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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04146623




Registration number
NCT04146623
Ethics application status
Date submitted
28/10/2019
Date registered
31/10/2019
Date last updated
11/06/2020

Titles & IDs
Public title
Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray
Scientific 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
Secondary ID [1] 0 0
CODA01-002
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 influenza vaccine
Other interventions - Normal Saline Placebo

Placebo Comparator: Normal Saline Placebo - Saline (0.9%)

Experimental: CodaVax-H1N1 - Live-attenuated influenza vaccine


Other interventions: CodaVax-H1N1 influenza vaccine
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).

Other interventions: Normal Saline Placebo
Saline (0.9%) administered intranasally via sprayer

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

Outcomes
Primary outcome [1] 0 0
Reactions to vaccine - Number of solicited local and systemic reactions for CodaVax-H1N1 and placebo
Timepoint [1] 0 0
6 days
Primary outcome [2] 0 0
Adverse events (AEs) - Number of subjects with AEs for CodaVax-H1N1 and placebo
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Serious adverse events (SAEs) - Number of subjects with SAEs for CodaVax-H1N1 and placebo
Timepoint [3] 0 0
180 days
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 0 and 30
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Day 0 and 30
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 0 and 30
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Day 0 and 30
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 0 and 30
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Day 0 and 30
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Day 0 and 30
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Day 0 and 30
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Day 0 and 30

Eligibility
Key inclusion criteria
1. 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.

2. Participants must use highly effective, double contraception from the Screening Visit
and up to the Follow-up Visit (Day 30).

3. 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):

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

4. Contact is not to be made with infants <6 months of age within 7 days of vaccination.

5. Adequate venous access in the left or right arms to allow collection of a number of
blood samples.

6. Must be sero-susceptible =10 hemagglutination inhibition (HAI) titre to CA/07/2009
Influenza virus (pre-screen).

7. Laboratory Testing:

1. 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;

2. 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)

8. Able to communicate effectively with study personnel and considered reliable, willing
and cooperative in terms of compliance with the protocol requirements

9. Participant does not intend to start or change an existing physical conditioning
regimen prior to or during the study period

10. Participant has voluntarily given written informed consent to participate in the study
(prior study entry)

11. 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
1. 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

2. Participant is not to have had Guillain-Barre Syndrome

3. Received blood or blood products in the 3 months prior to screening

4. Received another vaccine within 30 days before screening

5. Received another influenza vaccine from 2016 to present year

6. Participants with plans to travel to the Northern Hemisphere during the Screening
period

7. Participated in another clinical study (involving any investigational product or
device) within 60 days before screening

8. 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)

9. Participants with active asthma or a history of childhood asthma which was treated
with corticosteroids.

10. Participants with a known egg allergy

11. If female, pregnant, planning to become pregnant, or lactating, or participants is
living with somebody who is pregnant or lactating.

12. 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

13. History of any psychiatric illness or psychological disorder which may impair the
ability to provide written informed consent or participate in the study

14. Current or history of significant neurological, cardiovascular, pulmonary (including
asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder

15. Clinically significant abnormal laboratory value at screening as determined by the
Investigator

16. 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

17. Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion
of the Investigator, to affect safety parameters

18. Participant is sero-positive to hepatitis C virus or hepatitis B virus.

19. Body temperature (oral) =38.0ºC or acute illness within 5 days prior to vaccination

20. 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

21. 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
Active, not recruiting
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 Pty Limited - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

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
live-attenuated CodaVax-H1N1 influenza vaccine as compared to normal saline placebo both
administered via intranasal spray to healthy adults.
Trial website
https://clinicaltrials.gov/show/NCT04146623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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