Openly accessible

Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older

Cunningham, A.L., Lal, H., Kovac, M., Chlibek, R., Hwang, S.-J., Díez-Domingo, J., Godeaux, O., Levin, M.J., McElhaney, J.E., Puig-Barberà, J., Vanden Abeele, C., Vesikari, T., Watanabe, D., Zahaf, T., Ahonen, A., Athan, E., Barba-Gomez, J.F., Campora, L., de Looze, F., Downey, H.J., Ghesquiere, W., Gorfinkel, I., Korhonen, T., Leung, E., McNeil, S.A., Oostvogels, L., Rombo, L., Smetana, J., Weckx, L., Yeo, W. and Heineman, T.C. 2016, Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older, New England journal of medicine, vol. 375, no. 11, pp. 1019-1032, doi: 10.1056/NEJMoa1603800.

Attached Files
Name Description MIMEType Size Downloads
athan-efficacyofthe-2016.pdf Published version application/pdf 589.67KB 27

Title Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older
Author(s) Cunningham, A.L.
Lal, H.
Kovac, M.
Chlibek, R.
Hwang, S.-J.
Díez-Domingo, J.
Godeaux, O.
Levin, M.J.
McElhaney, J.E.
Puig-Barberà, J.
Vanden Abeele, C.
Vesikari, T.
Watanabe, D.
Zahaf, T.
Ahonen, A.
Athan, E.ORCID iD for Athan, E. orcid.org/0000-0001-9838-6471
Barba-Gomez, J.F.
Campora, L.
de Looze, F.
Downey, H.J.
Ghesquiere, W.
Gorfinkel, I.
Korhonen, T.
Leung, E.
McNeil, S.A.
Oostvogels, L.
Rombo, L.
Smetana, J.
Weckx, L.
Yeo, W.
Heineman, T.C.
Journal name New England journal of medicine
Volume number 375
Issue number 11
Start page 1019
End page 1032
Total pages 14
Publisher Massachusetts Medical Society
Place of publication Waltham, Mass.
Publication date 2016-09-15
ISSN 0028-4793
1533-4406
Summary Background: A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70).

Methods: This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50.

Results
: In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups.

Conclusions: In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older.
Notes Prepared for the ZOE-70 Study Group.
Language eng
DOI 10.1056/NEJMoa1603800
Field of Research 111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 920499 Public Health (excl. Specific Population Health) not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, Massachusetts Medical Society
Free to Read? Yes
Free to Read Start Date 2017-03-16
Persistent URL http://hdl.handle.net/10536/DRO/DU:30086550

Document type: Journal Article
Collections: School of Medicine
Open Access Collection
Connect to link resolver
 
Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved.

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.

Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 136 times in TR Web of Science
Scopus Citation Count Cited 155 times in Scopus
Google Scholar Search Google Scholar
Access Statistics: 151 Abstract Views, 27 File Downloads  -  Detailed Statistics
Created: Mon, 10 Oct 2016, 08:46:26 EST

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.