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

Infection Clinical Trial

— HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236234
• Other study ID #: 2010/07076-4
• Secondary ID: FAPESP
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2014
• Last updated: September 9, 2014
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria: HIV

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

Exclusion Criteria:

• Current or previous infection with human papillomavirus (HPV)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Biological:
• HPV vaccine
HPV vaccine

Locations

Country	Name	City	State
Brazil	Institute of Tropical Medicine of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Anti-HPV antibody titers	The anti-HPV titers will be compared from baseline to the date of sample collection	0, 30 and 180 days of vaccination anti-HPV	No