WHO Mpox (monkeypox) Research - What study designs can be used to address the remaining knowledge gaps for mpox vaccines?

2 August 2022 13:00 – 18:00 UTC Time

Date: Tuesday 2 August, 2022

Time: 13:00 to 18:00 CET

The WHO R&D Blueprint organized a consultation to discuss knowledge gaps and priority research questions for mpox (monkeypox) vaccine research.

OBJECTIVES

The Director-General of WHO decided that the global monkeypox outbreak represents a public health emergency of international concern. [Source: WHO Director-General's press statement]

WHO is recommending that Member States make all efforts to use existing or new vaccines against mpox within a framework of collaborative clinical efficacy studies, using standardized design methods and data collection tools for clinical and outcome data, to rapidly increase evidence generation on efficacy and safety, collect data on effectiveness of vaccines (e.g., such as comparison of one or two dose vaccine regimens), and conduct vaccine effectiveness studies.  [Source:Second meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country outbreak of monkeypox]

To facilitate the implementation of the above recommendations, the WHO R&D Blueprint for epidemics organized a global consultation to discuss mpox vaccine research. 

What study designs can be used to address the remaining knowledge gaps for mpox vaccines? 

During this forthcoming consultation global experts reviewed the available evidence in terms of:

  • Overview of potential study designs.
  • Plans to evaluate vaccine efficacy/effectiveness of mpox vaccines in different countries.
  • Optimal strategies for the design of randomised and non- randomised studies for vaccine efficacy and effectiveness.

EXPECTED OUTCOMES

  • Consensus critical attributes of optimal study designs
  • Outline of the next steps to share information on plans to evaluate and on emerging results

 

PRESENTATIONS

Session 1. Randomized Evidence

Session 2. Non-Randomized Evidence

RECORDING