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

Volumn 27, Issue 50, 2009, Pages 7080-7086

  Jin, Xia ^a   Newman, Mark J ^b   De Rosa, Stephen ^c   Cooper, Cristine ^c   Thomas, Evan ^c   Keefer, Michael ^a   Fuchs, Jonathan ^d   Blattner, William ^e   Livingston, Brian D ^b   McKinney, Denise M ^b   Noonan, Elizabeth ^c   deCamp, Allan ^c   Defawe, Olivier D ^c   Wecker, Margaret ^c  

^a UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^b Pharmexa Inc   (United States)

^c Fred Hutchinson Cancer Research Center   (United States)

^d SAN FRANCISCO DEPARTMENT OF PUBLIC HEALTH   (United States)

^e INSTITUTE OF HUMAN VIROLOGY   (United States)

Author keywords

HIV vaccine; Phase I clinical trial; T helper epitopes

Indexed keywords

EP 1043 VACCINE; EP 1090 VACCINE; GAMMA INTERFERON; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INTERLEUKIN 2; INTERLEUKIN 4; PLACEBO; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADULT; ARTHRALGIA; ARTICLE; CD4+ T LYMPHOCYTE; CHILL; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; GASTRIC ULCER BLEEDING; HEADACHE; HELPER CELL; HUMAN; HUMAN EXPERIMENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE REACTION; MALAISE; MYALGIA; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; VOMITING;

ADULT; AIDS VACCINES; CD4-POSITIVE T-LYMPHOCYTES; CYTOKINES; DOUBLE-BLIND METHOD; EPITOPES, T-LYMPHOCYTE; FEMALE; HIV INFECTIONS; HUMANS; IMMUNITY, CELLULAR; MALE; MIDDLE AGED; VACCINES, DNA; YOUNG ADULT;

EID: 70449084687     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.09.060     Document Type: Article

References (18)

1. Buchbinder S.P., Mehrotra D.V., Duerr A., Fitzgerald D.W., Mogg R., Li D., et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 372 November (9653) (2008) 1881-1893
2. McElrath M.J., De Rosa 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 372 November (9653) (2008) 1894-1905
3. Gilbert P.B., Peterson M.L., Follmann D., Hudgens M.G., Francis D.P., Gurwith M., et al. Correlation between immunologic responses to a recombinant glycoprotein 120 vaccine and incidence of HIV-1 infection in a phase 3 HIV-1 preventive vaccine trial. J Infect Dis 191 March (5) (2005) 666-677
4. Gorse G.J., Baden L.R., Wecker M., Newman M.J., Ferrari G., Weinhold K.J., et al. Safety and immunogenicity of cytotoxic T-lymphocyte poly-epitope, DNA plasmid (EP HIV-1090) vaccine in healthy, human immunodeficiency virus type 1 (HIV-1)-uninfected adults. Vaccine 26 January (2) (2008) 215-223
5. Wilson C.C., Palmer B., Southwood S., Sidney J., Higashimoto Y., Appella E., et al. Identification and antigenicity of broadly cross-reactive and conserved human immunodeficiency virus type 1-derived helper T-lymphocyte epitopes. J Virol 75 9 (2001) 4195-4207
6. Pantaleo G., and Koup R.A. Correlates of immune protection in HIV-1 infection: what we know, what we don't know, what we should know. Nat Med 10 8 (2004) 806-810
7. Bull M., Lee D., Stucky J., Chiu Y.L., Rubin 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)
8. 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 323 May (1) (2007) 39-54
9. Perfetto S.P., Chattopadhyay P.K., Lamoreaux L., Nguyen R., Ambrozak D., Koup R.A., et al. Amine reactive dyes: an effective tool to discriminate live and dead cells in polychromatic flow cytometry. J Immunol Methods 313 June (1-2) (2006) 199-208
10. Darrah P.A., Patel D.T., De Luca P.M., Lindsay R.W., Davey D.F., Flynn B.J., et al. Multifunctional TH1 cells define a correlate of vaccine-mediated protection against Leishmania major. Nat Med 13 7 (2007) 843-850
11. Kundu S.K., Katzenstein D., Moses L.E., and Merigan T.C. Enhancement of human immunodeficiency virus (HIV)-specific CD4+ and CD8+ cytotoxic T-lymphocyte activities in HIV-infected asymptomatic patients given recombinant gp160 vaccine. Proc Natl Acad Sci USA 89 December (23) (1992) 11204-11208
12. Redfield R.R., Birx D.L., Ketter N., Tramont E., Polonis V., Davis C., et al. A phase I evaluation of the safety and immunogenicity of vaccination with recombinant gp160 in patients with early human immunodeficiency virus infection. Military Medical Consortium for Applied Retroviral Research. N Engl J Med 324 June (24) (1991) 1677-1684
13. Valentine F.T., Kundu S., Haslett P.A., Katzenstein D., Beckett L., Spino C., et al. A randomized, placebo-controlled study of the immunogenicity of human immunodeficiency virus (HIV) rgp160 vaccine in HIV-infected subjects with > or = 400/mm3 CD4 T lymphocytes (AIDS Clinical Trials Group Protocol 137). J Infect Dis 173 6 (1996) 1336-1346
14. Clements-Mann M.L., Weinhold K., Matthews T.J., Graham B.S., Gorse G.J., Keefer M.C., et al. Immune responses to human immunodeficiency virus (HIV) type 1 induced by canarypox expressing HIV-1MN gp120, HIV-1SF2 recombinant gp120, or both vaccines in seronegative adults. NIAID AIDS Vaccine Evaluation Group. J Infect Dis 177 5 (1998) 1230-1246
15. Boaz M.J., Waters A., Murad S., Easterbrook P.J., and Vyakarnam A. Presence of HIV-1 Gag-specific IFN-gamma + IL-2+ and CD28 + IL-2+ CD4 T cell responses is associated with nonprogression in HIV-1 infection. J Immunol (Baltimore, MD: 1950) 169 11 (2002) 6376-6385
16. Iyasere C., Tilton J.C., Johnson A.J., Younes S., Yassine_Diab B., Sekaly R.P., et al. Diminished proliferation of human immunodeficiency virus-specific CD4+ T cells is associated with diminished interleukin-2 (IL-2) production and is recovered by exogenous IL-2. J Virol 77 20 (2003) 10900-10909
17. De Rosa S.C., Lu F.X., Yu J., Perfetto S.P., Falloon J., Moser S., et al. Vaccination in humans generates broad T cell cytokine responses. J Immunol 173 November (9) (2004) 5372-5380
18. Marrack P., McKee A.S., and Munks M.W. Towards an understanding of the adjuvant action of aluminium. Nat Rev Immunol 9 4 (2009) 287-293