Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Infection

Treatments: Biological: HPV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02236234

FAPESP (Other Identifier)

2010/07076-4

Details and patient eligibility

About

Besides the specific response to vaccine antigens, the investigators will analyze the anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess the range of the count with the highest possibility of vaccine response. Thus, knowledge of vaccine response in HIV-infected patients, indicate which patients would have greater potential for vaccine response in vivo.

Full description

The study will be divided into three groups. Patients with HIV-1 infection will be subdivided into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells count and bellow 500 CD4 T cells count. A healthy control group will be also studied.

Enrollment: 30 patients

Sex: Male

Ages: 35 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: HIV

• Men with age between 35 and 45 years of age.

Exclusion Criteria:

• Current or previous infection with human papillomavirus (HPV)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Vaccine

Experimental group

Description:

one group with HPV vaccine

Treatment:

Biological: HPV vaccine