None listed
Conditions
Brief summary
CodaVax, the study drug being researched in this project, is an experimental vaccine being developed by Codagenix, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. CodaVax is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax influenza vaccine compared to placebo controls when administered to healthy adults.
Interventions
The study will comprise of 50 participants who will be randomised into 2 groups where each participant will receive a single dose of either CodaVax or placebo (40:10).
Forty (40 participants will be administered CodaVax and ten (10) participants will be administered the placebo. All subjects will receive an intranasal (IN) dose of either CodaVax or Leibovitz's L-15 medium (placebo).
CodaVax is a live attenuated influenza vaccine (LAIV) manufactured using a proprietary SAVE platform against th
The study will comprise of 50 participants who will be randomised into 2 groups where each participant will receive a single dose of either CodaVax or placebo (40:10). Forty (40 participants will be administered CodaVax and ten (10) participants will be administered the placebo. All subjects will receive an intranasal (IN) dose of either CodaVax or Leibovitz's L-15 medium (placebo). CodaVax is a live attenuated influenza vaccine (LAIV) manufactured using a proprietary SAVE platform against the H1N1 A/California/07/2009 (H1N1) strain. The vaccination dose for cohort 1 will be 5 x 10^3 PFU in 200 microlitre of current Good Manufacturing Practice (cGMP) Leibovitz's L-15 media. Cohort 2 will be 1 x 10^5 PFU in 425 microliter and is to be administered through an intranasal sprayer into one nostril only. In the study, due to the increase in dose to 20-fold compared to the dose in part 1 of the study, as a safety measure, 2 sentinel participants (1 placebo and 1 CodaVax participant) will receive the first dose of placebo or CodaVax by IN sprayer and Placebo by IN sprayer on Day 0 and will be monitored for 7 days. If dosing of the sentinels proceeds without clinically significant adverse events (AEs) over 7 days, all remaining participants will be dosed. Following vaccination all participants (CodaVax and placebo) will be monitored at the clinic for at least 60-90 minutes following vaccination, after which they will return to the clinic (Day 2, 4 and 6) to be monitored until Day 6 post-vaccination and on Day 30 post-vaccination for a Follow-up visit. A soft-lock will be placed on the database after the Day 30 Follow-up visits are complete, at which point the data will be unblinded and an interim preliminary report will be written. All participants will then receive an open-label Close-out phone interview 6 months post-vaccination and a final clinical study report will be written. Strategies used to monitor fidelity to the intervention is not applicable. This is only a single dose only. Accountability will be reviewed at the end of the study
Sponsors
Clinical Network Services Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria: 1. Adult volunteers, aged 18–45 years (at the time of screening) 2. 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. A drug history identifying any known drug allergies and the presence of drug abuse; b. Any chronic use of medication(s); and c. Thorough review of body systems 3. 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: a. Established hormonal contraception (with approved oral, injected or depot regimen) for at least 2 months prior to screening b. Depot or injectable birth control c. Intrauterine device or intrauterine system in place for at least 2 months prior to screening d. 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. 4. Must be willing to comply with the following conditions to prevent the spread of GMOs according the OGTR Licence (DIR 144): a. 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 b. Blood, tissue or organs must not be donated within 7 days of vaccination c. Severely immunosuppressed persons who require a protective environment are not to be cared for by the participant within 7 days of vaccination d. Contact is not to be made with severely immunosuppressed persons who require a protective environment within 7 days of vaccination e. 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 5. Adequate venous access in the left or right arms to allow collection of a number of blood samples 6. No birthmarks, tattoos, wounds or other skin conditions which could reasonably obscure IM injection site reactions 7. Able to communicate effectively with study personnel and considered reliable, willing and cooperative in terms of compliance with the protocol requirements 8. Participant does not intend to start or change an existing physical conditioning regimen prior to or during the study period 9. Participant has voluntarily given written informed consent to participate in the study (prior study entry) 10. Participant is available for the duration of the study
Exclusion criteria
Exclusion criteria: 1. 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). 2. Received blood or blood products in the 3 months prior to screening 3. Received another vaccine within 30 days before screening 4. Received another influenza vaccine within 2 years prior to screening 5. Participated in another clinical study (involving an investigational product or device) within 60 days before screening (including studies for FluMist 'Registered Trademark') 6. 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) 7. If female, pregnant, planning to become pregnant, or lactating 8. 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 greater than 4 standard drinks (or equivalent) per day 9. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study 10. Current or history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder 11. Clinically significant abnormal laboratory value at screening as determined by the Investigator 12. Unusual dietary habits and excessive or unusual vitamin intake likely, in the opinion of the Investigator, to affect safety pathology parameters 13. Participant is seropositive to Human Immunodeficiency Virus (HIV-1 or HIV-2), Hepatitis C Virus (HCV) or HBV. 14. Body temperature (oral) greater than or equal to 38.0 degrees Celcius or acute illness within 5 days prior to vaccination 15. Any skin marking, tattoo or blemish precluding injection site inspection. 16. 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 17. 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 18. Participant is not to have had Guillain-Barre Syndrome
Outcome results
None listed