Crucell Terug naar discussie overzicht

Draadje pubmed.

1. [verwijderd] 27 juni 2009 11:11

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   J Virol. 2009 Jun 24.
   
   Protective Efficacy of a Single Immunization of a Chimeric Adenovirus Vector-Based Vaccine Against SIV Challenge in Rhesus Monkeys.
   
   Barouch DH, Liu J, Lynch DM, O'Brien KL, La Porte A, Simmons NL, Riggs AM, Clark S, Abbink P, Montefiori DC, Landucci G, Forthal DN, Self SG, Carville A, Mansfield K, Goudsmit J.
   Division of Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA 02215; Duke University Medical Center, Durham, NC 27710; University of California, Irvine School of Medicine, Irvine, CA 92697; Department of Biostatistics, University of Washington, Seattle, WA 98109; New England Primate Research Center, Southborough, MA 01772; Crucell Holland BV, 2301 CA, Leiden, The Netherlands.
   
   Rare serotype and chimeric recombinant adenovirus (rAd) vectors that evade anti-Ad5 immunity are currently being evaluated as potential vaccine vectors for both HIV-1 and other pathogens. We have recently reported that a heterologous rAd prime-boost regimen expressing SIV Gag afforded durable partial immune control of an SIV challenge in rhesus monkeys. However, a single-shot immunization may ultimately be preferable for global vaccine delivery. We therefore evaluated the immunogenicity and protective efficacy of a single immunization of hexon-chimeric rAd5HVR48 vectors expressing SIV Gag, Pol, Nef, and Env against a homologous SIV challenge in rhesus monkeys. Inclusion of Env resulted in improved control of peak and setpoint SIV RNA levels following challenge. In contrast, DNA vaccine priming did not further improve the protective efficacy of rAd5HVR48 vectors in this system.
   
   www.ncbi.nlm.nih.gov/pubmed/19553307
2. flosz 31 juli 2009 21:34

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   Inflexal v. Influvac(Solvay).
   
   Vaccine. 2009 Jul 14.
   
   Long-lasting immunogenicity of a virosomal vaccine in older children and young adults with type I diabetes mellitus.
   
   Zuccotti GV, Scaramuzza A, Riboni S, Mameli C, Pariani E, Tanzi E, Zanetti A, Radaelli G.
   Department of Pediatrics, University of Milan, Luigi Sacco Hospital, Via GB Grassi 74, 20157 Milan, Italy.
   
   To evaluate the long-lasting immunogenicity and reactogenicity of a virosomal influenza vaccine in subjects with type I diabetes, a trial was conducted during the 2007-2008 influenza season in Milan, Northern Italy. One hundred five subjects aged 9-30 years were randomized to receive by intramuscular injection vaccination by a single dose (0.5ml) of either a virosomal (Inflexal V((R))) (n=52) or a standard subunit (Influvac((R))) (n=53) vaccine. Serum hemagglutinin inhibition antibody titres were determined against the three recommended influenza-like strains, A/H1N1, A/H3N2 and B, at pre-vaccination, and 1 and 6 months post-vaccination. Geometric mean titres were increased in the two groups 1 and 6 months post-vaccination (P<0.001). One month post-vaccination both vaccines met the CPMP requirement for immunogenicity with high seroprotection rates (>95%) for strains A/H1N1 and A/H3N2, and a seroprotection of 73% and 70% in the virosomal and subunit vaccine for strain B. Mean fold increase ranged 2.8 (A/H3N2)-6.2 (A/H1N1) in the virosomal group and 2.3 (A/H3N2)-4.8 (A/H1N1) in the subunit group. Immunogenicity declined 6 months post-vaccination in both groups, and the CPMP requirement for immunogenicity was satisfied only in the virosomal group. In subjects without pre-existing antibodies to strain B (titre <10), the virosomal vaccine showed higher immune response than the subunit vaccine 6 months post-vaccination, with a geometric mean titre (95% CI) of 40.2 (30.7-54.6) vs. 21.2 (14.6-30.8). Reactogenicity was similar in the two vaccines. All reactions were transient and not severe. The results indicate that in older children and young adults with type I diabetes influenza vaccination with a virosomal or a standard subunit vaccine is safe and adequately immunogenic against the three influenza vaccine strains. In addition, the virosomal vaccine may show better long-lasting immune response than the standard subunit vaccine, especially in subjects without pre-existing antibodies to influenza strains.
   www.ncbi.nlm.nih.gov/pubmed/19607951
   
