PMID- 31325263
OWN - NLM
STAT- MEDLINE
DCOM- 20190815
LR  - 20220409
IS  - 0004-5772 (Print)
IS  - 0004-5772 (Linking)
VI  - 66
IP  - 7
DP  - 2018 Jul
TI  - Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus 
      Vaccine (ZOSTAVAX) in Healthy Adults in India.
PG  - 50-54
AB  - BACKGROUND: Herpes zoster (HZ) is caused by varicella-zoster virus ( VZV ) 
      reactivation. In the United States, Zoster vaccine (ZOSTAVAX) is indicated for HZ 
      prevention in patients >/=50 years. AIMS: To evaluate the immunogenicity, safety, 
      and tolerability of ZOSTAVAX in healthy Indian subjects, to support its 
      registration in India. METHODS: This open-label, single-arm study was conducted 
      at 10 sites in India. Healthy Indians (>/=50 years) received a single ZOSTAVAX 
      dose. Immunogenicity was assessed by VZV-specific antibody titer using gpELISA 
      assay. VZV-specific antibody geometric mean titers (GMT; Day 1 pre-vaccination, 
      Week 6 post-vaccination) and geometric mean fold-rise (GMFR; Week 6 
      post-vaccination) were assessed. Safety was evaluated by the incidence of adverse 
      events (AEs) and serious adverse events (SAEs) within 42 days of vaccination. 
      Two-sided 95% confidence intervals (CIs) were evaluated using t-distribution with 
      natural log-transformed values. RESULTS: Of the 250 subjects (mean age, 58.6 
      years) enrolled and vaccinated, 244 subjects completed the 6-week follow-up. 
      Overall, subjects in the per-protocol population had GMT of 149.8 gpELISA 
      units/mL (n=250; 95% CI: 132.6, 169.2) at Day 1 pre-vaccination, and 410.8 
      gpELISA units/mL (n=243; 95% CI: 373.0, 452.6) at Week 6 post-vaccination. GMFR 
      of VZV-specific antibody from Day 1 pre-vaccination to Week 6 post-vaccination 
      was 2.8 (95% CI: 2.5, 3.1). Overall, 67 subjects (26.8%) experienced AEs, with 48 
      (19.2%) reporting injection-site AEs and 38 (15.2%) reporting non-injection-site 
      AEs. SAE-abdominal pain and bronchitis-was reported in one (0.4%) patient each. 
      There was one death, which was unrelated to the vaccine. LIMITATIONS: Since 
      ZOSTAVAX introduces a new live attenuated virus, clinical reactivation of 
      ZOSTAVAX virus and wild-type VZV will need to be differentiated. CONCLUSIONS: In 
      healthy Indians >/=50 years, ZOSTAVAX was well tolerated and resulted in expected 
      VZV-specific antibody titer levels at 6 weeks post-vaccination.
CI  - (c) Journal of the Association of Physicians of India 2011.
FAU - Sreenivasamurthy, L
AU  - Sreenivasamurthy L
AD  - Lifecare Clinic and Research Center, Bangalore, Karnataka;Corresponding Author.
FAU - Pandey, Sudhanshu
AU  - Pandey S
AD  - MSD, Mumbai, Maharashtra.
FAU - Chandra, Bharija Subhash
AU  - Chandra BS
AD  - Department of Dermatology, Sir Ganga Ram Hospital, New Delhi.
FAU - Sharma, Monisha
AU  - Sharma M
AD  - MSD, Mumbai, Maharashtra.
FAU - Ranganathaiah, S R
AU  - Ranganathaiah SR
AD  - Mysore Clinisearch, Gopal Gowda Shanthaveri Memorial Hospital Campus, Mysore, 
      Karnataka.
FAU - Vaidya, P
AU  - Vaidya P
AD  - Department of Dermatology, Jehangir Clinical Development Centre Pvt Ltd, Pune, 
      Maharashtra.
FAU - Naik, Rajiv
AU  - Naik R
AD  - Ketki Hospital, Aurangabad,Maharashtra.
LA  - eng
PT  - Journal Article
PL  - India
TA  - J Assoc Physicians India
JT  - The Journal of the Association of Physicians of India
JID - 7505585
RN  - 0 (Antibodies, Viral)
RN  - 0 (Herpes Zoster Vaccine)
MH  - Adult
MH  - Antibodies, Viral
MH  - *Herpes Zoster
MH  - *Herpes Zoster Vaccine
MH  - Herpesvirus 3, Human
MH  - Humans
MH  - India
MH  - Middle Aged
EDAT- 2019/07/22 06:00
MHDA- 2019/08/16 06:00
CRDT- 2019/07/21 06:00
PHST- 2019/07/21 06:00 [entrez]
PHST- 2019/07/22 06:00 [pubmed]
PHST- 2019/08/16 06:00 [medline]
PST - ppublish
SO  - J Assoc Physicians India. 2018 Jul;66(7):50-54.