The trial will involve 612 adult volunteers
The biotech pharmaceutical company HIPRA has received authorisation from the Spanish Agency of Medicines and Health Products (AEMPS) to initiate a new Phase IIb/III, double-blind, randomised, active-controlled, multicentre, non-inferiority clinical trial to evaluate the safety and immune response of a booster dose of its adapted vaccine against current variants of COVID-19, specifically the XBB.1.16 variant, in adults previously vaccinated against this infection.
The new adapted vaccine consists of an adjuvanted recombinant protein based on the Omicron XBB.1.16 variant of SARS-CoV-2. This vaccine is the first adaptation of the BIMERVAX® vaccine already endorsed by the European Medicines Agency (EMA), approved by the European Commission and the Medicines and Healthcare products Regulatory Agency (HMRA) in England, and approved ('prequalified' in technical terms) by the World Health Organization (WHO).
Ten hospitals and primary care centres throughout Spain
The clinical trial will involve 612 volunteers over 18 years of age who are not affected by a serious pathology. They must have been previously vaccinated with a minimum of 3 doses of mRNA. All participants will receive a dose of an adapted vaccine against the current COVID-19 variants, which may be randomly selected from HIPRA or from another pharmaceutical company authorised in Spain. Neither the research team nor the participant will know which vaccine is assigned in each case.
The trial will be conducted in 10 hospitals and primary care centres across Spain: Hospital Germans Trias i Pujol (Barcelona), Hospital Clínico Universitario de Valencia, HM Nou Delfos (Barcelona), HM Sanchinarro (Madrid), HM Puerta del Sur (Madrid), Hospital Dr. Josep Trueta (Girona), Hospital Universitario Quirónsalud Madrid, Hospital Regional de Málaga, CAP Centelles y Hospital de Cruces (Barakaldo).
About the vaccine
HIPRA's recombinant protein COVID-19 vaccine has been shown in previous trials to be safe, low reactogenic and with a broad ability to neutralise the main variants of the virus. The administration of a booster dose of BIMERVAX® in previously vaccinated individuals (mRNA) has good tolerability and induces a large and sustained immune response over time, suggesting longer-lasting protection1, 2, 3, 4. HIPRA has also presented preliminary results on safety and humoral immunity against XBB.1.16 and other emerging variants from a study in adolescents and another study in people over 64 years of age co-administered with influenza vaccine at the Spanish Vaccinology Association congress (Palma de Mallorca, 15 November).
HIPRA is a biotech pharmaceutical company focused on prevention for animal and human health, with a wide range of highly innovative vaccines and an advanced diagnostic service. With its claim "Building immunity for a healthier world", HIPRA affirms its commitment to contribute with solutions that improve global health.
HIPRA has a solid international presence with its own subsidiaries in 40 countries, 3 R&D centres and 6 production centres located strategically in Europe (Spain) and America (Brazil). In addition, its extensive international distribution network keeps marketing channels open with close to 100 other countries, thus covering the 5 continents.
Research and development are at the core of its expertise. HIPRA devotes 10% of its annual turnover to R&D activities that focus on the creation and application of the latest scientific advances for the development of highly innovative vaccines. To add value to its vaccine expertise, the company also develops medical devices and traceability services.
1. BIMERVAX® technical 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
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.