# Presentation: 120342

## Update on the Development of a Group A Streptococcal Vaccine

- Fran A. Rubin, Ph.D.
- Program Officer for Group A Streptococci
- Respiratory Diseases Branch
- Division of Microbiology and Infectious Diseases
- National Institute of Allergy and Infectious Diseases
- National Institutes of Health
- Department of Health and Human Services

## Basic Research 
Genomic sequencing (M1, M3 and M18)
Contracts for applied clinical research
Partnerships with industry
Clinical trial network
Workshop (NVPO support)

- Genomic sequencing (M1, M3 and M18)
- Contracts for applied clinical research
- Partnerships with industry
- Clinical trial network
- Workshop (NVPO support)

- NIAID Activities

## Development of a GAS Vaccine

- Target identification
- Preclinical
- Immunogenicity
- Animal protection and/or colonization status
- Toxicology
- Standard toxicology
- Tissue cross-reactivity
- Histopathology (related to route)
- Human clinical trials
- Novel vector
- Parenteral vs mucosal routes
- Dose – concentration and schedule

## Obstacles in the Development of a GAS Vaccine

- Cross-reactivity of M protein epitopes with human tissue (heart, kidney)
- Limited animal models
- Mouse for skin infections
- Macques for pharyngitis (recent)
- Immunological studies
- Pathogenesis not understood

## Recent advances/opportunities

- Genomic sequencing/proteomics/microarrays
- Identification of new targets
- Immunogenetic studies
- Specific leukocyte antigen class II haplotypes associated with protection/risk of severe disease
- Epidemiology studies
- Current data on circulating M serotypes
- Longitudinal surveillance in school children

## Vaccine Candidates

- M protein based
- Type-specific-Jim Dale
- Conserved region-Vince Fischetti
- Combination-Michael Good
- Surface proteins
- C5a peptidase -  Pat Cleary
- Sfb – Singh Chhatwal
- Streptococcal pyrogenic exotoxins
- Spe A and/or C – Pat Schlievert
- Spe B – Jim Musser

## DMID Partnership Program

- Industry participation
- 	To facilitate collaborative partnerships among industry, academia, and government to develop novel approaches for controlling infectious diseases.

## Partnerships for Product Development

- Target identification
- Preclinical development
- Clinical trials

## DMID Partnership Program

- <date/time>

**DMID Partnership Program**

- FY03 Initiatives
- Biodefense
- Vaccines, adjuvants, therapeutics, diagnostics
- Clinical resources
- Non-biodefense RFA: 03-003
- Novel therapies against  hepatitis B virus
- Strategies for control of arthropod vector-borne  diseases

- http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-03-003.html

## Partnership: FY04 Initiative

- Vaccines
- Group A streptococci (GAS)
- Group B streptococci (GBS)
*Helicobacter pylori*
- Point of care diagnostics
- GAS and GBS

## Workshop on Prevention of GAS Diseases and their Sequelae

- Clinical investigators
- Research scientists
- Members of international community
- US government agencies
-       (NIH, CDC and FDA)
- Industrial partners

## Workshop on Prevention of GAS Diseases and their Sequelae

- Identify gaps in scientific understanding
- Identify logistical and scientific barriers to evaluation of vaccines
- Develop a strategic plan