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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01995721
Other study ID # 50934
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received November 20, 2013
Last updated November 20, 2013
Start date February 2014
Est. completion date February 2017

Study information

Verified date November 2013
Source National Institute of Child Health, Hungary
Contact Zsofia Meszner, MD, PhD
Phone +36 1 365 1540
Email zmeszner@gmail.com
Is FDA regulated No
Health authority Hungary: National Institute of Pharmacy
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 17 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hungary National Institute of Child Health Budapest

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Child Health, Hungary Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Papilloma relapses Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period 18 months after the 3rd vaccine No
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