3. flosz 7 augustus 2009 17:53

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   J Biol Chem. 2009 Aug 5.
   
   Cardiolipin molecular species with shorter acyl chains accumulate in S. cerevisiae mutants lacking the acyl-Coenzyme A-binding protein Acb1p. New insights into acyl chain remodeling of cardiolipin.
   
   Rijken PJ, Houtkooper RH, Akbari H, Brouwers JF, Koorengevel MC, de Kruijff B, Frentzen M, Vaz FM, de Kroon AI.
   Crucell, Netherlands;
   
   The function of the mitochondrial phospholipid cardiolipin (CL) is thought to depend on its acyl chain composition. The present study aims at a better understanding of the way the CL species profile is established in Saccharomyces cerevisiae by using depletion of the acyl-CoA binding protein Acb1p as a tool to modulate the cellular acyl chain content. Despite the presence of an intact CL remodeling system, acyl chains shorter than 16 carbon atoms (C16) were found to accumulate in CL in cells lacking Acb1p. Further experiments revealed that Taz1p, a key CL remodeling enzyme, was not responsible for the shortening of CL in the absence of Acb1p. This left de novo CL synthesis as the only possible source of acyl chains shorter than C16 in CL. Experiments in which the substrate specificity of the yeast cardiolipin synthase Crd1p and the acyl chain composition of individual short CL species were investigated, indicated that both CL precursors (i.e. phosphatidylglycerol (PG) and CDP-diacylglycerol (CDP-DAG)) contribute to comparable extents to the shorter acyl chains in CL in acb1 mutants. Based on the findings, we conclude that the fatty acid composition of mature CL in yeast is governed by the substrate specificity of the CL-specific lipase Cld1p and the fatty acid composition of the Taz1p substrates.
   
   www.ncbi.nlm.nih.gov/pubmed/19656950
4. [verwijderd] 13 augustus 2009 12:46

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   Biofocus e.a ook aan het stoeien op Per.C6.
   
   3. (WO 2009/098197) TARGET SEQUENCES AND METHODS TO IDENTIFY THE SAME, USEFUL IN TREATMENT OF NEURODEGENERATIVE DISEASES 13.08.2009 G01N 33/50 PCT/EP2009/051184 BIOFOCUS DPI B.V.
   
   4. (WO 2009/098196) MOLECULAR TARGETS AND COMPOUNDS, METHODS TO IDENTIFY THE SAME, USEFUL IN THE TREATMENT OF NEURODEGENERATIVE DISEASES. 13.08.2009 G01N 33/68 PCT/EP2009/051183 BIOFOCUS DPI B.V.
   
   5. (WO 2009/097128) MEMBRANE TRANSPORTER NAPI2B (SLC34A2) EPITOPE FOR ANTIBODY THERAPY, ANTIBODIES DIRECTED THERETO, AND TARGET FOR CANCER THERAPY 06.08.2009 C07K 16/30 PCT/US2009/000576 LUDWIG INSTITUTE FOR CANCER RESEARCH LTD.
   
   www.wipo.int
5. [verwijderd] 13 augustus 2009 12:58

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   Het lijkt net alsof er een "buzz" rondgaat door de industrie dat de business case van antistoffen veranderd is.
6. [verwijderd] 15 augustus 2009 09:25

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   In relatie met de aanschaf en installatie van de disposable produktie platforms, waar Cees de Jong over sprak bij halfjaar presentatie kwam ik dit bericht tegen:
   
   EMEA, FDA launch joint GCP inspection initiative
   05 August 2009
   A bilateral initiative aimed at maximising resources for Good Clinical Practice (GCP) inspections has been announced by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA).
   
