Julia M Janssen1, Sam Jackson1, William L Heyward2, Robert S Janssen3. 1. Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States. 2. Quattro Clinical Research, 6114 LaSalle Ave., #727, Oakland, CA 94611, United States. 3. Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, United States. Electronic address: rjanssen@dynavax.com.
Abstract
BACKGROUND: Immunologic response to a complete vaccine regimen of currently licensed alum-adjuvanted hepatitis B vaccines is reduced in several subpopulations, including older adults, men, obese persons, and smokers. Two phase 3 trials in healthy adults demonstrated that 2 doses over 1 month of an investigational hepatitis B vaccine (HBsAg-1018) induced superior seroprotection rates (SPRs) to 3 doses over 6 months of the licensed vaccine Engerix-B (HBsAg-Eng). METHODS: An exploratory analysis of immunogenicity was conducted in subpopulations from pooled data for the 2 phase 3 trials. RESULTS: In each subpopulation, the peak SPR in the HBsAg-1018 group was statistically significantly higher than the peak SPR in the HBsAg-Eng group. Peak HBsAg-1018 SPRs ranged from 91.6% to 99.7%, while peak HBsAg-Eng SPRs ranged from 67.7% to 92.9%. CONCLUSION: In these exploratory analyses, 2 doses of HBsAg-1018 induced statistically significantly higher rates of seroprotection than 3 doses of HBsAg-Eng across all subpopulations.
BACKGROUND: Immunologic response to a complete vaccine regimen of currently licensed alum-adjuvanted hepatitis B vaccines is reduced in several subpopulations, including older adults, men, obesepersons, and smokers. Two phase 3 trials in healthy adults demonstrated that 2 doses over 1 month of an investigational hepatitis B vaccine (HBsAg-1018) induced superior seroprotection rates (SPRs) to 3 doses over 6 months of the licensed vaccine Engerix-B (HBsAg-Eng). METHODS: An exploratory analysis of immunogenicity was conducted in subpopulations from pooled data for the 2 phase 3 trials. RESULTS: In each subpopulation, the peak SPR in the HBsAg-1018 group was statistically significantly higher than the peak SPR in the HBsAg-Eng group. Peak HBsAg-1018 SPRs ranged from 91.6% to 99.7%, while peak HBsAg-Eng SPRs ranged from 67.7% to 92.9%. CONCLUSION: In these exploratory analyses, 2 doses of HBsAg-1018 induced statistically significantly higher rates of seroprotection than 3 doses of HBsAg-Eng across all subpopulations.
Authors: Carolyn B Bridges; Tureka L Watson; Noele P Nelson; Maribel Chavez-Torres; Patrick Fineis; Boatemaa Ntiri-Reid; Edward Wake; Judith M Leahy; Anita K Kurian; Mary Ann K Hall; Erin D Kennedy Journal: Vaccine Date: 2019-07-11 Impact factor: 3.641