No registrations found.
ID
Source
Brief title
Health condition
Vaccination, HPV, Immunogenicity, Two-dose schedule
Vaccinatie, HPV, immunogeniciteit, twee-doses schema
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cohort 1997-2000
- Antibody responses of vaccine-induced types after a two dose schedule up to 4 1/2 years after the first dose.
Cohort 2001
- Level and kinetics of vaccine-induced antibody response after a two dose schedule at approximately 7,12 and 24 months.
Secondary outcome
Cohort 1997-2000
- Cross-protection
Cohort 2001
- Avidity of antibodies
- Cross-protection
- Cellular immunity
Background summary
Rationale:
The change from three- to two-dose schedule for HPV vaccination asks for monitoring of the kinetics of vaccine induced
antibodies over time and of quality of vaccine-induced antibodies and cellular
immunity after a two-dose schedule.
Objective:
- To study the level and quality of antibody response at approximately 7, 12 and 24
months following the first dose of HPV-16/18 vaccination in a two-dose schedule and check whether this level remains above plateau.
- To study whether antibody responses involved in a two-dose HPV-16/18-vaccination schedule compared to a three-dose schedule, are non-inferior at approximately 1 ½, 2 ½, 3 ½ and 4 ½ years after the first dose.
Study design:
In a prospective cohort study cellular immunity, the level and quality of vaccine-induced antibodies will be studied in girls born in 2001 who were vaccinated by a two-dose schedule in 2014. Cross-sectional observational sampling will be performed among girls born between 1997 and 2000, to compare the vaccine-induced antibody levels and avidity after a two-dose schedule with a three-dose schedule.
Study population:
Girls born in 2001 who received a two-dose schedule and girls born between 1997 and 2000 who received either two or three doses of the bivalent HPV vaccine.
Main study parameters/endpoints:
- Type specific antibody levels against HPV types 16,18 in serum following the two-dose
schedule and whether these levels remains above plateau for HPV-16/-18 up to 24
months after the first dose
- Kinetics of type specific antibody levels against HPV types 16,18 in serum following the two-dose schedule up to 24 months after the first dose
- Whether the two-dose schedule is non-inferior with regard to HPV16/18 antibody levels to the three-dose schedule up to approximately 4 ½ years after the first dose
Study objective
Antibody responses after a two-dose HPV vaccination schedule are non-inferior to a three-dose schedule.
Level of two-dose schedule antibodies remains above plateau.
Study design
Cohort 1997-2000
- 18, 30, 42, 54 months after the first dose
Cohort 2001
- 7, 12 and 24 months after the first dose
Intervention
None
Centre for Infectious Disease Control<br>
Epidemiology and Surveillance Unit<br>
PObox 1 (Pb.75)
Robine Donken
Bilthoven 3720 BA
The Netherlands
+31 (0)30 2744378
robine.donken@rivm.nl
Centre for Infectious Disease Control<br>
Epidemiology and Surveillance Unit<br>
PObox 1 (Pb.75)
Robine Donken
Bilthoven 3720 BA
The Netherlands
+31 (0)30 2744378
robine.donken@rivm.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
- Vaccinated with the bivalent HPV vaccine (Cervarix)
- Received two- (with at least five months interval) or three-doses (0,1,6 months) of the
vaccine
- Born between 1997 and 2001
- Female
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation
in this study:
- Unknown or incorrect address
- Deceased
- Participated in tolerability study and stated to be no longer approachable for further
research
Design
Recruitment
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 | NL4578 |
| NTR-old | NTR4719 |
| CCMO | NL48754.029.14 |
| OMON | NL-OMON53042 |