HPV vaccine about to be tested in children as young as 1yr old

HPV vaccine about to be tested in children as young as 1yr old
Children ages 1-17yrs old are being considered for a test market of the HPV vaccine for respiratory papillomatosis. According to the Centers for Disease Control and Prevention, the incidence of RRP is rare. Fewer than 2,000 children get RRP each year.
Below is the actual copy of information directly from the clinical trials website.
This study has not started yet.
If you look it says eligible participants are as young as 1yr of age, however the test administer is for infants from 0 to 6months???…..
Please keep up to date as much as you are able. There are so many government sites to keep track of and so much information from every direction. The government agencies do not play well with the concept of informed consent so there is no easy way to locate all the information you wish to dig up and research.
Follow this blog to keep up with HPV related information and the RI mandate of the HPV vaccine.

Trial record 2 of 266 for:    HPV children

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by National Institute of Child Health, Hungary
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
dr. med habil Zsófia Meszner PhD, National Institute of Child Health, Hungary
ClinicalTrials.gov Identifier:
NCT01995721
First received: November 20, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted

  Purpose

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.

Condition Intervention Phase
Recurrent Respiratory

Papillomatosis

Biological: 4-valent

HPV vaccine

Phase 3
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Resource links provided by NLM:
Further study details as provided by National Institute of Child Health, Hungary:

Primary Outcome Measures:

  • Papilloma relapses [ Time Frame: 18 months after the 3rd vaccine ] [ Designated as safety issue: No ]
    Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18–months follow-up period


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4-valent HPV vaccine

4-valent HPV vaccine administered in months 0., 2., 6.
Biological: 4-valent HPV vaccine

Vaccination with 4-valent HPV vaccine in months 0., 2., 6.

Other Names:

  • Silgard
  • Gardasil

Detailed Description:

  1. 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
  2. Immunization with 4-valent HPV vaccine at 0,2,6 months
  3. 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

  Eligibility

Ages Eligible for Study: 1 Year to 17 Years   (Child)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • respiratory papillomatosis
  • at least 3 relapses in patient history
  • HPV 6 and/or 11 positive papillomas
  • able to mount neutralizing antibodies

Exclusion Criteria:

  • other chronic underlying condition
  • other HPV type
  • no antibody response

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995721

Contacts
Contact:

Zsofia Meszner, MD, PhD

+36 1 365 1540 zmeszner@gmail.com

Locations
Hungary
National Institute of Child Health Not yet recruiting
Budapest, Hungary, 1113
Contact: Zsofia Meszner    +36 1 365-1540    zmeszner@gmail.com
Principal Investigator: Zsofia Meszner, MD, PhD
Sponsors and Collaborators
National Institute of Child Health, Hungary
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Zsofia Meszner, MD, PhD National Institute of Child Health

  More Information

Responsible Party: dr. med habil Zsófia Meszner PhD, Professor, National Institute of Child Health, Hungary
ClinicalTrials.gov Identifier: NCT01995721     History of Changes
Other Study ID Numbers: 50934
Study First Received: November 20, 2013
Last Updated: November 20, 2013
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by National Institute of Child Health, Hungary:

recurrent respiratory papillomatosis
human papillomavirus
vaccine
treatment
immunology
relapse

Additional relevant MeSH terms:

Papilloma
Respiratory Tract Infections
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 30, 2016



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