Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons

NCT01218113 | Completed Phase 2 Results

• 1 other identifier: 111679
• Study Type: interventional
• Target: 191
• Locations: 4 countries
• Sites: 42

Brief Summary

This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

Conditions

AIDS

Keywords

Human Immunodeficiency Virus (HIV)-1; safety; vaccine; immunogenicity; reactogenicity; HIV infection

Outcome Measures

Primary Outcomes (23)

• Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline

  Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter \[copies/mL\]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.

  At Week 48, post-Dose 3

• Geometric Mean Change in HIV-1 VL From Baseline

  Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.

  At Week 48, post-Dose 3

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

  During the 7-day (Days 0-6) period following Dose 1

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

  During the 7-day (Days 0-6) period following Dose 2

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

  During the 7-day (Days 0-6) period following Dose 3

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.

  During the 7-day (Days 0-6) post-vaccination period, across doses

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

  During the 7-day (Days 0-6) period following Dose 1

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

  During the 7-day (Days 0-6) period following Dose 2

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

  During the 7-day (Days 0-6) period following Dose 3

• Number of Subjects With Solicited General Symptoms

  Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)\&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social\&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination

  During the 7-day (Days 0-6) post-vaccination period, across doses

• Number of Subjects With Unsolicited Adverse Events (AEs)

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.

  During the 28-Day (Days 0-27) period following Dose 1 and Dose 2

• Number of Subjects With Unsolicited AEs

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 3 and across doses.

  During the 28-Day (Days 0-27) post-vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  During the entire study period (up to Week 48)

• Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs)

  Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

  During the entire study period (up to Week 48)

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Screening

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  Pre-vaccination, at Week 0

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 4

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 6

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 16

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 28

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 30

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 38

• Number of Subjects With Abnormal Haematological and Biochemical Values

  Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase \[ALT\], albumin \[ALB\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin (total) \[BIL\], creatinine \[CRE\], eosinophils \[EOS\], eosinophils/100 leukocytes \[EOS/100LEU\], bicarbonate \[BIC\], haemoglobin \[HGB\], potassium \[PTS\], lymphocytes \[LYM\], lymphocytes/100 leukocytes \[LYM/100LEU\], sodium \[SDI\], neutrophils \[NEU\], neutrophils/100 leukocytes \[NEU/100LEU\], platelet count \[PLC\], prothrombin time-international normalized ratio \[PTT\] and white blood cell count \[WBC\]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).

  At Week 48

Secondary Outcomes (29)

• Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline

  At Weeks 1, 4, 6, 16, 28, 30 and 38

• Geometric Mean Change in HIV-1 VL From Baseline

  At Weeks 1, 4, 6, 16, 28, 30 and 38

• Levels of HIV-1 Viral Load (VL)

  At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

• Levels of HIV-1 VL

  At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48

• Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1

  At Week 48

Study Arms (3)

3D_HIV Group

EXPERIMENTAL

HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Biological: GSK Biologicals HIV Vaccine 732462

2D_HIV Group

EXPERIMENTAL

HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm.

Biological: GSK Biologicals HIV Vaccine 732462; Drug: Placebo

Control Group

PLACEBO COMPARATOR

HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.

Drug: Placebo

Interventions

GSK Biologicals HIV Vaccine 732462 BIOLOGICAL

2 or 3 doses according to protocol schedule

2D_HIV Group; 3D_HIV Group

Placebo DRUG

1 or 3 doses according to protocol schedule

2D_HIV Group; Control Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects must satisfy ALL the following criteria at study entry:
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to any study procedure.
• A male or female between and including 18-55 years at the time of first vaccination.
• Known to be HIV-1 infected and under the care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with a clinical diagnosis of primary HIV infection need to have been diagnosed and under care for at least 12 months.
• ART-naïve. Individuals must never have received ART after HIV diagnosis, including lamivudine used for chronic hepatitis B infection, with the exception of short-term ART for prevention of mother-to-child transmission (PMTCT) at least 12 months prior to enrollment.
• Commencement of ART is not expected, based on current assessment, within the next 12 months.
• Viral load level of 2,000-80,000 copies/mL at screening.
• CD4 count \>= 500 cells per mm3 at screening.
• If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test at screening, and
• has agreed to continue adequate contraception during the entire study period.

You may not qualify if:

• Infection with HIV-2. This includes patients with dual infection with HIV-1/HIV-2.
• Had an Acquired Immune Deficiency Syndrome (AIDS) defining clinical illness.
• Use of any investigational or non-registered product within 4 weeks preceding the first dose of study vaccine/placebo, or planned use of any investigational or non-registered product other than the study vaccine during the study period.
• Administration of immunoglobulins and/ or any blood products within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period.
• Planned administration of a vaccine not foreseen by the study protocol during
• the period starting 2 weeks before the first dose of study vaccine/placebo and ending at Visit 3 (Week 6) (after blood sampling),
• the period starting from 2 weeks prior to Visit 5 (Week 28) and ending at Visit 6 (Week 30) (after blood sampling)
• the period starting from 2 weeks prior to Visit 8 (Week 48) and ending at Visit 8 (Week 48) (after blood sampling), with the exception of non-adjuvanted influenza vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Any previous vaccination or immunotherapy against HIV.
• A family history of hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute or chronic infective hepatitis.
• Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and/or medical history at screening.
• Grade 3 or grade 4 laboratory abnormality, as defined by Division od AIDS (DAIDS) grading table, at screening

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (42)

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Long Beach, California, 90813, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

Camden, New Jersey, 08103, United States

Location

GSK Investigational Site

Newark, New Jersey, 07102, United States

Location

GSK Investigational Site

Somers Point, New Jersey, 08244, United States

Location

GSK Investigational Site

Columbus, Ohio, 43210, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37604, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Annandale, Virginia, 22003, United States

Location

GSK Investigational Site

Seattle, Washington, 98122-4299, United States

Location

GSK Investigational Site

Bobigny, 93009, France

Location

GSK Investigational Site

Créteil, 94010, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Paris, 75571, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Paris, 75679, France

Location

GSK Investigational Site

Paris, 75908, France

Location

GSK Investigational Site

Paris, 75970, France

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Erlangen, Bavaria, 91054, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80331, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80801, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81371, Germany

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45122, Germany

Location

GSK Investigational Site

Berlin, 13353, Germany

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Móstoles, Madrid, 28935, Spain

Location

GSK Investigational Site

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 11, 2010
• Study Start: November 8, 2010
• Primary Completion: November 5, 2012
• Study Completion: November 5, 2012
• Last Updated: May 21, 2018
• Results First Posted: May 21, 2018

Record last verified: 2018-03

Locations

FR (10); US (17); DE (8); ES (7)