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 <11.0 g/dL; absolute neutrophil count (ANC) ≤ 1.3 x 109/L; absolute lymphocyte count (ALC) ≤ 0.9 x 109/L; platelets ≤ 125 x 109/L; creatinine >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), hepatitis C (HCV antibodies) or active syphilis;
• Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product; or receipt of other vaccine, allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product;
• Receipt of blood transfusion or blood-derived products within the previous 3 months;
• Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study;
• Prior receipt of another investigational HIV vaccine candidate (Note: receipt of placebo in a previous HIV vaccine trial will not exclude a volunteer from participation if documentation is available);
• History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema);
• Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years;
• Seizure disorder: a participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years.);
• If female, history of toxic shock syndrome (TSS), which would preclude the use of Softcup;
• If female, current use of intrauterine device (IUD), which would preclude the use of Softcup;
• If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.