LONDON (AP): Danica Marcos wants to be infected with COVID-19. While other people are wearing masks and staying home to avoid the disease, the 22-year-old Londoner has volunteered to contract the new coronavirus as part of a controversial study that hopes to speed development of a vaccine.
Marcos and other young volunteers say they want to take part to help bring an end to the pandemic after seeing the havoc it has wreaked. The grandparents of Marcos' best friend died early in the crisis, and as a volunteer for a homeless charity she has seen the struggles of those who have lost their jobs.
In the first phase of the study, researchers will expose paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19. Ultimately, the same model will be used to test the effectiveness of potential vaccines by exposing volunteers to the virus after they've received one of the candidate vaccines.
"So many people (are) struggling right now, and I want this pandemic to be over," Marcos told The Associated Press. "Every day that goes on, more cases are going on, more people are dying. And if this vaccine trial could mean that this period of trauma for the whole world will be over sooner, I want to help. I want to be a part of that.''
90 healthy volunteers to be infected
Imperial College London and a group of researchers said Tuesday that they are preparing to infect 90 healthy young volunteers with the virus, becoming the first to announce plans to use the technique to study COVID-19 and potentially speed up development of a vaccine that could help end the pandemic.
This type of research, known as a human challenge trial (or study), is used infrequently because some question the ethics of infecting otherwise healthy individuals.
It is a controversial method of vaccine development, in part, because, it goes against the Hippocratic oath among medical doctors (don’t cause harm).
A key benefit of human challenge trials for a COVID-19 vaccine, would be to speed up vaccine development by months or more. But it could also place study volunteers at a much greater risk.
As of October 27, 2020, more than 38,000 people from 166 countries have signed up as HCT volunteers, through a sign-up group called “1daysooner”.
What are the benefits of human challenge trial?
But the British researchers say that risk is warranted because such studies have the potential to quickly identify the most effective vaccines and help control a disease that has killed more than 1.1 million people worldwide.
"Deliberately infecting volunteers with a known human pathogen is never undertaken lightly," said Professor Peter Openshaw, co-investigator on the study. "However, such studies are enormously informative about a disease, even one so well studied as COVID-19."
Have such trials been done for other diseases?
Yes. Human challenge studies have been used to develop vaccines for diseases including typhoid, cholera and malaria.
Imperial College said the study, involving volunteers aged 18 to 30, would be conducted in partnership with the government's Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVIVO, a company that has experience conducting challenge studies. The government plans to invest 33.6 million pounds ($43.4 million) in the research.
11 vaccines in late-stage trials
Governments around the world are funding efforts to develop a vaccine in hopes of ending the pandemic that has pummeled the global economy, putting millions of people out of work. Forty-six potential vaccines are already in human testing, with 11 of them in late-stage trials — several are expected to report results later this year or in early 2021.
The Imperial College partnership plans to begin work in January, with results expected by May. Before any research begins, the study must be approved by ethics committees and regulators. While one or more vaccines are likely to be approved before then, the study is needed because the world may need multiple vaccines to protect different groups within the population, as well as treatments for those who continue to get sick, said Dr. Michael Jacobs, a consultant in infectious diseases at the Royal Free London NHS Foundation Trust who will take part in the research.
"I don't think many people think that what we're doing as scientists is searching for a silver bullet," Jacobs said. "We're going to need a whole raft of interventions in order to control this pandemic.''
Critics of challenge studies question the need to expose healthy people to the virus when the disease remains widespread and vaccine development is moving quickly. Tens of thousands of volunteers around the world have already signed up to participate in more traditional vaccine trials.
Alastair Fraser-Urquhart, 18, of Stoke-on-Trent in northwestern England, said he wants to take part in the challenge study because he's young and strong and can help move the vaccine research forward quickly. He is taking a year off school and working with 1Day Sooner, an organization created earlier this year to advocate on behalf of volunteers in COVID-19 challenge trials.
"I can't let this opportunity to do something, to really do something, pass me by when I'm at such low risk...,"' he said. "The idea that I could have a part to play in ending, you know, millions of people's misery and pain and I don't — It just doesn't sit well with me."
