Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program
Up to 900 healthy American volunteers aged 50 to 69 will participate in the phase 1/2 trial
Pfizer and BioNTech plan to use mRNA technology to meet the demand for highly effective, well tolerated, and efficiently produced shingles vaccines as the world’s population age
Without immunisation, shingles, a painful, localised rash brought on by the varicella zoster virus reactivation, is anticipated to affect almost half of those who survive to be 85 years old
Pfizer and BioNTech announced the beginning of a Phase 1/2 experiment investigating the safety, tolerability, and immunogenicity of the firms’ mRNA vaccine candidates against shingles, better known as herpes zoster, or “HZ,” a crippling condition brought on by the varicella zoster virus. Each year, shingles affects millions of people worldwide.
The Phase 1/2 multicenter, randomised, controlled, dose-selection research (NCT05703607) by the businesses will assess the immunogenicity, safety, and tolerance of potential mRNA shingles vaccines. The study is being done in the United States and aims to enlist up to 900 healthy volunteers between the ages of 50 and 69. For passage to Phase 2, Phase 1 will aid in choosing the best mRNA vaccine candidate, dosage level, dosing schedule, and formulation. The duration of potential protection will be determined by monitoring trial participants.
Although there are already shingles vaccines that have been approved, Pfizer and BioNTech hope to use mRNA technology to perhaps create a vaccine that has high efficacy, is well-tolerated, and is cost-effective to produce internationally. The firms’ COVID-19 vaccine will make use of the unique antigen technology from Pfizer and the patent mRNA platform technology from BioNTech. The many forms of the glycoprotein E (“gE”) on the surface of the varicella zoster virus are encoded by the mRNA shingles vaccine candidates. Following the virus’ reactivation in nerve cells, the gE protein is crucial for viral replication and cell-to-cell dissemination.
In January 2022, Pfizer and BioNTech announced a partnership to develop a shingles vaccine. Also, the businesses are collaborating on a COVID-19 and influenza combo vaccine programme.