- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01024842
Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART
HIV-CORE 001 - A Randomised Placebo-controlled Study to Evaluate the Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVconsv, Delivered by Intramuscular Needle Injection to HIV-1 Seropositive Adult Subjects Receiving Antiretroviral Therapy (ART).
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Oxon
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Oxford, Oxon, Storbritannien, OX3 7LJ
- Oxford Genitourinary Medicine
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Oxons
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Oxford, Oxons, Storbritannien, OX3 9DS
- Weatherall Institute of Molecular Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Low dose vaccinees
Individuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu.
|
Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10^8 pfu at week 0, 4 and 12.
|
Experimentell: High dose vaccinees
Individuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu.
|
Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10^8 pfu at week 0, 4 and 12.
|
Placebo-jämförare: Low dose placebo
Individuals will receive three intramuscular injections of low dose placebo
|
Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.
|
Placebo-jämförare: High dose placebo
Individuals will receive three intramuscular injections of high dose placebo
|
Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
Tidsram: Actively collected data throughout the study until 6 months after the last vaccination
|
Actively collected data throughout the study until 6 months after the last vaccination
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
A descriptive summary of grade 3 or 4 local and systemic events, including laboratory abnormalities
Tidsram: Actively collected data throughout the study until 6 months after the last vaccination
|
Actively collected data throughout the study until 6 months after the last vaccination
|
A descriptive summary of serious adverse events, including laboratory abnormalities
Tidsram: Actively collected data throughout the study until 6 months after the last vaccination
|
Actively 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 assay
Tidsram: 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)
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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)
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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 assay
Tidsram: 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)
|
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 assay
Tidsram: 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)
|
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)
|
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.
Tidsram: 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)
|
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)
|
PBMC will be stored for other exploratory assays to characterise vaccine-expanded T cell populations such as IL-10 secretion and CFSE proliferation assays.
Tidsram: 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)
|
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)
|
Serum and plasma will be stored for investigation of binding and neutralising antibodies to vaccinia and of pro-inflammatory cytokines.
Tidsram: 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)
|
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)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Andrew McMichael, University of Oxford
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HIV-CORE 001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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