The Spanish Medicines Agency (Aemps) has authorized a second phase IIb clinical trial of Hipra’s COVID-19 vaccine. The objective now, according to the Aemps, is to compare the changes in immunogenicity against the Omicron variant in volunteers who received two doses of the Vaxzevria (AstraZeneca) vaccine plus Hipra as a booster dose, versus those who received two doses of Vaxzevria and, as a booster dose, Comirnaty (BioNTech/Pfizer).
In the previous phase IIb trial, authorized on November 15, the study was carried out with volunteers who had been administered Comirnaty. And the new study is motivated by the good results of the three already authorized trials of the Hipra vaccine, in which no safety concerns were noted and the only adverse reactions that have been found are those common to any vaccine.
For his part, the phase III trialauthorized on February 1, is still ongoing and seeks to evaluate the safety and tolerability of this vaccine as a booster dose of any of the currently authorized vaccines (Janssen, AstraZeneca, Moderna and BioNTech/Pfizer).
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The new phase IIb trial, which has had the scientific and regulatory advice of the Aemps, will be randomized, controlled and double-blind (the Hipra vaccine or a masked authorized vaccine is administered). It will take place in five spanish hospitals and will have the participation of about 300 volunteers. To do this, the centers will begin as soon as possible to select those people who meet the inclusion criteria specified in the protocol.
They will participate volunteers who have not had COVID-19 and who have received two doses of Vaxzevria at least 91 days and no later than 365 days after the administration of the second dose, and will receive a single booster dose.
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