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The Oxford University and the laboratory AstraZeneca announced that their vaccine, the most promising in the world so far, will begin clinical trials Phase 3 in Chile, the last stage before mass distribution.
According to a statement from the laboratory, the US is already recruiting up to 30 thousand adults aged 18 or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection.
Countries outside the US are included based on anticipated virus transmission rates and it is anticipated that Peru and Chile start recruiting “Soon”, without specifying the number of volunteers or a specific date.
The trial in the country will be directed by the Las Condes Clinic, institution that already has the study protocol ready, approved almost entirely by the ethics committee of this center and is now awaiting approval from the Institute of Public Health (ISP).
If everything goes according to the expected deadlines, vaccination could start the week of September 14 and health officials will participate in it who have not been infected with the virus but have a higher exposure and risk of contracting it.
Participants are being randomly assigned to receive two doses of the experimental vaccine or a saline control (placebo), four weeks apart. The volunteers who receive the experimental vaccine will be twice as many as those who receive the placebo.
In this case, the trial will evaluate the efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3 thousand participants.
In relation to the vaccine, it is about AZD1222, which employs a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material for the SARS-CoV-2 virus protein.
After vaccination, the surface protein is produced, which prepares the immune system for attack the Sars-CoV-2 virus if it then infects the body.
In tests carried out last July, the results found two “strong” immune responses: the production of antibodies and T cells, than find and attack viral cells.
According to the study, it was observed a four-fold increase in antibodies against the SARS-CoV-2 virus protein in the 95% of participants one month after injection.
In all participants, a T-cell response was induced, which peaked day 14, and I know kept two months after inoculation.
In addition, neutralizing activity was observed against SARS-CoV-2 in 91% of the participants one month after vaccination and in 100% of the participantswhat did you recieve a second dose.
Regarding side effects, it was evidenced mild to moderate headache, fatigue, chills, fever, malaise, and muscle painAccording to the 1,077 participants, all adults between 18 and 55 years old.
Recall that in mid-August it was announced that Argentina and Mexico will be in charge of manufacturing the vaccine for Latin America, once Phase 3 ends, with 150 million doses as of the first half of 2021.
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