Vaccines against Covid-19 of Hipra.
The vaccine against Covid-19 from the Spanish pharmaceutical company Hipra demonstrates a good neutralizing antibody response against subvariants of Ómicron BA.2 and BA.4 and BA.5, which caused the last contagions registered in the population.
Hipra, which is developing a Adjuvanted recombinant protein bivalent vaccine against Covid-19has observed that, after fourteen days from the administration of their vaccine as a booster dose in participants previously vaccinated with two doses of the Pfizer/Biontech mRNA vaccine, there is a increased neutralizing antibodies against these Omicron variants. Likewise, an increase in neutralizing antibodies against BA.4 and BA.5 is also observed fourteen days after receiving the booster with the Hipra vaccine in a subgroup of participants previously vaccinated with Moderna’s messenger mRNA vaccine.
In addition, in the results obtained in the recently published Phase IIb trial, the Hipra vaccine, as a heterologous booster dose, gives rise to a strong neutralizing antibody response against all the variants studied (Wuhan, Beta, Delta and Ómicron) at 14 and 98 days, these increases being statistically higher than those obtained with the booster dose with the Pfizer-Biontech vaccine at 98 days against the variants Beta, Delta and Omicron, and to fourteen days against the Beta and Ómicron variants.
These results indicate that the Hipra vaccine generates a more sustained neutralizing antibody response over time than the Pfizer-Biontech mRNA vaccine, suggesting longer-lasting and more effective protection against new circulating variants.
Regarding the safety of the vaccine, during clinical trials the Hipra vaccine has been shown to have a good safety and tolerability profile since no relevant adverse effects have been detected in the study participants. The most common adverse effects have been pain in the inoculation area, headache or fatigue that has not prevented them from developing a normal life at any time and that have disappeared in the following days.
Clinical trial as a fourth dose
With the aim of expanding the data collected in clinical trials and, in parallel with the continuous review process of the European Medicines Agency (EMA), the company plans to start an extension of the phase IIb study. The objective is assess the safety and immune response of a fourth booster dose with the Hipra vaccine.
A total of 200 volunteers from ten hospitals in Spain. Of these participants, half will have previously received two doses of the Pfizer-Biontech vaccine and one dose of the Hipra vaccine. The other half will have received three doses of the Pfizer-Biontech vaccine.
The study, scheduled to start at the end of summer, will begin once authorization is received from the Ethics Committee of the Hospital Clínic de Barcelona and the Spanish Agency for Medicines and Health Products (Aemps).
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