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OpenTrials
Completed

NCT Number: NCT01375868

Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

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.

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Key information

Conditions

Squamous Papilloma of the Larynx Laryngeal papillomatosis Recurrent respiratory papillomatosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Hematology and Blood Transfusion

Prague, 128 20, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silgard

Biological

vaccination with tetravalent antiviral vaccine

Primary outcomes

  1. occurrence or frequency of recurrences of laryngeal papillomatosis

    Time frame: 5 years

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

Secondary outcomes

  1. HPV type present in the tissue

    Time frame: 2 years

    We will determine the type of human papillomavirus present in the surgically removed tissue.

  2. the presence of HPV specific antibodies

    Time frame: 5 years

    We will evaluate the presence of HPV-specific antibodies in sera of patients with recurrent papillomatosis before and after vaccination.

Sponsors and collaborators

Lead sponsor

Ruth Tachezy, PhD.

Other

Collaborators

  • Medical Healthcom Prague
  • Na Homolce Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2011
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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