PMID- 29126292
OWN - NLM
STAT- MEDLINE
DCOM- 20180518
LR  - 20220317
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 65
IP  - 7
DP  - 2017 Oct 1
TI  - Safety and Immunogenicity of Inactivated Varicella-Zoster Virus Vaccine in Adults 
      With Autoimmune Disease: A Phase 2, Randomized, Double-Blind, Placebo-Controlled 
      Clinical Trial.
PG  - 1174-1182
LID - 10.1093/cid/cix484 [doi]
AB  - BACKGROUND: Immunogenicity and safety of inactivated zoster vaccine (ZVIN) were 
      evaluated in adults with autoimmune disease. METHODS: Adults with autoimmune 
      disease treated with immunosuppressive therapy (biologic or nonbiologic) were 
      randomized to receive 4 doses of ZVIN, ZVIN containing a higher quantity of 
      antigen, or placebo. To measure varicella-zoster virus (VZV)-specific immune 
      responses using glycoprotein enzyme-linked immunosorbent assay (gpELISA) and 
      interferon-gamma enzyme-linked immunospot (IFN-gamma ELISPOT), blood samples were 
      collected at baseline, post-doses 2, 3, and 4. The primary hypothesis was that 
      ZVIN would elicit significant VZV-specific immune responses, measured by gpELISA 
      or ELISPOT, at approximately 28 days post-dose 4. Safety and tolerability was 
      assessed through 28 days post-dose 4. RESULTS: ZVIN elicited a statistically 
      significant VZV-specific immune response approximately 28 days post-dose 4, 
      measured by gpELISA (estimated geometric mean fold rise from baseline [GMFR] = 
      1.6 [95% confidence interval [CI], 1.4,1.7], P value < .0001) and IFN-gamma ELISPOT 
      (estimated GMFR = 2.0 [95% CI, 1.6,2.6], P value < .0001); both results met the 
      prespecified success criterion. Overall, 57% (164/289) of all ZVIN and 21% 
      (13/62) of placebo recipients reported >/=1 injection-site adverse events (AEs), 
      and 52% (149/289) and 47% (29/62) reported >/=1 systemic AEs, respectively. Eight 
      ZVIN and 1 placebo recipients experienced serious AEs, including 2 events (ZVIN 
      group) determined by the investigator to be vaccine related (keratitis; amnesia). 
      Overall frequency of AEs decreased with subsequent doses of vaccine. CONCLUSIONS: 
      In adults with autoimmune disease, ZVIN was well tolerated and elicited 
      statistically significant VZV-specific immune responses approximately 28 days 
      post-dose 4, measured by gpELISA and IFN-gamma ELISPOT. CLINICAL TRIALS REGISTRATION: 
      NCT01527383.
CI  - (c) The Author 2017. Published by Oxford University Press for the Infectious 
      Diseases Society of America. All rights reserved. For permissions, e-mail: 
      journals.permissions@oup.com.
FAU - Eberhardson, Michael
AU  - Eberhardson M
AD  - Karolinska University Hospital, Stockholm, Sweden.
FAU - Hall, Stephen
AU  - Hall S
AD  - Emeritus Research, Malvern, Australia.
FAU - Papp, Kim A
AU  - Papp KA
AD  - Probity Medical Research, Waterloo, Ontario, Canada.
FAU - Sterling, Tina M
AU  - Sterling TM
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Stek, Jon E
AU  - Stek JE
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Pang, Lei
AU  - Pang L
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Zhao, Yanli
AU  - Zhao Y
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Parrino, Janie
AU  - Parrino J
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Popmihajlov, Zoran
AU  - Popmihajlov Z
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
LA  - eng
SI  - ClinicalTrials.gov/NCT01527383
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Antibodies, Viral)
RN  - 0 (Herpes Zoster Vaccine)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antibodies, Viral/immunology
MH  - Autoimmune Diseases/*complications/immunology/virology
MH  - Double-Blind Method
MH  - Herpes Zoster/immunology/*prevention & control
MH  - Herpes Zoster Vaccine/adverse effects/immunology/*therapeutic use
MH  - Herpesvirus 3, Human/*immunology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Vaccines, Inactivated/adverse effects/immunology/therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - immunogenicity
OT  - inactivated herpes zoster vaccine
OT  - safety
OT  - tolerability
OT  - zoster vaccine
EDAT- 2017/11/11 06:00
MHDA- 2018/05/19 06:00
CRDT- 2017/11/11 06:00
PHST- 2017/01/23 00:00 [received]
PHST- 2017/05/30 00:00 [accepted]
PHST- 2017/11/11 06:00 [entrez]
PHST- 2017/11/11 06:00 [pubmed]
PHST- 2018/05/19 06:00 [medline]
AID - 4067376 [pii]
AID - 10.1093/cid/cix484 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2017 Oct 1;65(7):1174-1182. doi: 10.1093/cid/cix484.