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Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01375868
Recruitment Status : Active, not recruiting
First Posted : June 17, 2011
Last Update Posted : September 5, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Squamous Papilloma of the Larynx Biological: Silgard Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis
Study Start Date : October 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vaccine Silgard
vaccination with tetravalent antiviral vaccine, 3 doses
Biological: Silgard
vaccination with tetravalent antiviral vaccine

Outcome Measures

Primary Outcome Measures :
  1. occurrence or frequency of recurrences of laryngeal papillomatosis [ Time Frame: 5 years ]
    The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.

Secondary Outcome Measures :
  1. HPV type present in the tissue [ Time Frame: 2 years ]
    We will determine the type of human papillomavirus present in the surgically removed tissue.

  2. the presence of HPV specific antibodies [ Time Frame: 5 years ]
    We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375868

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
Principal Investigator: Ruth Tachezy, PhD. Institute of Hematology and Blood Transfusion
More Information

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 ( EudraCT Number )
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Keywords provided by Ruth Tachezy, PhD., Institute of Hematology and Blood Transfusion, Czech Republic:
recurrent respiratory papillomatosis

Additional relevant MeSH terms:
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Immunologic Factors
Physiological Effects of Drugs