NCT02236234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

April 17, 2014

Last Update Submit

September 9, 2014

Conditions

Infection

Keywords

HIVHPVClinical trialoutcome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Vaccine

EXPERIMENTAL

one group with HPV vaccine

Biological: HPV vaccine

Interventions

HPV vaccineBIOLOGICAL

HPV vaccine

Also known as: cerverix
Vaccine

Eligibility Criteria

Age35 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Current or previous infection with human papillomavirus (HPV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Tropical Medicine of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Infections

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • jorge casseb, phD

    USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 17, 2014

First Posted

September 10, 2014

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

September 10, 2014

Record last verified: 2014-09

Locations

BR(1)