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)

Human Vaccines & Immunotherapeutics
Zoran PopmihajlovEnglish D Willis

Abstract

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. 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 dif...Continue Reading

References

Aug 13, 2004·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Jennifer KatzRobert H Dworkin
Jun 3, 2005·The New England Journal of Medicine·M N OxmanUNKNOWN Shingles Prevention Study Group
May 5, 2010·Annals of Internal Medicine·Michael S SimberkoffUNKNOWN Shingles Prevention Study Group
Jun 17, 2010·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Michael N Oxman
Oct 27, 2011·Journal of Internal Medicine·H F TsengUNKNOWN Vaccine Safety Datalink (VSD) Team
Nov 4, 2011·Human Vaccines·Alexander V MurrayJanie Parrino
Feb 1, 2012·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Kenneth E SchmaderJanie Parrino
Sep 12, 2012·Vaccine·Roger BaxterPatricia Saddier
May 2, 2013·The Journal of Infectious Diseases·Vicki A MorrisonUNKNOWN Shingles Prevention Study Group
Jan 16, 2016·Journal of Korean Medical Science·Won Suk ChoiHee Jin Cheong

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