HIV InfectionsPhase 4GESIDA10017NCT03626467
A Clinical Trial to Evaluate the Immunogenicity of the Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017
A Phase 4 study testing HPV9v in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 3 sites in Spain.
Trial summary
Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM) Read more about this study
- Who is it for?
- Ages 18 to 36 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- HPV9v
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Oct 2018to 14 Jul 2021
- 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 18 to 36 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients able to give their written consent to participate in the study. (preferably in writing or, failing that, orally before independent witnesses of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment.
- Understand the purpose of the study and be available to perform the visits stipulated in the protocol.
- Be ≥18 years and <of 36 years.
- Patient with chronic infection with HIV-1.
- Viral HIV load <50 copies / ml and CD4> 200 cells / uL for at least the last six months.
- Transgender men or women who have had insertive or receptive anal sex with other men
Who cannot join
- Previous history of anal cancer.
- Have previously received any vaccine against HPV.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Ramón y Cajal
Madrid, 28034
Hospital Fundación Jimenez Díaz
Madrid
Hospital La Paz
Madrid
About this study
Official title: A Phase IV, Open-label, Multicenter and Single-arm on the Immunogenicity of Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017
Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM)
Read the detailed description
The investigators estimate that 166 participants will need to be included in the study to evaluate the immunogenicity of vaccine against human papillomavirus in men with HIV infection who have sex with men, by evaluating in two age groups and the seroconversion rate for each of the HPV genotypes included in the vaccine from baseline to month 7 and 24.
- Conditions
- HIV Infections
- Being tested
- HPV9v
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV9vBiological
Also called Gardasil9
Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Men infected by HIV who have sex with men Receives: Biological: HPV9v |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine
The HPV genotypes studied are: 6/11/16/18/31/33/45/52/58. The cut-off points to determine serological status 30, 16, 20, 24, 10, 8, 8, 8, and 8 units / mL for HPV genotypes 6, 11, 16, 18, 31, 33, 45, 52 , and 58, respectively
Measured: From basal until week 96
Secondary outcomes (8)
Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)
The low CD4 / CD8 ratio has been associated with immunosenescence in the serological response, such as worse immunogenicity and worse response to vaccines
Measured: From basal until week 96
Number and type of metabolites derived from the microbiota of patients
Detect biomarkers derived from microbiota and their relationship with the vaccine response
Measured: From basal until week 96
Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV
Measured: Basal, week 28 and week 96
The proportion of subjects experiencing adverse events
Adverse events
Measured: From basal until week 96
The proportion of subjects with a severe adverse experience
Adverse events
Measured: From basal until week 96
The proportion of subjects with an adverse experience leading to disruption
Adverse events
Measured: From basal until week 96
The proportion of subjects with an adverse experience related to medication
Adverse events
Measured: From basal until week 96
The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period
Adverse events
Measured: From basal until week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start15 Oct 2018
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A phase IV, open-label and single-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626467
- Sponsor's protocol ID
- GESIDA10017
- Acronym
- GESIDA10017
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2018
- Last updated
- 25 Aug 2023
- 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 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Multicenter and Single-arm on the Immunogenicity of Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017
- ClinicalTrials.gov ID
- NCT03626467
- Acronym / sponsor ID
- GESIDA10017 / GESIDA10017
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 13 Aug 2018 (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.
Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM)
Detailed description
The investigators estimate that 166 participants will need to be included in the study to evaluate the immunogenicity of vaccine against human papillomavirus in men with HIV infection who have sex with men, by evaluating in two age groups and the seroconversion rate for each of the HPV genotypes included in the vaccine from baseline to month 7 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A phase IV, open-label and single-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: HPV9vMen infected by HIV who have sex with men |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients able to give their written consent to participate in the study. (preferably in writing or, failing that, orally before independent witnesses of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment.
- Understand the purpose of the study and be available to perform the visits stipulated in the protocol.
- Be ≥18 years and <of 36 years.
- Patient with chronic infection with HIV-1.
- Viral HIV load <50 copies / ml and CD4> 200 cells / uL for at least the last six months.
Key exclusion criteria (2 listed)
- Previous history of anal cancer.
- Have previously received any vaccine against HPV.
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 |
|---|---|---|
| HPV9vAlso: Gardasil9Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24 | Biological | Arm 1 |
Primary outcome
Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine
Time frame: From basal until week 96
The HPV genotypes studied are: 6/11/16/18/31/33/45/52/58. The cut-off points to determine serological status 30, 16, 20, 24, 10, 8, 8, 8, and 8 units / mL for HPV genotypes 6, 11, 16, 18, 31, 33, 45, 52 , and 58, respectively
8 secondary outcomes
Number of participants with low CD4 / CD8 ratio (<0.5) and normal ratio (> 1)
Time frame: From basal until week 96
Number and type of metabolites derived from the microbiota of patients
Time frame: From basal until week 96
Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV
Time frame: Basal, week 28 and week 96
The proportion of subjects experiencing adverse events
Time frame: From basal until week 96
The proportion of subjects with a severe adverse experience
Time frame: From basal until week 96
The proportion of subjects with an adverse experience leading to disruption
Time frame: From basal until week 96
The proportion of subjects with an adverse experience related to medication
Time frame: From basal until week 96
The proportion of subjects experiencing adverse events related to laboratory values at any time during the study period
Time frame: From basal until week 96
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 25 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HPV9v in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 3 sites in Spain.
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 6 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Percentage of subjects who serocovertize for each of the HPV genotypes included in the vaccine (time frame: From basal until week 96). 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 25 Aug 2023.