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van CCT (UK)

van CCT (UK)

New influenza vaccine based on MVA.

- candidate number12252
- NTR NumberNTR3401
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-apr-2012
- Secondary IDs2011-003035-66 CCMO
- Public TitleNew influenza vaccine based on MVA.
- Scientific TitlePhase I clinical trial to assess safety and immunogenicity of an MVA-based influenza vaccine in healthy adults.
- hypothesisMVA-based influenza vaccine is safe and immunogenic in young healthy adults.
- Healt Condition(s) or Problem(s) studiedSmallpox, Influenza A/H5N1 virus
- Inclusion criteria1. 18-35 years of age;
2. Female volunteers must acquire an acceptable form of contraception during the study period and to have a negative pregnancy test on the days of immunization;
3. Refrain from blood donation during the study period;
4. Written informed consent;
5. Available for the complete study period;
6. Able and willing to comply with all study requirements.
- Exclusion criteria1. Pregnancy or lactation;
2. Acute or chronic illness;
3. Known allergy to eggs, egg products or chicken protein;
4. Previous immunization with a recombinant MVA;
5. Previous immunization with an influenza A/H5N1 vaccine;
6. Pre-existing immunity to influenza A/H5N1 virus;
7. Pre-existing immunity to vaccinia virus.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2012
- planned closingdate15-apr-2013
- Target number of participants80
- Interventions1 or 2 intramuscular immunizations with an MVA-based influenza vaccine. Two dosages are tested:
1. 10e7 pfu in 0.5ml;
2. 10e8 pfu in 0.5ml.
- Primary outcomeSafety assessment of the MVA-H5-sfMR vaccine in humans in a dose escalation setup and with one or two immunizations. Study subjects will undergo physical examinations will be performed before and on fixed time points during the study phase. Clinical chemistry is performed on the blood samples that are drawn throughout the study and local and systemic reactions are tracked with a daily dairy card during the first week after immunization.
- Secondary outcomeAssessment of the immunogenicity of the MVA-H5-sfMR vaccine in humans in a dose escalation setup and with one or two immunizations. The immunogenicity will be determined by measuring influenza-specific antibody titers in the hemagglutination inhibition assay and virus neutralization assay. Furthermore HA-specificity of cytotoxic T cells isolated from the vaccinees will be determined. Besides these responses the immunity against the vector will also be characterized and quantified.
- Timepoints1. Before immunization;
2. 1 hour after immunization;
3. 4 weeks after immunization;
4. 4 weeks after second immunization;
5. 20 weeks after second immunization.
- Trial web siteN/A
- statusplanned
- CONTACT for SCIENTIFIC QUERIESProf. dr. A.D.M.E. Osterhaus
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
European Research Council (ERC)
- PublicationsKreijtz et al, JID, 2007
Kreijtz et al, JID, 2009
Kreijtz et al, PLoSOne, 2009
- Brief summaryMVA expressing the HA gene from influenza virus A/Vietnam/1194/04 has been studied in depth in mice and a non-human primate model. Initially a two dose immunization regimen was tested in C57Bl6/J mice and induced sterile immunity in these animals against the homologous and heterologous strains.(Kreijtz et al JID 2007) As a follow-up study the two dose regimen was tested in cynomolgus macaques in which it proved to be safe and it induced also sterile immunity against the homologous and heterologous challenge viruses.(Kreijtz et al JID 2009)
In a dose escalation experiment in mice we determined the minimal dose to induce protection against challenge infection and explored the possibility to induce protection with a single immunization. Mice that were immunized once with a relatively high dose (10e8) or twice with a low dose (3log10 lower) were protected against challenge infection with the homologous or heterologous influenza A/H5N1 virus.(Kreijtz et al PLoS One 2009)
- Main changes (audit trail)
- RECORD18-apr-2012 - 17-nov-2012

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