   The EMEA described the initiative as an important step towards building “a global regulatory network for the supervision of clinical trials”, while the FDA said it should ensure trials submitted as part of marketing approval applications for medicines in the US and Europe were conducted “uniformly, appropriately and ethically”.
   
   The initiative, which will include information-sharing and collaborative GCP inspections of clinical trial sites and studies for products regulated by the EMEA and the FDA’s Center for Drug Evaluation and Research, will start with an 18-month pilot phase on 1 September 2009.
   
   Among the key objectives are periodic exchanges of GCP-related information in order to:
   
   • Streamline information-sharing relevant to GCP inspection planning, so that the selection of trials and sites for inspection is properly informed and inspection coverage improved
   • Share GCP-related information in applications for scientific advice, orphan drug status, paediatric investigation plans, and marketing authorisation or post-authorisation activities of significant public health interest
   
   • Communicate in an effective and timely fashion on inspection outcomes (both negative and positive) and their potential impact, where the clinical trials and/or inspected sites/organisations are of common interest.
   
   Other key goals include:
   
   • Conducting collaborative GCP inspections to build mutual understanding of, and confidence in, the inspection processes used by the European Union/EMEA and the FDA; and to improve the effectiveness of inspections by sharing best-practice knowledge to enhance inspection techniques and processes
   
   • Sharing information on the interpretation of Good Clinical Practice to keep the respective agencies informed of GCP-related legislation, regulatory guidance documents, position papers and policy documents, whether in draft or finalised form; and to identify and act on areas where greater convergence could be achieved to the benefit of the clinical research process.
   
   Once the pilot phase has concluded, the EMEA and the FDA will conduct a joint assessment of the scheme and will amend the process and modify its scope as necessary.
   
   The initiative is being pursued within the framework of the confidentiality arrangements between the European Commission, the EMEA and the FDA that were extended through an agreement signed in September 2005. The parties to these arrangements can exchange information as part of their regulatory processes.
   
   Increasing globalisation
   
   As the EMEA and the FDA pointed out, the increasing globalisation of clinical research, coupled with limited inspection resources, “means that only a sample of sites and clinical studies can be inspected”.
   
   If regulators can work “in a collaborative and synergistic manner” when carrying out GCP inspections and can exchange relevant information, “then GCP inspection resources can be used more efficiently”, the agencies added. Sponsors can facilitate this process “by informing regulators in the US and the EU of a joint filing which can be co-ordinated in both regions”.
   
   Dr Murray Lumpkin, the FDA’s deputy commissioner for international programs, commented: “This is another initiative that will further the very robust relationship between the FDA and the EMEA. This will allow both the FDA and the EMEA to leverage each other’s GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality.”
   
   By Peter Mansell
7. [verwijderd] 15 augustus 2009 12:53

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   @babylon:
   
   Is hier een relatie met dat Wyeth-verhaal waarbij niet de effectiviteit van het medicijn ter discussie, maar een aantoningsprocedure die meer tijd vergt?
8. [verwijderd] 16 augustus 2009 09:10

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   quote:

   munckf schreef:

   @babylon:
   
   Is hier een relatie met dat Wyeth-verhaal waarbij niet de effectiviteit van het medicijn ter discussie, maar een aantoningsprocedure die meer tijd vergt?
   

   De door de FDA extra gevraagde data betreft de samenstelling van Prevnar 13. In de laatse alinea wordt wel gesproken over de inspectie van de produktie fasciliteiten. Zie onderstaande artikel.
   
   New Prevnar sees delay in USA
   13 August 2009
   The much anticipated approval of Wyeth's new version of its blockbuster childhood vaccine Prevnar has been delayed by three months after the US Food and Drug Administration sought more time to review the data.
   
