Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response
► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20μg. ► Dose of 1.25 or 2.5μg of VAX128C gave peak GMT was 385, 79% SC and 92% SP. We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine cons...
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| Published in | Vaccine Vol. 30; no. 39; pp. 5761 - 5769 |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier Ltd
24.08.2012
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
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| Abstract | ► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20μg. ► Dose of 1.25 or 2.5μg of VAX128C gave peak GMT was 385, 79% SC and 92% SP.
We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C.
In a dose escalation trial, 112 healthy subjects 18–49 and 100 adults ≥65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20μg. VAX128C was selected for second study performed in 100 subjects 18–64 years old comparing 1.25 and 2.5μg doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured.
In the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses ≥2.5μg in adults 18–49. In adults ≥65 years, the vaccines doses of ≥4μg were required to induce a ≥4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8μg, VAX128B to 16μg and VAX128C to 20μg. Dose escalation for VAX128A was stopped at 8μg because one subject had temperature 101.6°F associated with a high CRP response, VAX128B was stopped at 16μg because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20μg dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5μg. The peak GMT was 385 (95%CI 272–546), 79% (71–87%) seroconversion and 92% (84–96%) seroprotection.
Flagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology. |
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| AbstractList | Highlights► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20 μg. ► Dose of 1.25 or 2.5 μg of VAX128C gave peak GMT was 385, 79% SC and 92% SP. ► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20μg. ► Dose of 1.25 or 2.5μg of VAX128C gave peak GMT was 385, 79% SC and 92% SP. We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C. In a dose escalation trial, 112 healthy subjects 18–49 and 100 adults ≥65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20μg. VAX128C was selected for second study performed in 100 subjects 18–64 years old comparing 1.25 and 2.5μg doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured. In the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses ≥2.5μg in adults 18–49. In adults ≥65 years, the vaccines doses of ≥4μg were required to induce a ≥4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8μg, VAX128B to 16μg and VAX128C to 20μg. Dose escalation for VAX128A was stopped at 8μg because one subject had temperature 101.6°F associated with a high CRP response, VAX128B was stopped at 16μg because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20μg dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5μg. The peak GMT was 385 (95%CI 272–546), 79% (71–87%) seroconversion and 92% (84–96%) seroprotection. Flagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology. We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C.BACKGROUNDWe evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C.In a dose escalation trial, 112 healthy subjects 18-49 and 100 adults ≥65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20 μg. VAX128C was selected for second study performed in 100 subjects 18-64 years old comparing 1.25 and 2.5 μg doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured.METHODSIn a dose escalation trial, 112 healthy subjects 18-49 and 100 adults ≥65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20 μg. VAX128C was selected for second study performed in 100 subjects 18-64 years old comparing 1.25 and 2.5 μg doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured.In the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses ≥2.5 μg in adults 18-49. In adults ≥65 years, the vaccines doses of ≥4 μg were required to induce a ≥4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8 μg, VAX128B to 16 μg and VAX128C to 20 μg. Dose escalation for VAX128A was stopped at 8 μg because one subject had temperature 101.6°F associated with a high CRP response, VAX128B was stopped at 16 μg because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20 μg dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5 