Pfizer and BioNTech have announced the start of a phase 1/2 study of their mRNA shingles vaccine candidates.
The US-based study is aiming to enrol up to 900 healthy volunteers aged from 50 to 69 years, with follow-ups being done to determine how long vaccine protection may last.
The first phase of the study is set to help select the optimal candidate, dose level, schedule and formulation for advancement to phase 2.
Shingles is caused by the reactivation of the same virus that causes chickenpox. After a patient recovers from chickenpox, usually as a child, the virus remains dormant in the nerve cells and can reactivate later in life due to stress or immunosuppression.
The disease typically presents as a rash, with painful blisters across the chest, abdomen or face and, in some cases, can cause persistent pain. In rare cases, shingles can also lead to hearing loss, brain inflammation or blindness.
Around 95% of people over the age of 50 have been exposed to the virus, placing them at risk of developing shingles, with both the incidence and severity of the disease increasing with age.
While there are currently approved vaccines for shingles, Pfizer and BioNTech explained in a statement that they are looking to develop an improved vaccine, with the potential for better tolerability and a more efficient global production by using mRNA technology.
The companies originally announced a shingles vaccine collaboration in January 2022, an agreement that would see Pfizer pay $225m in upfront payments to BioNTech, with the company also being eligible for future payments of up to $200m.
In exchange, Pfizer will have rights to commercialise the potential vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries, where BioNTech will have commercialisation rights.
At the time of the original collaboration announcement, Ugur Sahin, chief executive officer and co-founder of BioNTech, said:“The collaboration aims to develop a new mRNA-based vaccine against shingles, leveraging the expertise and resources of both companies.
“Adults aged 50 years and older as well as vulnerable populations like cancer patients are at an increased risk of shingles. Our goal is to develop an mRNA vaccine with a favourable safety profile and high efficacy, which is at the same time more easily scalable to support global access.”