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ID
Source
Brief title
Health condition
Human Papillomavirus
Sponsors and support
Intervention
Outcome measures
Primary outcome
To obtain insight into signature of immune responses triggered
by a bivalent- or nonavalent HPV vaccination.
Secondary outcome
To determine the most informative time-points to study diff
Background summary
Rationale: Since 2009, the bivalent HPV vaccine was introduced in the National
Immunisation Programme (NIP) for 12-year old girls. . The HPV vaccines are highly
efficacious in preventing HPV related diseases. However, the early/rapid immune responses
to HPV vaccines are not fully investigated yet. This study will investigate the early signature
of immune responses of HPV vaccines.
Objective: Primary objective: To obtain insight into signature of immune responses triggered
by a bivalent- or nonavalent HPV vaccination.
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 of a time finding study (Part I) and a longitudinal intervention study:
baseline and follow-up measurements of immune parameters (Part II).
Study population:
Part I and Part II: The study population will consist of healthy, pre-menopausal women who
are seronegative forhigh-risk HPV vaccine types.
Intervention (if applicable):
Participants will receive three injections of either the bivalent (Cervarix®) or nonavalent
(Gardasil9®) HPV vaccine. In Part I twelve venous blood samples will be drawn and in Part II
eight venous blood samples will be drawn.
Main study parameters/endpoints:
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.
Study will be finished after the last study visit of the last donor.
Study objective
To obtain insight into signature of immune responses triggered
by a bivalent- or nonavalent HPV vaccination.
Study design
In Part I twelve venous blood samples will be drawn and in Part II
eight venous blood samples will be drawn.
Intervention
Participants will receive three injections of either the bivalent (Cervarix®) or nonavalent
(Gardasil9®) HPV vaccine. In Part I twelve venous blood samples will be drawn and in Part II
eight venous blood samples will be drawn.
Inclusion criteria
Seronegative for hr-HPV vaccine types(16,18,31,33,45,52,58)
Female
Normal general health
Pre-menopausal
Willing to receive HPV vaccination
Provision of written informed consent
Willing to adhere to the protocol and be available during the study period
Exclusion criteria
present evidence of serious disease(s) within the last 3 months before inclusion
requiring immunosuppressive or immune modulating medical treatment, such as
systemic corticosteroids, that might interfere with the results of the study;
chronic infection
known or suspected immune deficiency;
history of any neurologic disorder, including epilepsy;
previous administration of serum products (including immunoglobulins) within 6
months before vaccination and blood sampling
known or suspected allergy to any of the vaccine components (by medical history)
previous vaccination with any HPV vaccine
pregnancy
participating in another vaccination/ medicine study
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7736 |
| CCMO | NL69015.100.19 |
| OMON | NL-OMON48227 |