Primary objective: To obtain insight into signature of immune responses triggered by a bivalent- or nonavalent HPV vaccination (three-dose schedule). Secondary objectives: To determine the most informative time-points to study different innate and…
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Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To obtain insight into signature of immune responses triggered by a bivalent-
or nonavalent HPV vaccination (three-dose schedule).
Detailed analysis of innate and adaptive immune cells and their kinetics over
time will be performed by the means of flow cytometry. In addition, a flow
cytometry-based approach will be developed to identify antigen-specific memory
B cells and plasma cells prior to analysis of their immunoglobulin receptors by
means of high throughput sequencing.
Secondary outcome
To determine the most informative time-points to study different innate and
adaptive immune subsets by tracking their expansion after vaccination.
Background summary
Since 2009, the bivalent HPV vaccine was introduced in the National
Immunisation Programme (NIP) for 12-year old girls. However, also other
vaccines are available to prevent HPV infections. Therefore, independent
comparison between the bivalent and nonavalent HPV vaccination should take
place on an immunological level to determine the differences and make an
adequate vaccine decision for the Dutch population
Study objective
Primary objective: To obtain insight into signature of immune responses
triggered by a bivalent- or nonavalent HPV vaccination (three-dose schedule).
Secondary objectives: To determine the most informative time-points to study
different innate and adaptive immune subsets by tracking their expansion after
vaccination.
Study design
This study consists out of a time finding study (Part I) and a longitudinal
intervention study: baseline and follow-up measurements of immune parameters
(Part II).
Intervention
Part I and II:Study particpants will either receive three-doses of the
bivalent- (Cervarix) or nonavalent (Gardasil9) HPV vaccine.
Study burden and risks
Part I and Part II: Participants will benefit from participating in this study
by receiving the vaccine they will be protected against future hrHPV
infections. Although vaccination and especially venepunctures may be
unpleasant, they are considered low risk invasive procedures. These risks will
be mitigated by the performance of all procedures by experienced personnel.
Cervarix® and Gardasil9® are both registered vaccines. Adverse reactions (ARs)
to the vaccine may occur but they are expected to be mainly local and
transient. Severe allergic reactions to one of the vaccine components are
unlikely to occur.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721MA
NL
Listed location countries
Age
Inclusion criteria
Part I and Part II:
Healthy, pre-menopausal women who have not been vaccinated against HPV yet and
are seronegative for high-risk HPV vaccine types
Exclusion criteria
Part I and II:Medical conditions that will severely affect immunological
responses to
vaccinations, such as, but not limited to, cancer or an immune disorder.
Vaccination should be postponed during any illness with fever >38.5°C
until the fever has disappeared.
An additional HPVvaccination during the study.
Coagulation disorder and/or anticoagulant medication.
Be or have been under immunosuppressive medical treatment, like
cytostatics, high-dose corticosteroids, immune globulins, blood or
plasma transfusions that might interfere with the results of the study
(within the previous 3 months)., Had experienced a previous severe adverse
reaction to any vaccine.
Being pregnant
Participating in another vaccine/ medicine study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000253-31-NL |
| CCMO | NL69015.100.19 |
| OMON | NL-OMON27917 |