Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants

Papillomavirus Res. 2020 Dec:10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.

Abstract

Aim: The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.

Methods: This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.

Results: Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.

Conclusions: Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.

Trial registration: Clinicaltrials. gov: NCT00378560 and NCT00411749.

Keywords: Clinical trial; Injection-site reaction; Japan; Post-hoc analysis; Quadrivalent human papillomavirus (4vHPV) vaccine; Safety.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Alphapapillomavirus / immunology
  • Double-Blind Method
  • Female
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / administration & dosage*
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / adverse effects
  • Humans
  • Injection Site Reaction / etiology*
  • Injections, Intramuscular / adverse effects*
  • Japan
  • Papillomavirus Infections / prevention & control*
  • Vaccination / adverse effects*
  • Young Adult

Substances

  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Associated data

  • ClinicalTrials.gov/NCT00378560
  • ClinicalTrials.gov/NCT00411749