They said so-called “human challenge trials” or “controlled infection trials” were of “great importance” to speed up testing of developing vaccines worldwide.
He urged the United States government to undertake immediate preparations for human challenge trials, “including support for the safe and reliable production of the virus and any necessary biocontainment facilities to house the participants.”
The letter said that human challenge trials, in which volunteers are deliberately exposed to the pathogen under controlled conditions, can provide information months before conventional efficacy trials, in which candidates receive a vaccine or control and resume their normal life, assuming you may eventually be exposed to the virus.
Adrian Hill, director of the Jenner Institute at Oxford University in England and a signer of the open letter, wrote in a statement that “collaborative human challenge studies should be feasible and informative in the coming months.”
The Jenner Institute at Oxford is working with 1Day Sooner to produce a human challenge virus Covid-19, and Hill said it had “considerable potential” to help accelerate vaccine development and optimize vaccination approaches.
According to the WHO, challenge trials were used in the first investigations with smallpox, yellow fever and malaria, which changed the course of global public health.
In the past 50 years, tens of thousands of consenting adult volunteers have safely undergone these trials under the supervision of research ethics committees, the WHO reported.
He said that controlled infection trials could be ethically acceptable if they met certain criteria. These include choosing young, healthy adults as participants, starting with low doses, ensuring public participation, and providing high-quality care and close follow-up.
Co-authored by Nir Eyal of Rutgers, Marc Lipsitch of Harvard and Peter Smith of the London School of Hygiene & Tropical Medicine, the piece concluded that while a study of human defiance would not be without risk, “the launch of the vaccine will be accompanied by thousands of deaths worldwide. “
In a comment published in the New England Journal of Medicine, ACTIV members wrote that using controlled models of human infection to support vaccine development requires “essential criteria” to limit risk for participants and could take “one or two years”.
“A single death or serious illness in a healthy volunteer would be inconceivable and would stop progress,” they wrote.
They said it would be unethical to organize an experiment in which people were deliberately infected unless there was rescue therapy, a life-saving treatment that does not exist for the coronavirus.
“Large, randomized, controlled trials of SARS-CoV-2 vaccines are currently the most efficient, generalizable, and scientifically sound way to establish vaccine efficacy,” the authors concluded.
CNN’s Robert Kuznia and Shelby Lin Erdman contributed to the reports.
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