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van CCT (UK)

van CCT (UK)

Protection against HPV

- candidate number19242
- NTR NumberNTR4719
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2014
- Secondary IDsNL48754.029.14 METC VUmc 2014/230
- Public TitleProtection against HPV
- Scientific TitleImmunogenicity of HPV-vaccination in a two-dose schedule
- hypothesisAntibody 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.
- Healt Condition(s) or Problem(s) studiedVaccination, Human Papilloma Virus (HPV), Immunogenicity
- Inclusion criteriaIn 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 criteriaA 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-apr-2016
- Target number of participants418
- InterventionsNone
- Primary outcomeCohort 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 outcomeCohort 1997-2000
- Cross-protection

Cohort 2001
- Avidity of antibodies
- Cross-protection
- Cellular immunity
- TimepointsCohort 1997-2000
- 18, 30, 42, 54 months after the first dose

Cohort 2001
- 7, 12 and 24 months after the first dose
- Trial web site
- statusplanned
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Ministry of Health, Welfare and Sport
- Publications
- Brief summaryRationale:
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.

- 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 , 2 , 3 and 4 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 years after the first dose
- Main changes (audit trail)
- RECORD4-aug-2014 - 31-aug-2014

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