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Clinical development strategy for a candidate group A streptococcal vaccine

Florian Schödel1, Nicole J Moreland2, Janet T Wittes3

  • 1Philimmune LLC, Philadelphia, PA, USA.

Vaccine
|March 21, 2017
PubMed

Insights

A Group A Streptococcus (GAS) vaccine could prevent pharyngitis, rheumatic fever, and other serious diseases. This review proposes a clinical development strategy for registering a GAS vaccine, starting with pharyngitis prevention.

Area of Science:

  • Infectious Diseases
  • Vaccinology
  • Clinical Trial Design

Background:

  • Group A Streptococcus (GAS) causes diverse illnesses, including pharyngitis, rheumatic fever, and invasive infections.
  • GAS pharyngitis is common in children, leading to significant antibiotic use and serving as a precursor to acute rheumatic fever and heart disease.
  • Currently, no clear clinical trial pathway exists for GAS vaccine registration.

Purpose of the Study:

  • To outline a clinical development strategy for a Group A Streptococcus (GAS) vaccine.
  • To detail the phases required for registering a GAS vaccine, initially targeting GAS pharyngitis.
  • To establish a pathway for subsequent vaccine studies for impetigo and associated sequelae.

Main Methods:

  • This review proposes a phased clinical development strategy.
  • The strategy prioritizes initial vaccine development for GAS pharyngitis.
  • Subsequent phases will address impetigo and other GAS-associated sequelae.

Main Results:

  • A phased approach allows for an early proof of principle for GAS vaccine efficacy.
  • Focusing initially on pharyngitis simplifies the development pathway.
  • This strategy aims to facilitate the global availability of a preventive tool for prevalent GAS diseases.

Conclusions:

  • A structured clinical development strategy is crucial for GAS vaccine registration.
  • Prioritizing GAS pharyngitis offers a pragmatic initial focus.
  • The ultimate goal is to provide a preventive measure against the most common GAS-related diseases worldwide.

Keywords:
Clinical development strategyGroup A streptococciImpetigoPharyngitisRheumatic feverVaccine

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