None listed
Conditions
Brief summary
CodaVax-H1N1, 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-H1N1 is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax-H1N1 influenza vaccine compared to placebo control when administered to healthy adults.
Interventions
A randomized, double-blind, placebo controlled, Phase I study with 33 sero-susceptible individuals aged 18 to 45 years.
A total of 33 healthy individuals will be enrolled and randomized into 2 groups where each participant will receive a single dose of either CodaVax-H1N1, or placebo (22:11). Participants will receive one 0.1ml into both nostrils (one immediately after the other).
Twenty-two (22) participants will be administered CodaVax-H1N1 and 11 participants will be administered a placebo
A randomized, double-blind, placebo controlled, Phase I study with 33 sero-susceptible individuals aged 18 to 45 years. A total of 33 healthy individuals will be enrolled and randomized into 2 groups where each participant will receive a single dose of either CodaVax-H1N1, or placebo (22:11). Participants will receive one 0.1ml into both nostrils (one immediately after the other). Twenty-two (22) participants will be administered CodaVax-H1N1 and 11 participants will be administered a placebo. All subjects will receive an intranasal (IN) dose of either CodaVax-H1N1, or saline (placebo). Arm 1: Intranasal dose of CodaVax-H1N1 Arm 2: Intranasal dose of Placebo (Saline) CodaVax-H1N1 is a potential universal live attenuated influenza vaccine (LAIV) manufactured using a proprietary SAVE platform based on the H1N1 A/California/07/2009 (H1N1) strain. The vaccination dose will be 8 x 10^5 PFU in 200 microlitre of current Good Manufacturing Practice (cGMP) Dulbecco Modified Eagle Medium media and 7.5% sucrose, and is to be administered through an intranasal sprayer into one or both nostrils. As the CodaVax-H1N1 dose is 8-times higher than the highest dose administered in the first clinical trial (UTN: U1111-1191-3515), the first 3 participants dosed with CodaVax-H1N1 will be sentinel participants. These participants will be monitored for 60 to 90 minutes immediately following dosing on Day 0 (visit 3), and return for testing on Day 2 (visit 3) and Day 6 (visit 4). 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 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.
Sponsors
Clincial Network Services (CNS) Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult volunteers, aged 18 to 45 years (at the time of screening). a. 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 with minor medical problems (for example, mild gastro-oesophageal reflux), which are unlikely to interfere with participant safety, the study procedures and/or results, and are not excluded elsewhere in the protocol, may be included at the discretion of the Medical Investigator. Furthermore, medications which are unlikely to interfere with participant safety, study procedures and/or results, and which are not excluded elsewhere in the protocol, may be permitted at the discretion of the Medical Investigator. 2. Participants must use highly effective, double contraception from the Screening Visit and up to the Follow-up Visit (Day 30). 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. WOCBP must have a negative serum pregnancy test at Screening and Day 30. WNOCBP must be post-menopausal (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. 3. Must be willing to comply with the following conditions to prevent the spread of GMOs according the Office of Gene Technology Regulator (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 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 HAI titre MI/45/2015 Influenza virus (pre-screen) 7. Laboratory Testing: a. 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; b. Urinalysis: Negative urine glucose, negative or trace urine protein, negative or trace urine HgB (if trace HgB 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
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 an 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 equals 12 weeks /equals 2 mg/kg body weight / day prednisone equals 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 equals 12 weeks /equals 2 mg/kg body weight/day prednisone equals 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 seropositive to HCV or HBV 19. Body temperature (oral) equals 38.0 degrees Celsius 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
Outcome results
None listed