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Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination (TANGO)

This study has been terminated.
(Due to recent strategic policy developments in the national vaccination program it is uncertain preadolescent girls will receive the HBV vaccin.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082861
First Posted: March 9, 2010
Last Update Posted: March 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute for Public Health and the Environment (RIVM)
  Purpose

Rationale:

In march 2009 the Dutch Health Council advised to introduce general infant hepatitis B (HBV) vaccination in the Dutch national immunization program (NIP) {Gezondheidsraad 2009 #16914}. To reach the anticipated health benefits earlier, a catch-up vaccination in pre-adolescents should complement the program, for girls preferably combined with human papillomavirus (HPV) vaccination at the age of 12 years. Although the rationale is clear, particular aspects of combining HPV and HBV vaccination deserve further attention, especially as it has been shown that combining HPV and HBV vaccination results in reduced HBV immunogenicity/seroresponses {Wheeler, Bautista, et al. 2008 #17284}{Pedersen 2009 #16684}. The reason for this interference is unknown, but might be due to concomitant use of different antigens and/or adjuvants, possibly skewing immunity in opposite directions. Despite proven immunostimulatory effects, the use of (new) adjuvants has raised safety concern among the general public as well {Israeli, Agmon-Levin, et al. 2009 #16924}.

Objective, Study design and Study population:

In view of the observations and concerns mentioned above, further investigation into interference of HPV and HBV vaccination and adjuvant use is justified. In this context RIVM propose to study single vs simultaneous HBV and HPV vaccination in 11-12-year-old girls while monitoring antigen-related and antigen-unrelated immunological parameters. The anticipated results will elucidate the extent of interference between simultaneous HPV and HBV vaccination in the target group, and guide the choice for a HBV vaccine and schedule when the HBV catch-up program is indeed introduced. Furthermore, specific immunological trends post single and combined HPV and HBV vaccination will be elucidated, increasing the investigators comprehension of adjuvant use.


Condition Intervention Phase
Human Papillomavirus Infection Biological: Cervarix Biological: Engerix-B Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)

Further study details as provided by National Institute for Public Health and the Environment (RIVM):

Primary Outcome Measures:
  • Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2. [ Time Frame: Month 7 ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPV&HBV vaccin
HPV&HBV vaccin
Biological: Cervarix
Cervarix, HPV vaccin
Biological: Engerix-B
Engerix-B, HBV vaccin
Experimental: HPV vaccination
HPV vaccination
Biological: Cervarix
Cervarix, HPV vaccin
Experimental: HBV vaccination
HBV vaccination
Biological: Engerix-B
Engerix-B, HBV vaccin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female pre-adolescents born in 1998, eligible for HPV vaccination in 2011.
  2. Able to fulfill all study requirements.

Exclusion Criteria:

  1. Previous vaccination with any licensed or experimental HPV or HBV vaccine.
  2. Contraindication for vaccination with Cervarix®.
  3. Contraindication for vaccination with Engerix-B®.
  4. Use of investigational vaccine or medication within 30 days before study
  5. History of severe adverse reaction associated with a vaccine or vaccine component.
  6. Heart disease
  7. Liver disease
  8. Spleen removal
  9. Asthma
  10. Immune deficiency or suppression
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Hein Boot, section head LIS, Institute of Public Health and the Environment
ClinicalTrials.gov Identifier: NCT01082861     History of Changes
Other Study ID Numbers: LIS144
2010-018459-86 ( EudraCT Number )
First Submitted: March 8, 2010
First Posted: March 9, 2010
Last Update Posted: March 19, 2010
Last Verified: March 2010

Keywords provided by National Institute for Public Health and the Environment (RIVM):
1998 female birth cohort eligible for HPV vaccination in 2011 within the Dutch NIP

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs