2007-03-22-世界卫生组织-WHO_workshop_in_Training_Performance_of_Rotavirus_Vaccine_Potency_Testing_8页_140kb

Rotavirus Vaccine Potency Testing Training Workshop Summary

Event: WHO Workshop in Training Performance of Rotavirus Vaccine Potency Testing
Location: NIBSC, Potters Bar, United Kingdom
Date: 19-23 March 2007

1. Background & Objective

• Context: Rotavirus vaccines are essential for disease control, especially in developing countries.
• Challenge: Lack of capacity in national control laboratories (NCLs) for potency testing.
• Workshop Goal: Strengthen NCL ability to perform batch release testing for Rotarix® (monovalent) and RotaTeq® (pentavalent) vaccines using CCID-based assays and quantitative PCR (Q-PCR).

2. Training Focus Areas

• Technical Training:
  • Rotarix® (monovalent): Cell culture, immune-staining techniques, CCID calculation, protocol review.
  • RotaTeq® (pentavalent): Q-PCR setup, data analysis, troubleshooting.
• Practical Skills: Hands-on training to enable independent assay performance.

3. Key Discussions & Recommendations

Standardization:

• Need for international reference materials and a WHO proficiency panel for harmonizing assays.
• Proposal to establish an International Cell Bank for MA-104 cells.

Methodological Challenges:

• Requirement for standardized assay protocols and clear validation guidelines.

4. Conclusions & Future Steps

• Workshop achieved its objectives, and further technical support is available from NIBSC upon request.
• Plans include:
  • Establishing an International Reference Preparation for rotavirus vaccines.
  • Evaluating feasibility of a proficiency study between laboratories.

(End of summary)