1230. Reactogenicity of an adjuvanted herpes zoster subunit vaccine in older adults: results of the phase 3 ZOE-50 trial
Session: Poster Abstract Session: Viral Infections: Pathogenesis and Immunity
Friday, October 9, 2015
Room: Poster Hall

Background: In the phase 3 ZOE-50 trial, the HZ/su investigational subunit vaccine, containing the varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, showed 97.2% vaccine efficacy for the prevention of herpes zoster in adults ≥50 years of age.1 Here, we present solicited injection site and systemic reactions to vaccinations in a sub-cohort of study participants.

Methods: We conducted a randomized, observer-blind, placebo-controlled, multi-country, phase 3 trial in adults ≥50 years of age (stratified by age: 5059, 6069, and ≥70 years). Subjects were randomized 1:1 to receive 2 intramuscular doses of HZ/su or placebo (saline) 2 months apart. Solicited injection site and systemic reactions were recorded for 7 days after each vaccination by a subset of subjects (all subjects ≥70 years of age and randomly-selected subjects in the 5059 and 6069 years age strata). Reaction intensity was scored on a scale of 0-3.

Results: Of the 15,411 evaluable subjects who received at least 1 dose of HZ/su or placebo, 8926 were assigned to the reactogenicity subset (HZ/su group, N=4460; placebo group, N=4466). Solicited reactions were more common in the HZ/su group than in the placebo group. Injection site reactions occurred in 81.5% of HZ/su and 11.9% of placebo recipients (grade 3 in 9.5% and 0.4%), and systemic reactions in 66.1% of HZ/su and 29.5% of placebo recipients (grade 3 in 11.4% and 2.4%). The most frequent reactions in the HZ/su group were injection site pain (HZ/su: 79.1%; placebo: 11.2%), myalgia (46.3% vs 12.1%), and fatigue (45.9% vs 16.6%). Median durations of the different solicited reactions were 13 days (Grade 3: 1-2 days; Figure 1). The frequencies of reported solicited reactions decreased with increasing age both in HZ/su recipients (from 91.4% in subjects aged 5059 years to 78.6% in those aged ≥70 years) and in placebo recipients (from 41.1% to 28.4%) (Figure 2).

Conclusion: The HZ/su vaccine was more reactogenic than placebo in the ZOE-50 study, with grade 3 reactions in up to 11.4% of HZ/su vaccine recipients. All reactions were transient and mostly of mild to moderate intensity. Reactogenicity decreased with increasing age (NCT01165177).

References.

1 Lal H, Cunningham TC, Godeaux O, et al. 2015 New Engl J Med

 

Timo Vesikari, MD, PhD1, Anthony L Cunningham, MB BS MD2, Olivier Godeaux, MD3, Anitta Ahonen, MD1, Laura Campora, MD3, Roman Chlibek, MD Ph.D.4, Iris Gorfinkel, MD5, Shinn-Jang Hwang, MD6, Martina Kovac, MD3, Tiina Korhonen, MD1, Myron Levin, MD, FIDSA7, Janet Mcelhaney, MD8, Shelly a. Mcneil, MD, FRCPC, FIDSA9, Lars Rombo, MD, PhD10, Daisuke Watanabe, MD Ph.D.11, Wilfred Yeo, MB ChB MD12, Toufik Zahaf, Ph.D.3, Himal Lal, MD13 and Thomas Heineman, MD, PhD13, (1)Tampere Vaccine Research Centre, University of Tampere, Tampere, Finland, (2)Westmead Millennium Institute for Medical Research, Westmead, Australia, (3)GSK Vaccines, Wavre, Belgium, (4)Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic, (5)PrimeHealth Clinical Research Organization, toronto, ON, Canada, (6)Taipei Veterans General Hospital; National Yang Ming University School of Medicine, Taipei, Taiwan, (7)Pediatrics & Medicine, University of Colorado Denver School of Medicine, Aurora, CO, (8)Advanced Medical Research Institute of Canada, Sudbury, ON, Canada, (9)Canadian Center for Vaccinology, IWK Health Center and Capital Health, Dalhousie University, Halifax, NS, Canada, (10)Karolinska University Hospital, Stockholm, Sweden, (11)Aichi Medical University, Nagakute, Japan, (12)School of Medicine, University of Wollongong, Wollongong, Australia, (13)GSK Vaccines, King of Prussia, PA

Disclosures:

T. Vesikari, GSK Vaccines: Grant Investigator , Research grant and Speaker honorarium
Merck: Grant Investigator , Research grant and Speaker honorarium
SP MSD: Board Member , Consulting fee

A. L. Cunningham, GSK Vaccines: Grant Investigator and Scientific Advisor , Consulting fee and Research grant
Merck International: Scientific Advisor , Consulting fee
Bio CSL: Scientific Advisor , Consulting fee

O. Godeaux, GSK Vaccines: Employee and Shareholder , Salary

A. Ahonen, None

L. Campora, GSK Vaccines: Employee , Salary

R. Chlibek, GSK Vaccines: Grant Investigator , Consulting fee , Research grant and Speaker honorarium
Pfizer: Grant Investigator and Scientific Advisor , Consulting fee and Speaker honorarium

I. Gorfinkel, None

S. J. Hwang, GSK Vaccines: Grant Investigator , Research grant

M. Kovac, GSK Vaccines: Employee and Shareholder , Salary

T. Korhonen, None

M. Levin, GSK Vaccines: Grant Investigator and Scientific Advisor , Consulting fee and Research grant
Merck, Sharp & Dohme: Grant Investigator and Shareholder , Consulting fee , Licensing agreement or royalty and Research grant

J. Mcelhaney, GSK Vaccines: Grant Investigator , Research grant and Speaker honorarium
Sanofi Pasteur: Speaker's Bureau , Speaker honorarium

S. A. Mcneil, GSK Vaccines: Grant Investigator , Research grant
Pfizer: Grant Investigator , Research grant
Sanofi Pasteur: Grant Investigator , Research grant

L. Rombo, None

D. Watanabe, GSK Vaccines: Scientific Advisor , Consulting fee

W. Yeo, GSK Vaccines: Grant Investigator , Research grant

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

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

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

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