   A decision had been expected end-September but the submission of more data in July covering the specifications of the chemical and physicial properties of Prevnar 13 triggered the agency request. "FDA considered this to be a major amendment and, as a result, they have elected to extend the review cycle for Prevnar 13 by 90 days," Wyeth said in a statement.
   
   Prevnar is a vaccine designed to prevent pneumococcal disease caused by six strains of Streptococcus pneumoniae, which is responsible for a broad sweep of conditions from ear infections through to pneumonia and potentially fatal blood poisoning and meningitis. Indeed, pneumococcal disease is the leading cause of vaccine preventable death worldwide in children under the age of five and is estimated to be responsible for up to 1 million deaths in children every year.
   
   Such has been the success of the original version of Prevnar that last year it reeled in $2.7 billion, making it Wyeth's number two drug after the antidepressant Effexor (venlafaxine). Prevnar 13 is the hugely anticipated follow up as it prevents 13 strains of Streptococcus pneumoniae and has been investigated in 13 Phase III studies involving more than 7,000 children.
   
   "We are working closely with the FDA on the review, including conduct of the pre-approval inspections," says Emilio Emini, Executive Vice President, Vaccine R&D, Wyeth. "We continue to believe that our application supports the approval of Prevnar 13." Certainly news that the agency is already conducting inspections of the manufacturing facilities will help buffer the news for Wyeth; it also recently won its first marketing clearance for Prevnar 13 in Chile and approval is pending in more than 50 countries worldwide with more filings planned.
   
   By Claire Bowie
9. [verwijderd] 19 augustus 2009 13:00

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   1: Vaccine. 2009 Aug 14. [Epub ahead of print]
   
   Evaluation of a prime-boost vaccine schedule with distinct adenovirus vectors against malaria in rhesus monkeys.
   Rodríguez A, Mintardjo R, Tax D, Gillissen G, Custers J, Pau MG, Klap J, Santra S, Balachandran H, Letvin NL, Goudsmit J, Radošević K.
   Crucell Holland BV, PO Box 2048, 2301 CA Leiden, The Netherlands.
   
   A vaccine that elicits both specific antibodies and IFN-gamma-producing T cells is required to protect against pre-erythrocytic malaria. Among the most promising approaches to induce such complex immunity are heterologous prime-boost vaccination regimens, in particular ones containing live viral vector. We have demonstrated previously that adenovectors serotype 35 (Ads35) encoding the circumsporozoite (CS) antigen or liver-stage antigen-1 (LSA-1) are highly effective in improving the T-cell responses induced by immunizations with protein-based vaccines in a heterologous prime-boost schedule. Here we evaluated the potential of a heterologous prime-boost vaccination that combines the Ad35.CS vector with the serologically distinct adenovector Ad5.CS, in rhesus macaques, after establishing the potency in mice. We show that the heterologous Ad35.CS/Ad5.CS prime-boost regimen elicits both antibody responses and robust IFN-gamma-producing CD8(+) T-cell responses against the CS antigen. Analysis of the quality of the antibody responses in rhesus macaques, using indirect immunofluorescence assay (IFA) with Plasmodium falciparum-coated slides, demonstrated that this heterologous prime-boost regimen elicits a high titer of antibodies that are able to bind to P. falciparum sporozoites. Level of the IFA response was superior to the response measured with sera of an adult human population living in endemic malaria region. In conclusion, the combination of Ad35.CS, a vaccine based on a rare serotype adenovirus, with Ad5.CS or possibly another adenovector of a distinct serotype, induces a complex immune response that is required for protection against malaria, and is thus a highly promising approach for pediatric vaccination.
   www.ncbi.nlm.nih.gov/pubmed/19686691
10. [verwijderd] 19 augustus 2009 15:55

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    Nat Med. 2009 Aug;15(8):873-5. Epub 2009 Jul 20.Click here to read
    
    Adenovirus-specific immunity after immunization with an Ad5 HIV-1 vaccine candidate in humans.
    O'Brien KL, Liu J, King SL, Sun YH, Schmitz JE, Lifton MA, Hutnick NA, Betts MR, Dubey SA, Goudsmit J, Shiver JW, Robertson MN, Casimiro DR, Barouch DH.
    
    Division of Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
    
    The immunologic basis for the potential enhanced HIV-1 acquisition in adenovirus serotype 5 (Ad5)-seropositive individuals who received the Merck recombinant Ad5 HIV-1 vaccine in the STEP study remains unclear. Here we show that baseline Ad5-specific neutralizing antibodies are not correlated with Ad5-specific T lymphocyte responses and that Ad5-seropositive subjects do not develop higher vector-specific cellular immune responses as compared with Ad5-seronegative subjects after vaccination. These findings challenge the hypothesis that activated Ad5-specific T lymphocytes were the cause of the potential enhanced HIV-1 susceptibility in the STEP study.
    
    www.ncbi.nlm.nih.gov/pubmed/19620961
11. [verwijderd] 20 augustus 2009 06:29

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    interview met CEO Pharma over opgerichte consortium vergeten tropische ziekten.
    
    www.tipharma.com/news/news-overview/n...
    
    boodschap samengevat:
    doel onderzoek naar medicijn voor 2 tropische ziekte:
    Afrikaanse slaapziekte, waarbij een parasiet zich nestelt in het hart en in de hersens. Wanneer het de hersens aantast is de ziekte dodelijk.
    
    Lysmiatis, waarbij een parasiet zich nestelt in lever, mild en beenmerg.
    
    100.000 sterven jaarlijks aan ziekten.
    
    Hoog op de lijst van WHO.
    
    Consortium heeft 3,6 miljoen bijeengebracht.
    
    Geen geld aan te verdienen, maar valt onder maatschappelijk verantwoord ondernemen.
    
    Vraag: Waarom participeert Crucell hier niet in?
    Lijkt me mooi initiatief om de bladzijde over Corporate Social Responsability in het jaarverslag over 2009 mee te vullen en de banden als beste leverancier van de WHO e benadrukken.
12. [verwijderd] 20 augustus 2009 06:40

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    FDA approval voor GSK
    
    www.prnewswire.com/mnr/hiberix/38399/
    
    
13. flosz 20 augustus 2009 08:25

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    quote:

    winx08 schreef:

    Nat Med. 2009 Aug;15(8):873-5. Epub 2009 Jul 20.
    Adenovirus-specific immunity after immunization with an Ad5 HIV-1 vaccine candidate in humans.
    

    Zie www.iex.nl/forum/topic.asp?forum=228&...
14. flosz 20 augustus 2009 08:29

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    quote:

    babylon schreef:

    interview met CEO Pharma over opgerichte consortium vergeten tropische ziekten.
    
    www.tipharma.com/news/news-overview/n...
    
    Vraag: Waarom participeert Crucell hier niet in?
    Lijkt me mooi initiatief om de bladzijde over Corporate Social Responsability in het jaarverslag over 2009 mee te vullen en de banden als beste leverancier van de WHO e benadrukken.
    

    Waarom is Crucell uit TI Pharma gestapt?
    www.iex.nl/Forum/topic.asp?forum=228&...
    Draadje Top Institute Pharma:
    www.iex.nl/forum/topic.asp?forum=228&...
    www.iex.nl/forum/topic.asp?forum=228&...
    
    Vriendelijk verzoek dit Pubmed-draadje niet te vervuilen en te gebruiken voor wetenschappelijke publicaties.
    
15. flosz 14 september 2009 10:32

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    Biotechnol Bioeng. 2009 Sep 8.
    Development of a polishing step using a hydrophobic interaction membrane adsorber with a PER.C6 derived recombinant antibody.
    
    Kuczewski M, Fraud N, Faber R, Zarbis-Papastoitsis G.
    PERCIVIA LLC, 1 Hampshire St., 5th Floor, Cambridge, MA 02139, USA.
    
