Giuseppe
Emeritus
Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin. (Vaccine, abstract, edited)
16. Vaccine. 2010 Jan 28. [Epub ahead of print]
Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin.
Smith LR, Wloch MK, Ye M, Reyes LR, Boutsaboualoy S, Dunne CE, Chaplin JA, Rusalov D, Rolland AP, Fisher CL, Al-Ibrahim MS, Kabongo ML, Steigbigel R, Belshe RB, Kitt ER, Chu AH, Moss RB. - Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States.
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((R))-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((R))-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.
Copyright ? 2010. Published by Elsevier Ltd.
PMID: 20117262 [PubMed - as supplied by publisher]
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16. Vaccine. 2010 Jan 28. [Epub ahead of print]
Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin.
Smith LR, Wloch MK, Ye M, Reyes LR, Boutsaboualoy S, Dunne CE, Chaplin JA, Rusalov D, Rolland AP, Fisher CL, Al-Ibrahim MS, Kabongo ML, Steigbigel R, Belshe RB, Kitt ER, Chu AH, Moss RB. - Vical Incorporated, 10390 Pacific Center Court, San Diego, CA 92121, United States.
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((R))-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((R))-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.
Copyright ? 2010. Published by Elsevier Ltd.
PMID: 20117262 [PubMed - as supplied by publisher]
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