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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: AIDS

Treatments: Biological: GSK Biologicals HIV Vaccine 732462; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01218113

111679

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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 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.

Exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

191 participants in 3 patient groups, including a placebo group

3D_HIV Group

Experimental group

Description:

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.

Treatment:

Biological: GSK Biologicals HIV Vaccine 732462

2D_HIV Group

Experimental group

Description:

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.

Treatment:

Biological: GSK Biologicals HIV Vaccine 732462

Drug: Placebo

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo