Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults

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• 作者：Roman Chlibek^a ; Karlis Pauksens^b ; Lars Rombo^c ; ^d ; Gini van Rijckevorsel^e ; Jan H. Richardus^f ; Georg Plassmann^g ; Tino F. Schwarz^h ; Gré ; gory Catteauⁱ ; Himal Lal^j ; ^{himal.x.lal@gsk.com" class="auth_mail" title="E-mail the corresponding author} ; Thomas C. Heineman^j
• 关键词：NCT01295320
• 刊名：Vaccine
• 出版年：2016
• 出版时间：3 February 2016
• 年：2016
• 卷：34
• 期：6
• 页码：863-868
• 全文大小：826 K

文摘

An investigational subunit vaccine containing the varicella-zoster virus (VZV) glycoprotein E (gE) and the AS01_B adjuvant system is being evaluated for the prevention of herpes zoster (HZ) in older adults. A phase II trial evaluating different formulations of this vaccine (containing 25 μg, 50 μg, or 100 μg gE) was conducted in adults ≥60 years of age and showed that all formulations elicited robust cellular and humoral immune responses for up to 3 years after vaccination. In this follow-up study in subjects who received two doses of the 50 μg gE/AS01_B formulation (HZ/su), we assessed the persistence of the immune responses for up to 6 years after vaccination.

Methods

This phase II, open-label, multicenter, single-group trial conducted in the Czech Republic, Germany, Sweden, and the Netherlands followed 129 subjects who had received two doses (2 months apart) of HZ/su during the initial trial. Vaccine-induced immune responses (frequencies of gE-specific CD4⁺ T cells expressing ≥2 activation markers and serum anti-gE antibody concentrations) were evaluated at 48, 60, and 72 months after the first HZ/su dose.

Results

Six years after vaccination with HZ/su, gE-specific cell-mediated immune responses and anti-gE antibody concentrations had decreased by 20–25% from month 36, but remained higher than the prevaccination values. At month 72, the gE-specific cell-mediated immune response was 3.8 times higher than the prevaccination value (477.3 vs. 119.4 activated gE-specific CD4⁺ T cells per 10⁶ cells), and the anti-gE antibody concentration was 7.3 times higher than the prevaccination value (8159.0 vs. 1121.3 mIU/mL). No vaccine-related serious adverse events were reported between months 36 and 72.

Conclusions

gE-specific cellular and humoral immune responses persisted for 6 years after two-dose vaccination with HZ/su in healthy older adults. No safety concerns were identified.