Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

• ClinicalTrials.gov Identifier: NCT01375868
• Recruitment Status: Completed
• First Posted: June 17, 2011
• Last Update Posted: January 9, 2019
• Sponsor: Ruth Tachezy, PhD.
• Collaborators: Medical Healthcom Prague; Na Homolce Hospital
• Information provided by (Responsible Party): Ruth Tachezy, PhD., Institute of Hematology and Blood Transfusion, Czech Republic

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)
• Actual Enrollment: 51 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: December 2018

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Czechia

Institute of Hematology and Blood Transfusion

Prague, Czechia, 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:

Tachezy R, Hamsikova E, Valvoda J, Van Ranst M, Betka J, Burk RD, Vonka V. Antibody response to a synthetic peptide derived from the human papillomavirus type 6/11 L2 protein in recurrent respiratory papillomatosis: correlation between Southern blot hybridization, polymerase chain reaction, and serology. J Med Virol. 1994 Jan;42(1):52-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Smahelova J, Hamsikova E, Ludvikova V, Vydrova J, Traboulsi J, Vencalek O, Lukeš P, Tachezy R. Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jun 2. doi: 10.1001/jamaoto.2022.1190. [Epub ahead of print]

• Responsible Party: Ruth Tachezy, PhD., M.Sc., PhD., Institute of Hematology and Blood Transfusion, Czech Republic
• ClinicalTrials.gov Identifier: NCT01375868
• Other Study ID Numbers: UHKT-RLP/2011; 2011-002667-14 ( EudraCT Number )
• First Posted: June 17, 2011
• Last Update Posted: January 9, 2019
• Last Verified: January 2019

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

HPV; recurrent respiratory papillomatosis; antibodies

Additional relevant MeSH terms:

Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Infections; Respiratory Tract Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections