Since the start of the pandemic, there has been an urgent need to accelerate the research and development of a safe and effective vaccine.
To facilitate research and vaccine development, WHO’s R&D Blueprint team convened:
- A process to develop a core clinical trial study protocol for a global, and globally coordinated , clinical trial for vaccines. The idea is to accelerate research on COVID-19 vaccines through a large, international, randomized controlled clinical trial using a standardized study protocol that enables the agile, simultaneous evaluation of the benefits and risks of multiple candidate vaccines in sites with sufficient COVID-19 attack rates.
To date, more than 120 different candidate vaccines are under development and could be available or suitable to enter the trial at different times. The aim of the Solidarity Trial, is to quickly enrol and individually randomize very large numbers of adult participants in many different populations and settings across the world. By using a shared placebo/control group and a common core study protocol to evaluate multiple candidate vaccines in the trial, resources allocated to the evaluation of each candidate vaccine can be saved while ensuring a high standard of scientific rigor and efficiency.
Following an in-depth review by experts and various consultations, a revi sed version of the WHO core protocol was recently published. In addition, WHO has also launched a call for expressions of interest from vaccine trial sites around the world to identify those that would participate in a vaccine Solidarity Trial using this core protocol.
- A multi-disciplinary group of experts from across the world to discuss, from different perspectives, to develop the concept of Human Challenge Studies. The WHO Advisory Group for “Human Challenges” was tasked with considering the feasibility, potential value and limitations of establishing a closely monitored human challenge model of experimental COVID-19 infection and illness in healthy young adult volunteers.
This Advisory Group included experts with experience in:
- Design and performance of many types of volunteer challenge studies,
- SARS-CoV-2 virology,
- Measurement of human immune responses to SARS-CoV-2 and to other microbial pathogens,
- Clinical management of COVID-19 clinical disease in different geographic settings,
- Regulatory considerations associated with testing and emergency pre-licensure use of vaccines and with larger-scale post-licensure deployment,
- And GMP manufacture of virulent viruses under BSL-3 containment.
The Working Group was sub-divided into four subgroups to address: Clinical Trials Issues, Challenge Virus Strain Issues, Measurement of Immune Responses Pre- and Post-Challenge, and Detection of SARS-CoV-2 in Clinical Specimens Post-challenge.
Since its constitution, the Advisory Group has convened several times to deliberate on this question and to make recommendations. A full report of this Advisory Group will be available shortly on the R&D Blueprint and COVID-19 webpage. This complements the 6 May 2020 document outlining the key criteria for the ethical acceptability of Covid-19 human challenge studies.