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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Squamous Papilloma of the Larynx

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

occurrence or frequency of recurrences of laryngeal papillomatosis

Outcome Description:

The main aim is to evaluate the effect of tetravalent HPV vaccine on occurrence or frequency of recurrences of laryngeal papillomatosis.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Ruth Tachezy, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Hematology and Blood Transfusion

Authority:

Czech Republic: State Institute for Drug Control

Study ID:

UHKT-RLP/2011

NCT ID:

NCT01375868

Start Date:

October 2011

Completion Date:

January 2017

Related Keywords:

  • Squamous Papilloma of the Larynx
  • HPV
  • recurrent respiratory papillomatosis
  • antibodies
  • Papilloma
  • Respiratory Tract Infections
  • Papillomavirus Infections

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