Cervical CancerNCT06915779
Long Term Follow-up of HPV Vaccine in HIV (CTN 236)
An observational study of Cervical Cancer and Human Papillomavirus Infection, run by University of British Columbia at 13 sites in Canada.
Trial summary
The purpose of this extension study is to determine whether HPV antibody levels in HIV-positive girls and women will decline more rapidly and more significantly than in HIV-negative girls and women and if this decline is determined by HIV parameters. Read more about this study
- Who is it for?
- Ages 11 to 60 years, women only
- Conditions the study is for
- Cervical Cancer, Human Papillomavirus Infection, Human Immunodeficiency Virus
- Type of treatment
- Vaccines
- How many people
- 241 participants
- Where
- 13 sitesCanada
- Study dates
- 1 Jun 2015to 30 Mar 2021
- 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 11 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: HIV positive girls and women (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who have enrolled in the original study, "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" and received at least one dose of the quadrivalent HPV vaccine, will be offered participation in the study.
Who may be able to join
- Enrolled in CTN 236 study, phase 1
- Able to give fully informed consent or assent
Who cannot join
- Did not receive at least one vaccination via CTN 236, phase 1
- Cannot provide fully informed consent or assent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Hamilton Health Sciences
Hamilton, Ontario, L8S 1A4
Infection & Immunology Clinic, Hotel Dieu
Kingston, Ontario, K7L 5G2
Centre de maternal et infantile sur le sida, CHU Sainte Justine
Montreal, Quebec, H3T 1C5
Chronic Viral Illness Service, Hopital Royal Victoria (McGill University)
Montreal, Quebec, H4A 3J1
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario, K1H 8L1
CHUL and Mother-Child Center Soleil, Centre de Recherche en Infectiologie CHU de Quebec, (Universite Laval)
Québec, Quebec, G1V 4G2
St. Michael's Hospital
Toronto, Ontario, M5C 1K2
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Maple Leaf Research
Toronto, Ontario, M5G 2N2
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Oak Tree Clinic, BC Women's Hospital & Health Centre
Vancouver, British Columbia, V6H 3N1
AIDS Research Program & the John Ruedy Immunodeficience Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
HIV Care Program
Windsor, Ontario, N8W 1E3
About this study
Official title: Long Term Follow-up Study of CTN 236 - A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women
The purpose of this extension study is to determine whether HPV antibody levels in HIV-positive girls and women will decline more rapidly and more significantly than in HIV-negative girls and women and if this decline is determined by HIV parameters.
Read the detailed description
Study hypothesis: HPV antibody levels in HIV-positive girls and women will decline more rapidly and more significantly than in HIV-negative girls and women and that this decline will be determined by HIV parameters.
Girls and women living with HIV (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who enrolled in and received at least one dose of quadrivalent HPV vaccine as part of "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" will be offered participation in this long term follow-up study.
OBJECTIVES
Primary:
To measure the antibody response to each genotype contained in the qHPV vaccine to 96 months post first dose of quadrivalent HPV vaccine.
Secondary:
- To determine the incidence rate and nature of 'breakthrough' HPV incidence and persistent (2 sequential positive HPV DNA in > 6 months) infections of vaccine - non-vaccine-containing high-risk types;
- To determine the incidence rate of cervical dysplasia (LSIL or greater) and/or vulvar and vaginal dysplasia associated HPV genotypes (both with and without vaccine types; and
- To determine the incidence rate of external genital warts.
Exploratory:
- To examine the relationship between HSV-2 serostatus and peak HPV antibody response as well as HPV incidence and persistent infections; and
- To relate vaginal microbiome profiles to HPV acquisition/persistence and cervical dysplasia.
STUDY DESIGN Phase 3, longitudinal, multi-center, 13 sites, girls and women living with HIV aged 11 years of age and older, received one plus dose of quadrivalent HPV vaccine in the precursor study.
