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

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.

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Key information

Conditions

Infection Infections

Age range

35 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Tropical Medicine of Sao Paulo

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV

Men with age between 35 and 45 years of age.

Exclusion criteria

Current or previous infection with human papillomavirus (HPV)

Treatment and study plan

HPV vaccine

Biological

HPV vaccine

Other names: cerverix

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Acronym: HPV

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Sep 10, 2014
Registry last updated: Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed