Hipra starts clinical trial to study its covid vaccine as a fourth dose
The multinational pharmaceutical company Amer () Hyper will start a clinical trial at the end of this summer, with the participation of 200 volunteers, to be implemented in ten Spanish hospitals to study its vaccine against Covid-19 as a fourth dose.
As reported by Hospital Clínic, one of the hospitals participating in this new trial, it is about expanding studies of a vaccine against covid-19 developed by the Catalan biotechnology company, which is awaiting approval by the European Medicines Agency (EMA) to begin marketing it. .
The clinical trial will evaluate the immunogenicity and safety of vaccination with the fourth dose of Hipra vaccine in subjects previously vaccinated with three doses of Comirnaty vaccine (Pfizer) or with two doses of Comirnaty vaccine plus a Hipra booster vaccine, given in place from the previous phase 2b trials. Clinical.
This test will also complement the results obtained by the Hipra vaccine so far.
The 10 Spanish hospitals will start this trial once the approval of the Spanish Agency for Medicines and Health Products (AEMPS) and the Ethics Committee of Medicines Research at the Clinical Hospital which is expected to be done by the end of this summer.
The vaccine will be tested in 200 adults and will continue to evaluate the safety, tolerability, and efficacy of a booster dose of Hebra against COVID-19 in a group of people vaccinated with either three doses of Kommernate (Pfizer) or two doses of Hebra vaccine. Comirnaty vaccine in addition to the “booster” of the Hipra vaccine.
These two groups will receive the fourth dose of Hipra vaccine and the results will be compared with those obtained in a group of people vaccinated with three doses of Comirnaty (Pfizer).
Volunteers will receive a 30-week follow-up to assess the long-term safety and immune response.
People who wish to participate in the trial must have received 3 doses of Komernate (Pfizer) (the last dose was taken between the last 6-12 months) and must not have passed COVID-19.
Hipra starts clinical trial to study its covid vaccine as a fourth dose
Each hospital has made a space available on its website so that those interested can register.
At this time, Hipra’s covid-19 vaccine is undergoing an ongoing review process (or “rolling review”) by the European Medicines Agency (EMA), the previous step to obtaining marketing authorization.
Hebra vaccine is a recombinant adjuvant protein vaccine based on a receptor-binding domain heterodimer (RBD) that contains the B.1.1.7 (alpha) and B.1.351 (beta) variants of SARS-CoV-2.
Hebra vaccine maintains refrigerator temperature (between 2 and 8 °C), which facilitates storage and distribution.
According to Hipra, the technology used allows for great versatility to adapt to new variants of the virus, if needed in the future.
Results obtained as of August 31 show that the vaccine produces neutralizing antibodies to the existing variants and is also effective in preventing disease.
Clinique de Barcelona, Josep Troita de Girona, Val Debron de Barcelona, Germans Trias y Pujol Can Ruti de Badalona, Gregorio Marañón de Madrid, La Paz de Madrid, Principe de Asturias de Alcala de Henares Hospitals participate in this new trial. and Cruces de Barakaldo, Carlos Haya de Málaga, and Clínico de Valencia.