STUDY VISITS 3 possible visits over a total of 5 years
- Visit 8 (month 36)
- Visit 9 (month 48)
- Visit 10 (month 60)
- Visit 11 (month 72)*
- Visit 12 (month 84)*
- Visit 13 (month 96)*
STUDY PROCEDURES:
Informed consent, Medical history, Height \& weight, Cervical cytology and HPV DNA (liquid prep method), Gynecological swab for vaginal microbiota, Serology for HPV antibodies, Serology for HSV-2, Lower Urinary Tract Symptoms Survey (at one time-point only for participants 18 years of age and older).
NOTE: Girls who are pre-menarchal and not sexually active will not be asked to undergo any genital examinations or sampling until they become menarchal and sexually active.
DATA COLLECTION Consent and source document templates will be provided by the Study Coordinating Center. Source data will be transferred to paper case report forms and sent to the Study Coordinating Center/CTN where it will be entered into an electronic database.
PRIMARY ENDPOINT The primary endpoint of this study will be the HPV antibody GMT for each of the 4 types contained in the GARDASIL™ vaccine up to month 96 after receiving at least one dose of the vaccine.
SECONDARY ENDPOINTS Incidence rates of: 1) breakthrough incidents and persistent HPV infections; 2) cervical dysplasia; 3) external genital warts
- Conditions
- Cervical Cancer, Human Papillomavirus Infection, Human Immunodeficiency Virus, Cervical Dysplasia, Genital Warts
- Keywords
- HPV, HPV Vaccine, HIV, Women, Genital Warts, Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, Acquired Immunodeficiency Syndrome, Uterine Cervical Dysplasia, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | HIV positive girls and women (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who have enrolled in the original study, "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" and received at least one dose of quadrivalent HPV vaccine, will be offered participation on this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To measure the antibody response to each genotype contained in the qHPV vaccine to 96 months post-vaccination regimen.
Measured: 96 month post-vaccination regimen
Secondary outcomes (3)
Secondary Objective #1
To determine the incidence rate and nature of 'breakthrough' HPV incidence and persistent (2 sequential positive HPV DNA in > 6 months) infections of vaccine - non-vaccine-containing high-risk types.
Measured: 96 month post-vaccination regimen
Secondary Objective #2
To determine the incidence rate of cervical dysplasia (LSIL or greater) and/or vulvar and vaginal dysplasia associated HPV genotypes (both with and without vaccine types
Measured: 96 month post-vaccination regimen
Secondary Objective #3
To determine the incidence rate of external genital warts.
Measured: 96 month post-vaccination regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Jun 2015
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, Women's Health Research Institute of British Columbia, Canadian Institutes of Health Research (CIHR), BC Women's Hospital & Health Centre, Merck Canada Inc., University Health Network, Toronto, McGill University, University of Saskatoon, British Columbia Centre for Disease Control, Vaccine Evaluation Center, Canada, British Columbia Cancer Agency
- Responsible party
- Principal investigator, Deborah Money, University of British Columbia
- Investigators
- Deborah M Money, MD, FRCSC, Principal investigator, Dept. OB/GYN, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915779
- Sponsor's protocol ID
- H14-02364
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up Study of CTN 236 - A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women
- ClinicalTrials.gov ID
- NCT06915779
- Acronym / sponsor ID
- H14-02364
- Conditions
- Cervical Cancer, Human Papillomavirus Infection, Human Immunodeficiency Virus, Cervical Dysplasia, Genital Warts
- Keywords
- HPV, HPV Vaccine, HIV, Women, Genital Warts, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, Women's Health Research Institute of British Columbia, Canadian Institutes of Health Research (CIHR), BC Women's Hospital & Health Centre, Merck Canada Inc., University Health Network, Toronto, McGill University, University of Saskatoon, British Columbia Centre for Disease Control, Vaccine Evaluation Center, Canada, British Columbia Cancer Agency
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Apr 2025 (actual)
- 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.
The purpose of this extension study is to determine whether HPV antibody levels in HIV-positive girls and women will decline more rapidly and more significantly than in HIV-negative girls and women and if this decline is determined by HIV parameters.
