HPV InfectionPhase 4NCT05435209
Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents
A Phase 4 study testing Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine in people with HPV Infection and HPV Vaccination, run by University of Washington at 1 site in Kenya.
Trial summary
The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HPV Vaccination
- What is being tested?
- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteKenya
- Study dates
- 25 May 2022to 31 Oct 2023
- Phase
- Phase 4
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV-infected
- enrolled previously and received received three doses of quadrivalent HPV- vaccine in 2014
Who cannot join
- Decline re-enrollment
- unable to provide informed consent
- minor without parent or guardian consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Cohort Study to Assess Effectiveness and B-memory Response to the Quadrivalent HPV Vaccine 9 Years Post-vaccination Among HIV-Infected Boys and Girls Ages 9-14 Years in Kenya
The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection.
Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection.
Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.
Read the detailed description
Background: Genital Human Papilloma Virus (HPV) infections occur rapidly after sexual debut, and immunosuppressed individuals are at greater risk for incident and persistent infection. HPV vaccine contains virus-like particles (VLP), which are highly immunogenic and induce a robust humoral response that has been demonstrated to confer long term protection from HPV infection and associated disease among HIV-uninfected individuals. The magnitude of type-specific vaccine induced neutralizing HPV antibody responses are diminished among HIV-infected compared to uninfected individuals.
There is no established minimum level of antibody that predicts protection against HPV infection or associated disease, the impact of lower antibody titers among HIV infected individuals on vaccine efficacy is unknown. The risk of HPV exposure persists throughout a person's sexual life and the duration of protection, especially when the vaccine is given in the early adolescent period is critical to vaccine effectiveness. Long lasting memory is characterized by memory B cells and long-lived plasma cells and a QHPV booster dose has demonstrated an anamnestic response among HIV-infected adolescents.
HPV efficacy and effectiveness data for HIV-uninfected individuals has informed the current World Health Organization (WHO) two-dose vaccine schedule. The field lacks data on effectiveness of three dose or two-dose for the HIV-infected adolescents. The current on-going research for single dose schedules gives urgency to the determination of long-term efficacy of three HPV vaccine 231 doses for the HIV-infected adolescent.
Investigators shall recall HIV-infected girls and boys who were previously vaccinated at ages 9-14 years with three doses of the quadrivalent vaccine (QHPV) in 2014 and evaluated for vaccine immunogenicity.
Method: The participants will be assessed for genital warts and genital HPV infection. Type specific HPV DNA will be assessed using genital swabs and genital warts assessed through physical examination among sexually active participants at enrollment, month 6 \&12.
Among those that have not become sexually active, or that decline a genital exam, a self-collected swab will be requested. A sub-set of approximately 30 participants, will receive a booster dose of QHPV, from this subset, Peripheral Blood Mononuclear Cells (PBMC) and plasma samples will be collected at enrollment, at month 1 and month 12 to evaluate for memory B and T cell responses.
The total duration of study follow up will be 12 months.
- Conditions
- HPV Infection, HPV Vaccination
- Being tested
- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
- Keywords
- Genital HPV infection, quadrivalent HPV vaccination, HIV-infected, adolescents
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineDrug
Also called Gardasil-4
Gardasil
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent HPV Vaccine | Experimental | Gardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh Receives: Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Genital HPV infection
Number of participants with incident persistent genital infection with the QHPV specific serotypes: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes (31,33,35,39,45,51,52,56,58,59,66, 68,73)
Measured: Nine years after primary vaccination
Sustained QHPV vaccine specific antibody titers
Concentration of QHPV specific antibody titers (HPV -6, -11, -16 \& -18) nine years after primary vaccination
Measured: Nine years after primary vaccination
Secondary outcomes (1)
Immune memory following three doses of QHPV
B cell marker concentration following a booster 4th dose of QHPV
Measured: One month after booster vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start25 May 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quadrivalent HPV vaccine
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Nelly Mugo, University of Washington
- Investigators
- Nelly Mugo, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435209
- Sponsor's protocol ID
- STUDY00013326
- Status last verified
- Nov 2023
- First submitted
- 10 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Cohort Study to Assess Effectiveness and B-memory Response to the Quadrivalent HPV Vaccine 9 Years Post-vaccination Among HIV-Infected Boys and Girls Ages 9-14 Years in Kenya
- ClinicalTrials.gov ID
- NCT05435209
- Acronym / sponsor ID
- STUDY00013326
- Conditions
- HPV Infection, HPV Vaccination
- Keywords
- Genital HPV infection, quadrivalent HPV vaccination, HIV-infected, adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Jun 2022 (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 risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection.
Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection.
Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.
Detailed description
Background: Genital Human Papilloma Virus (HPV) infections occur rapidly after sexual debut, and immunosuppressed individuals are at greater risk for incident and persistent infection. HPV vaccine contains virus-like particles (VLP), which are highly immunogenic and induce a robust humoral response that has been demonstrated to confer long term protection from HPV infection and associated disease among HIV-uninfected individuals. The magnitude of type-specific vaccine induced neutralizing HPV antibody responses are diminished among HIV-infected compared to uninfected individuals.
There is no established minimum level of antibody that predicts protection against HPV infection or associated disease, the impact of lower antibody titers among HIV infected individuals on vaccine efficacy is unknown. The risk of HPV exposure persists throughout a person's sexual life and the duration of protection, especially when the vaccine is given in the early adolescent period is critical to vaccine effectiveness. Long lasting memory is characterized by memory B cells and long-lived plasma cells and a QHPV booster dose has demonstrated an anamnestic response among HIV-infected adolescents.
HPV efficacy and effectiveness data for HIV-uninfected individuals has informed the current World Health Organization (WHO) two-dose vaccine schedule. The field lacks data on effectiveness of three dose or two-dose for the HIV-infected adolescents. The current on-going research for single dose schedules gives urgency to the determination of long-term efficacy of three HPV vaccine 231 doses for the HIV-infected adolescent.
Investigators shall recall HIV-infected girls and boys who were previously vaccinated at ages 9-14 years with three doses of the quadrivalent vaccine (QHPV) in 2014 and evaluated for vaccine immunogenicity.
Method: The participants will be assessed for genital warts and genital HPV infection. Type specific HPV DNA will be assessed using genital swabs and genital warts assessed through physical examination among sexually active participants at enrollment, month 6 \&12.
Among those that have not become sexually active, or that decline a genital exam, a self-collected swab will be requested. A sub-set of approximately 30 participants, will receive a booster dose of QHPV, from this subset, Peripheral Blood Mononuclear Cells (PBMC) and plasma samples will be collected at enrollment, at month 1 and month 12 to evaluate for memory B and T cell responses.
The total duration of study follow up will be 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quadrivalent HPV vaccine
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent HPV Vaccine | Experimental | Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineGardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- HIV-infected
- enrolled previously and received received three doses of quadrivalent HPV- vaccine in 2014
Key exclusion criteria (3 listed)
- Decline re-enrollment
- unable to provide informed consent
- minor without parent or guardian consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineAlso: Gardasil-4Gardasil | Drug | Quadrivalent HPV Vaccine |
Primary outcome
Persistent Genital HPV infection
Time frame: Nine years after primary vaccination
Number of participants with incident persistent genital infection with the QHPV specific serotypes: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes (31,33,35,39,45,51,52,56,58,59,66, 68,73)
Sustained QHPV vaccine specific antibody titers
Time frame: Nine years after primary vaccination
Concentration of QHPV specific antibody titers (HPV -6, -11, -16 \& -18) nine years after primary vaccination
1 secondary outcome
Immune memory following three doses of QHPV
Time frame: One month after booster vaccine
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 29 Nov 2023.
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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.
Nelly Mugo, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine in people with HPV Infection and HPV Vaccination, run by University of Washington at 1 site in Kenya.
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 3 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 29 Nov 2023. 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 Kenya. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Persistent Genital HPV infection (time frame: Nine years after primary vaccination). The study lists 2 primary outcomes in all. 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 29 Nov 2023.