2022-05-10-世界卫生组织-Solidarity_Trial_Vaccines_STV_presentation_63页_2mb

Solidarity Trial Vaccines (STV) Summary

Overview

The Solidarity Trial Vaccines (STV) is an international, individually randomised controlled trial led by the World Health Organization (WHO) to rapidly evaluate promising COVID-19 vaccines on a global scale. It aims to provide equitable access to effective vaccines by assessing their efficacy and safety under strict, adaptable protocols.

Key Objectives and Features

• Purpose: To quickly test vaccines for COVID-19 variants and determine if they reduce the risk of infection by at least 50%.
• Structure: Global, flexible trial with mobile and fixed sites, adapting to country-specific needs and rapidly changing conditions.
• Methodology: Uses standardised, rigorous methods with a comparison group (placebo or national vaccine), and large sample sizes for reliable results.
• Adaptive Design: Can add or drop vaccines based on WHO criteria, modify target populations, and adjust comparisons as needed during the trial.

Vaccine Evaluation

• Endpoints: Primary endpoint measures reduction in COVID-19 cases; secondary endpoints include immune response and mechanism analysis.
• Vaccines Tested: Includes types like mRNA (e.g., Arcturus), DNA (e.g., Innovio), and subunit vaccines (e.g., Medigen), evaluated for safety, efficacy, and practicality (e.g., storage, dosage).

Participant Inclusion

• Eligibility: Ages 16+, no prior COVID-19 vaccine or infection, willing to comply with trial procedures.
• Exclusions: History of adverse vaccine reactions, immunosuppressive conditions, or current pregnancy (with country-specific variations).

Potential Benefits and Risks

• Benefits: Participants contribute to global health research; vaccines may offer access to proven safe and effective options if successful.
• Risks: Mild side effects like pain or fatigue; no actual COVID-19 risk from trial vaccines.

Trial Operation

• Locations: High-COVID-rate countries with high case incidence; mobile sites facilitate rapid deployment.
• Follow-Up: Includes 4-6 visits for monitoring health; data collected at specific intervals for safety and efficacy assessment.

Resources and Updates

• Additional information available on STV websites, including guides and communications tools. For further details, visit dedicated STV links provided.