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Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medical Healthcom Prague
Na Homolce Hospital
Information provided by (Responsible Party):
Ruth Tachezy, PhD., Institute of Hematology and Blood Transfusion, Czech Republic
ClinicalTrials.gov Identifier:
NCT01375868
First received: June 16, 2011
Last updated: October 9, 2013
Last verified: October 2013
History of Changes
  Purpose

Vaccines against human papillomaviruses are now commercially available. One of the commercial vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP. Clinical trials have documented the safety and immunogenicity of this vaccine as well as its effectiveness in prevention of incident and persistent infection of the vaccinal types as well as a development of lesions caused by these types. After vaccination the antibodies level increases dramatically and the high levels of antibodies are present in the blood still after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been detected in the cervical mucus of vaccinated women. The preliminary data are now available showing the presence of HPV-specific antibodies in the oral cavity in women after vaccination. The level of antibodies has been dependent on time since vaccination.


Condition Intervention Phase
Squamous Papilloma of the Larynx
 Biological: Silgard
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Hematology and Blood Transfusion, Czech Republic:

Primary Outcome Measures:
  • occurrence or frequency of recurrences of laryngeal papillomatosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.


Secondary Outcome Measures:
  • HPV type present in the tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will determine the type of human papillomavirus present in the surgically removed tissue.

  • the presence of HPV specific antibodies [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination.
Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine Silgard
vaccination with tetravalent antiviral vaccine, 3 doses
 Biological: Silgard
vaccination with tetravalent antiviral vaccine

Detailed Description:

In our previous studies we have documented that in patients with RRP the level of HPV-specific antibodies is low and increases only after numerous surgery procedures. Therefore the application of this vaccine to patients with RRP can stimulate increased level of antibodies in the blood as well as presence of virus-specific neutralization antibodies on the surface of upper aero digestive tract and neutralize viruses shed from new papillomas and in this way protect patient from spreading of the infection as well as to facilitate the decrease of load of infectious virus shed from the lesion. This can possibly lead to the inhibition of growth of the papillomatous lesion.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with RRP which sign the informed consent form with both parts of the study will be enrolled.

Exclusion Criteria:

Patients who experience severe side effects of vaccination after the first or second dose will not be vaccinated with the third dose and they will be excluded from the study. Patients who will not receive all three doses within one year and 30 days will be also excluded.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375868

Locations
Czech Republic
Institute of Hematology and Blood Transfusion
Prague, Czech Republic, 128 20
Sponsors and Collaborators
Ruth Tachezy, PhD.
Medical Healthcom Prague
Na Homolce Hospital
Investigators
Principal Investigator: Ruth Tachezy, PhD. Institute of Hematology and Blood Transfusion
  More Information

Publications:

Responsible Party: Ruth Tachezy, PhD., M.Sc., PhD., Institute of Hematology and Blood Transfusion, Czech Republic
ClinicalTrials.gov Identifier: NCT01375868     History of Changes
Other Study ID Numbers: UHKT-RLP/2011, 2011-002667-14
Study First Received: June 16, 2011
Last Updated: October 9, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Institute of Hematology and Blood Transfusion, Czech Republic:
HPV
recurrent respiratory papillomatosis
antibodies

Additional relevant MeSH terms:
Papillomavirus Infections
Respiratory Tract Infections
DNA Virus Infections
Infection
 Respiratory Tract Diseases
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015