Comparative cell-mediated immunogenicity of DNA/DNA, DNA/adenovirus type 5 (Ad5), or Ad5/Ad5 HIV-1 clade B gag vaccine prime-boost regimens

Journal of Infectious Diseases

Volumn 201, Issue 1, 2010, Pages 132-141

  Asmuth, David M ^a,g   Brown, Elizabeth L ^b   Dinubile, Mark J ^b   Sun, Xiao ^b   Del Rio, Carlos ^c   Harro, Clayton ^d   Keefer, Michael C ^e   Kublin, James G ^f   Dubey, Sheri A ^b   Kierstead, Lisa S ^b   Casimiro, Danilo R ^b   Shiver, John W ^b   Robertson, Michael N ^b   Quirk, Erin K ^b   Mehrotra, Devan V ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c EMORY UNIVERSITY   (United States)

^d JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

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

^f Fred Hutchinson Cancer Research Center   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; ALUMINUM PHOSPHATE; CD4 ANTIGEN; CD8 ANTIGEN; DNA VACCINE; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; VIRUS DNA; VIRUS VACCINE;

ADULT; ARTICLE; CELLULAR IMMUNITY; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DNA IMMUNIZATION; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; HUMAN; HUMAN ADENOVIRUS 5; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NONHUMAN; PHASE 1 CLINICAL TRIAL; PLASMID; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADENOVIRIDAE; ADJUVANTS, IMMUNOLOGIC; ADULT; AIDS VACCINES; DNA, VIRAL; FEMALE; GENES, GAG; HIV-1; HUMANS; IMMUNIZATION, SECONDARY; MALE; MIDDLE AGED; PLACEBOS; YOUNG ADULT;

EID: 71949122352     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/648591     Document Type: Article

References (43)

