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

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