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

NCT01082861 | Terminated Phase 4

• 2 other identifiers: LIS1442010-018459-86
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Papillomavirus Infection

Keywords

1998 female birth cohort eligible for HPV vaccination in 2011 within the Dutch NIP

Outcome Measures

Primary Outcomes (1)

• Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2.

  Month 7

Study Arms (3)

HPV&HBV vaccin

EXPERIMENTAL

HPV\&HBV vaccin

Biological: Cervarix; Biological: Engerix-B

HPV vaccination

EXPERIMENTAL

HPV vaccination

Biological: Cervarix

HBV vaccination

EXPERIMENTAL

HBV vaccination

Biological: Engerix-B

Interventions

Cervarix BIOLOGICAL

Cervarix, HPV vaccin

HPV vaccination; HPV&HBV vaccin

Engerix-B BIOLOGICAL

Engerix-B, HBV vaccin

HBV vaccination; HPV&HBV vaccin

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Female pre-adolescents born in 1998, eligible for HPV vaccination in 2011.
• Able to fulfill all study requirements.

You may not qualify if:

• Previous vaccination with any licensed or experimental HPV or HBV vaccine.
• Contraindication for vaccination with Cervarix®.
• Contraindication for vaccination with Engerix-B®.
• Use of investigational vaccine or medication within 30 days before study
• History of severe adverse reaction associated with a vaccine or vaccine component.
• Heart disease
• Liver disease
• Spleen removal
• Asthma
• Immune deficiency or suppression

Sponsors & Collaborators

• National Institute for Public Health and the Environment (RIVM): lead

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

human papillomavirus vaccine, L1 type 16, 18; Engerix-B

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 19, 2010

Record last verified: 2010-03