Program Schedule

1173
Long-term Immunogenicity and Safety of an Investigational Herpes Zoster Subunit Vaccine in Older Adults

Session: Poster Abstract Session: Viral Infections: Treatment and Prevention
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC

Background: An investigational subunit vaccine containing varicella-zoster virus glycoprotein E (gE) and the AS01B Adjuvant System is being evaluated for the prevention of herpes zoster (HZ) in older adults. A phase II clinical trial evaluating different formulations of the candidate vaccine (containing 25 µg, 50 µg, or 100 µg gE; adjuvanted with AS01B) was conducted in adults ≥60 years of age, and showed that all 2-dose adjuvanted vaccine formulations elicited robust cellular and humoral immune responses in older adults, for up to 3 years post-vaccination.1 The 50 µg gE formulation (HZ/su) was selected for further clinical development. In order to gain insight into the potential of this investigational vaccine to provide long-term protection against HZ, we assessed the persistence of the vaccine-induced immune responses for up to 6 years post-vaccination in subjects who received 2-doses of HZ/su.

Methods: This phase II, open-label, multicenter, single group trial conducted in the Czech Republic, Germany, Sweden and the Netherlands (NCT01295320) followed 129 subjects who had received 2 doses (2 months [M] apart) of HZ/su (50 µg gE + AS01B) during the previous trial (NCT00434577). Vaccine-induced immune responses (frequencies of antigen-specific CD4+ T cells expressing ≥2 activation markers measured by intracellular cytokine staining after in vitro stimulation with gE and serum anti-gE antibody concentrations measured by ELISA) from these subjects were evaluated at 48, 60 and 72 M after the first HZ/su dose. Serious adverse events (SAEs) were recorded from M48 to M72.

Results: Participant flow is shown in Figure 1. 6 years after the 2-dose vaccination with HZ/su, gE-specific cell-mediated immune (CMI) responses and anti-gE antibody concentrations had decreased, but remained higher than pre-vaccination values (Figure 2). M72 gE-specific CMI response median values were 3.8 times higher than pre-vaccination values. No vaccine-related SAEs were reported from M48 to M72.

Conclusion: Persistence of immune response was observed for up to 6 years after 2-dose vaccination with HZ/su in healthy older adults. No safety concerns were identified.

1 R. Chlibek et al. Vaccine32(2014):1745–1753.

 

Himal Lal, MD1, Roman Chlibek, MD, PhD2, Lars Rombo, MD, PhD3, Karlis Pauksens, MD4, Tino F. Schwarz, PhD5, Georg Plassmann, MD, PhD6, Jan H. Richardus, MD, PhD7, Gini G.C. Van Rijckevorsel, MD, MSc, PhD8, Grégory Catteau, MSc9 and Thomas Heineman, MD, PhD1, (1)GlaxoSmithKline Vaccines, King of Prussia, PA, (2)University of Defence, Hradec Kralove, Czech Republic, (3)Karolinska University Hospital, Stockholm, Sweden, (4)Uppsala University Hospital, Uppsala, Sweden, (5)Stiftung Juliusspital, Wuerzburg, Germany, (6)Unterfrintroper Hausarztzentrum, Essen, Germany, (7)Municipal Public Health Service Rotterdam-Rijnmond, Rotterdam, Netherlands, (8)Public Health Service (GGD) Amsterdam, Amsterdam, Netherlands, (9)GlaxoSmithKline Biologicals, Wavre, Belgium

Disclosures:

H. Lal, GlaxoSmithKline Vaccines: Employee and Shareholder, Salary

R. Chlibek, None

L. Rombo, GSK: Investigator, Research support

K. Pauksens, None

T. F. Schwarz, GlaxoSmithKline: Board Member, Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium

G. Plassmann, GSK: Investigator, Investigator duty

J. H. Richardus, Glaxo Smith Kline: Grant Investigator, Grant recipient

G. G. C. Van Rijckevorsel, None

G. Catteau, GSK: Employee, Salary

T. Heineman, GSK Vaccines: Employee and Shareholder, Salary

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