Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018097-64 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study |
|
| Group B | Other | Subjects who were administered placebo in primary studies and who accepted to participate in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bakersfield | California | 93301 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29606517 | Derived | Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30. |
| Label | URL |
|---|---|
| Results for study 114083 can be found on the GSK Clinical Study Register | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GSK HIV vaccine 732462 | Biological | No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies. |
|
| 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) |
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198 | United States |
| GSK Investigational Site | Camden | New Jersey | 08103 | United States |
| GSK Investigational Site | Columbus | Ohio | 43210 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Annandale | Virginia | 22003 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Bobigny | 93009 | France |
| GSK Investigational Site | Créteil | 94010 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Paris | 75571 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Paris | 75908 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Erlangen | Bavaria | 91054 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80331 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80335 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80801 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81371 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Hamburg | 20095 | Germany |
| GSK Investigational Site | Hamburg | 20246 | Germany |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Móstoles, Madrid | 28935 | Spain |
| GSK Investigational Site | Valencia | 46014 | Spain |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided