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

NCT ID: NCT02236234

Last Updated: 2014-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaccine

one group with HPV vaccine

Group Type EXPERIMENTAL

HPV vaccine

Intervention Type BIOLOGICAL

HPV vaccine

Interventions

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HPV vaccine

HPV vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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cerverix

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Current or previous infection with human papillomavirus (HPV)
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jorge Casseb

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jorge casseb, phD

Role: PRINCIPAL_INVESTIGATOR

USP

Locations

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Institute of Tropical Medicine of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FAPESP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010/07076-4

Identifier Type: -

Identifier Source: org_study_id

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