Phase 1 study of pandemic H1 DNA vaccine in healthy adults

PLoS ONE

Volumn 10, Issue 4, 2015, Pages

  Crank, Michelle C ^a   Gordon, Ingelise J ^a   Yamshchikov, Galina V ^a   Sitar, Sandra ^a   Hu, Zonghui ^a   Enama, Mary E ^a   Holman, LaSonji A ^a   Bailer, Robert T ^a   Pearce, Melissa B ^b   Koup, Richard A ^a   Mascola, John R ^a   Nabel, Gary J ^c   Tumpey, Terrence M ^b   Schwartz, Richard M ^a   Graham, Barney S ^a   Ledgerwood, Julie E ^a   Plummer, Sarah ^a   Hendel, Cynthia Starr ^a   Novik, Laura ^a   Costner, Pamela ^a   Zephir, Kathy ^a   Mendoza, Floreliz ^a   Saunders, Jamie ^a   Berkowitz, Nina ^a   Wilson, Brandon ^a   Larkin, Brenda ^a   Casazza, Joseph ^a   Sarwar, Uzma ^a   Stein, Judy ^a   Vasilenko, Olga ^a   Decederfelt, Hope ^d   Starling, Judith ^d   Renehan, Phyllis ^e   more..

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES   (United States)

^c SANOFI   (United States)

^d NATIONAL INSTITUTES OF HEALTH   (United States)

^e EMMES CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DNA VACCINE; INFLUENZA VACCINE;

2009 H1N1 INFLUENZA; ADULT; AGED; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CD4 LYMPHOCYTE COUNT; CD8+ T LYMPHOCYTE; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLU LIKE SYNDROME; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE EROSION; MALE; MIGRAINE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; SYRINGE NEEDLE; UNITED STATES; CLINICAL TRIAL; IMMUNOLOGY; INFLUENZA A VIRUS (H1N1); INFLUENZA, HUMAN; MIDDLE AGED; PROCEDURES; VACCINATION; YOUNG ADULT;

INFLUENZA A VIRUS; ORTHOMYXOVIRIDAE; SUIDAE;

ADULT; AGED; FEMALE; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; VACCINATION; VACCINES, DNA; YOUNG ADULT;

EID: 84929485218     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0123969     Document Type: Article

References (37)

