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Safety of the HIV Vaccine 732461 in HIV Infected Subjects Aged 18 to 55 Years Old

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00814762
First received: December 23, 2008
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

The purpose of this research study is to evaluate the safety of GSK Biologicals' investigational HIV vaccine 732461, administered as two doses approximately 1 month apart, in a small group of HIV infected people.


Condition Intervention Phase
HIV (Human Immunodeficiency Virus)-Infected Adults
Biological: HIV Vaccine 732461
Biological: Placebo vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Study to Evaluate the Safety and Reactogenicity of the HIV Vaccine 732461 in HIV Infected Subjects Aged 18 to 55 Years Old

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general symptoms (any, grade ≥ 3, related, and grade ≥ 3 related) [ Time Frame: Day 0 - Day 6 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms (any, grade ≥ 3, related, and grade ≥ 3 related) [ Time Frame: Day 0-Day 29 after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (any and related) and medically attended visits (any) [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Occurrence of study pre-defined HIV-related adverse events [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Occurrence of abnormal biochemical and haematological values (any and grade ≥ 3) [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Occurrence and timing of initiation of HAART therapy (for treatment-naïve HIV-infected subjects) or change in HAART therapy (for HIV-infected subjects receiving HAART) [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD4 count and change of CD4 count from baseline [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • Viral load and change in viral load from baseline [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • CD40L+ CD4+ T-cell-mediated immune response (as measured by ICS) [ Time Frame: Months 0, 4, 12 and at Day 44 ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Vaccine
Biological: HIV Vaccine 732461
Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month.
Placebo Comparator: Group B
Placebo
Biological: Placebo vaccine
Two doses of placebo, injected intramuscularly, at an interval of approximately one month

Detailed Description:

This multicenter observer-blind study will determine the safety and reactogenicity of GSK Biologicals' investigational HIV vaccine 732461 in two sequentially enrolling cohorts of HIV-infected subjects treated with HAART (highly active antiretroviral therapy) and HIV infected treatment naïve subjects, respectively.

  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 the following criteria at screening and before vaccination:

  • A male or female, aged between and including 18-55 years at the time of first vaccination.
  • Known to be HIV-1 infected and under care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with primary HIV infection need to have been diagnosed and under care for 12 months.
  • Written informed consent obtained from the subject prior to any study procedure.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions throughout the duration of the study.
  • CD4 count ≥ 450 cells per mm³

Additional inclusion criteria for subjects enrolled in the first cohort (HIV-infected subjects receiving HAART):

  • Stable on highly active antiretroviral therapy (HAART) for at least one year.
  • Undetectable viral load

Additional inclusion criteria for subjects enrolled in second cohort (treatment-naïve HIV-infected subjects):

  • HAART-naïve (never received anti-retrovirals after HIV diagnosis)
  • VL 5000-80000 copies/mL at screening
  • Commencement of HAART is not expected based on current assessment within next year.

Exclusion Criteria:

The following criteria should be checked at the time of screening and before vaccination. If any apply, the subject must not be included in the study:

  • Infection with HIV-2
  • Had an AIDS defining illness (CDC Classification).
  • Use of any investigational or non-registered product (drug or vaccine) within 30 days 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 three months preceding the first dose of study vaccine/placebo or planned administration during the study period
  • Administration of immunoglobulins and/ or any blood products within the three months 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 30 days before the first dose of study vaccine/placebo and ending at Month 4 It is recommended that the vaccination history of all subjects has been reviewed with their health care provider and that they have been encouraged to be fully vaccinated according to their country vaccination schedule for HIV- infected persons before enrolment into this study.
  • 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 (pharmaceutical product or device).
  • Any previous vaccination or immunotherapy against HIV.
  • History of immune reconstitution disease when commencing antiretroviral therapy (for HIV-infected subjects receiving HAART)
  • 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 (A past history of hepatitis B or C is not an exclusion criterion).
  • Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any condition (including alcohol and drug abuse) 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
  • Asthma requiring daily steroid or long acting ß agonist prevention
  • Unstable asthma defined as:

    • Sudden acute attacks occurring in less than three hours without an obvious trigger.
    • Hospitalisation for asthma in the last two years
  • Food or wine induced asthma
  • Known sensitivity to sulfites or aspirin
  • Known sensitivity to aminoglycoside antibiotics
  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: NCT00814762

Locations
Germany
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
GSK Investigational Site
Berlin, Germany, 12157
GSK Investigational Site
Hamburg, Germany, 20099
GSK Investigational Site
Hamburg, Germany, 20246
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00814762     History of Changes
Other Study ID Numbers: 112353
Study First Received: December 23, 2008
Last Updated: October 27, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
immunogenicity
HIV
reactogenicity
safety
vaccine
HIV Infections

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014