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

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.
 
ClinicalTrials.gov Identifier: NCT01082861
Recruitment Status : Terminated (Due to recent strategic policy developments in the national vaccination program it is uncertain preadolescent girls will receive the HBV vaccin.)
First Posted : March 9, 2010
Last Update Posted : March 19, 2010
Sponsor:
Information provided by:
National Institute for Public Health and the Environment (RIVM)

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 9, 2010
Last Update Posted Date March 19, 2010
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2. [ Time Frame: Month 7 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01082861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination
Official Title  ICMJE A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Human Papillomavirus Infection
Intervention  ICMJE
  • Biological: Cervarix
    Cervarix, HPV vaccin
  • Biological: Engerix-B
    Engerix-B, HBV vaccin
Study Arms  ICMJE
  • Experimental: HPV&HBV vaccin
    HPV&HBV vaccin
    Interventions:
    • Biological: Cervarix
    • Biological: Engerix-B
  • Experimental: HPV vaccination
    HPV vaccination
    Intervention: Biological: Cervarix
  • Experimental: HBV vaccination
    HBV vaccination
    Intervention: Biological: Engerix-B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2010)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2010)
1400
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 11 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01082861
Other Study ID Numbers  ICMJE LIS144
2010-018459-86 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hein Boot, section head LIS, Institute of Public Health and the Environment
Study Sponsor  ICMJE National Institute for Public Health and the Environment (RIVM)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute for Public Health and the Environment (RIVM)
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP