HPVPhase 3NCT01512784
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
A Phase 3 study testing Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) in people with HPV and HIV, run by University of Milan at 1 site in Italy.
Trial summary
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. Read more about this study
- Who is it for?
- Ages 13 to 27 yearsHealthy volunteers can take part
- What is being tested?
- Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Jul 2013
- Phase
- Phase 3
- 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 13 to 27 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For both HIV-infected and healthy subjects:
- Subjects aged 13-27 years, females and males
- Written informed consent from parent or guardian if applicable (age<18 years)
- For HIV-infected subjects:
- HIV-positive
- Asymptomatic subjects (generalized lymphadenopathy is accepted)
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- Lymphocyte CD4+ count > or equal to 350 cells/mm3
- For subjects receiving HAART:
- Good compliance to therapy
- At least two suppressed viral loads HIV-RNA (<37copies/ml9 during 6 months prior to enrollment.
Who cannot join
- For female subjects (both HIV-infected and healthy)
- Pregnancy or breastfeeding
- Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.
- For both females and males (HIV-infected and healthy):
- Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry.
- History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component.
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- Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:
- Acute infection requiring therapy or fever at time of enrollment
- Chronic autoimmune or oncologic disease receiving chemotherapy
- Concomitant therapies (other than HAART):
- Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.
- Use of investigational agents within 4 weeks prior to study enrollment.
- Current drug or alcohol use or dependence.
- Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.
Trial locations and contacts
1 site in 1 country.
Gian Vincenzo Zuccotti, Head Paediatric Department contact
Italy1 site, 1 recruiting
- Recruiting
Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
Milan, Italy, 20157
Francesca Penagini, Doctor, 0039/02/39042234, frapenagini@tiscali.it
Alessandra Viganò, Paediatrician
About this study
Official title: Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults vs. Healthy Adolescents and Young Adults: Non-randomized Controlled Clinical Trial
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.
- Being tested
- Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)
- Keywords
- Quadrivalent Human Papillomavirus Vaccine (HPV) Gardasil, HIV infection, Evaluation of quadrivalent HPV vaccine in adolescents and young adults.
- 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 Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)Biological
Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).
Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:
First dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.
Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:
Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms.
Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)Biological
Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).
Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:
first dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.
Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:
Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected adolescents and young adults | Experimental | female and male HIV-infected subjects aged from 13-27 years old Receives: Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) |
| healthy adolescents and young adults | Active comparator | female and male healthy adolescents and young adults aged 13-27 years Receives: Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects
Immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) will be assessed by evaluation of type-specific antibody development for HPV types 6, 11, 16 and 18 from seronegative status at baseline (T0) to seropositive status at one month after the completion of HPV vaccine series (T3), compared with the same immunogenicity testings performed in healthy subjects matched for sex and age.
Measured: one month +/- 10 days after 3° vaccine dose
Secondary outcomes (5)
antibody HPV titers to types 6, 11, 16 and 18, one month after the first two vaccination series (T1 and T2) in HIV-infected subjects vs healthy subjects
Antibody titers for HPV types 6, 11, 16 and 18 will be evaluated one month after the first (T1) and second (T2) vaccination dose in HIV-infected adolescents and young adults compared with the same immunological testings in healthy adolescents and young adults.
Measured: one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose
antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0).
To assess long-term immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil® in HIV-infected and healthy subjects by evaluation of persistence of HPV antibody titers to types 6, 11, 16 and 18 at month 12 (T4) and 18(T5) from baseline (T0).
Measured: 12 months +/- 10 days and 18 months +/-10 days from baseline
local and systemic adverse events
Safety and tolerability of three doses of quadrivalent human papillomavirus vaccine (Gardasil ®) in HIV-infected and healthy subjects will be assessed by evaluating the occurrence and severity of local and systemic adverse events during the 7 days after each vaccination dose.
Measured: 7 days after each vaccination dose
HIV viral load and lymphocyte CD4+ count
Longitudinal monitoring of HIV-viral load and lymphocyte CD4+ count will be conducted in HIV-infected subjects from baseline (T0), throughout the study: one month after each vaccination dose (T1, T2, T3) and at month 12 and 18 from baseline (T4, T5).
