safety and immunogenicity of mva.hivconsv in hiv-1 seropositive adults on haart

Conditions: HIV-1

Summary: in this study, the novel vaccine candidate, mva.hivconsv, will be tested for safety, tolerability and immunogenicity in hiv-1-seropositive subjects receiving effective antiretroviral therapy. mva.hivconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.


Eligibility criteria:
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