Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART (NCT01024842) | Clinical Trial Compass
TerminatedPhase 1
Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART
Stopped: Slow recruitment therefore study was stopped after 95% volunteers were enrolled.
United Kingdom19 participantsStarted 2009-12
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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…
What they're measuring
1
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
Timeframe: Actively collected data throughout the study until 6 months after the last vaccination