Immune Response to a Refrigerator-Stable Zoster Vaccine
Year: 2009
Type: letter
Abstract: Immune Response to a Refrigerator-Stable Zoster VaccineWe wish to correct some errors made by Gilderman et al. in their article entitled "A Double-Blind, Randomized, Controlled, Multicenter Safety and Immunogenicity Study of a Refrigerator-Stable Formulation of Zostavax," published in Clinical and Vaccine Immunology (1).(i) They cite reference 19 as demonstrating that Zostavax decreased the frequency of herpes zoster (HZ) and postherpetic neuralgia.The study cited did not utilize Zostavax and did not have efficacy as an endpoint (2).(ii) In Materials and Methods, they cite reference 23 in their article as a source for statements about "assays correlated with vaccine-induced protection."Such studies were not undertaken in the study referenced (4).The authors likely meant to reference the 2008 article in The Journal of Infectious Diseases (JID) by Levin et al. (3).(iii) If the authors meant to cite the Levin et al.JID 2008 reference, we do not believe it is possible for the authors to conclude from that publication that "the immune response measured by gpELISA [glycoprotein enzyme-linked immunosorbent assay], in terms of postvaccination geometric mean titer (GMT) and the geometric mean rise (GMR) in the VZV [varicella-zoster virus] antibody titer from the baseline to the period postvaccination, correlated best with protection against HZ."The information pertinent to this issue in the JID 2008 article (3) is in Table 3, which lists many correlations between immune responses and the occurrence of HZ in the large pivotal trial of an HZ vaccine.The data provided in that table do not identify VZV-specific antibody as the "best correlate" for immunity postvaccination, and the JID 2008 paper clearly states that a surrogate marker of threshold for immunity was not identified.Furthermore, data on the relationship of GMR to HZ, referred to by Gilderman et al., are not provided in this paper.We believe that these corrections are important because the Gilderman et al. article concluded that the two zoster vaccine formulations tested were comparable in immunogenicity (and by implication in clinical efficacy) solely on the basis of gpELISA results, whereas there is strong clinical evidence that VZV cell-mediated immunity (CMI) is necessary and sufficient for the prevention of herpes zoster, and immunologic assessments in several studies, including the Levin et al.JID 2008 article, document that levels of antibody to VZV (e.g., measured by gpELISA) are not correlated with levels of VZV CMI (3).
Source: Clinical and Vaccine Immunology
DOI: 10.1128/cvi.00338-08
Institutions: University of Colorado Denver, United States Department of Veterans Affairs, VA San Diego Healthcare System, West Haven Cooperative Studies Program Coordinating Center, National Institutes of Health, National Institute of Allergy and Infectious Diseases, University of Colorado Anschutz
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W2000526469