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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01082861
Other study ID # LIS144
Secondary ID 2010-018459-86
Status Terminated
Phase Phase 4
First received March 8, 2010
Last updated March 18, 2010
Start date September 2010
Est. completion date April 2011

Study information

Verified date March 2010
Source National Institute for Public Health and the Environment (RIVM)
Contact n/a
Is FDA regulated No
Health authority Netherlands: Central Committee on Research inv. Human Subjects
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Cervarix
Cervarix, HPV vaccin
Engerix-B
Engerix-B, HBV vaccin

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute for Public Health and the Environment (RIVM)

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2. Month 7 No
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