Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates

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• 作者：Gianmaria Minervini^a ; ¹ ; Barbara J. McCarson^a ; ^{b_mccarson@merck.com} ; Keith S. Reisinger^b ; Jason C. Martin^a ; Jon E. Stek^a ; Barbara M. Atkins^a ; Karin B. Nadig^a ; Vladimir Liska^a ; ² ; Florian P. Schö ; del^a ; ³ ; Prakash K. Bhuyan^a ; ⁴
• 关键词：AEs ; adverse experiences ; ANOVAs ; analysis of variance ; anti-HBss ; serum antibody to HBsAg ; CIs ; confidence interval ; GMTss ; geometric mean titers ; HBsAgs ; hepatitis B surface antigen ; mpHBVs ; modified process hepatitis B vaccine ; SPRss ; seroprotection ra
• 刊名：Vaccine
• 出版年：2012
• 出版时间：14 February 2012
• 年：2012
• 卷：30
• 期：8
• 页码：1476-1480
• 全文大小：218 K

文摘

Background

A manufacturing process using a modified adjuvant was developed to optimize the consistency and immunogenicity for recombinant hepatitis B vaccine (control: RECOMBIVAX-HB?. This modified process hepatitis B vaccine (mpHBV), which was previously shown to have an acceptable safety and immunogenicity profile in young adults, has now been studied in newborn infants.

Methods

Healthy 1-10-day-old neonates (N = 566) received 3 intramuscular doses (5 ¦Ìg hepatitis B surface antigen [HBsAg] per dose) of either mpHBV or control at Day 1, and Months 1 and 6. Serum antibody to HBsAg (anti-HBs) was assayed at Month 7 (1 month Postdose 3). Anti-HBs geometric mean titers (GMTs) and seroprotection rates (SPRs) ( % of subjects with an anti-HBs titer ?0 mIU/mL) were compared at Month 7. After each dose, injection-site adverse experiences (AEs) and axillary temperatures were recorded for 5 days; systemic AEs were recorded for Days 1-14.

Results

Month 7 SPR was 97.9 % for the mpHBV group and 98.9 % for the control. The GMT was 843.7 mIU/mL for the mpHBV group and 670.1 mIU/mL for the control. The GMT ratio (mpHBV/control) was 1.26 (95 % confidence interval [CI]: 0.94, 1.69), meeting the prespecified non-inferiority criteria. The percentages of subjects reporting any AE, injection-site AEs, or systemic AEs were similar across the 2 vaccination groups. There were no serious AEs.

Conclusions

The safety profile of mpHBV was comparable to that of the control vaccine. The geometric mean antibody titer for mpHBV was higher than control vaccine in this infant population, but the difference did not meet the predefined statistical criterion for superiority.