PMID- 30024827
OWN - NLM
STAT- MEDLINE
DCOM- 20191021
LR  - 20231005
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 14
IP  - 12
DP  - 2018
TI  - A post hoc analysis utilizing the FDA toxicity grading scale to assess injection 
      site adverse events following immunization with the live attenuated Zoster 
      Vaccine (ZVL).
PG  - 2916-2920
LID - 10.1080/21645515.2018.1502517 [doi]
AB  - BACKGROUND: ZOSTAVAX (ZVL; Zoster Virus Live), is a single dose, live, attenuated 
      vaccine licensed for the prevention of herpes zoster (HZ) and post herpetic 
      neuralgia (PHN) in adults >/=50 years of age. Injection site adverse events (AEs) 
      of erythema, swelling and pain were solicited within 5 days post vaccination in 
      the 2 pivotal studies of ZVL; ZEST (ZOSTAVAX Efficacy and Safety Trial) and SPS 
      (Shingles Prevention Study). Protocol specified criteria were used to report the 
      frequency and intensity of injection site AEs in ZEST and SPS studies. 
      Subsequently, the FDA Toxicity Grading Scale provided guidance for uniform 
      assessment of AEs across all adult vaccine clinical trials. The objective of this 
      post-hoc analysis was to categorize the previously reported injection site AEs in 
      two pivotal trials of ZVL according to the current FDA Toxicity Grading Scale. 
      METHODS: The current FDA Toxicity Grading Scale provides a measure for 
      classifying injection site AEs by four grades [Grade 1 (mild); Grade 2 
      (moderate); Grade 3 (severe) and Grade 4 (life threatening)]. Injection site 
      erythema, swelling, and pain intensity gradings were assigned to the respective 
      FDA Toxicity Grade based on this appropriation. A descriptive analysis of the 
      proportion and risk difference (within 95% confidence intervals) of injection 
      site AEs per the FDA Toxicity Grading Scale is provided. RESULTS: The frequency 
      of injection site AEs (erythema, swelling, pain) after subcutaneous vaccination 
      with ZVL were higher in recipients of ZVL compared with placebo. Majority of the 
      injection site AEs observed were Grade 1 (mild) or Grade 2 (moderate) in 
      intensity. Additionally, Grade 3 (severe) injection site AEs were observed 
      infrequently. CONCLUSIONS: Application of the FDA Toxicity Grading Scale provides 
      a uniform AE assessment tool across different adult vaccines. This post hoc 
      summary of injection site AEs using FDA Toxicity Grading Scale provides further 
      evidence of low frequency of severe injection site AEs post ZVL vaccination.
FAU - Popmihajlov, Zoran
AU  - Popmihajlov Z
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
FAU - Pang, Lei
AU  - Pang L
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
FAU - Brown, Elizabeth
AU  - Brown E
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
FAU - Joshi, Amita
AU  - Joshi A
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
FAU - Su, Shu-Chih
AU  - Su SC
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
FAU - Kaplan, Susan S
AU  - Kaplan SS
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
FAU - Willis, English D
AU  - Willis ED
AD  - a Merck Research Laboratories , Merck & Co., Inc , Kenilworth , NJ , USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180905
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Herpes Zoster Vaccine)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Aged
MH  - Edema/chemically induced
MH  - Erythema/chemically induced
MH  - Herpes Zoster/prevention & control
MH  - Herpes Zoster Vaccine/*administration & dosage/*adverse effects/standards
MH  - Herpesvirus 3, Human
MH  - Humans
MH  - Immunization/*adverse effects/standards
MH  - Injection Site Reaction/*immunology/physiopathology
MH  - Injections/methods/standards
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/immunology/physiopathology
MH  - Pain/chemically induced
MH  - United States
MH  - United States Food and Drug Administration
MH  - Vaccination/adverse effects/standards
MH  - Vaccines, Attenuated/*administration & dosage/*adverse effects
PMC - PMC6343633
OTO - NOTNLM
OT  - Herpes Zoster
OT  - Shingles
OT  - Zoster vaccine
OT  - safety
OT  - severe adverse events
EDAT- 2018/07/20 06:00
MHDA- 2019/10/23 06:00
PMCR- 2019/09/05
CRDT- 2018/07/20 06:00
PHST- 2018/07/20 06:00 [pubmed]
PHST- 2019/10/23 06:00 [medline]
PHST- 2018/07/20 06:00 [entrez]
PHST- 2019/09/05 00:00 [pmc-release]
AID - 1502517 [pii]
AID - 10.1080/21645515.2018.1502517 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2018;14(12):2916-2920. doi: 10.1080/21645515.2018.1502517. 
      Epub 2018 Sep 5.