Pfizer and BioNTech have commenced a Phase I clinical trial of the Covid-19 vaccine candidate BNT162b4, which aims to improve the T cell responses of the SARS-CoV-2 virus and potentially broaden protection against the disease.
The US-based trial will assess the safety, tolerability, and immunogenicity of the next-generation vaccine candidate in nearly 180 healthy individuals aged between 18 and 55 years.
These subjects have received a minimum of three mRNA-based Covid-19 vaccine doses.
Comprising a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins, BNT162b4 will be evaluated along with the companies’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine.
Selected based on BioNTech’s target prioritisation platform, the non-spike proteins have been designed into a vaccine candidate to improve and broaden T-cell immunity.
The trial will analyse varying dose levels of the vaccine candidate administered along with a 30µg dose of the bivalent Covid-19 vaccine.
BNT162b4’s dose levels will also be compared to the administration of a 30µg dose of the bivalent Covid-19 vaccine as a booster.
The trial is part of the long-term and multi-pronged scientific strategy of Pfizer and BioNTech to generate strong, durable, and broader immune responses against the virus infections and associated Covid-19.
The companies are also developing several vaccines as part of this approach to deliver a potential pan-SARS-CoV-2 vaccine.
Comirnaty and BNT162b4, the Covid-19 vaccines of Pfizer and BioNTech, are based on the latter’s mRNA technology and were developed by both companies.
Pfizer and BioNTech recently reported data from a Phase II/III clinical trial of an Omicron BA.4/BA.5-adapted bivalent Covid-19 booster vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent [Original and Omicron BA.4/BA.5]).
The trial enrolled nearly 900 healthy subjects aged 12 years and above in the US.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.