Detailed description
Study hypothesis: HPV antibody levels in HIV-positive girls and women will decline more rapidly and more significantly than in HIV-negative girls and women and that this decline will be determined by HIV parameters.
Girls and women living with HIV (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who enrolled in and received at least one dose of quadrivalent HPV vaccine as part of "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" will be offered participation in this long term follow-up study.
OBJECTIVES
Primary:
To measure the antibody response to each genotype contained in the qHPV vaccine to 96 months post first dose of quadrivalent HPV vaccine.
Secondary:
- To determine the incidence rate and nature of 'breakthrough' HPV incidence and persistent (2 sequential positive HPV DNA in > 6 months) infections of vaccine - non-vaccine-containing high-risk types;
- To determine the incidence rate of cervical dysplasia (LSIL or greater) and/or vulvar and vaginal dysplasia associated HPV genotypes (both with and without vaccine types; and
- To determine the incidence rate of external genital warts.
Exploratory:
- To examine the relationship between HSV-2 serostatus and peak HPV antibody response as well as HPV incidence and persistent infections; and
- To relate vaginal microbiome profiles to HPV acquisition/persistence and cervical dysplasia.
STUDY DESIGN Phase 3, longitudinal, multi-center, 13 sites, girls and women living with HIV aged 11 years of age and older, received one plus dose of quadrivalent HPV vaccine in the precursor study.
STUDY VISITS 3 possible visits over a total of 5 years
- Visit 8 (month 36)
- Visit 9 (month 48)
- Visit 10 (month 60)
- Visit 11 (month 72)*
- Visit 12 (month 84)*
- Visit 13 (month 96)*
STUDY PROCEDURES:
Informed consent, Medical history, Height \& weight, Cervical cytology and HPV DNA (liquid prep method), Gynecological swab for vaginal microbiota, Serology for HPV antibodies, Serology for HSV-2, Lower Urinary Tract Symptoms Survey (at one time-point only for participants 18 years of age and older).
NOTE: Girls who are pre-menarchal and not sexually active will not be asked to undergo any genital examinations or sampling until they become menarchal and sexually active.
DATA COLLECTION Consent and source document templates will be provided by the Study Coordinating Center. Source data will be transferred to paper case report forms and sent to the Study Coordinating Center/CTN where it will be entered into an electronic database.
PRIMARY ENDPOINT The primary endpoint of this study will be the HPV antibody GMT for each of the 4 types contained in the GARDASIL™ vaccine up to month 96 after receiving at least one dose of the vaccine.
SECONDARY ENDPOINTS Incidence rates of: 1) breakthrough incidents and persistent HPV infections; 2) cervical dysplasia; 3) external genital warts
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –HIV positive girls and women (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who have enrolled in the original study, "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" and received at least one dose of quadrivalent HPV vaccine, will be offered participation on this study. |
Who may qualify
- Ages
- 11 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV positive girls and women (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who have enrolled in the original study, "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" and received at least one dose of the quadrivalent HPV vaccine, will be offered participation in the study.
Key inclusion criteria (2 listed)
- Enrolled in CTN 236 study, phase 1
- Able to give fully informed consent or assent
Key exclusion criteria (2 listed)
- Did not receive at least one vaccination via CTN 236, phase 1
- Cannot provide fully informed consent or assent
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
Primary Objective
Time frame: 96 month post-vaccination regimen
To measure the antibody response to each genotype contained in the qHPV vaccine to 96 months post-vaccination regimen.
3 secondary outcomes
Secondary Objective #1
Time frame: 96 month post-vaccination regimen
Secondary Objective #2
Time frame: 96 month post-vaccination regimen
Secondary Objective #3
Time frame: 96 month post-vaccination regimen
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 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Deborah M Money, MD, FRCSC principal investigator
Dept. OB/GYN, University of British Columbia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Human Papillomavirus Infection, run by University of British Columbia at 13 sites in Canada.
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 2 inclusion and 2 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. 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?
Primary Objective (time frame: 96 month post-vaccination regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.