Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Presence of Anti-HPV antibody titers
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men with age between 35 and 45 years of age.
Exclusion Criteria
- •Current or previous infection with human papillomavirus (HPV)
Outcomes
Primary Outcomes
Presence of Anti-HPV antibody titers
Time Frame: 0, 30 and 180 days of vaccination anti-HPV
The anti-HPV titers will be compared from baseline to the date of sample collection
Secondary Outcomes
No secondary outcomes reported
Investigators
Jorge Casseb
PI
University of Sao Paulo