Squamous Papilloma of the Larynx Clinical Trial
Official title:
Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis
| Verified date | January 2019 |
| Source | Institute of Hematology and Blood Transfusion, Czech Republic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Institute of Hematology and Blood Transfusion | Prague |
| Lead Sponsor | Collaborator |
|---|---|
| Ruth Tachezy, PhD. | Medical Healthcom Prague, Na Homolce Hospital |
Czechia,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | occurrence or frequency of recurrences of laryngeal papillomatosis | The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis. | 5 years | |
| Secondary | HPV type present in the tissue | We will determine the type of human papillomavirus present in the surgically removed tissue. | 2 years | |
| Secondary | the presence of HPV specific antibodies | We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination. | 5 years |