Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination
NCT ID: NCT01082861
Last Updated: 2010-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
INTERVENTIONAL
2010-09-30
2011-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HPV&HBV vaccin
HPV\&HBV vaccin
Cervarix
Cervarix, HPV vaccin
Engerix-B
Engerix-B, HBV vaccin
HPV vaccination
HPV vaccination
Cervarix
Cervarix, HPV vaccin
HBV vaccination
HBV vaccination
Engerix-B
Engerix-B, HBV vaccin
Interventions
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Cervarix
Cervarix, HPV vaccin
Engerix-B
Engerix-B, HBV vaccin
Eligibility Criteria
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Inclusion Criteria
2. Able to fulfill all study requirements.
Exclusion Criteria
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
11 Years
12 Years
FEMALE
Yes
Sponsors
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National Institute for Public Health and the Environment (RIVM)
OTHER_GOV
Responsible Party
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Institute of Public Health and the Environment
Other Identifiers
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2010-018459-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LIS144
Identifier Type: -
Identifier Source: org_study_id
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