Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals HIV Vaccine 732462 · 1 trial · 1 indication
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.
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.
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.
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
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.
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.
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.
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.
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).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals HIV Vaccine 732462 | BIOLOGICAL | 2 or 3 doses according to protocol schedule |
| Placebo | DRUG | 1 or 3 doses according to protocol schedule |
Inclusion Criteria: 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...
GSK Biologicals HIV Vaccine 732462 is an investigational vaccine candidate developed by GSK plc for HIV/AIDS. It is a Phase 2 therapeutic vaccine studied in HIV-1 infected adults who had not yet started antiretroviral therapy. It is not an approved product and remains in clinical development.
GSK Biologicals HIV Vaccine 732462 was studied for use in AIDS, specifically in antiretroviral therapy-naive HIV-1 infected persons. The Phase 2 trial evaluated its efficacy and safety in this population rather than in healthy volunteers. It is investigational and has no approved indication.
GSK Biologicals HIV Vaccine 732462 is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. The candidate sits within GSK's infectious disease portfolio and is identified by the internal designation 732462.
GSK Biologicals HIV Vaccine 732462 is in Phase 2 development. Its single registered trial, NCT01218113, is listed as completed, and no active trials are currently recorded for this candidate. It is an investigational vaccine and is not FDA approved.
GSK Biologicals HIV Vaccine 732462 has been studied in one Phase 2 trial, NCT01218113, titled Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naive HIV-1 Infected Persons. The completed trial enrolled 191 participants across the United States, France, Germany, and Spain.
The Phase 2 trial NCT01218113 was a randomized, double-blind, placebo-controlled study of GSK Biologicals HIV Vaccine 732462. It enrolled 191 participants aged 18 years and older of all sexes, all of whom were antiretroviral therapy-naive HIV-1 infected persons rather than healthy volunteers.