Human Papillomavirus Infection Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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