Influenza
Conditions
Keywords
live-attenuated vaccine, influenza vaccine
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.
Interventions
BIOLOGICALCodaVax-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).
BIOLOGICALNormal Saline Placebo
Saline (0.9%) administered intranasally via sprayer
Sponsors
Codagenix, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
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) 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
Exclusion criteria
1. Immunodeficiency (including HIV) or autoimmune disorder, or participant is currently taking drugs (excluding steroids, see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactions to vaccine | 6 days | Number of solicited local and systemic reactions for CodaVax-H1N1 and placebo |
| Adverse events (AEs) | 30 days | Number of subjects with AEs for CodaVax-H1N1 and placebo |
| Serious adverse events (SAEs) | 180 days | Number of subjects with SAEs for CodaVax-H1N1 and placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAI antibody titers against A/California/07/2009 | Day 0 and 30 | Geometric mean titers (GMT) of anti-A/California/07/2009 (H1N1) antibodies (Hemagglutination inhibition, HAI) for each treatment arm |
| Increase in HAI titer against A/California/07/2009 | Day 0 and 30 | Geometric mean fold increase (GMFI) of anti-A/California/07/2009 (H1N1) HAI serum antibodies for each treatment arm |
| HAI sero-response | Day 0 and 30 | 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. |
| Serum IgG response | Day 0 and 30 | 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 |
| Increase in serum IgG | Day 0 and 30 | Geometric mean fold increase (GMFI) within each treatment arm in serum lgG antibody responses to whole virus CA/07/2009 by ELISA |
| Serum IgA response | Day 0 and 30 | 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 |
| Increase in serum IgA | Day 0 and 30 | Geometric mean fold increase (GMFI) within each treatment arm in serum lgA antibody responses to whole virus CA/07/2009 by ELISA |
| Salivary IgA Response | Day 0 and 30 | 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 |
| Increase in salivary IgA | Day 0 and 30 | Geometric mean fold increase (GMFI) within each treatment arm in salivary lgA antibody responses to whole virus CA/07/2009 by ELISA |
Countries
Australia
Outcome results
None listed