HPV VaccineNCT04711265
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
An observational study of HPV Vaccine and HPV Infection, run by Kenya Medical Research Institute at 1 site in Kenya.
Trial summary
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- HPV Vaccine, HPV Infection, HIV-1-infection
- What is being tested?
- Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 176 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2015to Jan 2019
- 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 9 to 14 years
- All sexes
- Child
Study population: HIV-1 infected boys and girls who had received 3 doses of QHPV vaccine
Who may be able to join
- receipt of 3 doses of QHPV vaccine
- participated in primary immunogenicity study
- consent/assent with parental consent for participants age <18 years
- willing to continue extended follow up for 36 months
Who cannot join
- decline consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.
Read the detailed description
We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.
- Conditions
- HPV Vaccine, HPV Infection, HIV-1-infection
- Being tested
- Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
- Keywords
- HPV Vaccine, HIV infection, Adolescents, Africa
- Medical subject headings
- Papillomavirus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle VaccineDrug
Also called QHPV vaccine
Intramuscular injection with 3 doses of QHPV
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papillomavirus Antibody Titers
Geometric mean titers for HPV type -6, -11, -16 and -18
Measured: 48 months
Secondary outcomes (2)
HIV RNA viral load
Impact of HIV RNA viral load on HPV antibody response
Measured: 48 months
CD 4 cell count
Impact of immune status on HPV antibody response
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study startSep 2015
- Primary completionNov 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV VaccineStudies of the same condition, open and under way.
- 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenya Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Nelly Rwamba Mugo, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711265
- Sponsor's protocol ID
- KENYAMRI
- Status last verified
- Jan 2021
- First submitted
- 8 Dec 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya
- ClinicalTrials.gov ID
- NCT04711265
- Acronym / sponsor ID
- KENYAMRI
- Conditions
- HPV Vaccine, HPV Infection, HIV-1-infection
- Keywords
- HPV Vaccine, HIV infection, Adolescents, Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Kenya Medical Research InstituteUniversity, hospital or other
- Collaborators
- University of Washington, Merck Sharp & Dohme LLC
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 15 Jan 2021 (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.
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.
Detailed description
We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- HIV-1 infected boys and girls who had received 3 doses of QHPV vaccine
Key inclusion criteria (4 listed)
- receipt of 3 doses of QHPV vaccine
- participated in primary immunogenicity study
- consent/assent with parental consent for participants age <18 years
- willing to continue extended follow up for 36 months
Key exclusion criteria (1 listed)
- decline 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 HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle VaccineAlso: QHPV vaccineIntramuscular injection with 3 doses of QHPV | Drug | – |
Primary outcome
Human Papillomavirus Antibody Titers
Time frame: 48 months
Geometric mean titers for HPV type -6, -11, -16 and -18
2 secondary outcomes
HIV RNA viral load
Time frame: 48 months
CD 4 cell count
Time frame: 48 months
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 15 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for HPV Vaccine
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
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.
The record lists no contact. Use the official record to reach the sponsor.
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 HPV Vaccine and HPV Infection, run by Kenya Medical Research Institute 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 4 inclusion and 1 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 15 Jan 2021. 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.
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?
Human Papillomavirus Antibody Titers (time frame: 48 months). 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 15 Jan 2021.