At-birth immunisation against hepatitis B using a novel pre-filled immunisation device stored outside the cold chain

Area of Science:

• Immunology
• Vaccinology
• Public Health

Background:

• The hepatitis B (HB) vaccine is crucial for preventing HBV infection.
• Maintaining vaccine efficacy requires adherence to cold chain storage.
• UniJect is a novel pre-filled injection device for vaccine delivery.

Purpose of the Study:

• To assess the immunogenicity of the hepatitis B vaccine administered via UniJect devices stored under tropical conditions.
• To compare the efficacy of UniJect stored out of cold chain versus in cold chain, and standard cold chain methods.

Main Methods:

• Infants received their first HB vaccine dose using UniJect (out of cold chain), UniJect (in cold chain), or standard syringe/vial (in cold chain).
• Subsequent doses were administered conventionally.
• Blood samples were collected 4-6 weeks post-third dose for serological analysis.

Main Results:

• No statistically significant differences were observed in seroconversion rates among the three groups.
• Geometric mean titres of HB surface antibody showed no significant variation between the groups.
• UniJect demonstrated comparable immunogenicity regardless of cold chain storage in tropical environments.

Conclusions:

• The UniJect device maintains hepatitis B vaccine immunogenicity even when stored at tropical temperatures without refrigeration.
• This finding supports the potential of UniJect for improving vaccine accessibility in resource-limited settings with challenging climates.
• UniJect offers a viable alternative for HB vaccination, potentially simplifying logistics and enhancing coverage.