HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda
|First Received Date ICMJE||January 26, 2012|
|Last Updated Date||September 16, 2015|
|Start Date ICMJE||January 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||HPV Immunogenicity [ Time Frame: Ongoing ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01520272 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda|
|Official Title ICMJE||Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda|
- 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.
- To examine the immunogenicity (antibody levels) of girls in Uganda who received only one, two or three doses of HPV vaccine.
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.
To investigate whether the anti-HPV 16 and/or 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.
Girls who received at least one dose of the HPV vaccine, 12-20 years of old, in apparent good general health.
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 and/or 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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Cross-Sectional|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||600|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
The following inclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit, immediately prior to blood draw:
The following exclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit.
|Ages||12 Years to 20 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Uganda|
|Removed Location Countries|
|NCT Number ICMJE||NCT01520272|
|Other Study ID Numbers ICMJE||999912021, 12-C-N021|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP