NCT02564237

A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults

A Phase I, Randomized, Observer-blind, Comparator-controlled, Study of the Safety and Immunogenicity of StreptAnova™ Vaccine in Healthy Adults Age ≥ 18 - 50 Years

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Dalhousie University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	StreptAnova™ (Group A streptococcal (GAS) vaccine)	StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine
BIOLOGICAL	Hepatitis B 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.
BIOLOGICAL	Hepatitis A 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.
BIOLOGICAL	Human Papillomavirus 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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-03-01
• Completion: 2017-12-01
• First posted: 2015-09-30
• Last updated: 2017-01-19

Locations

1 site across 1 country: Canada