    Membrane chromatography has already proven to be a powerful alternative to polishing columns in flow-through mode for contaminant removal (Becerra-Arteaga 2008). As flow-through utilization has expanded, membrane chromatography applications have included the capturing of large molecules, including proteins such as IgGs. Such bind-and-elute applications imply the demand for high binding capacity and larger membrane surface areas as compared to flow-through applications. Given these considerations, a new Sartobind Phenyl membrane adsorber was developed for large scale purification of biomolecules based on hydrophobic interaction chromatography (HIC) principles. The new hydrophobic membrane adsorber combines the advantages of membrane chromatography-virtually no diffusion limitation and shorter processing time-with high binding capacity for proteins comparable to that of conventional HIC resins as well as excellent resolution.Results from these studies confirmed the capability of HIC membrane adsorber to purify therapeutic proteins with high dynamic binding capacities in the range of 20 mg-MAb/cm(3)-membrane and excellent impurity reduction. In addition the HIC phenyl membrane adsorber can operate at five- to ten-fold lower residence time when compared to column chromatography. A bind/elute purification step using the HIC membrane adsorber was developed for a recombinant monoclonal antibody produced using the PER.C6 cell line. Loading and elution conditions were optimized using statistical design of experiments. Scale up is further discussed, and the performance of the membrane adsorber is compared to a traditional HIC resin used in column chromatography. (c) 2009 Wiley Periodicals, Inc.
    PMID: 19739096
    
    www.ncbi.nlm.nih.gov/pubmed/19739096
    www.investorvillage.com/smbd.asp?mb=2...
16. flosz 29 oktober 2009 17:14

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    Vaccine. 2009 Oct 15.
    CD4+ T-cell responses to an oral inactivated cholera vaccine in young children in a cholera endemic country and the enhancing effect of zinc supplementation.
    Ahmed T, Arifuzzaman M, Lebens M, Qadri F, Lundgren A.
    International Centre for Diarrhoeal Disease Research (ICDDR,B), Bangladesh, GPO Box 128, Dhaka 1000, Bangladesh; Gothenburg University Vaccine Research Institute (GUVAX) and Department of Microbiology and Immunology, The Sahlgrenska Academy at University of Gothenburg, Box 435 S-40530, Gothenburg, Sweden.
    
    Immunization of young children with the oral inactivated whole cell cholera vaccine Dukoral((R)) containing recombinant cholera toxin B subunit (CTB) induces antibody responses which can be further enhanced by zinc supplementation. We have investigated if immunization with the cholera vaccine induces specific T-cell responses in young children and also whether zinc supplementation influences these responses. Bangladeshi children (10-18-month-old) received vaccine alone, vaccine together with zinc supplementation or only zinc. T-cell blast formation indicating a proliferative response was analyzed by the flow cytometric assay of cell-mediated immune response in activated whole blood (FASCIA) and cytokines were measured by ELISA. Stronger T-cell responses were detected if a modified CTB molecule (mCTB) with reduced binding to GM1 ganglioside was used for cell stimulation compared to normal CTB. After vaccination, CD4+ T-cells responded to mCTB with significantly increased blast formation (P<0.01) and IFN-gamma production (P<0.05) compared to before vaccination. No responses to mCTB were detected in children receiving zinc alone (P>0.05). The IFN-gamma production was significantly higher (P<0.01) but the blast formation comparable (P>0.05) in children receiving zinc plus vaccine compared to in children receiving vaccine alone. The vibriocidal antibody responses induced by the vaccine were also significantly higher in children receiving zinc supplementation (P<0.001). Our results thus show that oral cholera vaccination induces a Th1 T-cell response in young children, and that the IFN-gamma as well as the vibriocidal antibody responses can be enhanced by zinc supplementation.
    PMID: 19837094
    www.ncbi.nlm.nih.gov/pubmed/19837094
    
17. flosz 11 november 2009 17:41

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    Vaccine. 2009 Sep 30.
    Safety and immunogenicity of whole-virus, alum-adjuvanted whole-virus, virosomal, and whole-virus intradermal influenza A/H9N2 vaccine formulations.
    