1. 1. Beyrer C. HIV epidemiology update and transmission factors: risks and risk contexts-16th International AIDS Conference epidemiology plenary. Clin Infect Dis 2007; 44:981-987 (Pubitemid 46452067)
2. Joint United Nations Programme on HIV/AIDS. 2008 Report on the global AIDS epidemic: executive summary. July 2008. Available at http: //data.unaids.org/pub/GlobalReport/2008/JC1511-GR08-Executive Summary-en.pdf. Accessed 24 February 2009.
3. 3. Gray RH, Li X, Wawer MJ, et al. Stochastic simulation of the impact of antiretroviral therapy and HIV vaccines on HIV transmission: Rakai, Uganda. AIDS 2003; 17:1941-1951 (Pubitemid 37070280)
4. 4. John R, Arango-Jaramillo S, Self S, Schwartz DH. Modeling partially effective HIV vaccines in vitro. J Infect Dis 2004; 189:616-623 (Pubitemid 38270914)
5. Flynn NM, Forthal DN, Harro CD, Judson FN, Mayer KH, Para MF. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis 2005; 191:654-665
6. 6. Pitisuttithum P, Gilbert P, Gurwith M, et al. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. J Infect Dis 2006; 194:1661-1671 (Pubitemid 44901996)
7. Kwong PD, Doyle ML, Casper DJ, et al. HIV-1 evades antibody-mediated neutralization through conformational masking of receptorbinding sites. Nature 2002; 420:678-682
8. Lynch RM, Shen T, Gnanakaran S, Derdeyn CA. Appreciating HIV type 1 diversity: subtype differences in Env. AIDS Res Hum Retroviruses 2009; 25:237-248
9. Fu TM, Dubey SA, Mehrotra DV, et al. Evaluation of cellular immune responses in subjects chronically infected with HIV type 1. AIDS Res Hum Retroviruses 2007; 23:67-76.
10. 10. Harrer T, Harrer E, Kalams SA, et al. Strong cytotoxic T cell and weak neutralizing antibody responses in a subset of persons with stable nonprogressing HIV type 1 infection. AIDS Res Hum Retroviruses 1996; 12:585-592 (Pubitemid 26120291)
11. - T cell depletion in simian immunodeficiency virus-infected macaques. J Exp Med 1999; 189:991-998
12. 12. Matano T, Shibata R, Siemon C, Connors M, Lane HC, Martin MA. Administration of an anti-CD8 monoclonal antibody interferes with the clearance of chimeric simian/human immunodeficiency virus during primary infections of rhesus macaques. J Virol 1998; 72:164-169 (Pubitemid 28048825)
13. Schmitz JE, Kuroda MJ, Santra S, et al. Control of viremia in simian immunodeficiency virus infection by CD8+ lymphocytes. Science 1999; 283:857-860
14. Shiver JW, Fu TM, Chen L, et al. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature 2002; 415:331-335
15. 15. Harvey BG, Maroni J, O'Donoghue KA, et al. Safety of local delivery of low- and intermediate-dose adenovirus gene transfer vectors to individuals with a spectrum of morbid conditions. Hum Gene Ther 2002; 13:15-63. (Pubitemid 34075172)
16. Priddy FH, Brown D, Kublin J, et al. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Merck V520-016 study group. Clin Infect Dis 2008; 46:1769-1781
17. Harro CD, Robertson MN, Lally MA, et al. Safety and immunogenicity of adenovirus-vectored near-consensus HIV type 1 clade B gagvaccines in healthy adults. AIDS Res Hum Retroviruses 2009; 25:103-114
18. Hammer S, Miller M, Pape J, et al. Safety and immunogenicity of the MRKAd5 gag HIV-1 vaccine in a worldwide phase I study of healthy adults (Merck V520-018/HVTN 050) [abstract OA08-02]. In: Program and abstracts of AIDS Vaccine (Seattle), 2007.
19. Buchbinder SP, Mehrotra DV, Duerr A, et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a doubleblind, randomised, placebo-controlled, test-of-concept trial. Lancet 2008; 372:1881-1893.
20. McElrath MJ, De Rosa SC, Moodie Z, et al. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 2008; 372:1894-1905
21. Sekaly RP. The failed HIV Merck vaccine study: a step back for a launching point for future vaccine development. J Exp Med 2008; 205: 7-12.
22. Masopust D. Developing an HIV cytotoxic T-lymphocyte vaccine: issues of CD8 T-cell quantity, quality and location. J Intern Med 2009; 265:125-137
23. Casimiro DR, Chen L, Fu T-M, et al. Comparative immunogenicity of rhesus monkeys of DNA plasmid, recombinant vaccinia virus, and replication-defective adenovirus vectors expressing a human immunodeficiency virus type 1 gag gene. J Virol 2003; 77:6305-6313
24. Catanzaro AT, Koup RA, Roederer M, 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; 194:1638-1649
25. Sprangers MC, Lakhai W, Koudstaal W, et al. Quantifying adenovirusneutralizing antibodies by luciferase transgene detection: addressing preexisting immunity to vaccine and gene therapy vectors. J Clin Microbiol 2003; 41:5046-5052
26. Casimiro DR, Wang F, Schleif WA, et al. Attenuation of simian immunodeficiency virus SIVmac239 infection by prophylactic immunization with DNA and recombinant adenoviral vaccine vectors expressing gag. J Virol 2005; 79:15547-15555
27. Ulmer JB, DeWitt CM, Chastain M, et al. Enhancement of DNA vaccine potency using conventional aluminum adjuvants. Vaccine 1999; 18:18-28.
28. 28. Wang S, Liu X, Fisher K, et al. Enhanced type I immune response to a hepatitis B DNA vaccine by formulation with calcium- or aluminum phosphate. Vaccine 2000; 18:1227-1235 (Pubitemid 30001837)
29. 29. Newman MJ, Actor JK, Balusubramanian M, Jagannath C. Use of nonionic block copolymers in vaccines and therapeutics. Crit Rev Ther Drug Carrier Syst 1998; 15:89-142. (Pubitemid 28208749)
30. Todd CW, Lee E, Balusubramanian M, et al. Systematic development of a block copolymer adjuvant for trivalent influenza virus vaccine. Dev Biol Stand 1998; 92:341-351
31. Aste-Amezaga M, Bett AJ, Wang F, et al. Quantitative adenovirus neutralization assays based on the secreted alkaline phosphatase reporter gene: application in epidemiologic studies and in the design of adenovector vaccines. Human Gene Therapy 2004; 15:293-304.
32. Dubey S, Clair J, Fu Tong-Ming, et al. Detection of HIV vaccineinduced cell-mediated immunity in HIV seronegative clinical trial participants using an optimized and validated ELISPOT assay. J Acquir Immune Defic Syndr 2007; 45:20-27
33. 33. Trigona WL, Clair JH, Persaud N, et al. Intracellular staining for HIVspecific IFN-gamma production: statistical analyses establish reproducibility and criteria for distinguishing positive responses. J Interferon Cytokine Res 2003; 23:369-377 (Pubitemid 36876283)
34. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985; 4:213-226
35. Dunnett CW New tables for multiple comparisons with a control. Biometrics 1964; 20:482-491
36. Goepfert P, Priddy F, Spearman P, et al. Boosting adenovirus serotype 5 (Ad5) HIV-gag primed subjects with ALVAC HIV (vCP205) [abstract 505]. In: Program and abstracts of the 12th Conference on Retroviruses and Opportunistic Infections (Boston), 2005.
37. Cox KS, Clair JH, Prokop MT, et al. DNAgag/Ad5gag and Ad5gag/ Ad5gag vaccines induce multifunctional and distinct T-cell response profiles. J Virol 2008; 82:8161-8171
38. Roberts AD, Ely KH, Woodland DL. Differential contributions of central and defector memory T-cells to recall responses. J Exp Med 2005; 202:123-133
39. 39. Staprans SI, Barry AP, Silvestři G, et al. Enhanced SIV replication and accelerated progression to AIDS in macaques primed to mount a CD4 T cell response to the SIV envelope protein. Proc Natl Acad Sci USA 2004; 101:13026-13031 (Pubitemid 39167577)
40. 40. Barouch DH, Kunstman J, Glowczwskie J, et al. Viral escape from dominant simian immunodeficiency virus epitope-specific cytotoxic T lymphocytes in DNA-vaccinated rhesus monkeys. J Virol 2003; 77: 7367-7375 (Pubitemid 36734505)
41. 41. Tobery TW, Dubey SA, Anderson K, et al. A comparison of standard immunogenicity assays for monitoring HIV type 1 gag-specific T cell responses in Ad5 HIV type 1 gag vaccinated human subjects. AIDS Res Human Retrovir 2006; 22:1081-1090 (Pubitemid 44904257)
42. National Institute of Allergy and Infectious Diseases. NIAID will not move forward with the PAVE 100 HIV vaccine trial. 17 July 2008. Available at http://www3.niaid.nih.gov/news/newsreleases/2008/pave 100.htm. Accessed 7 April 2009.
43. Watkins DI, Burton ER, Kallas EG, Moore JP, Koff WC. Non-human primate models and failure of the Merck HIV-1 vaccine in humans. Nat Med 2008; 14:617-621