Safety and Immunogenicity of a Nonadjuvant Human Papillomavirus Type 6 Virus-like Particle Vaccine in Recurrent Respiratory Papillomatosis

J Voice. 2019 May;33(3):363-369. doi: 10.1016/j.jvoice.2017.12.002. Epub 2018 Sep 14.

Abstract

Objectives: To assess the safety and immunogenicity of a nonadjuvant human papillomavirus (HPV) type 6 L1 virus-like particle (VLP) vaccine in recurrent respiratory papillomatosis (RRP) in local Chinese patients.

Methods: Patients with RRP who had undergone surgical treatment before intramuscular administration of an escalating dose of HPV type 6 L1 VLPs (1, 5, and 25 µg at 4 weekly intervals) as part of their treatment were followed up for more than 10 years. Efficacy was assessed by detecting the vaccine-induced type-specific antibody titer, calculating the intersurgical interval, and observing recurrence or remission of papillomas after receiving the vaccine.

Results: Nonadjuvant HPV vaccine was generally well tolerated, with no serious vaccine-related adverse episodes. It induced seroconversion for each vaccine-related HPV type. At week 12 (4 weeks after injecting 25 µg), the vaccine-induced type-specific antibody titer was significantly high. Analysis of all patients found a significant increase in the intersurgical interval and decrease in the scores. One patient (16.7%; female) experienced complete remission. Five patients (83.3%) (two males and three females) experienced partial remission. In total, complete or partial remission was achieved in six (100%) patients.

Conclusions: Administration of nonadjuvant HPV type 6 L1 VLPs vaccine to RRP was generally well tolerated and highly immunogenic.

Keywords: Adjuvant therapy; HPV vaccine; Recurrent respiratory papilloma; Treatment; VLP.

MeSH terms

  • Adolescent
  • Antibodies, Viral / blood*
  • Biomarkers / blood
  • Capsid Proteins / administration & dosage*
  • Capsid Proteins / adverse effects
  • Capsid Proteins / immunology
  • Child
  • China
  • Clinical Trials, Phase I as Topic
  • Female
  • Human papillomavirus 6 / immunology*
  • Humans
  • Immunogenicity, Vaccine*
  • Male
  • Papillomavirus Infections / diagnosis
  • Papillomavirus Infections / immunology
  • Papillomavirus Infections / therapy*
  • Papillomavirus Infections / virology
  • Papillomavirus Vaccines / administration & dosage*
  • Papillomavirus Vaccines / adverse effects
  • Papillomavirus Vaccines / immunology
  • Remission Induction
  • Respiratory Tract Infections / diagnosis
  • Respiratory Tract Infections / immunology
  • Respiratory Tract Infections / therapy*
  • Respiratory Tract Infections / virology
  • Retrospective Studies
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vaccines, Virus-Like Particle / administration & dosage*
  • Vaccines, Virus-Like Particle / adverse effects
  • Vaccines, Virus-Like Particle / immunology

Substances

  • Antibodies, Viral
  • Biomarkers
  • Capsid Proteins
  • Papillomavirus Vaccines
  • Vaccines, Virus-Like Particle
  • L1 protein, Human papillomavirus type 6

Supplementary concepts

  • Recurrent respiratory papillomatosis