    Nicholson KG, Thompson CI, Clap JM, Wood JM, Batham S, Newman RW, Mischler R, Zambon MC, Stephenson I.
    Infectious Diseases Unit, University Hospitals Leicester, Leicester, LE1 5WW, UK.
    Avian influenza H9N2 viruses are considered as a pandemic threat. We assessed the safety and immunogenicity of fourteen H9N2 vaccine formulations. A randomized, phase I trial was done in 353 adults, aged 18-82 years. Subjects received two doses of A/Hong Kong/1073/99 (H9N2) whole-virus, alum-adjuvanted whole-virus, virosomal, or intradermal whole-virus vaccine at four doses (1.7, 5, 15 or 45mug haemagglutinin). Sera were obtained before and three weeks after each vaccination (days 0, 21, and 42) for haemagglutination-inhibition (HAI) and neutralization assays. All formulations were well tolerated. Pre-vaccination sera from subjects aged below or above 40 years had baseline antibody to H9N2 in 1% and 16% of samples. Compared to intramuscular whole-virus vaccine, alum-adjuvanted vaccine was more immunogenic, intradermal vaccine was comparable, and virosomal vaccine less immunogenic. Among subjects under 40 years, two doses (45, 15, and 5mug) of alum-adjuvanted vaccine achieved seroprotective HAI titres in 50%, 41%, and 39% respectively, and neutralization seroconversions in 83%, 82%, and 78% of recipients. Among subjects over 40 years, one dose (45, 15, and 5mug) of alum-adjuvanted vaccine achieved seroprotective HAI titres in 50%, 25% and 0% respectively, and neutralization seroconversions in 88%, 63% and 63% of recipients. Among immunologically naive subjects under 40 years, two doses of vaccine are required and alum-adjuvanted vaccines were most immunogenic. Among immunologically primed subjects over 40 years, one dose of whole-virus or alum-adjuvanted vaccine induced immune responses; the second dose provided less additional benefit.
    
    However, no vaccine formulation satisfied all European regulatory criteria for pandemic vaccines.
    
    PMID: 19799843
    www.ncbi.nlm.nih.gov/pubmed/19799843
    
18. MeawandMoo1 20 november 2009 12:24

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    • MeawandMoo1

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    We show that a SINGLE injection with 15 mg/kg CR6261 outperforms a 5-DAY COURSE of treatment with oseltamivir (10 mg/kg/day)
    
    www.ncbi.nlm.nih.gov/pubmed/19911992?...
    
    Pre- and Postexposure Use of Human Monoclonal Antibody against H5N1 and H1N1 Influenza Virus in Mice: Viable Alternative to Oseltamivir.
    Koudstaal W, Koldijk MH, Brakenhoff JP, Cornelissen LA, Weverling GJ, Friesen RH, Goudsmit J.
    
    Crucell Holland BV, Leiden, and 2Central Veterinary Institute, Wageningen University, Lelystad, the Netherlands.
    
    New strategies to prevent and treat influenza virus infections are urgently needed. A recently discovered class of monoclonal antibodies (mAbs) neutralizing an unprecedented spectrum of influenza virus subtypes may have the potential for future use in humans. Here, we assess the efficacies of CR6261, which is representative of this novel class of mAbs, and oseltamivir in mice. We show that a single injection with 15 mg/kg CR6261 outperforms a 5-day course of treatment with oseltamivir (10 mg/kg/day) with respect to both prophylaxis and treatment of lethal H5N1 and H1N1 infections.
    
    These results justify further preclinical evaluation of broadly neutralizing mAbs against influenza virus for the prevention and treatment of influenza virus infections.
    
19. harvester 20 november 2009 22:33

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    • harvester

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    vroeg gplaatst maar mooi bericht
    
    J Infect Dis. 2009 Dec 15;200(12):1870-1873.
    
