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Clinical and Vaccine Immunology, February 2008, p. 314-319, Vol. 15, No. 2
1071-412X/08/$08.00+0     doi:10.1128/CVI.00310-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

A Double-Blind, Randomized, Controlled, Multicenter Safety and Immunogenicity Study of a Refrigerator-Stable Formulation of Zostavax{triangledown}

Larry I. Gilderman,1 James F. Lawless,2 Thomas M. Nolen,3 Tina Sterling,4 Ruth Z. Rutledge,4 Doreen A. Fernsler,4 Neal Azrolan,5 Santosh C. Sutradhar,6 William W. Wang,4 Ivan S. F. Chan,6 Katia Schlienger,4 Florian Schödel,4 Jeffrey L. Silber,4* for the Zostavax Protocol 010 Study Group

University Clinical Research, Pembroke Pines, Florida,1 FFM Clinical Research, Camillus, New York,2 Tomac, Inc., Columbiana, Alabama,3 Infectious Disease/Vaccine Clinical Research, Merck & Co., Inc., West Point, Pennsylvania,4 Medical Communications, Merck & Co., Inc., West Point, Pennsylvania,5 Clinical Biostatistics, Merck & Co., Inc., West Point, Pennsylvania6

Received 27 July 2007/ Returned for modification 11 September 2007/ Accepted 21 November 2007

The vaccine Zostavax has been shown to prevent herpes zoster (HZ) and postherpetic neuralgia and is recommended for individuals ≥60 years of age. This study compared the safety and the immunogenicity of a refrigerator-stable formulation (Zostavax refrigerated) with those of the current formulation (Zostavax frozen) in subjects ≥50 years of age. Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation. Enrollment was stratified 1:2 by age (50 to 59 years and ≥60 years). Safety was evaluated for 28 days postvaccination. Varicella-zoster virus (VZV) antibody responses were measured by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary endpoints were the VZV antibody geometric mean titer (GMT; day 28), the VZV antibody geometric mean rise (GMR; days 1 to 28), and the incidence of vaccine-related serious adverse experiences (AEs) over 28 days. The refrigerated (n = 182) and frozen (n = 185) formulations induced similar GMTs (727.4 and 834.4 gpELISA units/ml, respectively); the estimated GMT ratio (refrigerated formulation/frozen formulation) was 0.87 (95% confidence interval, 0.71 to 1.07). The GMRs were 2.6- and 2.9-fold, respectively. No vaccine-related serious AEs were reported in either group, and the safety profiles of the formulations were generally similar. The frequencies of injection-site AEs during follow-up were 35.6% and 46.4% in the refrigerated and the frozen formulation groups, respectively, and were generally mild. The frequencies of systemic AEs were similar in the two groups, and those of vaccine-related AEs were ~6% in both groups. The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation; thus, the vaccine may be used in clinical settings where freezer availability is limited.

* Corresponding author. Mailing address: Merck Research Laboratories, P.O. Box 1000, UG3CD-28, North Wales, PA 19454-1099. Phone: (267) 305-7963. Fax: (267) 305-7769. E-mail: jeffrey_silber{at}merck.com

{triangledown} Published ahead of print on 12 December 2007.

Clinical and Vaccine Immunology, February 2008, p. 314-319, Vol. 15, No. 2
1071-412X/08/$08.00+0     doi:10.1128/CVI.00310-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Levin, M. J., Oxman, M. N., Johnson, G. R., Zhang, J. H., Hayward, A. R., Weinberg, A., Gilderman, L. I., Chan, I. S. F., Silber, J. (2009). Immune Response to a Refrigerator-Stable Zoster Vaccine. CVI 16: 1381-1382 [Full Text]  
  • Sutradhar, S. C., Wang, W. W. B., Schlienger, K., Stek, J. E., Xu, J., Chan, I. S. F., Silber, J. L. (2009). Comparison of the Levels of Immunogenicity and Safety of Zostavax in Adults 50 to 59 Years Old and in Adults 60 Years Old or Older. CVI 16: 646-652 [Abstract] [Full Text]  


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