NCT01375868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

7.2 years

First QC Date

June 16, 2011

Last Update Submit

January 7, 2019

Conditions

Squamous Papilloma of the Larynx

Keywords

HPVrecurrent respiratory papillomatosisantibodies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • HPV type present in the tissue

    2 years

  • the presence of HPV specific antibodies

    5 years

Study Arms (1)

Vaccine Silgard

EXPERIMENTAL

vaccination with tetravalent antiviral vaccine, 3 doses

Biological: Silgard

Interventions

SilgardBIOLOGICAL

vaccination with tetravalent antiviral vaccine

Vaccine Silgard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology and Blood Transfusion

Prague, 128 20, Czechia

Location

Related Publications (2)

  • 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. doi: 10.1002/jmv.1890420111.

    PMID: 8308521BACKGROUND

  • Smahelova J, Hamsikova E, Ludvikova V, Vydrova J, Traboulsi J, Vencalek O, Lukes P, Tachezy R. Outcomes After Human Papillomavirus Vaccination in Patients With Recurrent Respiratory Papillomatosis: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):654-661. doi: 10.1001/jamaoto.2022.1190.

    PMID: 35653138DERIVED

MeSH Terms

Conditions

Laryngeal papillomatosisRecurrent respiratory papillomatosis

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • Ruth Tachezy, PhD.

    Institute of Hematology and Blood Transfusion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.Sc., PhD.

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 17, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

CZ(1)