as compared to normal saline placebo both administered via intranasal spray 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 influenza vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteAustralia
Study dates
7 May 2019to 11 Nov 2020
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

  • Adult volunteers, aged 18 to 45 years (at the time of screening) in good general health in the opinion of the Medical Investigator or delegate, with no significant medical history and no clinically significant abnormal findings at screening.
  • Participants must use highly effective, double contraception from the Screening Visit and up to the Follow-up Visit (Day 30).
  • Must be willing to comply with the following conditions to prevent the spread of Genetically modified organisms (GMO) according the Office of Gene Technology Regulator (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
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  • 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
  • Contact is not to be made with infants <6 months of age within 7 days of vaccination.
  • Adequate venous access in the left or right arms to allow collection of a number of blood samples.
  • Must be sero-susceptible ≤10 hemagglutination inhibition (HAI) titre to CA/07/2009 Influenza virus (pre-screen).
  • Laboratory Testing:
  • Full blood examination and biochemistry within the laboratory defined normal range unless deemed not clinically significant by the investigator, however a small drop below the normal range for Absolute Neutrophil Count (ANC) may be acceptable as per investigator discretion;
  • Urinalysis: Negative urine glucose, negative or trace urine protein, negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional range)
  • 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 (excluding steroids, see exclusion criteria 16) or was undergoing a form of treatment within 3 months prior to study entry that affects the immune system, or participant is living with somebody with the same
  • 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 from 2016 to present year
  • Participants with plans to travel to the Northern Hemisphere during the Screening period
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  • Participated in another clinical study (involving any investigational product or device) within 60 days before screening
  • 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 or a history of childhood asthma which was treated with corticosteroids.
  • Participants with a known egg allergy
  • If female, pregnant, planning to become pregnant, or lactating, or participants is living with somebody who is 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, hematological, metabolic or renal disorder
  • Clinically significant abnormal laboratory value at screening as determined by the Investigator
  • Known or suspected impairment/alteration of immune function, including: Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks /≥2 mg/kg body weight / day prednisone ≥2 weeks) within 60 days prior to Day 0 (use of inhaled, IN, or topical corticosteroids is allowed, unless used for the management of asthma - see exclusion criteria 9). Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks /≥2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 0. Or participant is living with somebody with the same
  • Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety parameters
  • Participant is sero-positive to hepatitis C virus or hepatitis B virus.
  • Body temperature (oral) ≥38.0ºC or acute illness within 5 days prior to vaccination
  • 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 Pty Limited

    Brisbane, Queensland, 4006

Other trials in Australia

About this study

Official title: A Randomized Double-Blind, Placebo Controlled, Phase I Study of the Safety, Tolerability and Immunogenicity of a Live Attenuated H1N1 Vaccine in Healthy Individuals

This study is being conducted to assess the safety, tolerability, and immunogenicity of the live-attenuated CodaVax-H1N1 influenza vaccine as compared to normal saline placebo both administered via intranasal spray to healthy adults.

Conditions
Influenza
Being tested
CodaVax-H1N1 influenza vaccine, Normal Saline Placebo
Keywords
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-H1N1 influenza vaccineBiological

    CodaVax-H1N1, a live attenuated vaccine (LAIV) strain based on the A/California/07/2009 (H1N1) influenza virus, administered once intranasally via a sprayer at a dose of 8 x10^5 plaque forming units (PFU).

  • Normal Saline PlaceboBiological

    Saline (0.9%) administered intranasally via sprayer

Study groups in NCT04146623
Study groupRoleWhat they receive
Normal Saline PlaceboPlacebo comparatorSaline (0.9%)
Receives: Biological: Normal Saline Placebo
CodaVax-H1N1ExperimentalLive-attenuated influenza vaccine
Receives: Biological: CodaVax-H1N1 influenza vaccine

What is being measured

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

  1. Reactions to vaccine

    Number of solicited local and systemic reactions for CodaVax-H1N1 and placebo

    Measured: 6 days

  2. Adverse events (AEs)

    Number of subjects with AEs for CodaVax-H1N1 and placebo

    Measured: 30 days

  3. Serious adverse events (SAEs)

    Number of subjects with SAEs for CodaVax-H1N1 and placebo

    Measured: 180 days

Secondary outcomes (9)

  1. HAI antibody titers against A/California/07/2009

    Geometric mean titers (GMT) of anti-A/California/07/2009 (H1N1) antibodies (Hemagglutination inhibition, HAI) for each treatment arm

    Measured: Day 0 and 30

  2. Increase in HAI titer against A/California/07/2009

    Geometric mean fold increase (GMFI) of anti-A/California/07/2009 (H1N1) HAI serum antibodies for each treatment arm

    Measured: Day 0 and 30

  3. HAI sero-response

    The proportion of participants, regardless of sero-status, within each treatment arm who experience an H1N1 CA/07/2009 specific sero-response post-dose. Sero-response is defined as a ≥4-fold rise in HAI titer from baseline.

    Measured: Day 0 and 30

  4. Serum IgG response

    The proportion of participants within each treatment arm with a greater or equal to 2-fold rise in serum lgG antibody responses to whole virus CA/07/2009 by ELISA

    Measured: Day 0 and 30

  5. Increase in serum IgG

    Geometric mean fold increase (GMFI) within each treatment arm in serum lgG antibody responses to whole virus CA/07/2009 by ELISA

    Measured: Day 0 and 30

  6. Serum IgA response

    The proportion of participants within each treatment arm with a greater or equal to 2-fold rise in serum lgA antibody responses to whole virus CA/07/2009 by ELISA

    Measured: Day 0 and 30

  7. Increase in serum IgA

    Geometric mean fold increase (GMFI) within each treatment arm in serum lgA antibody responses to whole virus CA/07/2009 by ELISA

    Measured: Day 0 and 30

  8. Salivary IgA Response

    The proportion of participants within each treatment arm with a greater or equal to 2-fold rise in salivary lgA antibody responses to whole virus CA/07/2009 by ELISA

    Measured: Day 0 and 30

  9. Increase in salivary IgA

    Geometric mean fold increase (GMFI) within each treatment arm in salivary lgA antibody responses to whole virus CA/07/2009 by ELISA

    Measured: Day 0 and 30

Timeline

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

  1. First posted31 Oct 2019
  2. Study start7 May 2019
  3. Primary completion11 Oct 2020
  4. Study completion11 Nov 2020

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146623
Sponsor's protocol ID
CODA01-002
Status last verified
Nov 2020
First submitted
28 Oct 2019
Last updated
1 Dec 2020
Results posted
No
Data monitoring committee
Yes
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 influenza vaccine 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 18 inclusion and 21 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 1 Dec 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?

Reactions to vaccine (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 NCT04146623.

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 1 Dec 2020.

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