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

March 18, 2010 updated by: National Institute for Public Health and the Environment (RIVM)

A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPV&HBV vaccin
Biological: Cervarix
Cervarix, HPV vaccin
Biological: Engerix-B
Engerix-B, HBV vaccin
Experimental: HPV vaccination
Biological: Cervarix
Cervarix, HPV vaccin
Experimental: HBV vaccination
Biological: Engerix-B
Engerix-B, HBV vaccin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2.
Time Frame: Month 7
Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute for Public Health and the Environment (RIVM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIS144
  • 2010-018459-86 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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