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.
This randomized, double-blind, placebo and active controlled Phase I study is intended to study the effects of a live-attenuated vaccine against influenza A H1N1. Part 1 of this study will enroll 75 participants at a single site. Participants will be randomized in a 2:2:1 ratio to receive one dose each of either CodaVax-H1N1, FluZone quadrivalent, or placebo. This study is conducted during the influenza "off season" in Australia. Part 2 of the study will enroll an 50 additional participants randomized to receive either CodaVax-H1N1 at a higher dose or placebo (40:10).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
125
Live-attenuated vaccine against influenza A H1N1, A/California/07/2009
Fluzone® (QuadriFlu - TIV), inactivated, quadrivalent influenza vaccine
Q-Pharm
Herston, Queensland, Australia
Number of subjects with solicited local and/or systemic reactions after each vaccination, for each treatment group
Number of volunteers that experience adverse events
Time frame: 6 days
Incidence of Adverse Events (AE)
Number of subjects with AEs
Time frame: 30 days
Incidence of Serious Adverse Events (SAE)
Number of subjects with SAEs
Time frame: Days 1-168
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)
Time frame: 30 days post-vaccination
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
Time frame: 30 days post-vaccination
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
Time frame: 30 days post-vaccination
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
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Time frame: 30 days post-vaccination
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
Time frame: 30 days post-vaccination
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
Time frame: 30 days post-vaccination