|- candidate number||19242|
|- NTR Number||NTR4719|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-aug-2014|
|- Secondary IDs||NL48754.029.14 METC VUmc 2014/230|
|- Public Title||Protection against HPV|
|- Scientific Title||Immunogenicity of HPV-vaccination in a two-dose schedule|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Vaccination, Human Papilloma Virus (HPV), Immunogenicity|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following
- Vaccinated with the bivalent HPV vaccine (Cervarix)
- Received two- (with at least five months interval) or three-doses (0,1,6 months) of the
- Born between 1997 and 2001
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation
in this study:|
- Unknown or incorrect address
- Participated in tolerability study and stated to be no longer approachable for further
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-apr-2016|
|- Target number of participants||418|
|- 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.
- 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|
- Avidity of antibodies
- Cellular immunity
|- Timepoints||Cohort 1997-2000|
- 18, 30, 42, 54 months after the first dose
- 7, 12 and 24 months after the first dose
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Robine Donken|
|- CONTACT for SCIENTIFIC QUERIES|| Robine Donken|
|- Sponsor/Initiator ||National Institute for Public Health and the Environment (RIVM)|
(Source(s) of Monetary or Material Support)
|Dutch Ministry of Health, Welfare and Sport|
|- Brief 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.
- 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.
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.
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
|- Main changes (audit trail)|
|- RECORD||4-aug-2014 - 31-aug-2014|