Immunogenicity of HPV-vaccination in a reduced-dose schedule

Immunogenicity of HPV-vaccination in a reduced-dose schedule - HPV-2/1D

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53042

Enrollment

1305

Registered

2014-04-24

Start date

2014-08-26

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer, HPV

Interventions

None listed

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in the cohort study among girls, a  subject must meet all of the following criteria: - Vaccinated with the bivalent HPV vaccine (Cervarix) - Received one-, two- (with at least five months interval) or three-doses (0,1,6 months) of the vaccine - Born between 1997 and 2003 - Female The inclusion criteria for the cohort study among boys are as follows: - Vaccinated with the bivalent HPV vaccine (Cervarix) - Received two-doses (with at least five months interval) of the vaccine - Born in 2012 - Male

Exclusion criteria

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 no longer be approachable for further research

Design outcomes

Primary

Measure	Time frame
Type specific antibody levels against HPV types 16 and 18,in serum following the two-dose schedule and whether these levels remain above plateau for HPV-16/-18 up to 24 months after the first dose.Kinetics of type specific antibody levels against HPV types 16 and 18 in serum following the two-dose schedule up to 120 months after the first dose.Whether the two-dose schedule is non-inferior for HPV 16 and HPV 18 to the three-dose schedule up to approximately 7.5 years after the first dose.To study HPV-16/-18 antibody responses after a one-dose schedule at approximately 1 ½, 2 ½, 3 ½, 4 ½, 5 ½, 6 ½ and 7 ½ years following vaccination.To study the kinetics of the antibody response against HPV types 16 and 18 at approximately 7, 12, 24, and 36 months after the first dose of HPV vaccination in a two-dose schedule among boys.To study whether the antibody response against HPV types 16 and 18 after HPV vaccination in a two-dose schedule among boys vaccinated at 9-10 years of age is non-inferior to that of a two-dose schedule among girls vaccinated at 12-13 years of age approximately 7, 12, 24, and 36 months after the first dose.	—

Measure

Time frame

Type specific antibody levels against HPV types 16 and 18,in serum following the two-dose schedule and whether these levels remain above plateau for HPV-16/-18 up to 24 months after the first dose.Kinetics of type specific antibody levels against HPV types 16 and 18 in serum following the two-dose schedule up to 120 months after the first dose.Whether the two-dose schedule is non-inferior for HPV 16 and HPV 18 to the three-dose schedule up to approximately 7.5 years after the first dose.To study HPV-16/-18 antibody responses after a one-dose schedule at approximately 1 ½, 2 ½, 3 ½, 4 ½, 5 ½, 6 ½ and 7 ½ years following vaccination.To study the kinetics of the antibody response against HPV types 16 and 18 at approximately 7, 12, 24, and 36 months after the first dose of HPV vaccination in a two-dose schedule among boys.To study whether the antibody response against HPV types 16 and 18 after HPV vaccination in a two-dose schedule among boys vaccinated at 9-10 years of age is non-inferior to that of a two-dose schedule among girls vaccinated at 12-13 years of age approximately 7, 12, 24, and 36 months after the first dose.

—

Secondary

Measure	Time frame
Avidity of HPV types 16 and 18 specific IgG antibodies in serum following the two-dose schedule up to 120 months after the first dose.A comparison of the avidity of HPV-16/-18 specific IgG antibodies following a three or two dose schedule up to 7.5 years after the first dose.Explorative: Functionality of antibodies against HPV types 16 and 18 in serum (PBNA) following the two-dose schedule up to 60 months after the first dose.Whether the level of antibodies against HPV 16/18 after a two-dose schedule remains above plateau in a cross-sectional design up to approximately 7.5 years after the first dose.Type specific antibody levels against HPV 31/33/45/52/58 in serum measured at 7, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months following the two-dose vaccination schedule.Differences in type specific antibody levels against possible cross-protection types HPV 31 and 45 in serum measured up to 7.5 years after the first dose in both vaccinated in a two dose schedule and vaccinated in a three dose schedule.The kinetics of the antibody response against HPV types 31/33/45/52/58 at approximately 7, 12, 24, and 36 months after the first dose of HPV vaccination in a two-dose schedule among boys.To compare the antibody response against HPV types 31/33/45/52/58 after HPV vaccination in a two-dose schedule among 9-10 year old boys compared to a two-dose schedule among 12-13 year old girls at approximately 7, 12, 24, and 36 months after the first dose.Cellular immunity represented by the number of HPV-specific B-cells.Whether HPV-16/-18 antibody responses after a one-dose schedule are non-inferior compared to a two-dose schedule, at approximately 1 ½, 2 ½, 3 ½, 4 ½, 5 ½, 6 ½ and 7 ½ years following vaccination.A comparison of the avidity of antibodies against HPV-16/-18 after a one-dose schedule with the avidity after a two-dose schedule, at approximately 1 ½, 2 ½, 3 ½, 4 ½, 5 ½, 6 ½ and 7 ½ years after vaccination.Possible differences in antibody responses after a one-dose sch	—

Measure

Time frame

Avidity of HPV types 16 and 18 specific IgG antibodies in serum following the two-dose schedule up to 120 months after the first dose.A comparison of the avidity of HPV-16/-18 specific IgG antibodies following a three or two dose schedule up to 7.5 years after the first dose.Explorative: Functionality of antibodies against HPV types 16 and 18 in serum (PBNA) following the two-dose schedule up to 60 months after the first dose.Whether the level of antibodies against HPV 16/18 after a two-dose schedule remains above plateau in a cross-sectional design up to approximately 7.5 years after the first dose.Type specific antibody levels against HPV 31/33/45/52/58 in serum measured at 7, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months following the two-dose vaccination schedule.Differences in type specific antibody levels against possible cross-protection types HPV 31 and 45 in serum measured up to 7.5 years after the first dose in both vaccinated in a two dose schedule and vaccinated in a three dose schedule.The kinetics of the antibody response against HPV types 31/33/45/52/58 at approximately 7, 12, 24, and 36 months after the first dose of HPV vaccination in a two-dose schedule among boys.To compare the antibody response against HPV types 31/33/45/52/58 after HPV vaccination in a two-dose schedule among 9-10 year old boys compared to a two-dose schedule among 12-13 year old girls at approximately 7, 12, 24, and 36 months after the first dose.Cellular immunity represented by the number of HPV-specific B-cells.Whether HPV-16/-18 antibody responses after a one-dose schedule are non-inferior compared to a two-dose schedule, at approximately 1 ½, 2 ½, 3 ½, 4 ½, 5 ½, 6 ½ and 7 ½ years following vaccination.A comparison of the avidity of antibodies against HPV-16/-18 after a one-dose schedule with the avidity after a two-dose schedule, at approximately 1 ½, 2 ½, 3 ½, 4 ½, 5 ½, 6 ½ and 7 ½ years after vaccination.Possible differences in antibody responses after a one-dose sch

—

Countries

Netherlands

Contacts

Public ContactH.E. de Melker

RIVM

info@rivm.nl088 689 8989

Outcome results