This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age.
This is a single-centered trial of a group A streptococcal (GAS) vaccine, StreptAnova™, to be performed in Canada. It will be randomized, observer-blinded, and comparator controlled. The study is designed to assess safety and immunogenicity of three doses (0, 1, 6 months) of one dosage (600 µg protein) in healthy adults 18 through 50 years of age. A comparator vaccine is included at 2:1 ratio (StreptAnova™ to comparator). Assignment to StreptAnova™ or comparator vaccine will be both randomized and observer-blinded. Three (3) 0.6 mL doses (600 µg protein) of StreptAnova™ or 0.5 mL doses of comparator will be administered on days 0, 30 and 180 (N= 30 StreptAnova™, 15 comparator); each subject will receive three doses of the same treatment. Forty-five subjects will be enrolled. At each vaccine dose, detailed safety data will be collected from the first 15 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the 30 remaining subjects. Detailed safety data will be collected from the remaining 30 randomized subjects until seven days after administration and used to determine whether to proceed to immunizing the first 15 randomized subjects at the next dose. Treatments will be followed by standard clinical parameters for evaluating the safety of a biologic/vaccine product including standardized methods for local and systemic vaccine reactions, repeated vital signs and physical examinations, 12-month follow-up (6 months post-dose 3) for adverse events and concomitant medication changes, and monitoring of clinical laboratory values as clinically indicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
39
StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine
Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
IWK Health Centre
Halifax, Nova Scotia, Canada
Occurrence of adverse events
Time frame: Injection to Day 360, 6 months post dose 3
Occurrence of any hematological and biochemical laboratory abnormality
Time frame: Screening, day 0, day 7, day 30, day 44, day 180 and day 194
Occurrence of any unsolicited AE
Time frame: During 28-day follow-up period after injection (i.e. the day of injection and 27 subsequent days), and through to day 360.
Serum antibodies against M protein and Spa antigens in the vaccine measured by ELISA
Time frame: Visit 2 (day 0, pre dose 1), Visit 4 (day 30, 30 days post dose 1), Visit 5 (day 44, 14 days post dose 2), Visit 8 (day 210, 30 days post dose 3) and Visit 10 (day 360, 6 months post dose 3)
Functional opsonophagocytosis antibody determination for a subset of M protein serotypes
Time frame: Visit 2 (day 0, pre dose 1), Visit 8 (day 210, 30 days post dose 3) and Visit 9 (day 280, 100 days post dose 3).
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Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.