Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin
Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. We conducted two double-blin...
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| Published in | Vaccine Vol. 28; no. 13; pp. 2565 - 2572 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
16.03.2010
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0264-410X 1873-2518 1873-2518 |
| DOI | 10.1016/j.vaccine.2010.01.029 |
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| Abstract | Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches.
We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin
®-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1
mg of DNA/injection.
All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of ≥40 and 4-fold rises from baseline were achieved in 47–67% of subjects and H5-specific T-cell responses in 75–100%. Trivalent cohorts had lower HI response rates (≤20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens.
Vaxfectin
®-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. |
|---|---|
| AbstractList | Background Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. Methods We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin®-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1mg of DNA/injection. Results All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of >=40 and 4-fold rises from baseline were achieved in 47-67% of subjects and H5-specific T-cell responses in 75-100%. Trivalent cohorts had lower HI response rates (<=20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens. Conclusions Vaxfectin®-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. Abstract Background Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. Methods We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin® -adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1 mg of DNA/injection. Results All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of ≥40 and 4-fold rises from baseline were achieved in 47–67% of subjects and H5-specific T-cell responses in 75–100%. Trivalent cohorts had lower HI response rates (≤20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens. Conclusions Vaxfectin® -adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1mg of DNA/injection. All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of > or =40 and 4-fold rises from baseline were achieved in 47-67% of subjects and H5-specific T-cell responses in 75-100%. Trivalent cohorts had lower HI response rates (< or = 20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens. Vaxfectin-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin ®-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1 mg of DNA/injection. All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of ≥40 and 4-fold rises from baseline were achieved in 47–67% of subjects and H5-specific T-cell responses in 75–100%. Trivalent cohorts had lower HI response rates (≤20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens. Vaxfectin ®-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches. Methods - We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1 mg of DNA/injection. Results - All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of >=40 and 4-fold rises from baseline were achieved in 47-67% of subjects and H5-specific T-cell responses in 75-100%. Trivalent cohorts had lower HI response rates (<=20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens. Conclusions - Vaxfectin-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches.BACKGROUNDDevelopment of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing capacity and production time of conventional inactivated vaccines highlight the need for additional approaches.We conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1mg of DNA/injection.METHODSWe conducted two double-blind, placebo-controlled phase 1 studies involving a total of 103 healthy adults who received two intramuscular injections of Vaxfectin-adjuvanted plasmid DNA vaccine or placebo 21 days apart. Vaccine cohorts received either a monovalent vaccine containing an A/Vietnam/1203/04 H5 hemagglutinin-encoding plasmid or a trivalent vaccine with plasmids encoding H5, NP, and M2 proteins in doses from 0.1 to 1mg of DNA/injection.All doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of > or =40 and 4-fold rises from baseline were achieved in 47-67% of subjects and H5-specific T-cell responses in 75-100%. Trivalent cohorts had lower HI response rates (< or = 20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens.RESULTSAll doses were well tolerated without vaccine-related serious adverse events or discontinuations. In the monovalent cohorts, hemagglutination inhibition (HI) titers of > or =40 and 4-fold rises from baseline were achieved in 47-67% of subjects and H5-specific T-cell responses in 75-100%. Trivalent cohorts had lower HI response rates (< or = 20%), but 72% of subjects achieved T-cell and/or antibody responses to one or more antigens.Vaxfectin-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control.CONCLUSIONSVaxfectin-adjuvanted monovalent H5 DNA vaccines were well tolerated and induced HI response rates and titers in the reported range of inactivated protein-based H5 vaccines, suggesting that adjuvanted DNA vaccines with rapid vaccine production could be useful for pandemic control. |
| Author | Chaplin, Jennifer A. Al-Ibrahim, Mohamed S. Rolland, Alain P. Kitt, Ernest R. Smith, Larry R. Rusalov, Denis Chu, Alice H. Ye, Ming Belshe, Robert B. Wloch, Mary K. Dunne, Casey E. Kabongo, Martin L. Steigbigel, Roy Boutsaboualoy, Souphaphone Fisher, Cindy L. Reyes, Luane R. Moss, Ronald B. |
| Author_xml | – sequence: 1 givenname: Larry R. surname: Smith fullname: Smith, Larry R. email: lsmith@vical.com organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 2 givenname: Mary K. surname: Wloch fullname: Wloch, Mary K. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 3 givenname: Ming surname: Ye fullname: Ye, Ming organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 4 givenname: Luane R. surname: Reyes fullname: Reyes, Luane R. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 5 givenname: Souphaphone surname: Boutsaboualoy fullname: Boutsaboualoy, Souphaphone organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 6 givenname: Casey E. surname: Dunne fullname: Dunne, Casey E. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 7 givenname: Jennifer A. surname: Chaplin fullname: Chaplin, Jennifer A. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 8 givenname: Denis surname: Rusalov fullname: Rusalov, Denis organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 9 givenname: Alain P. surname: Rolland fullname: Rolland, Alain P. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 10 givenname: Cindy L. surname: Fisher fullname: Fisher, Cindy L. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 11 givenname: Mohamed S. surname: Al-Ibrahim fullname: Al-Ibrahim, Mohamed S. organization: SNBL, Clinical Pharmacology Center, Baltimore, MD, United States – sequence: 12 givenname: Martin L. surname: Kabongo fullname: Kabongo, Martin L. organization: University of California at San Diego, San Diego, CA, United States – sequence: 13 givenname: Roy surname: Steigbigel fullname: Steigbigel, Roy organization: University at Stony Brook, Stony Brook, NY, United States – sequence: 14 givenname: Robert B. surname: Belshe fullname: Belshe, Robert B. organization: St. Louis University, St. Louis, MO, United States – sequence: 15 givenname: Ernest R. surname: Kitt fullname: Kitt, Ernest R. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 16 givenname: Alice H. surname: Chu fullname: Chu, Alice H. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States – sequence: 17 givenname: Ronald B. surname: Moss fullname: Moss, Ronald B. organization: Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States |
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| ContentType | Journal Article |
| Copyright | 2010 Elsevier Ltd Elsevier Ltd 2015 INIST-CNRS Copyright 2010 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Mar 16, 2010 Copyright 2010 Elsevier Ltd. All rights reserved. |
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| Keywords | DNA vaccine Vaxfectin H5N1 influenza virus Hemagglutinin Orthomyxoviridae Zoopathogen Genetic vaccine Virus Plasmid Influenzavirus A Immunogenicity Avian influenzavirus Influenza A virus Immunological adjuvant Clinical trial |
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article-title: Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial publication-title: Lancet doi: 10.1016/S0140-6736(06)68656-X – volume: 118 start-page: 3478 year: 2008 ident: 10.1016/j.vaccine.2010.01.029_bib22 article-title: Memory T cells established by seasonal human influenza A infection cross-react with avian influenza A (H5N1) in healthy individuals publication-title: J Clin Invest |
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| Snippet | Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in manufacturing... Abstract Background Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority.... Background Development of vaccines against highly pathogenic avian influenza virus H5N1 subtypes posing a pandemic threat remains a priority. Limitations in... |
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| Title | Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin |
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