Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

age between 18 and 55 years on the day of screening
available for follow-up for the duration of the study (78 weeks from screening)
able to give written informed consent

at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection 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 positive partner) either currently or within the past six months
no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
willing to undergo a HIV test
willing to undergo a genital infection screen
if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; IUCD; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
if heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination

for French volunteers only :

subjects registered in French Health ministry computerised file and authorised to participate in a clinical trial
subjects covered by Health Insurance
subjects included in the ANRS vaccine research network of volunteers

Exclusion Criteria:

pregnant or lactating
clinically relevant abnormality on history or examination including history of grand-mal epilepsy; severe eczema; allergy to eggs or gentamicin; severe allergic diseases; liver disease with inadequate hepatic function; haematological, metabolic or gastrointestinal disorders; uncontrolled infection; autoimmune disease, immunodeficiency or use of immunosuppressives in preceding 3 months
receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
receipt of blood products or immunoglobin within 4 months of screening
participation in another trial of a medicinal product, completed less than 30 days prior to enrolment

history of severe local or general reaction to vaccination defined as

local: extensive, indurated redness and swelling involving most of the anterolateral thigh or the major circumference of the arm, not resolving within 72 hours
general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
HIV 1/2 positive or indeterminate on screening
positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory
grade 1 or above routine laboratory parameters (see section 4.1.4 & appendix 4 for definitions) Note of clarification 18th april 2008: hyperbilirubinemia has to be considered as an exclusion criterion only when confirmed to be conjugated bilirubinemia
unlikely to comply with protocol