Last updated: 09/04/2019 07:00:32
Dose-ranging study to evaluate the safety & immunogenicity of a HIV vaccine 732461 in healthy HIV seronegative volunteers
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A dose-ranging study to compare the safety and immunogenicity of a candidate Human deficiency virus (HIV) vaccine 732461, adjuvanted or not, administered according to a 0, 1 month schedule to healthy adult HIV seronegative volunteers.
Trial description: GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag, pol and nef). The principal objectives of this study are to evaluate the reactogenicity and safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders to the antigens two weeks after the second vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination and overall
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-day (Days 0-6) follow-up period after each vaccination and overall
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: During the 30-day (Days 0-29) follow-up period after each vaccination and overall
Number of subjects with serious adverse events (SAEs)
Timeframe: During the whole study period (From Month 0 to Month 12)
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Month 0
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Month 1
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Day 44
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Month 2
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Month 6
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Month 7
Number of subjects with abnormal haematological and biochemical levels
Timeframe: At Month 12
Number of subjects with a response in terms of cluster of differentiation 4 (CD4+) T-cells expressing at least two cytokines including IL-2 equal or above the cut-off to at least 1, 2, 3 antigens and to all 4 antigens
Timeframe: At Day 44
Secondary outcomes:
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells expressing IL-2 and at least another marker
Timeframe: At Months 0, 2, 6, 12 and at Day 44
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells expressing at least 2 immune markers
Timeframe: At Months 0, 2, 6, 12 and at Day 44
Antibody titers against p17, p24, Nef, RT and F4co antigens
Timeframe: At Months 0, 2, 6, 12 and at Day 44
Interventions:
Enrollment:
180
Primary completion date:
2008-13-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
AIDS
Product
SB732461
Collaborators
Not applicable
Study date(s)
February 2007 to June 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- A male or female between and including 18-40 years at the time of first vaccination.
- Written informed consent obtained from the subject prior to any study procedure.
- Women who are pregnant or breast-feeding.
- Subjects with a history of, or current, alcohol or substance abuse.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between and including 18-40 years at the time of first vaccination.
- 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.
- Good general health without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
- 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 for 2 months after completion of the vaccination series.
- Negative for antibodies against HIV-1, HIV-2 and negative for HIV p24 antigen within 56 days (8 weeks) prior to enrolment. Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
- Negative for anti-HBc Ab, HBsAg and anti-HCV Ab.
Exclusion criteria:
- Women who are pregnant or breast-feeding.
- Subjects with a history of, or current, alcohol or substance abuse.
- The subject is at high risk of acquiring HIV according to the behavioural risk assessment questionnaire.
- Morbid obesity
- Previous inclusion in a HIV vaccines trial.
- Receipt of live attenuated vaccines within 30 days of enrolment.
- Receipt of medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days of study vaccine administration.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of HIV-1 vaccines or placebo in a previous HIV vaccine trial.
- Receipt of blood products 120 days prior to HIV screening.
- Receipt of immunoglobulin 120 days prior to HIV screening.
- History of serious adverse reactions including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain to vaccines.
- History of serious allergic reaction to any substance requiring hospitalization or emergency medical care.
- History of immunodeficiency or autoimmune disease.
- History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination.
- History of type I or type II diabetes mellitus including cases controlled with diet alone. A subject with past gestational diabetes is eligible.
- Thyroid disease including history of thyroidectomy and diagnoses requiring medication. A subject not requiring thyroid medicine within the past 12 months is eligible.
- Acute disease at the time of enrolment.
- Asthma requiring daily steroid or long acting β agonist prevention.
- Unstable asthma.
- Food- or wine-induced asthma.
- Known sensitivity to sulfites or aspirin.
- Bleeding disorder that was diagnosed by a physician. A subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
- History of any serious neurologic disorder or seizure
- History of major congenital defect
- History of chronic fatigue syndrome or fibromyalgia
- Splenectomy
- Hypertension. A subject with hypertension is eligible if he or she is controlled on medication and the documented blood pressure is less than 150/100.
- Any medical, psychiatric or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contradiction to adherence to the study protocol or ability to give informed consent.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-13-06
Actual study completion date
2008-13-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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