Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials

Vaccine

Volumn 33, Issue 20, 2015, Pages 2347-2353

  Jin, Xia ^a,d   Morgan, Cecilia ^b   Yu, Xuesong ^b   DeRosa, Stephen ^b   Tomaras, Georgia D ^c   Montefiori, David C ^c   Kublin, James ^b   Corey, Larry ^b   Keefer, Michael C ^a  

^a UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^b USA   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d INSTITUTE PASTEUR OF SHANGHAI   (China)

Author keywords

Clinical trial; DNA vaccine; HIV; Immune response

Indexed keywords

DNA VACCINE; GAG PROTEIN; GAMMA INTERFERON; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INTERLEUKIN 2; NEF PROTEIN; NEUTRALIZING ANTIBODY; PLASMID DNA; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS ANTIGEN; IMMUNOLOGICAL ADJUVANT;

ADULT; ANTIBODY RESPONSE; ARTICLE; BODY MASS; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; DNA IMMUNIZATION; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; VACCINATION; VIRUS ENVELOPE; ADOLESCENT; BLOOD; CLINICAL TRIAL; GENETICS; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; MIDDLE AGED; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PLASMID; YOUNG ADULT;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AIDS VACCINES; BODY MASS INDEX; CD4-POSITIVE T-LYMPHOCYTES; CD8-POSITIVE T-LYMPHOCYTES; ENZYME-LINKED IMMUNOSPOT ASSAY; FEMALE; HEALTHY VOLUNTEERS; HIV ANTIBODIES; HIV ANTIGENS; HIV-1; HUMANS; INJECTIONS, INTRAMUSCULAR; INTERFERON-GAMMA; MALE; MIDDLE AGED; PLASMIDS; RETROSPECTIVE STUDIES; VACCINES, DNA; YOUNG ADULT;

EID: 84928589624     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.03.036     Document Type: Article

References (42)

