Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine

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.