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: April 17, 2014
Last verified: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 17, 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 September 22, 2014