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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03926416




Registration number
NCT03926416
Ethics application status
Date submitted
18/04/2019
Date registered
24/04/2019
Date last updated
29/04/2019

Titles & IDs
Public title
Safety Study of Live Attenuated Influenza Vaccine, CodaVax
Scientific 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
Secondary ID [1] 0 0
CODA01-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CodaVax-H1N1
Other interventions - Fluzone quadrivalent

Experimental: CodaVax-H1N1, low dose - Participants will receive a single dose of either CodaVax (5 x 10^3 PFU in 200 uL) and an intramuscular injection of placebo

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

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

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


Other interventions: CodaVax-H1N1
Live-attenuated vaccine against influenza A H1N1, A/California/07/2009

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with solicited local and/or systemic reactions after each vaccination, for each treatment group
Timepoint [1] 0 0
6 days
Secondary outcome [1] 0 0
Incidence of Adverse Events (AE) - Number of subjects with AEs
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Incidence of Serious Adverse Events (SAE) - Number of subjects with SAEs
Timepoint [2] 0 0
Days 1-168
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
30 days post-vaccination
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
30 days post-vaccination
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
30 days post-vaccination
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
30 days post-vaccination
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
30 days post-vaccination
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
30 days post-vaccination

Eligibility
Key inclusion criteria
- 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):

1. 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

2. Blood, tissue or organs must not be donated within 7 days of vaccination

3. Severely immunosuppressed persons who require a protective environment are not to
be cared for by the participant within 7 days of vaccination

4. Contact is not to be made with severely immunosuppressed persons who require a
protective environment within 7 days of vaccination

5. 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Codagenix, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03926416
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Griffin, MD
Address 0 0
Q-Pharm Pty Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications