Safety and Immunogenicity Study of Three Candidate HIV-1 Vaccines, Administered in Combination to Healthy HIV-1 Uninfected Adults (HIV-CORE 002)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety and immunogenicity of three novel HIV vaccines.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy males or females, as assessed by a medical history, physical examination and laboratory tests.
- Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- In the opinion of the principal investigator or designee, the volunteer has understood the information provided. Written informed consent must be given before any study-related procedures are performed.
- Willing to undergo HIV-1 testing, HIV-1 counselling and receive HIV-1 test results.
- If heterosexually active female; using an effective method of contraception (e.g. hormonal contraception, diaphragm, intra-uterine device (IUD), condoms, anatomical sterility in self or partner) from 14 days prior to the first vaccination until at least 6 weeks after the last vaccination; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
- If heterosexually active male; willing to use an effective method of contraception (condoms; anatomical sterility in self or partner) from the day of the first vaccination until 6 weeks after the last vaccination.
- Willing to forgo donations of blood during the study.
Exclusion criteria
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Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the principal investigator or designee, would make the volunteer unsuitable for the study.
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Any of the following abnormal laboratory parameters listed below:
Haematology
- Haemoglobin < 10.0 g/dl
- Absolute Neutrophil Count (ANC) ≤ 1000 /mm3 (≤ 1 x 109 /l)
- Absolute Lymphocyte Count (ALC) ≤ 600 /mm3 (≤ 1 x 109 /l)
- Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 90 /l, ≥ 550 /l) Biochemistry
- Creatinine > 1.3 x ULN
- Aspartate aminotransferase (AST) > 2.5 x ULN
- Alanine aminotransferase (ALT) > 2.5 x ULN Urinalysis
- Abnormal dipstick confirmed by microscopy
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Reported high-risk behaviour for HIV infection. High-risk behaviour for HIV-1 infection is defined as follows. Within the previous 6 months the volunteer has:
- Had unprotected vaginal or anal sex with a known HIV-infected person or a casual partner (i.e., no continuing, established relationship)
- Engaged in sex work for money or drugs
- Used injection drugs
- Acquired one of the following sexually transmitted disease (STD); Chlamydia, gonorrhoea and syphilis.
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Confirmed HIV-1 or HIV-2 infection.
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If female, pregnant or planning a pregnancy within 6 weeks after last vaccination; or lactating.
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Receipt of live attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product or receipt of other vaccine within the previous 14 days or planned receipt within14 days after vaccination with Investigational Product.
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Receipt of blood transfusion or blood products within the previous 6 months.
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Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study.
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Receipt of any investigational HIV vaccine within the last 6 years.
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History of severe or very severe local or systemic reactogenicity events, or history of severe or very severe allergic reactions.
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Confirmed diagnosis of hepatitis B virus (surface antigen, HBsAg), hepatitis C virus (HCV antibodies) or active syphilis.
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Smallpox vaccination within the previous 3 years (smallpox vaccination prior to 3 years should be documented but is not an exclusion criterion).
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Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years.
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 7 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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