Three-antigen HBV vaccine noninferior to single-antigen vaccine in Russian population
The three-antigen hepatitis B virus vaccine was noninferior to the single-antigen vaccine, according to results from a randomized, double-blind trial of Russian adults.
“The enhanced immunogenicity of the three-antigen vaccine (3AV) may be attributable to the inclusion of all three antigenic determinants of the HBV envelope — S, pre-S2 and pre-S1,” Elena V. Esaulenko, MD, head of the department of adult communicable diseases and epidemiology at Saint Petersburg State Pediatric Medical University in Russia, and colleagues wrote in Clinical Infectious Diseases. “This unique feature of 3AV may enable it to play a critical public health role in prevention of HBV infection, including for those requiring quick and effective HBV protection (eg, health care workers) and those who are immunocompromised and at risk of delayed or suboptimal response to conventional second-generation vaccines.”
Esaulenko and colleagues compared the immunogenicity of 3AV and the single-antigen vaccine (1AV) in Russian adults aged 18 to 45 years. The study’s primary outcome was the difference in serocoversion at day 210, and the seroprotection rate was the secondary outcome.
The seroconversion rate of 3AV (100%) was found to be noninferior to 1AV (97.9%) at day 210, and was significantly better in 3AV at day 28 of the study. Additionally, anti-HBV titers were significantly higher for 3AV at days 90 and 180. BMI, sex and age did not have any influence on anti-HBV titer levels.
The researchers said that one of the study’s three major limitations was the homogeneity of the Russian population because it may not be directly comparable to the North American population.
Secondly, “the limited sample size affects generalizability of the results,” the authors wrote. “Thirdly, despite the nonrestrictive inclusion criteria allowing a representative cohort of eligible participants, most participants were young, healthy and nonobese, and participants with any comorbidities were too few to conduct meaningful subgroup analyses that may have been useful for hypothesis testing in a larger population of participants.”
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