HIV Long-Term Survivors
Conditions
Interventions
This is a prospective, longitudinal cohort study with 4 arms to evaluate the humoral and cellular immune response in HIV-infected patients at early and chronic stages followed at the Ambulatory of Sec
group 3 receives a single dose of PCV-13 with initial collection. Follow-up blood collections occur at T-60, T-365, and T-730, with all biological collections ending on May 15, 2026. Blood samples inv
0.35 µg/mL. Statistical analyses will employ Generalized Estimating Equations (GEE) models and post-hoc power analysis to compensate for the sample size adjustment.
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Serviço de Atendimento Especializado (SAE) Carlos Cruz
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: HIV-infected patients confirmed by confirmatory tests (Western-Blott and/or HIV polymerase chain reaction viral load) who are of any gender identity. Being in regular use of highly effective antiretroviral, according to the definitions of the Ministry of Health, for at least four weeks. Minimum age 18 years old. Signature of the Free and Informed Consent Form (Appendix A) . For the control group: negative quick test for HIV
Exclusion criteria
Exclusion criteria: Patient with a history of anaphylactic reaction to pneumococcal conjugate vaccines (PCV-7, PCV-10 or PCV-13) or 23-valent pneumococcal polysaccharide vacines. Previous vaccination with PCV-7, PCV-10, PCV-13 (interference in the evaluation of the pre-vaccination humoral immune response). Have been vaccinated with PPV-23 less than 1 year ago. Transfusion of blood components or Immunoglobulins in the last 28 days before vaccination with PCV-13 or PPV-23. Blood dyscrasias that prevent intramuscular vaccine application; Fever in the last 24 hours before vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the group with chronic immune activation due to human immunodeficiency virus (HIV) will present anti-pneumococcal IgG antibody concentrations (specific to serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) approximately 20-30% lower than those observed in groups without chronic immune activation and the control group (non-HIV). This analysis will be performed using multiplex immunoassay (Luminex), a methodology that replaces the originally planned ELISA to provide higher analytical sensitivity for the final cohort of 99 individuals. Scientific integrity and the statistical power of the comparisons will be maintained through the use of Generalized Estimating Equations (GEE) models and post-hoc power analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
BR
Contacts
Public ContactNajara Nascimento
Laboratório de Investigação Médica 56 da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed