From the Hospital Trueta de Girona, IDIBGI and the biotech pharmaceutical company HIPRA we are looking for volunteers aged 65 years or older who want to participate in a study to evaluate the safety and immune response of the COVID-19 vaccine BIMERVAX ® when administered together (one in each arm) with the seasonal flu vaccine next autumn/winter 2023/2024.
Both COVID-19 and seasonal flu are respiratory illnesses that are spread from person to person primarily through small droplets 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 licensed 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, it is necessary to verify the safety and immune response of co-administration.
Eight hospitals will participate in the study, which will recruit 300 volunteers. The study will last 2 months and each volunteer will have to visit the hospital three times. If you are carrying at least two doses of any messenger RNA vaccine (Pfizer or Moderna), and you are interested in participating, please send an e-mail to hiprahh11@idibgi.org or fill in the web form that you can find by clicking here:
The clinical trial investigators will contact all individuals who have filled out the form and sent an e-mail to participate.
The clinical trial has been authorized by the Spanish Agency for Medicines and Health Products (AEMPS)
The study, already authorized by the Spanish Agency for Medicines and Health Products (AEMPS), will involve 300 volunteers and will be carried out in eight hospitals in Spain: Hospital Dr. Josep Trueta (Girona), Hospital Clínic Barcelona (Barcelona), 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. The clinical trial will last 2 months and each volunteer will have to visit the hospital three times. Each hospital has set up a space on its website so that those interested can enroll in the study.
The 300 participating 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 2023/2024 season.
The study is being evaluated by the Ethics Committee of HM Hospitales and the Spanish Agency for Medicines and Health Products (AEMPS).
About the BIMERVAX® vaccine
It consists of 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 persons older than 16 years of age. In studies, it has been shown to be a safe, low reactogenic vaccine with a broad capacity to neutralize the main variants of the virus, including the Omicron variants. In addition, it suggests longer-lasting protection with fewer adverse effects than the mRNA vaccine.
The vaccine is kept at refrigerated temperature, between 2ºC and 8ºC, facilitating logistics and distribution. It is a "ready-to-use" vaccine, i.e., it is not necessary to reconstitute it before use, thus facilitating the task of health personnel.
Reference article: Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A, et al. Safety and immunogenicity of protein-based PHH-1V comparisons in BNT162b2 as a heterologous SARS-CoV-2 booster vaccination in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority trial. Lancet Reg Health. 2023.
