Evaluation of the Potency, Neutralizing Antibody Response, and Stability of a Recombinant Fusion Protein Vaccine for

E Burlet1, H HogenEsch2, A Dunham2

  • 1VaxForm, LLC, Bethlehem, Pennsylvania, USA.

The AAPS Journal
|March 12, 2017
PubMed

Insights

A new recombinant fusion protein vaccine (SpeAB) shows promise for preventing Group A Streptococcus (GAS) infections. The vaccine is stable and elicits neutralizing antibodies against key GAS virulence factors.

Area of Science:

  • Microbiology
  • Immunology
  • Vaccinology

Background:

  • Group A Streptococcus (GAS) causes significant global health issues, including pharyngitis and severe invasive diseases.
  • There is a critical unmet need for a vaccine to prevent GAS infections, as none are currently licensed.
  • GAS virulence is mediated by toxins like streptococcal pyrogenic exotoxin A (SpeA) and streptococcal pyrogenic exotoxin B (SpeB).

Purpose of the Study:

  • To evaluate the immunogenicity and stability of a novel recombinant fusion protein vaccine targeting GAS infections.
  • To assess the vaccine's ability to induce neutralizing antibodies against major GAS virulence factors.
  • To determine the potential of this vaccine to reduce the global burden of GAS disease.

Main Methods:

  • Development of a recombinant fusion protein (SpeAB) combining inactive mutant forms of SpeA and SpeB.
  • Adsorption of the SpeAB vaccine to an aluminum adjuvant for enhanced immunogenicity.
  • Assessment of vaccine immunogenicity, antibody induction, and stability through rigorous testing.

Main Results:

  • The SpeAB vaccine demonstrated robust immunogenicity in studies.
  • Specific neutralizing antibodies against SpeA and SpeB were successfully elicited.
  • Stability studies indicated the vaccine retains immunogenicity for at least two years under refrigeration.

Conclusions:

  • The novel SpeAB vaccine is a promising candidate for protection against GAS infections.
  • This vaccine has the potential to significantly reduce the global health burden associated with GAS.
  • Further development could lead to the first licensed vaccine against Group A Streptococcus.

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