Post-licensure safety study of new-onset immune-mediated diseases,herpes zoster,and anaphylaxis in adult recipients of HepB-CpG vaccine versus HepB-alum vaccine |
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Institution: | 1. Department of Research & Evaluation, Kaiser Permanente Southern California, 100 S Los Robles Ave, Pasadena, CA 91101, USA;2. Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, 1665 University Blvd, Birmingham, AL 35233, USA |
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Abstract: | BackgroundHepB-CpG (Heplisav-B) is a licensed hepatitis B vaccine with a novel adjuvant that requires 2 doses (0, 1 month) compared to HepB-alum (Engerix-B) which requires 3 doses (0, 1, 6 months). Monitoring safety outcomes following receipt of vaccines with novel adjuvants outside trial settings is important. Hence, as part of a post-marketing commitment, we compared the incidence of new-onset immune-mediated diseases, herpes zoster (HZ), and anaphylaxis among recipients of HepB-CpG versus HepB-alum.MethodsThis cohort study included adults not on dialysis who received ≥1 dose of hepatitis B vaccine from 8/7/2018 to 10/31/2019, during which HepB-CpG was routinely administered in 7 of 15 Kaiser Permanente Southern California medical centers while HepB-alum was administered in the other 8 centers. Recipients of HepB-CpG or HepB-alum were followed through electronic health records for 13 months for occurrence of pre-specified new-onset immune-mediated diseases, HZ, and anaphylaxis identified using diagnosis codes. Incidence rates were compared using Poisson regression with inverse probability of treatment weighting when there was ≥80 % power to detect a relative risk (RR) of 5 for anaphylaxis and RR of 3 for other outcomes. Chart review to confirm new-onset diagnosis was conducted for outcomes with statistically significant elevated risk.ResultsThere were 31,183 HepB-CpG and 38,442 HepB-alum recipients (overall 49.0 % female, 48.5 % age ≥50 years, and 49.6 % Hispanic). Among immune-mediated events that occurred frequently enough for formal comparison, rates among HepB-CpG versus Hep-B-alum recipients were similar except for rheumatoid arthritis (RA) (adjusted RR 1.53 95 % CI: 1.07, 2.18]). After chart confirmation of new-onset RA, the adjusted RR was 0.93 (0.34, 2.49). The adjusted RR for HZ was 1.06 (0.89, 1.27). Anaphylaxis occurred in 0 HepB-CpG and 2 HepB-alum recipients.ConclusionsThis large post-licensure study did not identify evidence of safety concerns for HepB-CpG compared to HepB-alum for immune-mediated diseases, HZ, or anaphylaxis. |
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Keywords: | Hepatitis B vaccine Safety HepB-CpG Immune-mediated events Herpes zoster Anaphylaxis 95?% CI"} {"#name":"keyword" "$":{"id":"k0040"} "$$":[{"#name":"text" "_":"95?% confidence interval EHR"} {"#name":"keyword" "$":{"id":"k0050"} "$$":[{"#name":"text" "_":"electronic health record HBV"} {"#name":"keyword" "$":{"id":"k0060"} "$$":[{"#name":"text" "_":"hepatitis B virus HepB-alum"} {"#name":"keyword" "$":{"id":"k0070"} "$$":[{"#name":"text" "_":"Engerix-B HepB-CpG"} {"#name":"keyword" "$":{"id":"k0080"} "$$":[{"#name":"text" "_":"Heplisav-B HZ"} {"#name":"keyword" "$":{"id":"k0090"} "$$":[{"#name":"text" "_":"herpes zoster IPTW"} {"#name":"keyword" "$":{"id":"k0100"} "$$":[{"#name":"text" "_":"inverse probability of treatment weighting KPSC"} {"#name":"keyword" "$":{"id":"k0110"} "$$":[{"#name":"text" "_":"Kaiser Permanente Southern California RA"} {"#name":"keyword" "$":{"id":"k0120"} "$$":[{"#name":"text" "_":"rheumatoid arthritis RR"} {"#name":"keyword" "$":{"id":"k0130"} "$$":[{"#name":"text" "_":"relative risk |
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