μg. The peak GMT was 385 (95%CI 272-546), 79% (71-87%) seroconversion and 92% (84-96%) seroprotection.CONCLUSIONSIn the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses ≥2.5 μg in adults 18-49. In adults ≥65 years, the vaccines doses of ≥4 μg were required to induce a ≥4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8 μg, VAX128B to 16 μg and VAX128C to 20 μg. Dose escalation for VAX128A was stopped at 8 μg because one subject had temperature 101.6°F associated with a high CRP response, VAX128B was stopped at 16 μg because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20 μg dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5 μg. The peak GMT was 385 (95%CI 272-546), 79% (71-87%) seroconversion and 92% (84-96%) seroprotection.Flagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology.DISCUSSIONFlagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology. We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C. In a dose escalation trial, 112 healthy subjects 18-49 and 100 adults ≥65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20 μg. VAX128C was selected for second study performed in 100 subjects 18-64 years old comparing 1.25 and 2.5 μg doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured. In the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses ≥2.5 μg in adults 18-49. In adults ≥65 years, the vaccines doses of ≥4 μg were required to induce a ≥4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8 μg, VAX128B to 16 μg and VAX128C to 20 μg. Dose escalation for VAX128A was stopped at 8 μg because one subject had temperature 101.6°F associated with a high CRP response, VAX128B was stopped at 16 μg because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20 μg dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5 μg. The peak GMT was 385 (95%CI 272-546), 79% (71-87%) seroconversion and 92% (84-96%) seroprotection. Flagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology. Highlights * Recombinant influenza vaccines differ in safety profiles according to configuration. * VAX128C was well tolerated up to a dose of 20μg. * Dose of 1.25 or 2.5μg of VAX128C gave peak GMT was 385, 79% SC and 92% SP. BACKGROUND: We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C. METHODS: In a dose escalation trial, 112 healthy subjects 18–49 and 100 adults ≥65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20μg. VAX128C was selected for second study performed in 100 subjects 18–64 years old comparing 1.25 and 2.5μg doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured. CONCLUSIONS: In the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses ≥2.5μg in adults 18–49. In adults ≥65 years, the vaccines doses of ≥4μg were required to induce a ≥4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8μg, VAX128B to 16μg and VAX128C to 20μg. Dose escalation for VAX128A was stopped at 8μg because one subject had temperature 101.6°F associated with a high CRP response, VAX128B was stopped at 16μg because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20μg dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5μg. The peak GMT was 385 (95%CI 272–546), 79% (71–87%) seroconversion and 92% (84–96%) seroprotection. DISCUSSION: Flagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology. Background: We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1 genetically fused to the TLR5 ligand, flagellin. HA1 was fused to the C-terminus of flagellin in VAX128A, replaced the D3 domain of flagellin in VAX128B and was fused in both positions in VAX128C. Methods: In a dose escalation trial, 112 healthy subjects 18-49 and 100 adults similar to 65 years old were enrolled in a double blind, placebo controlled clinical trial at two centers. Vaccines were administered IM at doses ranging from 0.5 to 20 mu g. VAX128C was selected for second study performed in 100 subjects 18-64 years old comparing 1.25 and 2.5 mu g doses. All subjects were followed for safety and sera collected pre- and post-vaccination were tested by hemagglutination-inhibition (HAI). Serum C-reactive protein and cytokine levels were also measured. Conclusions: In the first study high HAI titers and high seroconversion and seroprotection rates were observed at doses similar to 2.5 mu g in adults 18-49. In adults similar to 65 years, the vaccines doses of similar to 4 mu g were required to induce a similar to 4-fold rise in HAI titer, 50% seroconversion