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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01218113
First received: October 7, 2010
Last updated: March 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
AIDS
Biological: GSK Biologicals HIV Vaccine 732462
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HIV-1 viral load change [ Time Frame: throughout the study period (from baseline to Week 48) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: during a 7-day (Day 0 to Day 6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: within 28 days (Day 0 - Day 27) after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) and potentially immune mediated diseases (pIMDs) [ Time Frame: From baseline to Week 48 ] [ Designated as safety issue: No ]
  • Biochemistry and haematology parameters [ Time Frame: throughout the study period (from baseline to Week 48) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV-1 viral load [ Time Frame: throughout the study period (from baseline to Week 48) ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: throughout the study period (from baseline to Week 48) ] [ Designated as safety issue: No ]
  • Initiation of ART [ Time Frame: throughout the study period (from baseline to Week 48) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the investigational vaccine [ Time Frame: throughout the study period (from baseline to Week 48) ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: GSK Biologicals HIV Vaccine 732462
2 or 3 doses according to protocol schedule
Experimental: Group B
Not Applicable
Biological: GSK Biologicals HIV Vaccine 732462
2 or 3 doses according to protocol schedule
Drug: Placebo
1 or 3 doses according to protocol schedule
Placebo Comparator: Group C
Not Applicable
Drug: Placebo
1 or 3 doses according to protocol schedule

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218113

  Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01218113     History of Changes
Other Study ID Numbers: 111679
Study First Received: October 7, 2010
Last Updated: March 13, 2014
Health Authority: Germany: Paul-Ehrlich Institute
Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Human Immunodeficiency Virus (HIV)-1
safety
vaccine
immunogenicity
reactogenicity
HIV infection

ClinicalTrials.gov processed this record on April 16, 2014