The study will involve 300 volunteers aged 65 years and over
The biotech pharmaceutical company HIPRA will initiate a study to evaluate the safety and immune response of the COVID-19 vaccine BIMERVAX® when co-administered (one in each arm) with the seasonal influenza vaccine in adults 65 years of age or older who were first vaccinated against COVID-19 with an mRNA vaccine. The clinical trial has been authorised by the Spanish Agency for Medicines and Health Products (AEMPS).
COVID-19 and seasonal influenza are respiratory diseases that are transmitted from person to person mainly through small drops that come from the nose or mouth. Most people experience both illnesses mildly, although they can become severe. The vaccines to be used in this study are already authorised to prevent these diseases, and both their safety and efficacy have been tested and described. However, in order to administer these two vaccines together in the future, the safety and immune response of the co-administration needs to be verified.
The study will involve 300 volunteers, aged 65 and over, and will be carried out in eight hospitals in Spain: Hospital Clínic Barcelona (Barcelona), Hospital Dr. Josep Trueta (Girona), Hospital Germans Trias i Pujol (Badalona), Hospital Clínico Universitario de Valladolid (Valladolid), HM Modelo (A Coruña), Hospital de Santiago (Santiago de Compostela), Hospital Regional de Málaga (Málaga) and CAP Centelles (Centelles, Barcelona). The clinical trial will last two months, and each volunteer will have to visit the hospital three times. Each hospital has set up a section on its website so that those interested can sign up for the study.
The 300 volunteers will be randomly divided into three groups. The first group will receive one dose of influenza vaccine and one dose of placebo in the other arm. The second group will receive one dose of BIMERVAX® and one dose of placebo. The third group will be vaccinated with one dose of influenza vaccine and one dose of the COVD-19 vaccine BIMERVAX®. Volunteers who have received one dose of influenza vaccine will already be protected against influenza for the upcoming 2023/2024 season.
The study will be evaluated by the Ethics Committee of HM Hospitales and by the Spanish Agency of Medicines and Health Products (AEMPS).
About the BIMERVAX® vaccine
BIMERVAX® is a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2 and is indicated as a booster dose for people over 16 years of age1, 2. Studies have shown it to be a safe, low reactogenic vaccine with a broad ability to neutralise all major variants of the virus, including the Omicron variants. It also suggests longer-lasting protection with fewer adverse effects than the mRNA vaccine1, 2.
The vaccine is stored at refrigerated temperature, between 2°C and 8°C, facilitating logistics and distribution. It is a "ready-to-use" vaccine, meaning that it does not need to be reconstituted before use, facilitating the task of healthcare workers.
Hospitals
Hospital Dr. Josep Trueta de Girona:
Institut Català de la Salut Girona
Hospital Clínic Barcelona:
634 264 791
ABS Centelles:
93 881 04 85
Hospital Regional de Málaga:
preventiva.hrmal.sspa@juntadeandalucia.es
1. BIMERVAX® data sheet
2. Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A, et al. Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial. Lancet Reg Health. 2023; doi https://doi.org/10.1016/j.lanepe.2023.100613