and 70% seroprotection. Based on safety, VAX128A was tested up to 8 mu g, VAX128B to 16 mu g and VAX128C to 20 mu g. Dose escalation for VAX128A was stopped at 8 mu g because one subject had temperature 101.6 degree F associated with a high CRP response, VAX128B was stopped at 16 mu g because of a severe AE associated with a high CRP and IL-6 response. VAX128C was not stopped before reaching the 20 mu g dose. In the second study VAX128C was well tolerated among 100 subjects who received 1.25 or 2.5 mu g. The peak GMT was 385 (95%CI 272-546), 79% (71-87%) seroconversion and 92% (84-96%) seroprotection. Discussion: Flagellin adjuvanted vaccines can be designed to minimize reactogenicity and retain immunogenicity, thereby representing a promising next generation vaccine technology. |
| Author | Kavita, Uma Liu, Ge Hofstaetter, Thomas Song, Langzhou Taylor, David N. Treanor, John J. Johnson, Casey Shaw, Alan Sheldon, Eric A. Umlauf, Scott Ozer, Karen Tussey, Lynda |
| Author_xml | – sequence: 1 givenname: David N. surname: Taylor fullname: Taylor, David N. email: david.taylor@vaxinnate.com organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 2 givenname: John J. surname: Treanor fullname: Treanor, John J. organization: University of Rochester, School of Medicine and Dentistry, Rochester, NY 14642, United States – sequence: 3 givenname: Eric A. surname: Sheldon fullname: Sheldon, Eric A. organization: Miami Research Associates, 6141 Sunset Drive, Suite 501, Miami, FL 33143, United States – sequence: 4 givenname: Casey surname: Johnson fullname: Johnson, Casey organization: Johnson County Clin-Trials, Lenexa, KS 66219, United States – sequence: 5 givenname: Scott surname: Umlauf fullname: Umlauf, Scott organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 6 givenname: Langzhou surname: Song fullname: Song, Langzhou organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 7 givenname: Uma surname: Kavita fullname: Kavita, Uma organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 8 givenname: Ge surname: Liu fullname: Liu, Ge organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 9 givenname: Lynda surname: Tussey fullname: Tussey, Lynda organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 10 givenname: Karen surname: Ozer fullname: Ozer, Karen organization: CYTEL, Inc., 675 Massachusetts Avenue, Cambridge, MA 02139, United States – sequence: 11 givenname: Thomas surname: Hofstaetter fullname: Hofstaetter, Thomas organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States – sequence: 12 givenname: Alan surname: Shaw fullname: Shaw, Alan organization: VaxInnate Corporation, 3 Cedar Brook Drive, Cranbury, NJ 08512, United States |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22796139$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2012 Elsevier Ltd Elsevier Ltd Copyright © 2012 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Aug 24, 2012 |
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| DOI | 10.1016/j.vaccine.2012.06.086 |
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| Keywords | Vaccine Influenza prevention Influenza vaccine Flagellin adjuvant Recombinant vaccine |
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| References | Taylor, Treanor, Strout, Johnson, Fitzgerald, Kavita (bib0025) 2011; 29 Song, Zhang, Yun (bib0030) 2009; 27 Lodes, Cong, Elson, Mohamath, Landers, Targan (bib0060) 2004; 113 Podolsky (bib0055) 2002; 347 Liu, Tarbet, Song, Reiserova, Weaver, Chen (bib0015) 2011; 6 Black, Kushner, Samols (bib0040) 2004; 279 Lambert, Fauci (bib0005) 2010; 363 Dowdle, Kendal, Noble (bib0035) 1979 Smith, Andersen-Nissen, Hayashi, Strobe, Bergman, Barrett (bib0045) 2003; 4 Andersen-Nissen, Smith, Strobe, Barrett, Cookson, Logan (bib0050) 2005; 102 Song, Nakaar, Kavita, Price, Huleatt, Tang (bib0010) 2008; 3 Treanor, Taylor, Tussey, Hay, Nolan, Fitzgerald (bib0020) 2010; 28 Song (10.1016/j.vaccine.2012.06.086_bib0010) 2008; 3 Lambert (10.1016/j.vaccine.2012.06.086_bib0005) 2010; 363 Smith (10.1016/j.vaccine.2012.06.086_bib0045) 2003; 4 Lodes (10.1016/j.vaccine.2012.06.086_bib0060) 2004; 113 Dowdle (10.1016/j.vaccine.2012.06.086_bib0035) 1979 Black (10.1016/j.vaccine.2012.06.086_bib0040) 2004; 279 Song (10.1016/j.vaccine.2012.06.086_bib0030) 2009; 27 Andersen-Nissen (10.1016/j.vaccine.2012.06.086_bib0050) 2005; 102 Liu (10.1016/j.vaccine.2012.06.086_bib0015) 2011; 6 Taylor (10.1016/j.vaccine.2012.06.086_bib0025) 2011; 29 Podolsky (10.1016/j.vaccine.2012.06.086_bib0055) 2002; 347 Treanor (10.1016/j.vaccine.2012.06.086_bib0020) 2010; 28 |
