PMID- 35005428
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220111
IS  - 2515-1355 (Print)
IS  - 2515-1363 (Electronic)
IS  - 2515-1355 (Linking)
VI  - 9
DP  - 2021
TI  - Safety and reactogenicity of the adjuvanted recombinant zoster vaccine: 
      experience from clinical trials and post-marketing surveillance.
PG  - 25151355211057479
LID - 10.1177/25151355211057479 [doi]
LID - 25151355211057479
AB  - An adjuvanted recombinant zoster vaccine (RZV) is licensed for the prevention of 
      herpes zoster. This paper reviews its safety and reactogenicity. A pooled 
      analysis of two pivotal randomized Phase-3 trials (NCT01165177, NCT01165229) in 
      adults ⩾50 years found that more solicited adverse events (AEs) were reported 
      with RZV than placebo. Injection site pain was the most common solicited AE (RZV: 
      78.0% participants; placebo: 10.9%). Grade-3 pain occurred in 6.4% of RZV and 
      0.3% of placebo recipients. Myalgia, fatigue, and headache were the most commonly 
      reported general solicited AEs (RZV: 44.7%, 44.5%, and 37.7%, respectively; 
      placebo: 11.7%, 16.5%, and 15.5%, respectively). Most symptoms were mild to 
      moderate in intensity with a median duration of 2-3 days. The intensity of 
      reactogenicity symptoms did not differ substantially after the first and second 
      vaccine doses. The pooled analysis of the pivotal Phase-3 trials did not identify 
      any clinically relevant differences in the overall incidence of serious adverse 
      events (SAEs), fatal AEs or potential immune-mediated diseases (pIMDs) between 
      RZV and placebo. Reactogenicity in five studies of immunocompromised patients ⩾18 
      years (autologous stem cell transplant, human immunodeficiency virus, solid 
      tumors, hematological malignancies, and renal transplant; NCT01610414, 
      NCT01165203, NCT01798056, NCT01767467, and NCT02058589) was consistent with that 
      observed in the pivotal Phase-3 trials. There were no clinically relevant 
      differences between RZV and placebo in the immunocompromised populations with 
      regard to overall incidence of SAEs, fatal AEs, pIMDs, or AEs related to 
      patients' underlying condition. Post-marketing surveillance found that the most 
      commonly reported AEs were consistent with the reactogenicity profile of the 
      vaccine in clinical trials. Overall, the clinical safety data for RZV are 
      reassuring.
CI  - (c) The Author(s), 2021.
FAU - Fiore, Joseph
AU  - Fiore J
AUID- ORCID: 0000-0003-0591-1877
AD  - GSK, Philadelphia, PA 19112, USA.
FAU - Co-van der Mee, Maribel Miranda
AU  - Co-van der Mee MM
AD  - GSK, Wavre, Belgium.
FAU - Maldonado, Andres
AU  - Maldonado A
AD  - ViiV Healthcare, Wavre, Belgium.
FAU - Glasser, Lisa
AU  - Glasser L
AD  - Former affiliation: GSK, Philadelphia, PA, USA.
FAU - Watson, Phil
AU  - Watson P
AD  - GSK, Brentford, UK.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20211130
PL  - England
TA  - Ther Adv Vaccines Immunother
JT  - Therapeutic advances in vaccines and immunotherapy
JID - 101718382
PMC - PMC8734271
OTO - NOTNLM
OT  - clinical trial
OT  - reactogenicity
OT  - real-world
OT  - safety
OT  - zoster vaccine
COIS- Conflict of interest statement: The authors declared the following potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: AM, JF, MC, and PW are employed by the GSK group of 
      companies. AM, JF, and PW hold shares in the GSK group of companies. LG was 
      employed by the GSK group of companies at the moment of the study and is now 
      employed by AstraZeneca. The authors declare no other financial and non-financial 
      relationships and activities.
EDAT- 2022/01/11 06:00
MHDA- 2022/01/11 06:01
PMCR- 2021/11/30
CRDT- 2022/01/10 09:32
PHST- 2021/05/12 00:00 [received]
PHST- 2021/10/15 00:00 [accepted]
PHST- 2022/01/10 09:32 [entrez]
PHST- 2022/01/11 06:00 [pubmed]
PHST- 2022/01/11 06:01 [medline]
PHST- 2021/11/30 00:00 [pmc-release]
AID - 10.1177_25151355211057479 [pii]
AID - 10.1177/25151355211057479 [doi]
PST - epublish
SO  - Ther Adv Vaccines Immunother. 2021 Nov 30;9:25151355211057479. doi: 
      10.1177/25151355211057479. eCollection 2021.