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

Phase 1
Terminated
Conditions
HIV-1
Registration Number
NCT01024842
Lead Sponsor
University of Oxford
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
19
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactionsActively collected data throughout the study until 6 months after the last vaccination
Secondary Outcome Measures
NameTimeMethod
PBMC will be stored for other exploratory assays to characterise vaccine-expanded T cell populations such as IL-10 secretion and CFSE proliferation assays.Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Evaluation of the effect of MVA.HIVconsv vaccinations on viral suppressive capacity of CD8+ T cells in vitro, using a novel flow cytometric assayScreen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Magnitude and phenotype, including but not limited to activation status, of HIV-1-specific CD8+ T cell populations identified by tetramer staining before and after vaccination, in selected volunteers with appropriate HLA class I alleles.Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
A descriptive summary of grade 3 or 4 local and systemic events, including laboratory abnormalitiesActively collected data throughout the study until 6 months after the last vaccination
A descriptive summary of serious adverse events, including laboratory abnormalitiesActively collected data throughout the study until 6 months after the last vaccination
The proportion of volunteers who develop CD8+ T cell responses to a new HIV-1 epitope, as determined by IFN-γ ELISPOT assayScreen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
The proportion of volunteers in whom the magnitude of CD8+ T cell responses to HIVconsv peptides increases by ≥ 3-fold, as determined by IFN-γ ELISPOT assayScreen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)
Serum and plasma will be stored for investigation of binding and neutralising antibodies to vaccinia and of pro-inflammatory cytokines.Screen (≤ day -28); Day 0; Day 14; Day 28; Day 42; Day 56; Day 84; Day 112; Day 182; Final visit (day 266 / early termination)

Trial Locations

Locations (2)

Weatherall Institute of Molecular Medicine

🇬🇧

Oxford, Oxons, United Kingdom

Oxford Genitourinary Medicine

🇬🇧

Oxford, Oxon, United Kingdom

Weatherall Institute of Molecular Medicine
🇬🇧Oxford, Oxons, United Kingdom

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