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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02236234
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Information provided by (Responsible Party):
Jorge Casseb, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Infection Biological: HPV vaccine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Vaccine
one group with HPV vaccine
Biological: HPV vaccine
HPV vaccine
Other Name: cerverix

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: HIV

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

Exclusion Criteria:

  • Current or previous infection with human papillomavirus (HPV)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02236234

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Institute of Tropical Medicine of Sao Paulo
Sao Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
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Principal Investigator: jorge casseb, phD USP

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Responsible Party: Jorge Casseb, PI, University of Sao Paulo Identifier: NCT02236234     History of Changes
Other Study ID Numbers: 2010/07076-4
FAPESP ( Other Grant/Funding Number: 2010/07076-4 )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by Jorge Casseb, University of Sao Paulo:
Clinical trial

Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs