Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART

Inclusion Criteria:

• Male or female, aged 18-60 years
• Confirmed HIV-1 seropositive
• Willing and able to give written informed consent for participation in the study
• Treated continuously with a combination of 3 or more antiretroviral agents for the preceding 12 months
• Willing and able to adhere to an effective ART regimen for the duration of the study (switching from current regimen is allowed if for reasons of tolerability or toxicity)
• CD4 cell count > 350 cells/μl at screening and at the preceding clinic visit
• Plasma viral load < 50 copies / ml at screening and at the preceding clinic visit
• No new AIDS-defining diagnosis or progression of HIV-related disease in the preceding 6/12 months

• Haematological and biochemical laboratory parameters as follows:

  • Haemoglobin > 10g/dl
  • Platelets > 100,000/μl
  • ALT ≤ 2.5 x ULN
  • Creatinine ≤ 1.3 x ULN
• Serology: negative for hepatitis B surface antigen OR HbsAg positive with HBV DNA < 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of HCV infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive EIA IgG or TPHA
• Available for follow up for duration of study (screening + 38 weeks) and willing to comply with the protocol requirements
• Women of child-bearing age must not be pregnant, 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 third 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 third immunisation.

Exclusion Criteria:

• Confirmed HIV-2 seropositive
• Positive pregnancy test
• Participation in another clinical trial within 12 weeks of study entry
• History of autoimmune disease other than HIV-related auto-immune disease which has resolved with ART
• History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study
• History of anaphylaxis or severe adverse reaction to vaccines
• History of alcohol or drug dependency which could, in the opinion of the investigators, impair the subject's ability to complete the study
• Previous immunisation with a recombinant MVA vaccine
• Immunisation with any experimental immunogens within 6 months of study entry
• Receipt of blood products or immunoglobulins within 6 months of study entry
• Treatment for cancer or lymphoproliferative disease within 1 year of study entry
• Receipt of vaccines other than Hepatitis B vaccine within 2 weeks of study entry or planned receipt within 2 weeks of vaccination
• Any other prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
• Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents