HPV16 Anitbody Levels Post VaccinationNCT01520272
HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda
An observational study of HPV16 Anitbody Levels Post Vaccination and HPV18 Antibody Levels Post Vaccination, run by National Cancer Institute (NCI) at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV16 Anitbody Levels Post Vaccination, HPV18 Antibody Levels Post Vaccination
- How many people
- 376 participants
- Where
- 1 siteUganda
- Study dates
- 2 Jan 2012to 28 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
- Subject is aged 12-17 years as of August 31, 2011.
- Subject received at least one dose of HPV vaccine, Cervarix (GSK, UK), from October 1, 2008 through October 31, 2009 as a part of the PATH HPV vaccine demonstration project in Nakasongola, Uganda.
- Signed and dated informed written consent form (with both parent and subject s signatures) received (confirmed at clinic visit).
- Subject is afebrile, in good apparent health (confirmed at clinic visit).
- Subject assents to participate (confirmed at clinic visit).
- Subject is able to comply with the study protocol (confirmed at clinic visit).
- Subject plans to stay in Nakasongola for the duration of enrolment, which is expected to be about week between signed consent and blood draw.
Who cannot join
- The following exclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit.
- Prior HPV vaccination outside the PATH HPV vaccine demonstration project period.
- Subject is known to be pregnant or lactating at the time of the scheduled blood draw (confirmed at clinic visit).
- Subject has an apparent moderate or severe acute illness or has fever (confirmed at clinic visit).
- Clinical history of bleeding disorders such as haemophilia, thrombocytopenia, or anticoagulant therapy.
- Investigational drug or investigational vaccine or licensed vaccine administered during the period from 30 days before the date of the scheduled blood draw (confirmed at clinic visit).
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- Subject receives immunoglobulins and/or any blood products during the period from 30 days before the date of the scheduled blood draw (confirmed at clinic visit).
- Subject or subject s parents refused to sign written consent.
- Subject does not assent at the time of the blood draw.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda
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.
Read more
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.
Read the 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 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.
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 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.
- Keywords
- HPV18 Immunogenicity, HPV16 Immunogenicity, Bivalent HPV16/18 Vaccine, Less than 3 Dosed of the Bivalent HPV Vaccine, HP Vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV Immunogenicity
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study start2 Jan 2012
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPV16 Anitbody Levels Post VaccinationStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Allan Hildesheim, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520272
- Sponsor's protocol ID
- 999912021
- Other IDs
- 12-C-N021
- Status last verified
- 28 Jun 2017
- First submitted
- 26 Jan 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Banura C, Mirembe FM, Katahoire AR, Namujju PB, Mbonye AK, Wabwire FM. Epidemiology of HPV genotypes in Uganda and the role of the current preventive vaccines: A systematic review. Infect Agent Cancer. 2011 Jul 12;6(1):11. doi: 10.1186/1750-9378-6-11.
PubMed 21749691Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
PubMed 17079588Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years --- United States, 2009. MMWR Morb Mortal Wkly Rep. 2010 Aug 20;59(32):1018-23.
PubMed 20724968
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda
- ClinicalTrials.gov ID
- NCT01520272
- Acronym / sponsor ID
- 999912021
- Keywords
- HPV18 Immunogenicity, HPV16 Immunogenicity, Bivalent HPV16/18 Vaccine, Less than 3 Dosed of the Bivalent HPV Vaccine, HP Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Jan 2012
- Study completion
- 28 Jun 2017
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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:
- Subject is aged 12-17 years as of August 31, 2011.
- Subject received at least one dose of HPV vaccine, Cervarix (GSK, UK), from October 1, 2008 through October 31, 2009 as a part of the PATH HPV vaccine demonstration project in Nakasongola, Uganda.
- Signed and dated informed written consent form (with both parent and subject s signatures) received (confirmed at clinic visit).
- Subject is afebrile, in good apparent health (confirmed at clinic visit).
Key exclusion criteria (9 listed)
- The following exclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit.
- Prior HPV vaccination outside the PATH HPV vaccine demonstration project period.
- Subject is known to be pregnant or lactating at the time of the scheduled blood draw (confirmed at clinic visit).
- Subject has an apparent moderate or severe acute illness or has fever (confirmed at clinic visit).
- Clinical history of bleeding disorders such as haemophilia, thrombocytopenia, or anticoagulant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV Immunogenicity
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 21749691Banura C, Mirembe FM, Katahoire AR, Namujju PB, Mbonye AK, Wabwire FM. Epidemiology of HPV genotypes in Uganda and the role of the current preventive vaccines: A systematic review. Infect Agent Cancer. 2011 Jul 12;6(1):11. doi: 10.1186/1750-9378-6-11.
- Background: PubMed 17079588Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
- Background: PubMed 20724968Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years --- United States, 2009. MMWR Morb Mortal Wkly Rep. 2010 Aug 20;59(32):1018-23.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Hildesheim, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV16 Anitbody Levels Post Vaccination and HPV18 Antibody Levels Post Vaccination, run by National Cancer Institute (NCI) at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV Immunogenicity (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01520272, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.