A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART

Inclusion criteria

• Patient is ≥ 18 years of age;
• Voluntarily signed informed consent;
• Patient is male, or female with negative pregnancy test prior to enrolment;
• Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA);
• Patient must be on stable treatment with HAART for at least 6 months (HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents*);
• Mean of all measured CD4+ cell counts during the 6 months prior to the start of HAART must be above or equal to 200 cells/ mm3
• Current CD4+ cell count must be at least 450 cells/ mm3;
• HIV-RNA must be below 50 copies/ mL for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/mL are permitted);
• Patient is one of the following: not sexually active, or a heterosexually active female, agreeing to use condoms with her partner from 14 days prior to the first vaccination until 4 months after the last, even though using another method of contraception, and willing to undergo pregnancy tests during screening and prior to each vaccination, or a male, agreeing to use condoms with his partner from the day of the first vaccination until 4 months after the last vaccination.

Exclusion criteria

• Treatment with a non-HAART regimen of antiretroviral agents prior to the start of HAART;
• History of a CDC class C event (see Appendix);
• Interruption of HAART during the course of the study which is expected at the time of inclusion;
• History of exposure <20 years ago to any poxvirus based vaccine;
• Patient is female and has a positive pregnancy test or the wish of pregnancy:
• Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
• Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
• History of allergy to any vaccine component;
• Use of anti-coagulant medication;
• Use of any investigational drug during the 90 days prior to study entry;
• Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy
• Any other condition which, in the opinion