Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01092611

Collaborator

(none)

190

Enrollment

Locations

Arms

49.9

Actual Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

Condition or Disease	Intervention/Treatment	Phase
AIDS	Procedure: Blood collection Biological: GSK HIV vaccine 732462	Phase 1

Detailed Description

General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

Study Design

Study Type:

Interventional

Actual Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

Actual Study Start Date :

Mar 22, 2010

Actual Primary Completion Date :

Mar 17, 2014

Actual Study Completion Date :

May 19, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Group A Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study	Procedure: Blood collection Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick. Biological: GSK HIV vaccine 732462 No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
Other: Group B Subjects who were administered placebo in primary studies and who accepted to participate in this study	Procedure: Blood collection Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

Arm

Intervention/Treatment

Other: Group A

Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study

Procedure: Blood collection

Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

Biological: GSK HIV vaccine 732462

No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.

Other: Group B

Subjects who were administered placebo in primary studies and who accepted to participate in this study

Procedure: Blood collection

Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

Outcome Measures

Primary Outcome Measures

Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification) [Once a year after Visit 1 (during a maximum of 4 years)]
CD4 count [Once a year after Visit 1 (during a maximum of 4 years)]
Viral load (VL) and method of measurement [Once a year after Visit 1 (during a maximum of 4 years)]
Occurrence of HIV disease progression [Once a year after Visit 1 (during a maximum of 4 years)]
Occurrence of each separate defining condition for HIV-disease progression [Once a year after Visit 1 (during a maximum of 4 years)]
Occurrence of specific clinical events and death [Once a year after Visit 1 (during a maximum of 4 years)]
Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study) [Once a year after Visit 1 (during a maximum of 4 years)]
Occurrence of potential immune-mediated diseases (pIMDs) [Once a year after Visit 1 (during a maximum of 4 years)]
Occurrence of SAEs related to study participation [Once a year after Visit 1 (during a maximum of 4 years)]

Secondary Outcome Measures

Time between dose 1 and ART (re)-initiation or ART modification [Once a year after Visit 1 (during a maximum of 4 years)]
Time between dose 1 and CD4 count measurement [Once a year after Visit 1 (during a maximum of 4 years)]
Time between dose 1 and VL measurement [Once a year after Visit 1 (during a maximum of 4 years)]
Time between dose 1 and occurrence of HIV disease progression [Once a year after Visit 1 (during a maximum of 4 years)]
Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression [Once a year after Visit 1 (during a maximum of 4 years)]
Antibody concentrations to vaccine antigens [Once a year after Visit 1 (during a maximum of 4 years)]
Cell-mediated immunity responses [Once a year after Visit 1 (during a maximum of 4 years)]
Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays) [Once a year after Visit 1 (during a maximum of 4 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

HIV-infected subject.
Previous participation in a study evaluating GSK HIV vaccine 732462.
Written informed consent obtained from the subject.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Subjects who did not receive a complete vaccination course in previous studies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bakersfield	California	United States	93301
2	GSK Investigational Site	Fort Lauderdale	Florida	United States	33308
3	GSK Investigational Site	Orlando	Florida	United States	32803
4	GSK Investigational Site	Omaha	Nebraska	United States	68198
5	GSK Investigational Site	Camden	New Jersey	United States	08103
6	GSK Investigational Site	Columbus	Ohio	United States	43210
7	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
8	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19107
9	GSK Investigational Site	Dallas	Texas	United States	75246
10	GSK Investigational Site	Annandale	Virginia	United States	22003
11	GSK Investigational Site	Seattle	Washington	United States	98104
12	GSK Investigational Site	Bobigny		France	93009
13	GSK Investigational Site	Créteil		France	94010
14	GSK Investigational Site	Nantes		France	44093
15	GSK Investigational Site	Paris Cedex 10		France	75475
16	GSK Investigational Site	Paris Cedex 12		France	75571
17	GSK Investigational Site	Paris Cedex 13		France	75651
18	GSK Investigational Site	Paris cedex 15		France	75908
19	GSK Investigational Site	Paris Cedex 20		France	75970
20	GSK Investigational Site	Paris		France	75018
21	GSK Investigational Site	Paris		France	75679
22	GSK Investigational Site	Freiburg	Baden-Wuerttemberg	Germany	79106
23	GSK Investigational Site	Erlangen	Bayern	Germany	91054
24	GSK Investigational Site	Muenchen	Bayern	Germany	80331
25	GSK Investigational Site	Muenchen	Bayern	Germany	80335
26	GSK Investigational Site	Muenchen	Bayern	Germany	80801
27	GSK Investigational Site	Muenchen	Bayern	Germany	81371
28	GSK Investigational Site	Bochum	Nordrhein-Westfalen	Germany	44791
29	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45122
30	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50937
31	GSK Investigational Site	Berlin		Germany	12157
32	GSK Investigational Site	Berlin		Germany	13353
33	GSK Investigational Site	Hamburg		Germany	20095
34	GSK Investigational Site	Hamburg		Germany	20246
35	GSK Investigational Site	Badalona		Spain	08916
36	GSK Investigational Site	Barcelona		Spain	08036
37	GSK Investigational Site	Barcelona		Spain	08907
38	GSK Investigational Site	Madrid		Spain	28034
39	GSK Investigational Site	Madrid		Spain	28041
40	GSK Investigational Site	Móstoles, Madrid		Spain	28935
41	GSK Investigational Site	Valencia		Spain	46014

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01092611

Other Study ID Numbers:

114083
2009-018097-64

First Posted:

Mar 25, 2010

Last Update Posted:

Mar 2, 2018

Last Verified:

Mar 1, 2018

Keywords provided by GlaxoSmithKline

long-term follow-up study

HIV-infected subjects

HIV therapeutic vaccine

Study Results

No Results Posted as of Mar 2, 2018