1. Liu M.A. DNA vaccines: an historical perspective and view to the future. Immunol Rev 2011, 239(1):62-84.
2. Mann J.F., McKay P.F., Fiserova A., Klein K., Cope A., Rogers P., et al. Enhanced immunogenicity of an HIV-1 DNA vaccine delivered with electroporation via combined intramuscular and intradermal routes. J Virol 2014, 88(12):6959-6969.
3. Shibui A., Nakae S., Watanabe J., Sato Y., Tolba M.E., Doi J., et al. Screening of novel malaria DNA vaccine candidates using full-length cDNA library. Exp Parasitol 2013, 135(3):546-550.
4. Kang T.H., Mao C.P., La V., Chen A., Hung C.F., Wu T.C. Innovative DNA vaccine to break immune tolerance against tumor self-antigen. Hum Gene Ther 2013, 24(2):181-188.
5. Ahmad G., Zhang W., Torben W., Ahrorov A., Damian R.T., Wolf R.F., et al. Preclinical prophylactic efficacy testing of Sm-p80-based vaccine in a nonhuman primate model of Schistosoma mansoni infection and immunoglobulin G and E responses to Sm-p80 in human serum samples from an area where schistosomiasis is endemic. J Infect Dis 2011, 204(9):1437-1449.
6. De Rosa S.C., Thomas E.P., Bui J., Huang Y., deCamp A., Morgan C., et al. HIV-DNA priming alters T cell responses to HIV-adenovirus vaccine even when responses to DNA are undetectable. J Immunol 2011, 187(6):3391-3401.
7. Churchyard G.J., Morgan C., Adams E., Hural J., Graham B., Moodie Z., et al. A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204). PLoS ONE 2011, 6(8):e21225.
8. Kalams S.A., Parker S., Jin X., Elizaga M., Metch B., Wang M., et al. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS ONE 2012, 7(1):e29231.
9. Jin X., Newman M.J., De-Rosa S., Cooper C., Thomas E., Keefer M., et al. A novel HIV T helper epitope-based vaccine elicits cytokine-secreting HIV-specific CD4+ T cells in a phase I clinical trial in HIV-uninfected adults. Vaccine 2009, 27(50):7080-7086.
10. Kalams S.A., Parker S.D., Elizaga M., Metch B., Edupuganti S., Hural J., et al. Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid interleukin 12 and impact of intramuscular electroporation for delivery. J Infect Dis 2013, 208(5):818-829.
11. Koblin B.A., Casapia M., Morgan C., Qin L., Wang Z.M., Defawe O.D., et al. Safety and immunogenicity of an HIV adenoviral vector boost after DNA plasmid vaccine prime by route of administration: a randomized clinical trial. PLoS ONE 2011, 6(9):e24517.
12. Baden L.R., Blattner W.A., Morgan C., Huang Y., Defawe O.D., Sobieszczyk M.E., et al. Timing of plasmid cytokine (IL-2/Ig) administration affects HIV-1 vaccine immunogenicity in HIV-seronegative subjects. J Infect Dis 2011, 204(10):1541-1549.
13. Bull M., Lee D., Stucky J., Chiu Y.L., Robin A., Horton H., et al. Defining blood processing parameters for optimal detection of cryopreserved antigen-specific responses for HIV vaccine trials. J Immunol Methods 2007, 322(1-2):57-69.
14. Horton H., Thomas E.P., Stucky J.A., Frank I., Moodie Z., Huang Y., et al. Optimization and validation of an 8-color intracellular cytokine staining (ICS) assay to quantify antigen-specific T cells induced by vaccination. J Immunol Methods 2007, 323(1):39-54.
15. McElrath M.J., DeRosa S.C., Moodie Z., Dubey S., Kierstead L., Janes H., et al. HIV-1 vaccine-induced immunity in the test-of-concept step study: a case-cohort analysis. Lancet 2008, 372:1894-1905.
16. Li F., Malhotra U., Gilbert P.B., Hawkins N.R., Duerr A.C., McElrath J.M., et al. Peptide selection for human immunodeficiency virus type 1 CTL-based vaccine evaluation. Vaccine 2006, 24(47-48):6893-6904.
17. Dubey S., Clair J., Fu T.M., Guan L., Long R., Mogg R., et al. Detection of HIV vaccine-induced cell-mediated immunity in HIV-seronegative clinical trial participants using an optimized and validated enzyme-linked immunospot assay. J Acquir Immune Defic Syndr 2007, 45:20-27.
18. Goepfert P.A., Tomaras G.D., Horton H., Montefiori D., Ferrari G., Deers M., et al. Durable HIV-1 antibody and T-cell responses elicited by an adjuvanted multi-protein recombinant vaccine in uninfected human volunteers. Vaccine 2007, 25(3):510-518.
19. Tomaras G.D., Yates N.L., Liu P., Qin L., Fonda G.G., Chavez L.L., et al. Initial B-cell responses to transmitted human immunodeficiency virus type 1: virion-binding immunoglobulin M (IgM) and IgG antibodies followed by plasma anti-gp41 antibodies with ineffective control of initial viremia. J Virol 2008, 82(24):12449-12463.
