Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants

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• 作者：Andrew W. Lee^a ; ^{andrew_wen-tseng_lee@merck.com} ; Timo Vesikari^b ; Christopher L. Gilbert^a ; ^{christopher_gilbert@merck.com} ; Stephanie O. Klopfer^a ; Florian P. Schö ; del^a ; ¹ ; Prakash K. Bhuyan^a ; ²
• 关键词：AE ; adverse event ; ANOVA ; analysis of variance ; anti-HBs ; anti-hepatitis B surface antigen antibody titers ; APC ; antigen-presenting cells ; GMT ; geometric mean titer ; HBsAg ; hepatitis B surface antigen ; HBV ; hepatitis B virus ; Hib ; Haemophilus influenzae t
• 刊名：Vaccine
• 出版年：2011
• 出版时间：19 October, 2011
• 年：2011
• 卷：29
• 期：45
• 页码：7942-7948
• 全文大小：1K

文摘

Background

A hepatitis B vaccine was manufactured with a modified process (mpHBV) that incorporated double the usual amount of phosphate. Following a study in young adults, the mpHBV was evaluated in infants in a combination hepatitis B and Haemophilus influenzae B vaccine (mpHBV-Hib).

Methods

The mpHBV-Hib was compared with the licensed bivalent HBV-Hib vaccine Comvax?for immunogenicity and safety. Both vaccines contained 5 ¦Ìg/0.5 mL of hepatitis B surface antigen (HBsAg) and 7.5 ¦Ìg/0.5 mL of PRP-OMPC (polyribosylribitol phosphate outer membrane protein complex). A total of 543 infants were randomized 1:1 to receive either vaccine at 2, 4 and 12 months of age. A pneumococcal conjugate vaccine (PCV) was given concomitantly. Immunogenicity was assessed at 1-month post-dose 3.

Results

Seroprotection rates [ % subjects with anti-hepatitis B surface antigen antibody titers (anti-HBs) ?0 mIU/mL)] were 100 % and 99 % for mpHBV-Hib and the licensed control (Comvax?, respectively. Anti-HBs geometric mean titers (GMTs) were 4204 (95 % CI, 3411-5182) and 1683 (95 % CI, 1350-2099) mIU/mL, respectively. Anti-PRP seroprotection rates (SPR) at ?.15 ¦Ìg/mL and at ?.0 ¦Ìg/mL were 97 % and 94 % , respectively, for mpHBV-Hib and 96 % and 92 % , respectively, for the control. Anti-PRP GMTs were 7.1 ¦Ìg/mL for mpHBV-Hib and 8.0 ¦Ìg/mL for the control. Reactogenicity of the two vaccines was similar.

Conclusions

The mpHBV in combination with Hib and with co-administered PCV was highly immunogenic. The safety profile of mpHBV-Hib was comparable to the licensed control. Both the control and mpHBV-Hib met acceptability criteria for seroprotection rates to hepatitis B, with higher anti-HBs GMTs noted for mpHBV-Hib.