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Abstract Details
Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease
Vaccine. 2023 May 11;41(20):3224-3232. doi: 10.1016/j.vaccine.2023.04.028.Epub 2023 Apr 19.
1Department of Internal Medicine II, Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Strasse 40, Halle 06120, Germany.
2Amherst Family Practice, 1867 Amherst Street, Winchester, VA 22601, USA.
3Gamma Medical Research, Inc., 222 East Ridge Road, Suite 214, Mcallen, TX 78503, USA.
4Center for Pharmaceutical Research, 1010 Carondelet Drive, Suite 426, Kansas City, MO 64114, USA.
5New York-Presbyterian Queens, 56-45 Main Street, Flushing, NY 11355, USA.
6Department of Medicine, Michael Garron Hospital, 825 Coxwell Avenue, Toronto, ON, Canada.
7National Institute of Clinical Research, 1000 Corporate Center Drive, Suite 330, Monterey Park, CA 91754, USA.
8Kidney Specialists of Southern Nevada, 500 S Rancho Drive, #12, Las Vegas, NV 89106, USA.
9Nephrology Associates, 28 White Bridge Pike, Suite 300, Nashville, TN 37205, USA.
10Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, USA.
11Gemeinschaftspraxis für Innere Medizin, Pferdebachstr. 29, 58455 Witten, Germany.
12Dynavax Technologies Corporation, 2100 Powell Street, Suite 720, Emeryville, CA 94608, USA.
13Dynavax Technologies Corporation, 2100 Powell Street, Suite 720, Emeryville, CA 94608, USA. Electronic address: rjanssen@dynavax.com.
Abstract
Background: Hepatitis B virus (HBV) infection remains a significant global burden, especially for patients with chronic kidney disease (CKD) receiving hemodialysis. Three doses of HepB-CpG (HEPLISAV-B® vaccine) induced a superior immune response compared with 4 double doses of HepB-Eng (Engerix-B®) in a phase 3 trial (HBV-17) in adults with CKD. Here we report the long-term immunogenicity and safety of HepB-CpG and HepB-Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19).
Methods: HBV-19 is a multicenter, open-label, phase 3b trial of adults with CKD who previously received a complete series of HepB-CpG or HepB-Eng in the HBV-17 trial. Participants were assigned to seroprotection categories at enrollment on the basis of their antibody response to hepatitis B surface antigen (anti-HBs) in HBV-17. The objective was to evaluate the durability of seroprotection (defined as an anti-HBs concentration ≥ 10mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10mIU/mL received additional HepB-CpG or HepB-Eng doses.
Results: 147 participants were enrolled; 66.7 % were men, median age was 65.0 years, and 83.7 % were white. The durability of seroprotection in participants with CKD was similar in those who received HepB-CpG and those who received HepB-Eng. Antibody concentrations ≥ 100mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100mIU/mL post vaccination. The geometric mean anti-HBs concentration in the HepB-CpG group was significantly higher than in the HepB-Eng group over time (P ≤ 0.0001). The safety profiles were similar between the vaccine groups.
Conclusions: Due to the higher antibody levels induced by HepB-CpG in participants with CKD, seroprotection against HBV may be expected to persist longer than that induced by HepB-Eng.