WASHINGTON — A trivalent hepatitis B virus vaccine demonstrated noninferiority in adults older than age 18 years and superiority in adults aged 45 years or older compared with a monovalent vaccine, according to phase 3 study data presented at IDWeek.
“Currently available monovalent hepatitis B vaccines have been tremendously successful in reducing the burden of hepatitis B worldwide through prevention, particularly in terms of cirrhosis and liver cancer. However, there are unserved populations and these remain a public health priority, particularly the waning of immunity with age to such an extent that people over 60 will not meet the seroprotection goal of 10 IU after a full dose series,” Joanne M. Langley, MD, division head for infectious diseases and a professor of pediatrics and community health and epidemiology at Dalhousie University in Canada, said during a presentation.
Langley and colleagues compared the immunogenicity of a 10 g dose of a trivalent vaccine (Sci-B-Vac, VBI Vaccines) with a 20 g dose of monovalent vaccine (Engerix-B, GlaxoSmithKline) given at days 0, 28 and 168.
In total, 1,607 participants were randomly assigned to one of the two vaccines. Randomization was stratified by study center and age group — ages 18 to 44 years, 45 to 64 years, and those 65 years or older. The researchers tracked immunogenicity and safety outcomes to day 336.
According to study data, the seroprotection rate among recipients aged 18 years or older who received the trivalent vaccine was 91.4% compared with 76.5% for monovalent vaccine recipients (difference, 14.9%; 95% CI, 11.2%-18.6%). Additionally, a superiority analysis found that among trivalent vaccine recipients age 45 years or older, seroprotection was 89.4%, compared with 73.1% for the monovalent vaccine (difference, 16.4%; 95% CI, 12.2%-20.7%).
Langley said the safety profile of the trivalent vaccine was acceptable and consistent with known vaccine safety profiles.
“When compared to Engerix-B, Sci-B-Vac tends to have higher rates of protection among adults over age 18 with superiority in those older than 45. It also shows that all the sub-populations had higher seroprotection rates,” she concluded. “Next steps are to write up the study and submit to regulators.”
Langley said another large study that is underway will expand the safety data and provide additional seroprotection data in the 18 to 45 age group. – by Caitlyn Stulpin
Langley JM, et al. Abstract LB13. Presented at: IDWeek; Oct. 2-6, 2019; Washington.
Disclosure: Langley reports no relevant financial disclosures.