Ignite Creation Date:
2024-05-06 @ 12:13 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01520272
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2012-01-26
Brief Title:
HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda
Status:
COMPLETED
Status Verified Date:
2017-06-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Cervical cancer is one of the leading causes of cancer death in women worldwide and in Uganda It is caused by the human papillomavirus HPV A vaccine against HPV was offered for all 10-year-old girls in the Nakasongola district of Uganda from October 1 2008 to October 31 2009 The HPV vaccine requires three doses however some girls received only one or two doses Researchers want to compare vaccine immunogenicity in girls who received all three doses with those who had only one or two doses
Objectives
- To examine the immunogenicity antibody levels of girls in Uganda who received only one two or three doses of HPV vaccine
Eligibility
Girls who will be at least 12 years old by October 31 2011 and had at least one dose of the HPV vaccine
All participants will come from the Nakasongola district of Uganda
Design
Participants will have a physical exam and answer questions about their medical history and HPV risk
Participants will provide a single blood sample for testing
Treatment and vaccines will not be provided as part of this study Girls who did not receive all three doses of the HPV vaccine will be given information about the nearest health center Health centers will provide the missed doses free of charge
- Cervical cancer is one of the leading causes of cancer death in women worldwide and in Uganda It is caused by the human papillomavirus HPV A vaccine against HPV was offered for all 10-year-old girls in the Nakasongola district of Uganda from October 1 2008 to October 31 2009 The HPV vaccine requires three doses however some girls received only one or two doses Researchers want to compare vaccine immunogenicity in girls who received all three doses with those who had only one or two doses
Objectives
- To examine the immunogenicity antibody levels of girls in Uganda who received only one two or three doses of HPV vaccine
Eligibility
Girls who will be at least 12 years old by October 31 2011 and had at least one dose of the HPV vaccine
All participants will come from the Nakasongola district of Uganda
Design
Participants will have a physical exam and answer questions about their medical history and HPV risk
Participants will provide a single blood sample for testing
Treatment and vaccines will not be provided as part of this study Girls who did not receive all three doses of the HPV vaccine will be given information about the nearest health center Health centers will provide the missed doses free of charge
Detailed Description:
Background
Recent experience with HPV vaccine implementation in low resource settings has suggested that high vaccine coverage for all three doses could be achieved provided programs are planned well and have full and complementary components in place However some locations experienced substantial rates of partially vaccinated girls those who received only one or two doses From the vaccine trial data published thus far we know that the vaccines produce high levels of type-specific anti-HPV antibodies which begin to stabilize past 24 months post-vaccination Without an immune correlate of protection it is difficult to know whether girls who received one or two vaccine doses will still experience the same benefit of protection from HPV infection as those who received all three doses of vaccine
Recent data from a trial of a two-dose regimen of vaccination of girls aged 9-13 years in Vancouver Canada have suggested that the immune response of girls who received only two doses was non-inferior both to that of girls who received 3 doses and to that of adult women aged 16-25 years who also received 3 doses In a complementary study in Guanacaste Costa Rica vaccine efficacy defined as 12-month vaccine type-specific infection persistence among adult women who received either one or two doses of HPV vaccine as a part of the Phase IIb clinical trials of Cervarix GSK was similar to women who received all three vaccines doses
This proposed study would provide additional insight into the immunogenicity of HPV vaccine among partially vaccinated girls in Uganda which could add supportive evidence in an African adolescent population currently not represented in any clinical studies of HPV vaccines of the immunological implications of receiving less than 3 doses of HPV vaccine
Objective
To investigate whether the anti-HPV 16 andor anti-HPV-18 immune responses elicited by the bivalent vaccine for girls who received one dose and those who received two doses are similar at greater than or equal to 24 months after last dose to girls who received all three doses of bivalent HPV vaccine
Eligibility
Girls who received at least one dose of the HPV vaccine 12-20 years of old in apparent good general health
Design
This is a cross-sectional immunogenicity study with three groups
Group 1 - 200 girls who received only one dose of HPV vaccine as a part of the PATH-UNEPI HPV vaccine demonstration project
Group 2 - 200 girls who received only two doses of HPV vaccine as a part of the PATH-UNEPI
HPV vaccine demonstration project and
Group 3 - 200 girls who received all three doses of HPV vaccine as a part of the PATH-UNEPI HPV vaccine demonstration project
This study will enroll girls by group within one district of Uganda from an HPV vaccine registry maintained by the district
Antibody level will be parameterized as the geometric mean titre of serum antibody to HPV types 16 andor 18 at greater than or equal to 24 months after last dose of vaccine Titres will be measured using the polyclonal Direct VLP ELISA
Recent experience with HPV vaccine implementation in low resource settings has suggested that high vaccine coverage for all three doses could be achieved provided programs are planned well and have full and complementary components in place However some locations experienced substantial rates of partially vaccinated girls those who received only one or two doses From the vaccine trial data published thus far we know that the vaccines produce high levels of type-specific anti-HPV antibodies which begin to stabilize past 24 months post-vaccination Without an immune correlate of protection it is difficult to know whether girls who received one or two vaccine doses will still experience the same benefit of protection from HPV infection as those who received all three doses of vaccine
Recent data from a trial of a two-dose regimen of vaccination of girls aged 9-13 years in Vancouver Canada have suggested that the immune response of girls who received only two doses was non-inferior both to that of girls who received 3 doses and to that of adult women aged 16-25 years who also received 3 doses In a complementary study in Guanacaste Costa Rica vaccine efficacy defined as 12-month vaccine type-specific infection persistence among adult women who received either one or two doses of HPV vaccine as a part of the Phase IIb clinical trials of Cervarix GSK was similar to women who received all three vaccines doses
This proposed study would provide additional insight into the immunogenicity of HPV vaccine among partially vaccinated girls in Uganda which could add supportive evidence in an African adolescent population currently not represented in any clinical studies of HPV vaccines of the immunological implications of receiving less than 3 doses of HPV vaccine
Objective
To investigate whether the anti-HPV 16 andor anti-HPV-18 immune responses elicited by the bivalent vaccine for girls who received one dose and those who received two doses are similar at greater than or equal to 24 months after last dose to girls who received all three doses of bivalent HPV vaccine
Eligibility
Girls who received at least one dose of the HPV vaccine 12-20 years of old in apparent good general health
Design
This is a cross-sectional immunogenicity study with three groups
Group 1 - 200 girls who received only one dose of HPV vaccine as a part of the PATH-UNEPI HPV vaccine demonstration project
Group 2 - 200 girls who received only two doses of HPV vaccine as a part of the PATH-UNEPI
HPV vaccine demonstration project and
Group 3 - 200 girls who received all three doses of HPV vaccine as a part of the PATH-UNEPI HPV vaccine demonstration project
This study will enroll girls by group within one district of Uganda from an HPV vaccine registry maintained by the district
Antibody level will be parameterized as the geometric mean titre of serum antibody to HPV types 16 andor 18 at greater than or equal to 24 months after last dose of vaccine Titres will be measured using the polyclonal Direct VLP ELISA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-C-N021 | None | None | None |