Early effects of Vaccine Immunisatio

Phase 4

Completed

Conditions: 10047438
human papillomavirus infection

Registration Number: NL-OMON48227

Lead Sponsor: RIVM

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To obtain insight into signature of immune responses triggered by a bivalent-<br /><br>or nonavalent HPV vaccination (three-dose schedule).<br /><br>Detailed analysis of innate and adaptive immune cells and their kinetics over<br /><br>time will be performed by the means of flow cytometry. In addition, a flow<br /><br>cytometry-based approach will be developed to identify antigen-specific memory<br /><br>B cells and plasma cells prior to analysis of their immunoglobulin receptors by<br /><br>means of high throughput sequencing. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the most informative time-points to study different innate and<br /><br>adaptive immune subsets by tracking their expansion after vaccination.</p><br>