Efficacy and safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 infected persons
Trial overview
Geometric mean change in human immunodeficiency virus type 1 (HIV-1) viral load (VL) from baseline
Timeframe: At Week 48, post-Dose 3
Geometric mean change in HIV-1 VL from baseline
Timeframe: At Week 48, post-Dose 3
Number of subjects with solicited local symptoms
Timeframe: During the 7-day (Days 0-6) period following Dose 1
Number of subjects with solicited local symptoms
Timeframe: During the 7-day (Days 0-6) period following Dose 2
Number of subjects with solicited local symptoms
Timeframe: During the 7-day (Days 0-6) period following Dose 3
Number of subjects with solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, across doses
Number of subjects with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) period following Dose 1
Number of subjects with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) period following Dose 2
Number of subjects with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) period following Dose 3
Number of subjects with solicited general symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period, across doses
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 28-Day (Days 0-27) period following Dose 1 and Dose 2
Number of subjects with unsolicited AEs
Timeframe: During the 28-Day (Days 0-27) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (up to Week 48)
Number of subjects with potentially Immune-Mediated Diseases (pIMDs)
Timeframe: During the entire study period (up to Week 48)
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Screening
Number of subjects with abnormal haematological and biochemical values
Timeframe: Pre-vaccination, at Week 0
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 4
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 6
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 16
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 28
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 30
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 38
Number of subjects with abnormal haematological and biochemical values
Timeframe: At Week 48
Geometric mean change in HIV-1 viral load (LV) from baseline
Timeframe: At Weeks 1, 4, 6, 16, 28, 30 and 38
Geometric mean change in HIV-1 VL from baseline
Timeframe: At Weeks 1, 4, 6, 16, 28, 30 and 38
Levels of HIV-1 viral load (VL)
Timeframe: At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48
Levels of HIV-1 VL
Timeframe: 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
Timeframe: At Week 48
Cluster of differentiation 4 (CD4) absolute cell count
Timeframe: At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48
Mean change in CD4 cell count from baseline
Timeframe: At Weeks 1, 4, 6, 16, 28, 30, 38 and 48
Percentage of subjects with ART (Anti-Retroviral Therapy) initiation and HIV-related clinical events
Timeframe: During the entire study period (up to Week 48)
Magnitude of antigen specific cluster of differentiation-40 ligand (CD40L)+CD4+ T-cells expressing at least Interleukin-2 (IL-2)
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Magnitude of antigen specific CD40L+CD4+ T-cells expressing at least one cytokine
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Magnitude of antigen specific CD40L-CD4+ T-cells expressing at least one cytokine.
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Magnitude of antigen specific CD4+ T-cells expressing at least one cytokine
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Magnitude of antigen specific CD8+ T-cells expressing at least one cytokine
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Number of subjects with response to at least 1, 2, 3 or 4 antigens
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of F4co-Computed CD4+ T cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of Nef antigen-specific CD4+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of P17 antigen-specific CD4+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of P24 antigen-specific CD4+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of RT antigen-specific CD4+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of F4co-Computed CD8+ T cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of Nef antigen-specific CD8+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of P17 antigen-specific CD8+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of P24 antigen-specific CD8+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Cytokine expression profile of RT antigen-specific CD8+ T-cells
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Number of seropositive subjects for anti-P17 antibodies
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Number of seropositive subjects for anti-P24 antibodies
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Number of seropositive subjects for anti-Nef antibodies
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Number of seropositive subjects for anti-RT antibodies
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Number of seropositive subjects for anti-F4co antibodies
Timeframe: During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)
Participation 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.
- The following criteria should be checked at the time of screening and before vaccination. If ANY exclusion criterion applies, the subject must not be included in the study:
- * Infection with HIV-2. This includes patients with dual infection with HIV-1/HIV-2.
- 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.
- The following criteria should be checked at the time of screening and before vaccination. If ANY exclusion criterion applies, the subject must not be included in the study: * 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. * Drug therapy with immunomodulators or steroids within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period. Acute use of steroids up to 4 weeks preceding the first dose for treatment of hypersensitivity reactions is not an exclusion criterion. Inhaled and topical steroids are allowed. * 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 * Pregnant or lactating female. * Any condition which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the study protocol. * History of medically confirmed autoimmune disease. * History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. * Unstable asthma * Food or wine induced asthma. * Known sensitivity to sulfites or aspirin. * Known sensitivity to aminoglycoside antibiotics. * Contraindication to intramuscular injection
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.