Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT01082861
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.
Study:
NCT01082861
Study Brief:
Protocol Section:
NCT01082861