Preliminary analysis of the study of BIMERVAX®, HIPRA’s vaccine against COVID-19, shows positive results in the adolescent population in the framework of the RBDCOV project

This clinical trial is part of the European project RBDCOV, led by HIPRA, in which different hospitals are participating, including Vall d’Hebron, and whose recruitment is still open.

Vall d’Hebron and four other hospitals in Spain are conducting a clinical trial to study the safety, immunogenicity and efficacy of a booster dose of the COVID-19 adjuvanted recombinant protein vaccine (BIMERVAX®) from the biotech company HIPRA in healthy adolescents. So far, 150 participants have already been included in the study and preliminary data show optimistic results for the vaccination of this group.

Based on the data obtained so far, it has already been confirmed that this vaccine has proven to be safe, low reactogenic and able to reactivate the immune response against COVID-19, also with respect to currently circulating variants. 1, 2, 3, 4..

“With these initial results we see that it is a suitable vaccine for the pediatric population. It is important to continue research in order to have more robust data that will allow us to have a recombinant vaccine as a booster also in the pediatric population. To this end, it is important to recruit the 300 volunteers needed to complete this study and initiate it in children under 12 years of age”, assures Dr. Pere Soler Palacín, principal investigator of the project, head of the Infectious Pathology and Immunodeficiency Unit of Paediatrics at Vall d’Hebron University Hospital and of the Infection and Immunity in Paediatric Patients group at Vall d’Hebron Research Institute (VHIR).

The study will include a total of 300 adolescents aged between 12 and 18 years, who have already received two doses of Pfizer’s Comirnaty at least six months ago, whether they have passed the COVID-19 or not. In this trial, in addition to Vall d’Hebron, Hospital Josep Trueta (Girona), Hospital Universitario de la Paz (Madrid) and the hospitals HM Montepríncipe and Puerta del Sur (Madrid) are participating.

The search for volunteers is still open:

Parents or tutors of minors interested in participating in this study can still do so to collaborate in the research of this vaccine, which has been completely developed and manufactured by the biotechnology company HIPRA in our country. To do so, they should contact the team responsible for the work by e-mail or telephone:

• Vall d’Hebron University Hospital (Barcelona)

+34 667 93 56 77 / 934 89 31 00 (Extension 3271)

miriam.gonzalezamores@vallhebron.cat / stephany.zelada@vhir.org

• Dr. Josep Trueta Hospital (Girona)

872.98.70.87    extensión: 323

jcastells@idibgi.org/sjane@idibgi.org

www.icsgirona.cat/ca/noticies/hospital/2087

hiprahh3@idibgi.org

• Hospital HM Montepríncipe (Madrid) and Hospital HM Puerta del Sur (Madrid)

639 50 13 40 / 659 33 61 84

unidadvacunas@hmhospitales.com

• Hospital La Paz (Madrid)

608 427 004 / 91 727 1644

ucicec.hulp@salud.madrid.org

servicio.pediatria@salud.madrid.org

The RBDCOV project

This clinical trial is part of the “RBD Dimer recombinant protein vaccine against SARSCoV2” (RBDCOV) project, within the Horizon Europe program. The objective is to test the efficacy, tolerability and safety of HIPRA’s recombinant COVID-19 vaccine in children (including adolescents) and immunocompromised individuals.

RBDCOV is one of the international projects committed to test the vaccine against COVID-19 and allows the creation of links with other European initiatives to reinforce existing research infrastructures.

1. Technical data of BIMERVAX®

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

3. Barreiro A, Prenafeta A, Moros A, Madrenas L, Cañete M, Corominas J, et al. Humoral immune response against SARS-CoV-2 variants (Omicron BA.1, BA.4/5, Beta and Delta) of PHH-1V booster vaccine in subjects previously vaccinated with a mRNA vaccine. Results of a randomised controlled trial up to 6 months. Poster in: 17th Vaccine Congress. Glasgow; 24-27 sept 2023.

4. Prenafeta A, Moros A, Barreiro A, Madrenas L, Cañete M, Corominas J, et al. Humoral response of Bimervax (PHH-1V, HIPRA) heterologous booster against SARS-CoV-2 in subjects with different prime-vaccination regimes. Results of a phase 3 clinical trial. Poster 106 in: 2023 ISV Annual Congress. Lausanne; 22-24 oct 2023.