4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01995721

Enrollment

Registered

2013-11-27

Start date

2014-02-28

Completion date

2017-02-28

Last updated

2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Respiratory Papillomatosis

Keywords

recurrent respiratory papillomatosis, human papillomavirus, vaccine, treatment, immunology, relapse

Brief summary

Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process. After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

Detailed description

1. Enrollment * ear-nose-throat (ENT) examination + oesophagoscopy * immunological assessment * assessment of selected humoral (antibodies) and * cellular immune response parameters(INF gamma and granzyme B testing) * in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine 2. Immunization with 4-valent HPV vaccine at 0,2,6 months 3. Follow up * 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase) * 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy

Interventions

BIOLOGICAL4-valent HPV vaccine

Vaccination with 4-valent HPV vaccine in months 0., 2., 6.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

Inclusion criteria

* respiratory papillomatosis * at least 3 relapses in patient history * HPV 6 and/or 11 positive papillomas * able to mount neutralizing antibodies

Exclusion criteria

* other chronic underlying condition * other HPV type * no antibody response

Design outcomes

Primary

Measure	Time frame	Description
Papilloma relapses	18 months after the 3rd vaccine	Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period

Countries

Hungary

Contacts

Primary ContactZsofia Meszner, MD, PhD

zmeszner@gmail.com+36 1 365 1540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026