Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age: 18 to 26 years
Willing to undergo HIV (Human Immunodeficiency Virus) counseling and testing
Have a negative antigen/antibody or antibody ELISA for HIV infection
Able to give informed consent
Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test
Basic abilities to read and write
Resident in Maputo, and willing to remain so for the duration of the study

At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior (their presence is therefore an exclusion criteria):

sexual partner with HIV
sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations
sexual partner is known to be at high risk for HIV
more than one sexual partner in the last 6 months
history of being an alcoholic [as medically defined or more than 35 units /week]
history of Sexually Transmitted Infection (STI) within past 6 months
Verbal assurances that adequate birth control methods are used not to conceive/father a child during the study and up to 3 months after the last vaccine injection.
Women shall have a negative urine pregnancy test
Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV
Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters as judged by the study physician.

Laboratory criteria:

Hemoglobin >10.5g/dl
White blood cell count <13,000/mm3
Neutrophils >1,300/mm3
Lymphocytes >1.000/ mm3
Platelets >120,000/ mm3
Random Blood Glucose < 6.44 mmol/L; if elevated, then a Fasting Blood Glucose < 6.11mmol/L (according to DAIDS Table for Lab Criteria)
Bilirubin <1.25 x uln
Alanine transaminase (ALT) <1.25 x uln
Urine dipstick for protein and blood: negative or trace. (If either is ¿ 1+, complete urinalysis (UA) will be performed.

Exclusion Criteria:

At risk of HIV infection as mentioned above in the inclusion criteria
Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection
A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention
Autoimmune disease by history and physical examination
Hives or recurrent hives and severe eczema
A history of psychiatric, medical (including traditional medicine) and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial
History of epilepsy, or currently taking anti-epileptics
Received blood or blood products or immunoglobulins in the past 3 months
Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
Use of experimental therapeutic agents within 30 days of study entry
Reception of any live, attenuated vaccine within 60 days of study entry.
Abnormality in Electrocardiogram (ECG) that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures
Previously received an HIV vaccine candidate

History of severe local or general reaction to vaccination defined as:

Local: Extensive, indurate redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours
General: Fever >= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours
Being a lactating mother
Study site employees who are involved in the protocol and may have direct access to the immunogenicity results
Unlikely to comply with protocol as judged by the principal investigator or his designate.