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

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.

Timeline

Start

2015-08

Primary completion

2017-03

Completion

2017-12

Outcome

Met primary endpoint

paper The Strep A vaccine was well-tolerated and there was no clinical evidence of autoimmunity and no laboratory evidence of tissue cross-reactive antibodies. PMID 31843270 ↗

paper The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA. PMID 31843270 ↗

Publications

• Finn MB, Penfound TA, Salehi S, Ogega CO, Dold C, Plante O, Dale JB. Immunogenicity of a 30-valent M protein mRNA group A Streptococcus vaccine. Vaccine. 2024 Sep 17;42(22):126205. doi: 10.1016/j.vaccine.2024.126205. Epub 2024 Aug 13.
• Pastural E, McNeil SA, MacKinnon-Cameron D, Ye L, Langley JM, Stewart R, Martin LH, Hurley GJ, Salehi S, Penfound TA, Halperin S, Dale JB. Safety and immunogenicity of a 30-valent M protein-based group a streptococcal vaccine in healthy adult volunteers: A randomized, controlled phase I study. Vaccine. 2020 Feb 5;38(6):1384-1392. doi: 10.1016/j.vaccine.2019.12.005. Epub 2019 Dec 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	StreptAnova™	Vaccine	600 ug	Intramuscular

Indications

No indication recorded.