Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv Candidate HIV-1 Vaccines in Recently HIV-1 Infected Individuals

Inclusion Criteria

• •1. Male or female, aged 18-60 years
• •2. Confirmed HIV-1 seropositive documented in the past 6 months (by acute antiretroviral syndrome, p24 antigenemia and/or ELISA seroconversion)
• •3. Willing and able to give written informed consent for participation in the study
• •4. Willing and able to adhere to an effective HAART regimen for the duration of the study
• •5. Cluster of differentiation 4 (CD4)+ T cell count \> 350 cells/ml at screening and at the preceding clinic visit
• •6. No new AIDS-defining diagnosis or progression of HIV-related disease.
• •7. Haematological and biochemical laboratory parameters as follows: Haemoglobin \> 10g/dl, Platelets \> 100.000/dl, alanine aminotransferase (ALT) ≤ 2.5 x ULN, Creatinine ≤ 1.3 x upper limit of normal (ULN)
• •8. Serology: negative for hepatitis B surface antigen OR HbsAg positive with Hepatitis B Virus (HBV)-DNA \< 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of Hepatitis C Virus (HCV) infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive enzimeimmunoassay (EIA) Immonoglobulin G (IgG) or Treponema pallidum hemagglutination assay (TPHA)
• •9. Available for follow up for duration of study (screening + 72 weeks) and willing to comply with the protocol requirements
• •10. Women of child-bearing age must not be pregnant, not be planning a pregnancy or breast-feeding. Sexually active women must be willing to use an approved method of contraception from screening until 4 months after the second immunisation. Sexually active men in heterosexual relationships must be willing to use an approved method of contraception with their partners from screening until 4 months after the second immunisation.