The Safety and Immunogenicity of a Potential HIV Vaccine

Inclusion Criteria

• Healthy male or female, as assessed by medical history, physical exam, and laboratory tests;
• At least 18 years of age on the day of screening and has not reached his/her 46th birthday on the day of first vaccination;
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;
• Willing and able to give written informed consent;
• Willing to undergo HIV testing, receive HIV test results and be committed to maintaining low risk behaviour for the trial duration;
• If a female who is sexually active with male partner(s), willing to use an effective method of contraception from screening until at least 4 months after the last study vaccination [e.g., hormonal contraceptives, consistent record with condoms, physiological or anatomical sterility in self or partner, but excluding intrauterine device (IUD) which would preclude the collection of cervico-vaginal secretions with Softcup];
• All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures (Appendices A-B) and must test negative prior to each study vaccination;
• All sexually active males (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented non-barrier method of birth control) must be willing to use an effective method of contraception (e.g., consistent condom use) from the day of first vaccination until at least 4 months after the last vaccination;
• Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV-positive due to trial vaccination (vaccine-induced HIV seropositivity), until the anti-HIV antibody titres become undetectable.
• Registered with a general practitioner for at least the past three months

Exclusion Criteria

• Confirmed HIV-1 or HIV-2 infection;
• Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted); immunosuppressive, anti-cancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months;
• Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study;
• Reported risky behaviour for HIV infection within the 6 months prior to vaccination as defined by: history of injecting drug use in the previous ten years; gonorrhoea or syphilis in the last six months; high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months; unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative; or unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner.
• Reported abnormal cervical cytology or previous or ongoing treatment for Cervical Intraepithelial Neoplasia;
• If female, pregnant or planning a pregnancy within 4 months after last study vaccination; or lactating;
• Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions) (Note: A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible);
• History of splenectomy;
• Any of the following abnormal laboratory parameters listed below: haemoglobin 1.1 x upper limit of normal (ULN); aspartate aminotransferase >1.25 x ULN; alanine aminotransferase >1.25 x ULN; clinically significant abnormal urinalysis dipstick confirmed by microscopy (protein 2+ or more, blood 2+ or more not due to menses); positive for hepatitis B surface antigen (HbsAg