Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons
- Conditions
- ART-naïve HIV-infected adults (ART: anti-retroviral therapy)MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-021356-26-DE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 189
•Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., compliance with study regimen, visit schedule).
•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-1 infection need to have been diagnosed and under care for at least 12 months.
Primary HIV infection refers to the very early stages (2-8 weeks) of HIV infection characterized by a clinical syndrome of acute seroconversion illness, very high viral load and negative HIV antibody test. Acute seroconversion illness may include symptoms such as night sweats, fever, exanthema, and general feeling of malaise and fatigue.
•ART-naïve. Individuals must never have received ART after HIV diagnosis, including lamuvidine 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 189
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Infection with HIV-2. This includes patients with dual infection with HIV-1/HIV-2.
•Had an AIDS defining clinical illness (CDC Category C event).
•Use of any investigational or non-registered product (drug or vaccine) 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 corticosteroids within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period. Acute use of corticosteroids (i.e. prednisone, or equivalent, < or = 0.5 mg/kg/day for up to 5 days) up to 4 weeks preceding the first dose for treatment of hypersensitivity reactions is allowed. Inhaled and topical corticosteroids 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.
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 at least 4 weeks prior to enrollment into this study (e.g. influenza and travel vaccines).
•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.
•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 and/or medical history at screening.
•Grade 3 or grade 4 laboratory abnormality, as defined by DAIDS grading table, at screening.
•Pregnant or lactating female.
•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.
•Unstable asthma defined as:
- Sudden acute attacks occurring in less than three hours without an obvious trigger.
-Hospitalization for asthma in the last two years.
•Food or wine induced asthma.
•Known sensitivity to sulfites or aspirin.
•Known sensitivity to aminoglycoside antibiotics.
•Contraindication to intramuscular injection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method