Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine

Inclusion criteria

• Women aged between 18 and 55 years on the day of screening
• Available for a maximal study duration of 8 months from screening
• Willing and able to give written informed consent
• At low risk of HIV infection and willing to remain so for the duration of the study defined as:

• no history of injecting drug use in the previous ten years
• no gonorrhoea or syphilis in the last six months
• no high risk partner (e.g. injecting drug use, HIV infected sexual partner) either currently or within the past six months
• no unprotected vaginal or anal intercourse in the last six months outside a relationship with a regular partner known to be HIV negative
• no unprotected sex with someone from a high HIV prevalence region where HIV is more common than in the UK (e.g. Sub-Saharan Africa, Caribbean, South-East Asia)
• Negative HIV1/2 antibody/antigen test result at screening
• If heterosexually active female, using an effective method of contraception using a double barrier method of contraception (combined oral contraceptive pill, injectable or implanted contraceptive and use of condoms incorporating spermicide; physiological or anatomical sterility) from 14 days prior to the first vaccine administration until 3 months after the last administration, and willing to undergo urine pregnancy tests prior to each vaccine administration and blood pregnancy test at screening and final follow-up visits. Heterosexual females who become sexually active during the trial should also follow the same guidance
• Agree to abstain from donating blood during their participation in the trial
• Registered with a General Practitioner and medical history available for 12 months before dosing
• Satisfactory response received from General Practitioner relating to medical history before randomization

Exclusion criteria

• Pregnant or lactating or planning to get pregnant within the next year
• Clinically relevant abnormality on history or examination:

• central nervous system disorder or disease, including history of grand-mal epilepsy
• severe eczema
• clinically significant haematological, cardio-pulmonary, metabolic, gastrointestinal, renal, psychiatric or ophthalmological disorders
• acute infection or illness
• autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
• Known hypersensitivity to any component of the vaccine formulation used in this trial, or have severe or multiple allergies
• History of severe local or general reaction to previous vaccination defined as:

• local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
• general: fever >39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
• Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of schedules study vaccine dosing
• Receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
• Receipt of blood products or immunoglobulin within 4 months of screening
• Participation in another trial of a medicinal product, completed less than 90 days prior to Visit 2 and planned participation in another clinical trial during the present trial
• HIV 1/2 antibody/antigen positive or indeterminate on screening
• Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
• Clinically significant abnormal result in routine laboratory parameters.
• Unable to read and speak English to a fluency level adequate for the full comprehension of study and procedures required in participation and consent
• Unlikely to comply with protocol
• History of drug or alcohol abuse or regular use of drugs, or who test positive for alcohol test at screening
• On regular medication which in the opinion of the investigator makes volunteer unsuitable for participation in the study
• Any local vaginal, cervical or gynaecological condition which may interfere with collection or interpretation of data collected through vaginal samples
• Using any Intra Uterine Contraceptive Device as there is a risk of dislodging, displacing or removing the device when pulling or removing Softcup used for vaginal sampling
• Clinically significant abnormality on ECG performed at the screening visit
• Any condition that, in the investigator's opinion, compromises the volunteer's ability to meet protocol requirements or to complete the study