| References_xml | – volume: 27 start-page: 5875 year: 2009 end-page: 5884 ident: bib0030 article-title: Superior efficacy of a recombinant flagellin: H5N1 HA globular head vaccine is determined by the placement of the globular head within flagellin publication-title: Vaccine – start-page: 603 year: 1979 end-page: 605 ident: bib0035 article-title: Influenza viruses publication-title: Diagnostic procedures for viral, rickettsial, and chlamydial infections – volume: 4 start-page: 1247 year: 2003 end-page: 1253 ident: bib0045 article-title: Toll-like receptor 5 recognizes a conserved site on flagellin required for protofilament formation and bacterial motility publication-title: Nat Immunol – volume: 279 start-page: 48487 year: 2004 end-page: 48490 ident: bib0040 article-title: C-reactive protein publication-title: J Biol Chem – volume: 28 start-page: 8268 year: 2010 end-page: 8274 ident: bib0020 article-title: Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults publication-title: Vaccine – volume: 3 start-page: e2257 year: 2008 ident: bib0010 article-title: Efficacious recombinant influenza vaccines produced by high yield bacterial expression: a solution to global pandemic and seasonal needs publication-title: PLoS One – volume: 6 start-page: e20928 year: 2011 ident: bib0015 article-title: Immunogenicity and efficacy of flagellin-fused vaccine candidates targeting 2009 pandemic H1N1 influenza in mice publication-title: PLoS One. – volume: 29 start-page: 4897 year: 2011 end-page: 4902 ident: bib0025 article-title: Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI) publication-title: Vaccine – volume: 347 start-page: 417 year: 2002 end-page: 429 ident: bib0055 article-title: Inflammatory bowel disease publication-title: N Engl J Med – volume: 363 start-page: 2036 year: 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10.1016/j.vaccine.2011.05.001 – volume: 3 start-page: e2257 year: 2008 ident: 10.1016/j.vaccine.2012.06.086_bib0010 article-title: Efficacious recombinant influenza vaccines produced by high yield bacterial expression: a solution to global pandemic and seasonal needs publication-title: PLoS One doi: 10.1371/journal.pone.0002257 – volume: 347 start-page: 417 year: 2002 ident: 10.1016/j.vaccine.2012.06.086_bib0055 article-title: Inflammatory bowel disease publication-title: N Engl J Med doi: 10.1056/NEJMra020831 – volume: 113 start-page: 1296 year: 2004 ident: 10.1016/j.vaccine.2012.06.086_bib0060 article-title: Bacterial flagellin is a dominant antigen in Crohn disease publication-title: J Clin Invest doi: 10.1172/JCI200420295 – volume: 6 start-page: e20928 year: 2011 ident: 10.1016/j.vaccine.2012.06.086_bib0015 article-title: Immunogenicity and efficacy of flagellin-fused vaccine candidates targeting 2009 pandemic H1N1 influenza in mice publication-title: PLoS One. doi: 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10.1016/j.vaccine.2009.07.060 – volume: 279 start-page: 48487 year: 2004 ident: 10.1016/j.vaccine.2012.06.086_bib0040 article-title: C-reactive protein publication-title: J Biol Chem doi: 10.1074/jbc.R400025200 – volume: 102 start-page: 9247 year: 2005 ident: 10.1016/j.vaccine.2012.06.086_bib0050 article-title: Evasion of toll-like receptor 5 by flagellated bacteria publication-title: Proc Natl Acad Sci USA doi: 10.1073/pnas.0502040102 |
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| Snippet | ► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20μg. ► Dose of 1.25 or... Highlights► Recombinant influenza vaccines differ in safety profiles according to configuration. ► VAX128C was well tolerated up to a dose of 20 μg. ► Dose of... BACKGROUND: We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of... We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of the Novel H1N1... Highlights * Recombinant influenza vaccines differ in safety profiles according to configuration. * VAX128C was well tolerated up to a dose of 20μg. * Dose of... Background: We evaluated the safety and immunogenicity profiles of 3 novel influenza vaccine constructs consisting of the globular head of the HA1 domain of... |
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| Title | Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response |
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