First phase of COVID-19 human challenge trial
In the first phase of the study, researchers will expose paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19. Ultimately, the same model will be used to test the effectiveness of potential vaccines by exposing volunteers to the virus after they've received one of the candidate vaccines.
The research will be conducted at the Royal Free Hospital in London, which has a specially designed area to contain the disease. Volunteers will be monitored for at least a year to ensure they don't suffer any long-term effects.
Challenge studies are typically used to test vaccines against mild infections to avoid exposing volunteers to a serious illness if the vaccine doesn't work. While the coronavirus causes only mild or moderate symptoms in most people and seems to be especially mild in young, healthy individuals, the long-term effects of the disease aren't well understood, and there have been reports of lingering problems in the heart and other organs even in those who don't ever feel sick.
In the US, the National Institutes of Health has downplayed the need for challenge studies given the speed with which vaccines are being developed, but it has taken preliminary steps to prepare for such research in case the approach eventually is required. Those steps include examining the ethics of a challenge study, and funding research to create lab-grown virus strains that potentially could be used.
Not a replacement for Phase 3 trials
But even if they are needed, "human challenge trials would not replace Phase 3 trials'' of COVID-19 vaccines, according to a September statement from NIH that said standard, rigorous studies were its priority. Estefania Hidalgo, 31, a potential volunteer from Bristol in southern England, said she's not worried about taking part because the study will be conducted in a controlled environment and the participants will be closely monitored.
Hidalgo, a student from Venezuela, wants to take part because of the toll COVID has taken on minority communities — and because she believes science is the way out of the pandemic. "I am a person of color, a woman ..." she said. "I also think it's important that the trials have, like, representation from everybody. So I just figure, 'why not me?'"
AstraZeneca, Oxford buoyed by vaccine response
LONDON (AFP): British pharma giant AstraZeneca said on Monday trials of its coronavirus vaccine pioneered with Oxford University had shown "encouraging" responses among elderly, as well as younger participants. The potential vaccine, one of 10 around the world in the most advanced phase III of trials, showed "strong immune responses" in all adult groups during the previous stage, according to an update from Oxford.
An AstraZeneca spokesman said the initial results "further build the body of evidence for the safety and immunogenicity" of its experimental vaccine. "It is encouraging to see immunogenicity responses were similar between older and younger adults, the spokesman added.
The positive news emerged in data on the safety and immune responses of participants in the phase II stage of the trial Oxford has submitted for peer review in a medical journal. They include results for UK volunteers aged 56-69 and over 70, with formal publication of the data expected "in the coming weeks".
"Our ongoing trials will provide further data, but this marks a key milestone and reassures us that the vaccine is safe for use and induces strong immune responses in both parts of the immune system in all adult groups," the university said. Oxford and AstraZeneca have been trialing their potential vaccine for months in various countries around the world.
It was suspended worldwide on September 6 after a participant's illness, but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan. Authorities determined the illness was not apparently linked to the vaccine, with the US Food and Drug Administration also authorising the restart in the United States at the weekend. The AstraZeneca/Oxford vaccine is one of the most promising and advanced in the world to combat the global pandemic.
Israel to begin human trials of coronavirus vaccine
The state-run Israel Institute for Biological Research says says it will begin human testing on its coronavirus vaccine next week
JERUSALEM (AP): The state-run Israel Institute for Biological Research announced Sunday (October 25) that researchers will begin human testing on its coronavirus vaccine "next week". The institute said clinical tests on an initial group of 80 people would begin November 1. The testing is to expand to a second phase of 960 people in December, with a third and final phase of 30,000 people next April or May depending on the results of the earlier phases.
"I believe in the abilities of our scientists and I am confident that we can produce a safe and effective vaccine," said Dr. Shmuel Shapira, director of the institute. He said the goal is to produce 15 million doses "for the benefit of the residents of the state of Israel and our close neighbours." He did not elaborate.
The institute is run by the Defense Ministry. "This is a day of hope for the citizens of Israel,'' said Defense Minister Benny Gantz. Over 40 coronavirus vaccine candidates are in clinical trials worldwide, according to the World Health Organization. Israel, a country of about 9 million people, has reported over 300,000 cases of COVID-19 and nearly 2,400 deaths.
