Human PapillomavirusNCT01446718
A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years
An observational study of Human Papillomavirus and HIV-1 Infection, run by Kenya Medical Research Institute.
Trial summary
The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Human Papillomavirus, HIV-1 Infection
- What is being tested?
- Gardasil vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2014to 30 Jun 2018
- 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
- No healthy volunteers
- Child
Study population: Study participants will be enrolled from the paediatric HIV-care clinic
Who may be able to join
- HIV-infected
- age 9-14 years
- guardian/parental consent
Who cannot join
- Participants will be excluded if they
- are severely ill as defined by Karnofsky <70
- have a diagnosis of malignancy
- on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection
- have received systemic corticosteroids within prior one year
- have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks
Show all 10Show fewer
- have history of allergy to any products included in the HPV vaccine
- have received any of blood derivatives within prior 6 months
- are pregnant
- lack parental consent and/or parent declines to provide assent
About this study
Official title: A Longitudinal Observational Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 9-14 Years in Kenya
The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine.
Read the detailed description
HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have a 2-22 fold increased risk for cervical cancer compared to uninfected women. The quadrivalent HPV vaccine marketed as "Gardasil" has demonstrated efficacy against type specific HPV infections known to cause 70% cervical cancer (HPV 16 \& 18) and HPV 6 \& 11 known to cause 90% of anogenital warts in populations of HIV negative young women.
Since the risk of HPV exposure persists throughout a person's sexual life, the duration of protection, especially when the vaccine is given in the pre-adolescent period, is critical to overall vaccine effectiveness. Extended follow up of HIV-uninfected individuals has shown sustained response to HPV vaccine for 8.4 and 6 years respectively to the bivalent and quadrivalent vaccines. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.
Data on immunogenicity of the HPV vaccine among HIV infected adolescents is limited to a 12 month follow up period.
Current HPV vaccine guidelines target pre-sexual adolescents. Since the risk of HPV exposure persists throughout an individual's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. Duration of sustained HPV 6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the need for booster dosing.
The investigators therefore propose to extend follow up of 179 girls and boys in Kenya, age 9-14 years who have received 3 doses of the quadrivalent 'Gardasil' vaccine and assess for immunogenicity annually.
Study Location: Partners in Prevention, Thika site
- Conditions
- Human Papillomavirus, HIV-1 Infection
- Being tested
- Gardasil vaccine
- Keywords
- quadrivalent vaccine, Human Papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil vaccineBiological
Also called Gardasil
0.5ml of intramuscular vaccine in three doses
| Study group | Role | What they receive |
|---|---|---|
| Gardasil Vaccine | This is an extension of follow up for participants who received 3 doses of Gardasil vaccine in the "Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-Infected Pre-Adolescent Girls and Boys in Kenya" study. Receives: Biological: Gardasil vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune response to vaccine specific HPV types
antibody response to HPV type 6, 11, 16, 18 measured by cLIA
Measured: 48 months
Secondary outcomes (1)
immune response to vaccine specific HPV types
HPV infection among sexually active HIV infected adolescents
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 posted5 Oct 2011 (estimated)
- Study start15 Dec 2014
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies 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
- 179 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
- Investigators
- Nelly R Mugo, MMed, MPH, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446718
- Sponsor's protocol ID
- (MISP)IISP 51802
- Status last verified
- Jul 2019
- First submitted
- 30 Sep 2011
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Observational Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 9-14 Years in Kenya
- ClinicalTrials.gov ID
- NCT01446718
- Acronym / sponsor ID
- (MISP)IISP 51802
- Conditions
- Human Papillomavirus, HIV-1 Infection
- Keywords
- quadrivalent vaccine, Human Papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Kenya Medical Research InstituteUniversity, hospital or other
- Collaborators
- University of Washington, Merck Sharp & Dohme LLC
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 5 Oct 2011 (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.
The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine.
Detailed description
HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have a 2-22 fold increased risk for cervical cancer compared to uninfected women. The quadrivalent HPV vaccine marketed as "Gardasil" has demonstrated efficacy against type specific HPV infections known to cause 70% cervical cancer (HPV 16 \& 18) and HPV 6 \& 11 known to cause 90% of anogenital warts in populations of HIV negative young women.
Since the risk of HPV exposure persists throughout a person's sexual life, the duration of protection, especially when the vaccine is given in the pre-adolescent period, is critical to overall vaccine effectiveness. Extended follow up of HIV-uninfected individuals has shown sustained response to HPV vaccine for 8.4 and 6 years respectively to the bivalent and quadrivalent vaccines. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.
Data on immunogenicity of the HPV vaccine among HIV infected adolescents is limited to a 12 month follow up period.
Current HPV vaccine guidelines target pre-sexual adolescents. Since the risk of HPV exposure persists throughout an individual's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. Duration of sustained HPV 6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the need for booster dosing.
The investigators therefore propose to extend follow up of 179 girls and boys in Kenya, age 9-14 years who have received 3 doses of the quadrivalent 'Gardasil' vaccine and assess for immunogenicity annually.
Study Location: Partners in Prevention, Thika site
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gardasil Vaccine | – | Biological: Gardasil vaccineThis is an extension of follow up for participants who received 3 doses of Gardasil vaccine in the "Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-Infected Pre-Adolescent Girls and Boys in Kenya" study. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study participants will be enrolled from the paediatric HIV-care clinic
Key inclusion criteria (3 listed)
- HIV-infected
- age 9-14 years
- guardian/parental consent
Key exclusion criteria (10 listed)
- Participants will be excluded if they
- are severely ill as defined by Karnofsky <70
- have a diagnosis of malignancy
- on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection
- have received systemic corticosteroids within prior one year
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 |
|---|---|---|
| Gardasil vaccineAlso: Gardasil0.5ml of intramuscular vaccine in three doses | Biological | Gardasil Vaccine |
Primary outcome
immune response to vaccine specific HPV types
Time frame: 48 months
antibody response to HPV type 6, 11, 16, 18 measured by cLIA
1 secondary outcome
immune response to vaccine specific HPV types
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 5 Jul 2019.
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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 R Mugo, MMed, MPH principal investigator
Kenya Medical Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus and HIV-1 Infection, run by Kenya Medical Research Institute.
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 3 inclusion and 10 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
immune response to vaccine specific HPV types (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 5 Jul 2019.