To speed up research and development of the new crown vaccine, the British government will fund the world’s first “human challenge trial” of the new crown vaccine in the country, in which volunteers will be infected with the new crown virus after being vaccinated against the candidate new crown vaccine to test its effectiveness, the Financial Times reported recently.
Despite many precedents, “human challenge trials” are still a controversial method of testing, and volunteers who “test poison them themself” need to be isolated and subject to certain health risks. Is this unconventional experimental approach feasible under the dual pressure of the new crown pandemic, the global public health and economic crisis?
How the experiment was conducted.
The trial is expected to be officially launched in January, the project officially told the Financial Times. Its academic leader is Imperial College, which is run by an institution called hvivo. The test site has not yet been finalized and could take place at a quarantine clinic in east London, or another facility nearby. Subjects will be given the candidate new crown vaccine first, and the new coronavirus will be given a “challenging” dose under controlled conditions after about a month, with a quarantine period of up to one month.
About 2,000 people have reportedly signed up for the trial, which will take place in the UK, “one day early” through the US-based human challenge advocacy group. To prevent subjects from developing serious diseases after contracting the virus, the trial will begin with the use of the antiviral drug Redsyvir, which has been approved in several countries to treat new coronavirus infections.
Such trials in the UK must be approved by the UK Medicines and Healthcare Products Authority and an independent research ethics committee. “The safety of the subjects is our top priority,” the Financial Times quoted a statement from the UK’s Medicines and Healthcare Products Administration as saying. Any proposal from (vaccine) developers to make the human infection challenge part of clinical trials for vaccine development will be considered on a (trade-off) benefit-risk basis and will monitor and minimize risk in the proposed trial design.”
A joint appeal by the academic community.
In vaccine research and development, the general solution is to evaluate vaccine effectiveness through Phase 3 clinical trials, why should new crown vaccine development consider “human challenge trials” as an unconventional research method? Some experts believe that the current increase of thousands of new crown deaths around the world makes vaccine research and development an extremely urgent task, and that “human challenge trials” can significantly speed up the process.
Claire Waddington, clinical lecturer in infectious diseases at the University of Cambridge in the UK, said: “The advantage of a controlled human infection model is that it gives us an accurate picture of when people are exposed to the relevant pathogens, allowing us to directly and accurately study the response and protective effects of any vaccine used in the model. “
In fact, U.S. and British scientists have been discussing or calling for “human challenge trials” in the development of new crown vaccines for months. Researchers at Rutgers University, Harvard University and others published an article in the American Journal of Infectious Diseases in May entitled “Accelerated Coronavirus Vaccine Licensing for Human Challenge Research”, saying that controlled new crown vaccine “human challenge trials” could shorten the time it takes to evaluate vaccines and allow them to be rolled out earlier.
The paper suggests that most new crown vaccines can be “human challenge trials” before they are ready for effectiveness trials. In addition to measuring vaccine effectiveness, the Human Challenge Trials help to evaluate drugs used to prevent infection before exposure, discontinue infection after exposure, or prevent morbidity in high-risk individuals, and to improve understanding of mechanisms related to the development of infection to disease.
In mid-July, more than 170 U.S. and British scientists, including 15 Nobel Laureates in Science, sent an open letter to Francis Collins, president of the National Institutes of Health, urging the U.S. government to prepare for “human challenge trials,” including support for safe and reliable new coronavirus culture and isolation facilities for subjects.
Whether it’s against ethics.
The Human Challenge Trial dates back to 1796, when vaccine pioneer Edward Jenner inoculated eight-year-old James Phipps with the live bovine pox virus, an adventurous approach that allowed the little boy to gain miraculous immunity. Since then, such “test-and-test” research has played an active role in developing vaccines and therapies for infectious diseases such as typhoid fever, cholera and malaria, as well as in understanding how the human immune system responds to viruses such as influenza.
Despite many precedents, the “human challenge trial” is still a highly controversial way of studying, especially for the new coronavirus, a virus with a certain lethality, no special effects drugs and therapies, “test-to-poison” is a violation of medical ethics norms?
In a May article in the British journal The Lancet Infectious Diseases, researchers at Monash University in Australia said such studies are ethically acceptable when a particular pathogen creates a significant public health threat, especially in the absence of special-effects therapies and vaccines. They can accelerate and improve vaccine development, and trial design can limit and reduce the risk to subjects.
According to the aforementioned Article “Accelerated Coronavirus Vaccine Licensing for Human Challenge Research”, the “challenge trial” was carried out against the background of the volunteer’s informed consent, the minimization of research risk and the subject’s “baseline infection risk (risk of infection in normal life), and as an emergency response, it does not infringe on the individual rights and interests of the subjects, but takes into account the individual’s rights and interests and global public health emergencies.”
In response to the scientific community’s discussions, the World Health Organization issued in May the Key Guidelines on Ethical Acceptability of Research on the Human Challenge of the New Coronavirus, stressing the importance of conducting “human challenge trials” of the new coronavirus in accordance with the “highest scientific and ethical” standards, and the need to comply with at least eight ethical guidelines, including a strong scientific basis for obtaining information through consultation between the public, relevant experts and decision makers, and close coordination among researchers, funders, policy makers and regulators, To ensure that subject screening criteria limit and minimize trial risk, subject to review by an independent commission and strict informed consent procedures.