    

    quote:

    MeawandMoo1 schreef:

    We show that a SINGLE injection with 15 mg/kg CR6261 outperforms a 5-DAY COURSE of treatment with oseltamivir (10 mg/kg/day)
    
    www.ncbi.nlm.nih.gov/pubmed/19911992?...
    
    Pre- and Postexposure Use of Human Monoclonal Antibody against H5N1 and H1N1 Influenza Virus in Mice: Viable Alternative to Oseltamivir.
    Koudstaal W, Koldijk MH, Brakenhoff JP, Cornelissen LA, Weverling GJ, Friesen RH, Goudsmit J.
    
    Crucell Holland BV, Leiden, and 2Central Veterinary Institute, Wageningen University, Lelystad, the Netherlands.
    
    New strategies to prevent and treat influenza virus infections are urgently needed. A recently discovered class of monoclonal antibodies (mAbs) neutralizing an unprecedented spectrum of influenza virus subtypes may have the potential for future use in humans. Here, we assess the efficacies of CR6261, which is representative of this novel class of mAbs, and oseltamivir in mice. We show that a single injection with 15 mg/kg CR6261 outperforms a 5-day course of treatment with oseltamivir (10 mg/kg/day) with respect to both prophylaxis and treatment of lethal H5N1 and H1N1 infections.
    
    These results justify further preclinical evaluation of broadly neutralizing mAbs against influenza virus for the prevention and treatment of influenza virus infections.
    
    

20. flosz 9 december 2009 20:21

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    • flosz

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    JTravel Med. 2009 Nov-Dec;16(6):413-9.
    Virosomal hepatitis a vaccine: comparing intradermal and subcutaneous with intramuscular administration.
    
    Frösner G, Steffen R, Herzog C.
    Department of Virology, Max von Pettenkofer-Institute, Ludwig-Maximilians-University Munich, Germany.
    
    BACKGROUND: Vaccination against hepatitis A virus (HAV) is unaffordable to many developing countries. Substantial reductions in cost occur when vaccines are administered intradermally at low doses. Aluminum-free HAV vaccines are considered more suitable for intradermal use than traditional vaccines which can cause long-lasting local reactions. Thus, we compared the immunogenicity and safety of an aluminum-free virosomal HAV vaccine (Epaxal) administered by different routes: intradermal (i.d.), subcutaneous (s.c.), and intramuscular (i.m.). METHODS: Two open pilot studies were conducted as sub-studies of a large lot consistency trial. Healthy subjects aged 18 to 45 were enrolled. Study 1 compared two i.d. regimens of a lower dose of Epaxal [0.1 mL (4.8 IU), one or two injection sites] with i.m. administration of the standard dose [0.5 mL (24 IU)]. Study 2 compared the s.c. with the i.m. administration of the standard dose. At month 12, subjects in study 1 received a booster dose of 0.1 mL i.d. or 0.5 mL i.m.; subjects in study 2 received 0.5 mL via the respective route (s.c. or i.m.). Serum was tested for antibodies at baseline, 2 weeks (study 1), and 1 and 6 months after the primary vaccination as well as prior and 1 month after the booster dose. Incidences of solicited and unsolicited adverse events were recorded. RESULTS: Seroprotection rates (anti-HAV geometric mean concentration of > or =20 mIU/mL) after 1 month ranged from 93.2% to 100% in all groups and remained high until month 12 (range 85.2&-90.2%). Complete (100%) seroprotection was achieved by all subjects in all groups after booster vaccination. All routes of administration were well tolerated. Local reactions were more common in subjects vaccinated i.d. and s.c. than i.m.
    
    CONCLUSIONS: The aluminum-free virosomal HAV vaccine Epaxal is highly immunogenic and well tolerated when administered either via i.d., s.c., or i.m. Vaccination via the i.d. route may confer significant cost savings over the conventional i.m. route.
    
    PMID: 19930383
    www.ncbi.nlm.nih.gov/pubmed/19930383