Safety and Immunogenicity Study of Three Candidate HIV-1 Vaccines, Administered in Combination to Healthy HIV-1 Uninfected Adults

Exclusion Criteria

• •1. 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.
• •2. 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
• •3. 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.
• •4. Confirmed HIV-1 or HIV-2 infection.
• •5. If female, pregnant or planning a pregnancy within 6 weeks after last vaccination; or lactating.
• •6. 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.
• •7. Receipt of blood transfusion or blood products within the previous 6 months.
• •8. Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study.
• •9. Receipt of any investigational HIV vaccine within the last 6 years.
• •10. History of severe or very severe local or systemic reactogenicity events, or history of severe or very severe allergic reactions.
• •11. Confirmed diagnosis of hepatitis B virus (surface antigen, HBsAg), hepatitis C virus (HCV antibodies) or active syphilis.
• •12. Smallpox vaccination within the previous 3 years (smallpox vaccination prior to 3 years should be documented but is not an exclusion criterion).
• •13. Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years.