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

NCT ID: NCT01995721

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-02-28

Brief Summary

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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

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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

Conditions

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Recurrent Respiratory Papillomatosis

Keywords

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recurrent respiratory papillomatosis human papillomavirus vaccine treatment immunology relapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4-valent HPV vaccine

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

Group Type EXPERIMENTAL

4-valent HPV vaccine

Intervention Type BIOLOGICAL

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

Interventions

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4-valent HPV vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Silgard Gardasil

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

National Institute of Child Health, Hungary

OTHER

Sponsor Role lead

Responsible Party

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dr. med habil Zsófia Meszner PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zsofia Meszner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Child Health

Locations

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National Institute of Child Health

Budapest, , Hungary

Site Status

Countries

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Hungary

Central Contacts

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Zsofia Meszner, MD, PhD

Role: CONTACT

Phone: +36 1 365 1540

Email: [email protected]

Facility Contacts

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Zsofia Meszner

Role: primary

Other Identifiers

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50934

Identifier Type: -

Identifier Source: org_study_id