Pfizer has launched a new study of its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) along with a booster dose of its BioNTech-partnered COVID-19 jab.
The trial will enrol 600 adults, aged 65 and older, from the phase 3 Pfizer/BioNTech COVID-19 vaccine trial.
Participants will have already received their second dose of the COVID-19 vaccine, at least six months prior to entering the co-administration study.
The study will randomise participants into one of three groups: 20vPnC plus the COVID-19 booster, 20vPnC plus placebo or the COVID-19 vaccine booster plus placebo.
The primary objective of the trial is to evaluate the safety of co-administration of both vaccines, with six months of follow-up after vaccination.
Secondary objectives include identifying immune responses produced by each of the vaccines.
In February, the European Medicines Agency (EMA) accepted Pfizer’s marketing authorisation application for 20vPnC for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 and older.
The submission includes data from Pfizer’s clinical programme evaluating 20vPnC in adults, including phase 1 and 2 trials and three phase 3 trials describing the safety and evaluating the immunogenicity of the vaccine.
20vPnC includes capsular polysaccharide conjugates for the 13 serotypes in Pfizer’s licensed Prevnar 13 pneumococcal vaccine candidate.
In addition, 20vPnC also contains capsular polysaccharide conjugates for a further seven serotypes that cause invasive pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance and meningitis.
Meanwhile, Pfizer and BioNTech are separately evaluating a third dose of their COVID-19 vaccine in a bid to understand the effect of a booster on immunity against the virus, due to circulating and potential newly emerging SARS-CoV-2 variants.
The companies also announced that they are planning a study to evaluate a variant-specific vaccine, using a new construct of their jab based on the B.1.351 variant first identified in South Africa.
“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine. This booster study is critical to understanding the safety of a third dose and immunity against circulating strains,” said Albert Bourla, chairman and chief executive officer, Pfizer.