Recurrent Respiratory PapillomatosisPhase 3NCT01995721
4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children
A Phase 3 study testing 4-valent HPV vaccine in people with Recurrent Respiratory Papillomatosis, run by National Institute of Child Health, Hungary at 1 site in Hungary.
Trial summary
Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Recurrent Respiratory Papillomatosis
- What is being tested?
- 4-valent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- Feb 2014to Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- respiratory papillomatosis
- at least 3 relapses in patient history
- HPV 6 and/or 11 positive papillomas
- able to mount neutralizing antibodies
Who cannot join
- other chronic underlying condition
- other HPV type
- no antibody response
Trial locations and contacts
1 site in 1 country.
Hungary1 site
National Institute of Child Health
Budapest, 1113
Zsofia Meszner, +36 1 365-1540, zmeszner@gmail.com
Zsofia Meszner, MD, PhD
About this study
Official title: Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children
Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.
After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.
Read the detailed description
- Enrollment
- ear-nose-throat (ENT) examination + oesophagoscopy
- immunological assessment
- assessment of selected humoral (antibodies) and
- cellular immune response parameters(INF gamma and granzyme B testing)
- in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
- Immunization with 4-valent HPV vaccine at 0,2,6 months
- Follow up
- 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
- 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy
- Conditions
- Recurrent Respiratory Papillomatosis
- Being tested
- 4-valent HPV vaccine
- Keywords
- recurrent respiratory papillomatosis, human papillomavirus, vaccine, treatment, immunology, relapse
- Medical subject headings
- Recurrent respiratory papillomatosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-valent HPV vaccineBiological
Also called Silgard, Gardasil
Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
| Study group | Role | What they receive |
|---|---|---|
| 4-valent HPV vaccine | Experimental | 4-valent HPV vaccine administered in months 0., 2., 6. Receives: Biological: 4-valent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilloma relapses
Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period
Measured: 18 months after the 3rd vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Respiratory PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Child Health, Hungary
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary
- Investigators
- Zsofia Meszner, MD, PhD, Principal investigator, National Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995721
- Sponsor's protocol ID
- 50934
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children
- ClinicalTrials.gov ID
- NCT01995721
- Acronym / sponsor ID
- 50934
- Conditions
- Recurrent Respiratory Papillomatosis
- Keywords
- recurrent respiratory papillomatosis, human papillomavirus, vaccine, treatment, immunology, relapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Institute of Child Health, HungaryUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.
After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.
Detailed description
- Enrollment
- ear-nose-throat (ENT) examination + oesophagoscopy
- immunological assessment
- assessment of selected humoral (antibodies) and
- cellular immune response parameters(INF gamma and granzyme B testing)
- in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
- Immunization with 4-valent HPV vaccine at 0,2,6 months
- Follow up
- 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
- 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-valent HPV vaccine | Experimental | Biological: 4-valent HPV vaccine4-valent HPV vaccine administered in months 0., 2., 6. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- respiratory papillomatosis
- at least 3 relapses in patient history
- HPV 6 and/or 11 positive papillomas
- able to mount neutralizing antibodies
Key exclusion criteria (3 listed)
- other chronic underlying condition
- other HPV type
- no antibody response
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-valent HPV vaccineAlso: Silgard, GardasilVaccination with 4-valent HPV vaccine in months 0., 2., 6. | Biological | 4-valent HPV vaccine |
Primary outcome
Papilloma relapses
Time frame: 18 months after the 3rd vaccine
Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zsofia Meszner, MD, PhD principal investigator
National Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4-valent HPV vaccine in people with Recurrent Respiratory Papillomatosis, run by National Institute of Child Health, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zsofia Meszner, MD, PhD (+36 1 365 1540, zmeszner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Papilloma relapses (time frame: 18 months after the 3rd vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.