Measured: baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations
To evaluate in a subgroup of subjects (20 HIV-infected and 20 healthy) the following immunological parameters at baseline and at 1 month after 1° vaccination dose (T1) and at 1 month after 3° vaccination dose (T3):
lymphoproliferative responses to HPV-16 L1 from PBMCs in peripheral blood
Immunophenotype analysis of lymphocyte subpopulations in peripheral blood
Cytokine production from peripheral lymphocyte subpopulations at baseline and after stimulation with HPV-16 recombinant protein L1.
Measured: baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Vincenzo Zuccotti, University of Milan
- Investigators
- Gian Vincenzo Zuccotti, Head of Paediatric Department, Principal investigator, L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512784
- Sponsor's protocol ID
- HLS04/2011
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults vs. Healthy Adolescents and Young Adults: Non-randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01512784
- Acronym / sponsor ID
- HLS04/2011
- Keywords
- Quadrivalent Human Papillomavirus Vaccine (HPV) Gardasil, HIV infection, Evaluation of quadrivalent HPV vaccine in adolescents and young adults.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 19 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.
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected adolescents and young adults | Experimental | Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)female and male HIV-infected subjects aged from 13-27 years old |
| healthy adolescents and young adults | Active comparator | Biological: Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)female and male healthy adolescents and young adults aged 13-27 years |
Who may qualify
- Ages
- 13 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- For both HIV-infected and healthy subjects:
- For HIV-infected subjects:
- For subjects receiving HAART:
Key exclusion criteria (15 listed)
- For female subjects (both HIV-infected and healthy)
- Pregnancy or breastfeeding
- Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.
- For both females and males (HIV-infected and healthy):
- Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry.
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 (6, 11, 16 and 18) vaccine (Gardasil ®)Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed). Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule: First dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1. Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately: Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms. | Biological | HIV-infected adolescents and young adults |
| Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed). Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule: first dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1. Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately: Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms. | Biological | healthy adolescents and young adults |
Primary outcome
type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects
Time frame: one month +/- 10 days after 3° vaccine dose
Immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) will be assessed by evaluation of type-specific antibody development for HPV types 6, 11, 16 and 18 from seronegative status at baseline (T0) to seropositive status at one month after the completion of HPV vaccine series (T3), compared with the same immunogenicity testings performed in healthy subjects matched for sex and age.
5 secondary outcomes
antibody HPV titers to types 6, 11, 16 and 18, one month after the first two vaccination series (T1 and T2) in HIV-infected subjects vs healthy subjects
Time frame: one month +/- 10 days after 1°vaccine dose and month+/- 10 days after 2° vaccine dose
antibody titers to HPV types 6, 11, 16 and 18 at month 12(T4)and 18 (T5)from baseline (T0).
Time frame: 12 months +/- 10 days and 18 months +/-10 days from baseline
local and systemic adverse events
Time frame: 7 days after each vaccination dose
HIV viral load and lymphocyte CD4+ count
Time frame: baseline (T0), one month after each vaccination dose (T1, T2 and T3) and at month 12 (T4) and 18 (T5) from baseline.
lymphoproliferative responses, cytokine production and immunophenotype analysis of lymphocyte subpopulations
Time frame: baseline (T0), one month after 1° vaccination dose (T1) and one month after 3° vaccination dose (T3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Gian Vincenzo Zuccotti, Head Paediatric Department contact
Gian Vincenzo Zuccotti, Head of Paediatric Department principal investigator
L.Sacco Hospital, via G.B Grassi, 74 20157 Milano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®) in people with HPV and HIV, run by University of Milan at 1 site in Italy.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Jan 2012. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gian Vincenzo Zuccotti, Head Paediatric Department (0039/02/39042253, gianvincenzo.zuccotti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type specific antibody titers for HPV types 6, 11, 16 and 18 at one month after completion of HPV vaccine series (T3) in HIV infected subjects vs. healthy subjects (time frame: one month +/- 10 days after 3° vaccine dose). 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 19 Jan 2012.