Completed Infection & Immunity NIHR-supported project Lungs & Breathing

A Study to Assess the Immunogenicity, Tolerability and Safety of SPVX02 (a Td Vaccine) and Revaxis in Healthy Adults

In plain English

AI plain-English summary

A single jab of a new tetanus and diphtheria vaccine could survive for months without refrigeration, eliminating one of the biggest logistical headaches in global immunisation. Most vaccines, including the standard Td booster, must be kept cold from factory to injection site. This "cold chain" is expensive and fragile—a power cut or a broken fridge in a remote clinic can ruin an entire batch. SPVX02 is a freeze-dried reformulation designed to sit on a shelf at room temperature. This Phase I trial in healthy adults will test whether this thermostable version triggers an immune response as strong as the two currently licensed comparators, Tetadif® and diTeBooster®. If the data show comparable safety and immunogenicity, the practical impact would be immediate. Supply chains for routine boosters in low- and middle-income countries could be radically simplified. Clinics without reliable electricity could stock the vaccine without fear of spoilage. Humanitarian teams responding to outbreaks would carry a product that does not demand cold storage. The research is still early—this is a first-in-human safety and dose-finding study—but success would turn a fundamental weakness of current vaccines into a solved engineering problem.

View original technical description
Stablepharma is developing a thermostable lyophilized tetanus and diphtheria (Td) vaccine (SPVX02) based on a reformulation of Tetadif® vaccine. This Phase I, first-in-human study aims to evaluate the safety, immunogenicity and tolerability of SPVX02 whilst also providing comparative immunogenicity data with Tetadif® and diTeBooster® (comparator investigational medicinal products) using a randomised, single-blind design. This study aims to demonstrate that SPVX02, Tetadif® and diTeBooster® generate comparable anti-tetanus and anti-diphtheria post-boost immune responses in healthy adults.

Researchers

Adam Dale (Principal Investigator)

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