Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Therapeutic Treatment With Human Papillomavirus Quadrivalent Vaccine for Recurrent Respiratory Papillomatosis

NCT00829608

Recurrent Respiratory Papillomatosis

WITHDRAWN EARLY_PHASE1

Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*

NCT07339163

Recurrent Respiratory Papillomatosis (RRP)

NOT_YET_RECRUITING PHASE1/PHASE2

4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

NCT01995721

Recurrent Respiratory Papillomatosis

UNKNOWN PHASE3

A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis

NCT00038714

Papilloma Recurrent Respiratory Papillomatosis

COMPLETED PHASE2

Phase II Study of Treatment for HPV16+ ASC-US, ASC-H and LSIL

NCT03911076

ASC-US ASC-H LSIL

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Squamous Papilloma of the Larynx

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaccine Silgard

vaccination with tetravalent antiviral vaccine, 3 doses

Group Type EXPERIMENTAL

Silgard

Intervention Type BIOLOGICAL

vaccination with tetravalent antiviral vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Silgard

vaccination with tetravalent antiviral vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No