CVI Accepts, published online ahead of print on 4 March 2009
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Clin. Vaccine Immunol. doi:10.1128/CVI.00407-08
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

A Comparison of the Immunogenicity and Safety of ZOSTAVAX® in Adults 50 to 59 Years Old and Adults ≥60 Years Old

Santosh C. Sutradhar, William W.B. Wang, Katia Schlienger, Jon E. Stek*, Jin Xu, Ivan S.F. Chan, and Jeffrey L. Silber

Merck Research Laboratories, Upper Gwynedd, PA

* To whom correspondence should be addressed. Email: jon_stek{at}merck.com.


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Abstract

Background: ZOSTAVAX® has been shown to be efficacious in the prevention of herpes zoster (HZ), and generally well tolerated in clinical trials among subjects ≥60 years old. This prespecified combined analysis from 2 studies compares immunogenicity and safety of ZOSTAVAX® in subjects 50 to 59 years old versus those ≥60 years old.

Methods: VZV Ab titers were measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) at baseline and 4 weeks postvaccination. Noninferiority was evaluated by estimated geometric mean fold rise (GMFR) ratio [50 to 59 years old/≥60 years old] and 2-sided 95% confidence interval (CI). Success was defined by lower bound (LB) of 95% CI of GMFR ratio >0.67. Acceptability of postvaccination VZV Ab was defined by LB of 95% CI of GMFR >1.4. Safety data was recorded for 28 days postvaccination by standardized Vaccination Report Card.

Results: Estimated GMFR from baseline to 4 weeks postvaccination was 2.6 (95% CI: 2.4, 2.9) in subjects 50 to 59 years old and 2.3 (95% CI: 2.1, 2.4) in subjects ≥60 years old. The estimated GMFR ratio [50 to 59 years old/≥60 years old] was 1.13 (95% CI: 1.02, 1.25). No ZOSTAVAX®-related serious AEs were reported.

Conclusions: After a dose of ZOSTAVAX®, GMFR of VZV Ab response in subjects 50 to 59 years old was noninferior to that in subjects ≥60 years old. VZV Ab response was acceptable in both age groups. ZOSTAVAX® was generally well tolerated in both age groups.






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