20. Li M., Gao F., Mascola J.R., Stamatatos L., Polonis V.R., Koutsoukos M., et al. Human immunodeficiency virus type 1 env clones from acute and early subtype B infections for standardized assessments of vaccine-elicited neutralizing antibodies. J Virol 2005, 79(16):10108-10125.
21. Westfall P., Wolfinger R. Multiple tests with discrete distributions. Am Stat 1997, 51:3-8.
22. Moodie Z., Huang Y., Gu L., Hural J., Self S.G. Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials. J Immunol Methods 2006, 315(1-2):121-132.
23. Agresti A., Coull B.A. Approximate is better than exact for interval estimation of binomial proportions. Am Stat 1998, 52:119-126.
24. Boyer J.D., Cohen A.D., Vogt S., Schumann K., Nath B., Ahn L., et al. Vaccination of seronegative volunteers with a human immunodeficiency virus type 1 env/rev DNA vaccine induces antigen-specific proliferation and lymphocyte production of β-chemokines. J Infect Dis 2000, 181:476-483.
25. Roy M.J., Wu M.S., Barr L.J., Fuller J.T., Tussey L.G., Speller S., et al. Induction of antigen-specific CD8+ T cells, T helper cells, and protective levels of antibody in humans by particle-mediated administration of hepatitis B virus DNA vaccine. Vaccine 2001, 19:764-778.
26. Wang R., Richie T.L., Baraceros M.F., Rahardjo N., Gay T., Banania J.G., et al. Induction of CD4+ T cell-dependent CD8+ type 1 responses in humans by a malaria DNA vaccine. PNAS 2001, 98(19):10817-10822.
27. Bagarazzi M.L., Yan J., Morrow M.P., Shen X., Parker R.L., Lee J.C., et al. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med 2012, 4(155):155ra138.
28. Van der Wielen M., Van Damme P., Chlibek R., Smetana J., von Sonnenburg F. Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors. Vaccine 2006, 24(June (26)):5509-5515.
29. Sheridan P.A., Paich H.A., Handy J., Karlsson E.A., Hudgens M.G., Sammon A.B., et al. Obesity is associated with impaired immune response to influenza vaccination in humans. Int J Obes (Lond) 2012, 36(8):1072-1077.
30. White S.J., Taylor M.J., Hurt R.T., Jensen M.D., Poland G.A. Leptin-based adjuvants: an innovative approach to improve vaccine response. Vaccine 2013, 31:1666-1672.
31. Han S.N., Jeon K.J., Kim M.S., Kim H.K., Lee A.J. Obestity with a body mass index under 30 does not significantly impair the immune response in young adults. Nutr Res 2011, 31:362-369.
32. Williams J.A. Improving DNA vaccine performance through vector design. Curr Gene Ther 2014, 14(3):170-189.
33. Flingai S., Czerwonko M., Goodman J., Kudchodkar S.B., Muthumani K., Weiner D.B. Synthetic DNA vaccines: improved vaccine potency by electroporation and co-delivered genetic adjuvants. Front Immunol 2013, 4(November):354.
34. Letvin N.L., Huang Y., Chakrabarti B.K., Xu L., Seaman M.S., Beaudry K., et al. Heterologous envelope immunogens contribute to AIDS vaccine protection in rhesus monkeys. J Virol 2004, 78(14):7490-7497.
35. Barouch D.H., Yang Z.Y., Kong W.P., Korioth-Schmitz B., Sumida S.M., Truitt D.M., et al. A human T-cell leukemia virus type 1 regulatory element enhances the immunogenicity of human immunodeficiency virus type 1 DNA vaccines in mice and nonhuman primates. J Virol 2005, 79(14):8828-8834.
36. Chong S.Y., Egan M.A., Kutzler M.A., Megati S., Masood A., Roopchard V., et al. Comparative ability of plasmid IL-12 and IL-15 to enhance cellular and humoral immune responses elicited by a SIVgag plasmid DNA vaccine and alter disease progression following SHIV(89.6P) challenge in rhesus macaques. Vaccine 2007, 25(26):4967-4982.
37. Wirtz P.H., Ehlert U., Emini L., Suter T. Higher body mass index (BMI) is associated with reduced glucocorticoid inhibition of inflammatory cytokine production following acute psychosocial stress in men. Psychoneuroendocrinology 2008, 33(8):1102-1110.
38. + monocytes in obesity and during weight loss: relationships with fat mass and subclinical atherosclerosis. Arterioscler Thromb Vasc Biol 2011, 31:2322-2330.
39. Subramanian V., Ferrante A.W. Obesity, inflammation, and macrophages. Nestle Nutr Workshop Ser Pediatr Progr 2009, 63:151-159.
40. O'Shea D., Corrigan M., Dunne M.R., Jackson R., Woods C., Gaoatswe G., et al. Changes in human dendritic cell number and function in severe obesity may contribute to increased susceptibility to viral infection. Int J Obes (Lond) 2013, 37(11):1510-1513.
41. Goepfert P.A., Elizaga M.L., Sato A., Qin L., Cardinali M., Hay C.M., et al. Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 2011, 203:610-619.
42. Koup R.A., Roederer M., Lamoreaux L., Fischer J., Novik L., Nason M.C., et al. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS ONE 2010, 5:e9015.