Human-Challenge COVID-19 Vaccine Study Contemplated
Researchers in the Netherlands based at the Leiden University Medical Center (LUMC) announced they are preparing to launch a “human challenge trial,” in which willing volunteers would be deliberately exposed to the SARS-CoV-2 coronavirus under controlled conditions to test vaccines and study the disease.
These researchers have not yet decided to conduct the trial, which would still need regulatory approval to begin, stated a press release issued on November 25, 2020.
Meta Roestenberg, a LUMC researcher, preparing for the trial, added: “Such a study can be important in answering questions we still have about COVID-19: How long will you stay protected after an infection? How do we compare vaccines? How many antibodies are you producing? How much virus load causes an infection in which cases? You can answer such questions with this research.”
Professor Robert Sauerwein, Chief Scientific Officer at TropIQ Health Sciences, commented that "controlled human infections in the past have proven to be of great value in the combat against major human infectious diseases.”
“A controlled human COVID-19 infection is timely and will contribute to the most needed rapid development of drugs and vaccines. Ensuring the safety of volunteers will be a key objective."
The World Health Organization (WHO) has released strict ethical guidelines for conducting COVID-19 human challenge trials, and researchers in the United Kingdom plan to conduct a similar trial in January 2021.
On May 6, 2020, the WHO published a document that ‘aims to guide scientists, research ethics committees, funders, policy-makers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining key criteria that would need to be satisfied for such studies to be ethically acceptable.’
1Day Sooner, a non-profit organization, advocating for COVID-19 human challenge trial volunteers, stated, ‘240 Dutch have already expressed interest in volunteering for such a trial. These studies may be essential to developing enough proven vaccines to vaccinate the whole world in 2021, not just the wealthy.’
Leiden University was founded in 1575 and is one of the leading international research universities in Europe. It has seven faculties and a campus in both Leiden and The Hague.
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