Human Papillomavirus InfectionPhase 4TANGONCT01082861
Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination
A Phase 4 study testing Cervarix and Engerix-B in people with Human Papillomavirus Infection, run by National Institute for Public Health and the Environment (RIVM).
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}. Read more about this study
- Who is it for?
- Ages 11 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Cervarix and Engerix-B
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female pre-adolescents born in 1998, eligible for HPV vaccination in 2011.
- Able to fulfill all study requirements.
Who cannot join
- 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
Show all 10Show fewer
- Liver disease
- Spleen removal
- Asthma
- Immune deficiency or suppression
About this study
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}.
Read more
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
- Being tested
- Cervarix, Engerix-B
- Keywords
- 1998 female birth cohort eligible for HPV vaccination in 2011 within the Dutch NIP
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CervarixBiological
Cervarix, HPV vaccin
Engerix-BBiological
Engerix-B, HBV vaccin
| Study group | Role | What they receive |
|---|---|---|
| HPV&HBV vaccin | Experimental | HPV\&HBV vaccin Receives: Biological: Cervarix; Biological: Engerix-B |
| HPV vaccination | Experimental | HPV vaccination Receives: Biological: Cervarix |
| HBV vaccination | Experimental | HBV vaccination Receives: Biological: Engerix-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2.
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: Due to recent strategic policy developments in the national vaccination program it is uncertain preadolescent girls will receive the HBV vaccin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Public Health and the Environment (RIVM)
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082861
- Sponsor's protocol ID
- LIS144
- Other IDs
- 2010-018459-86
- Acronym
- TANGO
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Open Label Clinical Trial to Determine Efficacy and Immunomodulation of Simultaneous HPV/HBV Vaccination Tango-trial)
- ClinicalTrials.gov ID
- NCT01082861
- Acronym / sponsor ID
- TANGO / LIS144
- Conditions
- Human Papillomavirus Infection
- Keywords
- 1998 female birth cohort eligible for HPV vaccination in 2011 within the Dutch NIP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recent strategic policy developments in the national vaccination program it is uncertain preadolescent girls will receive the HBV vaccin.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute for Public Health and the Environment (RIVM)Other government
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HPV&HBV vaccin | Experimental | Biological: Cervarix, Biological: Engerix-BHPV\&HBV vaccin |
| HPV vaccination | Experimental | Biological: CervarixHPV vaccination |
| HBV vaccination | Experimental | Biological: Engerix-BHBV vaccination |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Female pre-adolescents born in 1998, eligible for HPV vaccination in 2011.
- Able to fulfill all study requirements.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CervarixCervarix, HPV vaccin | Biological | HPV vaccination, HPV&HBV vaccin |
| Engerix-BEngerix-B, HBV vaccin | Biological | HBV vaccination, HPV&HBV vaccin |
Primary outcome
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2.
Time frame: Month 7
Results and safety
The study was stopped early (reason given: Due to recent strategic policy developments in the national vaccination program it is uncertain preadolescent girls will receive the HBV vaccin.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervarix and Engerix-B in people with Human Papillomavirus Infection, run by National Institute for Public Health and the Environment (RIVM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to recent strategic policy developments in the national vaccination program it is uncertain preadolescent girls will receive the HBV vaccin.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody seroprotection proportion for HBV in groups 1, 2 and 3 measured in Sample 2. (time frame: Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2010.