Men
Conditions
Interventions
Experimental group - A total of 100 HIV-positive men aged 18-45 who agree to participate in the study will be screened for the production of protective antibodies after the HPV vaccine. In this case t
will subsequently receive the quadrivalent HPV vaccine in a 3-dose regimen (0,2,6)
and at the 7th month or 1 month after the 3rd dose a blood sample will be collected for antibody testing.
Control group - A total of 100 HIV-seronegative men between the ages of 18-45 who agree to pa
and at the 7th month or 1 month after the 3rd dose a blood sample will be collected for antibody testing.
Both groups will be randomly selected through the Ministry of Health's SI-PNI program.
Biological/vaccine
Genetics
E01.370.225.998.110.625
Sponsors
Infant Care Serviços medicos LTDA
Infant Care Serviços medicos LTDA
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Man with confirmed serological diagnosis of HIV; men aged 18-45 years; men attended at the Center for Infectious and Parasitic Diseases of the Municipal Secretariat of Campos dos Goytacazes; Accept participation in the study; complete the three doses of the quadrivalent HPV vaccine in the dosage regimen offered
Exclusion criteria
Exclusion criteria: Do not agree to participate in the study; abandonment of research; individuals who do not complete the 3 doses of the vaccine; individuals treated at another infectious disease center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presentation of expected outcome: The expected outcome is the elevation of HPV antibody titers after vaccination in both groups for the types of HPV contained in the vaccine Method Used - For this outcome a most commonly used Laboratory Test for the determination of HPV-specific antibodies derived from vaccines or naturally derived is the virus-like enzyme-linked immunosorbent assay (VLP-ELISA). This test will be used one month after the last dose of the vaccine Parameter presentation - A mean reduction of 25% of HPV (GMT) Geometric mean titers for the 4 types of HPV contained in the vaccine in the M1 (HIV positive) group compared to the M2 group (HIV negative) ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Presentation of the expected outcome - Differential analysis of the protective efficacy of the HPV vaccine to protect against low grade and high grade lesions of the HIV positive (M1) group in relation to HIV negative (M2) Method used - by analyzing the humoral response by the production of neutralizing antibodies against HPV and by analyzing the cellular response through virus whitening from inside the virus infected cells. This outcome will be analyzed in conjunction with the analysis of vaccine antibodies. The analysis of this outcome will occur from 1 month after the last dose of the vaccine in the candidates. Presentation of the parameters to be analyzed - in HIV negative patients, the humoral response of expected efficacy and at least two to seven times the basal level of protective antibodies against HPV, generating a protective efficacy of at least 95%; In HIV-positive patients a considerable reduction in protective efficacy is expected due to factors related to HIV immunosuppression | — |
Countries
Brazil
Contacts
Public ContactCharbell Hadadd Kury
Infant Care Serviços medicos LTDA
Outcome results
None listed