A phase 3 clinical trial found the 3-antigen (3A) formulation of the hepatitis B virus (HBV) vaccine was more effective than the single-antigen (1A) formulation. These findings were published in JAMA Network Open.
Healthy adults (N=2838) aged 18 to 45 years were recruited for this randomized, double-blind trial. Between 2017 and 2019 at 37 centers in 6 countries across Europe and North America, participants were randomly assigned in a 1:1:1:1 ratio to receive 3 doses on days 0, 28, and 168 of the 1A-HBV vaccine or the 3A-HBV vaccine from 1 of 3 consecutive lots (A, B, and C). Immunogenicity was assessed up to day 336.
The study population consisted of 57.8% women. Participants were aged mean 33.5 (SD, 8.0) years, 91.5% were White, and median body mass index was 25.4 (IQR, 13.9-34.9) kg/m2.
Geometric mean concentration (GMC) ratios of antihepatitis B surface antigens were within the prespecified range of 0.67 to 1.50 for those who received the 3A-HBV vaccine from all lots (A vs B: 0.82; A vs C: 0.95; B vs C: 1.16).
The seroprotection rate of the pooled 3A formulation was 99.3% (95% CI, 98.8%-99.6%) compared with 94.8% (95% CI, 92.7%-96.4%) for 1A. The proportion of individuals achieving antihepatitis B surface antigen concentrations of ³100 mlU/mL was higher among 3A recipients at days 168 (55.3% vs 16.6%), 196 (95.8% vs 86.3%), and 336 (92.7% vs 74.0%).
Vaccine discontinuation for adverse events occurred among 0.5% of the pooled 3A recipients and 0.3% for the 1A recipients. Vaccine-related events included injection site pain, osteoarthritis, dizziness, and oropharyngeal pain. Any adverse events were reported by 68.0% of the 3A and 60.1% of the 1A recipients. There was 1 case of sudden cardiac death 7 days after receiving the 3A-HBV vaccine.
This study was limited by defining protection against hepatitis B infection as the seroprotection rate.
These data indicate that 3 doses of the 3A-HBV vaccine formulation is likely more protective against hepatitis B infection among heathy adults.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Vesikari T, Finn A, van Damme P, et al. Immunogenicity and safety of a 3-antigen hepatitis B vaccine vs a single-antigen hepatitis B vaccine. a phase 3 randomized clinical trial. JAMA Netw Open. 2021;4(10):e2128652. doi:10.1001/jamanetworkopen.2021.28652