1. WHO. Influenza (Seasonal) 2009. Available: Http://www.who.int/mediacentre/factsheets/fs211/en/.
2. Osterholm MT, Kelley NS, Sommer A, Belongia EA. Efficacy and effectiveness of influenza vaccines: A systematic review and meta-analysis. The Lancet Infectious Diseases. 2012; 12(1):36-44. doi:10.1016/S1473-3099(11)70295-X PMID: 22032844.
3. CDC. Early estimates of seasonal influenza vaccine effectiveness-United States, January 2013. MMWR Morb Mortal Wkly Rep. 2013; 62:32-5. Epub 2013/01/18. PMID: 23325354.
4. Novel Swine-Origin Influenza AVIT. Emergence of a Novel Swine-Origin Influenza A (H1N1) Virus in Humans. N Engl J Med. 2009; 360(25):2605-15. doi:10.1056/NEJMoa0903810 PMID: 19423869.
5. WHO. Statement to the press by WHO Director-General Dr Margaret Chan. 11 June 2009. 2009. Available: Http://www.who.int/mediacentre/news/statements/2009/h1n1-pandemic-phase6-20090611/en/index.html.
6. CDC. The 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2010 2010. Available: Http://www.cdc.gov/h1n1flu/cdcresponse.htm.
7. FDA. FDA Approves Vaccines for 2009 H1N1 Influenza Virus 2009. Available: Http://www.fda.gov/NewsEvents/Newsroom/pressannouncements/ucm182399.htm.
8. Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, et al. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009; 361(25):2405-13. Epub 2009/09/12. doi:10.1056/NEJMoa0907413 PMID: 19745216.
9. Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, et al. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009; 361(25):2424-35. Epub 2009/09/12. doi:10.1056/NEJMoa0907650 PMID: 19745215.
10. Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: A preliminary report of two randomised controlled phase 2 trials. Lancet. 2010; 375(9708):41-8. Epub 2009/12/19. doi:10.1016/S0140-6736(09)62026-2 PMID: 20018365.
11. Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: A multicentre, randomised controlled trial. Lancet. 2010; 375(9708):49-55. Epub 2009/12/19. doi:10.1016/S0140-6736(09)62039-0 PMID: 20018367.
12. Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, et al. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009; 361(25):2414-23. Epub 2009/10/23. doi:10.1056/NEJMoa0908535 PMID: 19846844.
13. Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med. 2009; 361(20):1945-52. Epub 2009/09/12. doi: NEJMoa0906453 [pii] doi:10.1056/NEJMoa0906453 PMID: 19745214.
14. Ledgerwood JE, Graham BS. DNA vaccines: A safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009; 5(9):623-6. Epub 2009/09/26. doi: 8627 [pii]. PMID: 19779298.
15. Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, et al. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011; 203(10):1396-404. Epub 2011/03/15. doi: jir054 [pii] doi:10.1093/infdis/jir054 PMID: 21398392; PubMed Central PMCID: PMC3080891.
16. Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, et al. DNA priming and influenza vaccine immunogenicity: Two phase 1 open label randomised clinical trials. Lancet Infect Dis. 2011; 11 (12):916-24. Epub 2011/10/07. doi: S1473-3099(11)70240-7 [pii] doi:10.1016/S1473-3099(11)70240-7 PMID: 21975270.
17. Martin JE, Louder MK, Holman LA, Gordon IJ, Enama ME, Larkin BD, et al. A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial. Vaccine. 2008; 26(50):6338-43. PMID: 18824060. doi:10.1016/j.vaccine.2008.09.026.
18. Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, et al. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis. 2007; 196 (12):1732-40. Epub 2008/01/15. doi:10.1086/523650 PMID: 18190252; PubMed Central PMCID: PMC2714735.
19. Graham BS, Enama ME, Nason MC, Gordon IJ, Peel SA, Ledgerwood JE, et al. DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial. PloS one. 2013; 8(4):e59340. doi:10.1371/journal.pone.0059340 PMID: 23577062; PubMed Central PMCID: PMC3620125.
20. Yang ZY, Kong WP, Huang Y, Roberts A, Murphy BR, Subbarao K, et al. A DNA vaccine induces SARS coronavirus neutralization and protective immunity in mice. Nature. 2004; 428(6982):561-4. PMID: 15024391.
21. CDC. Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR-Morbidity & Mortality Weekly Report. 2009; 58(19):521-4.
22. Stephenson I, Wood JM, Nicholson KG, Charlett A, Zambon MC. Detection of anti-H5 responses in human sera by HI using horse erythrocytes following MF59-adjuvanted influenza A/Duck/Singapore/97 vaccine. Virus Res. 2004; 103(1-2):91-5. PMID: 15163495.
23. Garten RJ, Davis CT, Russell CA, Shu B, Lindstrom S, Balish A, et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science. 2009; 325 (5937):197-201. Epub 2009/05/26. doi: 1176225 [pii] doi:10.1126/science.1176225 PMID: 19465683.
24. Pearce MB, Belser JA, Gustin KM, Pappas C, Houser KV, Sun X, et al. Seasonal trivalent inactivated influenza vaccine protects against 1918 Spanish influenza virus infection in ferrets. Journal of virology. 2012; 86(13):7118-25. doi:10.1128/JVI.00674-12 PMID: 22553323; PubMed Central PMCID: PMC3416326.
25. Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, et al. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol. 2006; 13(11):1267-77. PMID: 16988008.
26. Kong WP, Hood C, Yang ZY, Wei CJ, Xu L, Garcia-Sastre A, et al. Protective immunity to lethal challenge of the 1918 pandemic influenza virus by vaccination. Proc Natl Acad Sci U S A. 2006; 103 (43):15987-91. PMID: 17043214.
27. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, et al. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006; 194(12):1638-49. PMID: 17109335.
28. Catanzaro AT, Roederer M, Koup RA, Bailer RT, Enama ME, Nason MC, et al. Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine. Vaccine. 2007; 25(20):4085-92. PMID: 17391815.
29. Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, et al. Prime-Boost Interval Matters: A Randomized Phase 1 Study to Identify the Minimum Interval Necessary to Observe the H5 DNA Influenza Vaccine Priming Effect. J Infect Dis. 2013; 208(3):418-22. doi:10.1093/infdis/jit180 PMID: 23633407.
30. Khurana S, Wu J, Dimitrova M, King LR, Manischewitz J, Graham BS, et al. DNA priming prior to inactivated influenza A(H5N1) vaccination expands the antibody epitope repertoire and increases affinity maturation in a boost-interval-dependent manner in adults. J Infect Dis. 2013; 208(3):413-7. Epub 2013/05/02. doi:10.1093/infdis/jit178 PMID: 23633404; PubMed Central PMCID: PMC3699004.
31. Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, et al. Prime-boost interval matters: A randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013; 208(3):418-22. Epub 2013/05/02. doi:10.1093/infdis/jit180 PMID: 23633407; PubMed Central PMCID: PMC3699006.
32. Jilg W, Schmidt M, Deinhardt F. Vaccination against hepatitis B: comparison of three different vaccination schedules. J Infect Dis. 1989; 160(5):766-9. Epub 1989/11/01. PMID: 2530289.
33. Oliveira PM, Silva AE, Kemp VL, Juliano Y, Ferraz ML. Comparison of three different schedules of vaccination against hepatitis B in health care workers. Vaccine. 1995; 13(9):791-4. Epub 1995/06/01. PMID: 7483798.
34. Drape RJ, Macklin MD, Barr LJ, Jones S, Haynes JR, Dean HJ. Epidermal DNA vaccine for influenza is immunogenic in humans. Vaccine. 2006; 24(21):4475-81. Epub 2005/09/10. doi:10.1016/j.vaccine.2005.08.012 PMID: 16150518.
35. Jones S, Evans K, McElwaine-Johnn H, Sharpe M, Oxford J, Lambkin-Williams R, et al. DNA vaccination protects against an influenza challenge in a double-blind randomised placebo-controlled phase 1b clinical trial. Vaccine. 2009; 27(18):2506-12. Epub 2009/04/17doi:10.1016/j.vaccine.2009.02.061 PMID: 19368793.
36. Smith LR, Wloch MK, Ye M, Reyes LR, Boutsaboualoy S, Dunne CE, et al. Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin. Vaccine. 2010; 28(13):2565-72. Epub 2010/02/02. doi:10.1016/j.vaccine.2010.01.029 PMID: 20117262.
37. Vasan S, Hurley A, Schlesinger SJ, Hannaman D, Gardiner DF, Dugin DP, et al. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers. PloS one. 2011; 6(5):e19252. doi:10.1371/journal.pone.0019252 PMID: 21603651; PubMed Central PMCID: PMC3095594.