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Risks of human exposure clinical trials

2020-10-21T18:51:51.313Z


Dr. Elmer Huerta explains the phases and risks of human exposure clinical trials of the COVID-19 vaccine.What are human exposure clinical trials? 1:57 (CNN Spanish) -  The British government announced that at the beginning of 2021 it will initiate a study in which it will intentionally infect a group of human beings with the new coronavirus in a controlled environment, to find out if a vaccine is really effective. Dr. Elmer Huerta explains the phases of the study and the risks of this controversial


What are human exposure clinical trials?

1:57

(CNN Spanish) - 

The British government announced that at the beginning of 2021 it will initiate a study in which it will intentionally infect a group of human beings with the new coronavirus in a controlled environment, to find out if a vaccine is really effective.

Dr. Elmer Huerta explains the phases of the study and the risks of this controversial trial.

You can listen to this episode on Spotify or your favorite podcast platform or read the transcript below.

Hello, I am Dr. Elmer Huerta and this is your daily dose of information about the new coronavirus.

Information that we hope will be useful to take care of your health and that of your family.

Today we will see what the controversial "human challenge" trial of the covid-19 vaccine consists of.

Recently, the British government announced that it will launch a controversial study in early 2021.

The trial consists of intentionally infecting a group of human beings with the new coronavirus in a controlled environment, to find out if a vaccine is really effective.

In other words, instead of waiting for volunteers who participate in phase 3 of a candidate vaccine to become spontaneously infected in their daily lives - which obviously can take some time to happen - researchers at Imperial College London want to speed up the process and infect on purpose to a group of volunteers to see if a vaccine can protect them or not.

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Phases of clinical trials of human exposure of the vaccine against covid-19

The study will consist of inviting 90 healthy people between the ages of 18 and 30 to participate and will have two phases.

In the first, we will try to determine what is the infective dose of SARS CoV2, which, as we saw in the episode of August 11, is defined as the minimum number of viruses necessary to cause the disease, in this case, covid-19 .

As we mentioned in that episode, the exact number of the infective dose is not known for now, although it is believed that 1,000 viral particles are needed for a person to get sick.

In the experiments of this first phase, the volunteers will receive increasing doses of the new coronavirus.

The goal is to determine the minimum infective dose necessary to cause disease.

Once the infective dose has been determined, the second phase will proceed, which will consist of applying one of the vaccines and then deliberately infecting the volunteers.

This way they will be able to know if the previously applied vaccine protects them from the disease.

That kind of study is not new and has been done in the past to develop vaccines against cholera and typhoid.

It has not yet been revealed which vaccine would be used for the 'human challenge', but Imperial is developing its own alternative based on the RNA or self-amplifying RNA method, having been chosen by the British government as the target institution for public funding for create a vaccine against covid-19.

Concern about human exposure clinical trials

The big problem, and the huge ethical debate originating from the study that the researchers at Imperial College London are planning, is that - unlike cholera and typhoid, they have a curative antibiotic medical treatment that prevents a deliberately infected person from dying - Covid-19 has no known effective treatment.

That means that if during the experiment, the deliberately infected volunteer becomes ill and dies, that death would be a huge ethical misconduct in the research.

Another ethical problem is that, knowing - as we mentioned in the episode of September 3 - that a significant proportion of people who suffer from the disease are left with sequelae, it would not be fair for volunteers to see their health affected for an unpredictable time.

What has been announced is that, at least initially, all volunteers will be between 18 and 30 years old, and will be financially compensated for the two or three weeks that they have to isolate themselves to participate.

Obviously, the findings cannot be generalized to older people.

If you think that taking part in a vaccine 'human challenge' study is a very big risk that very few people can dare to take, I tell you that there are already over 2,000 people in Britain who have shown an interest in taking part.

Do you have questions about the coronavirus?

Send me your questions on Twitter, we will try to answer them in our next episodes.

You can find me at @Drhuerta.

If you think this podcast is helpful, help others find it by rating and reviewing it on your favorite podcast app.

We will be back tomorrow so be sure to subscribe to get the latest episode on your account.

And for the most up-to-date information, you can always head to CNNEspanol.com.

Thanks for your attention.

If you have any questions you can send them to Dr. Elmer Huerta via Twitter.

You can also head over to CNNE.com/coronaviruspodcast for all episodes of our “Coronavirus: Reality vs. Reality” podcast.

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Clinical trial Great Britain Vaccines

Source: cnnespanol

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