Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Men infected by HIV who have sex with men |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV9v | Biological | Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From basal until week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From basal until week 96 |
| Number and type of metabolites derived from the microbiota of patients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón y Cajal | Madrid | 28034 | Spain | |||
| Hospital Fundación Jimenez Díaz |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2024 | |
| Reset | Oct 4, 2024 | |
| Release | Feb 28, 2025 |
Not provided
A phase IV, open-label and single-arm clinical trial
Not provided
Not provided
Not provided
Not provided
Detect biomarkers derived from microbiota and their relationship with the vaccine response |
| From basal until week 96 |
| Percentage of participants <26 years and ≥ 26 years with persistent anal infection due to HPV | Basal, week 28 and week 96 |
| The proportion of subjects experiencing adverse events | Adverse events | From basal until week 96 |
| The proportion of subjects with a severe adverse experience | Adverse events | From basal until week 96 |
| The proportion of subjects with an adverse experience leading to disruption | Adverse events | From basal until week 96 |
| The proportion of subjects with an adverse experience related to medication | Adverse events | 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 | From basal until week 96 |
| Madrid |
| Spain |
| Hospital La Paz | Madrid | Spain |
| Reset | Mar 24, 2025 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2024 | Oct 4, 2024 | |||
| Feb 28, 2025 | Mar 24, 2025 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided