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Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

Phase IIIb Study of Recombinant Tetravalent HPV Vaccine in Patients With Recurrent Respiratory Papillomatosis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01375868
Enrollment
51
Registered
2011-06-17
Start date
2011-10-31
Completion date
2018-12-31
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Papilloma of the Larynx

Keywords

HPV, recurrent respiratory papillomatosis, antibodies

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.

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.

Interventions

BIOLOGICALSilgard

vaccination with tetravalent antiviral vaccine

Sponsors

Medical Healthcom Prague
CollaboratorUNKNOWN
Na Homolce Hospital
CollaboratorOTHER
Ruth Tachezy, PhD.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
occurrence or frequency of recurrences of laryngeal papillomatosis5 yearsThe main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.

Secondary

MeasureTime frameDescription
HPV type present in the tissue2 yearsWe will determine the type of human papillomavirus present in the surgically removed tissue.
the presence of HPV specific antibodies5 yearsWe will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026