Safety and immunogenicity of a replication-defective adenovirus type 5 HIV vaccine in Ad5-seronegativepersons: A randomized clinical trial (HVTN 054)

PLoS ONE

Volumn 5, Issue 10, 2010, Pages

  Peiperl, Laurence ^a   Morgan, Cecilia ^b   Moodie, Zoe ^b   Li, Hongli ^b   Russell, Nina ^c   Graham, Barney S ^d   Tomaras, Georgia D ^e   de Rosa, Stephen C ^b,f   Juliana McElrath, M ^b,f  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c BILL AND MELINDA GATES FOUNDATION   (United States)

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

^e DUKE UNIVERSITY   (United States)

^f UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CD8 ANTIGEN; EPITOPE; GAG PROTEIN; GAMMA INTERFERON; HUMAN IMMUNODEFICIENCY VIRUS 1 ANTIGEN; HUMAN IMMUNODEFICIENCY VIRUS ANTIGEN; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; NEUTRALIZING ANTIBODY; PLACEBO; POL PROTEIN; RECOMBINANT REPLICATION DEFECTIVE ADENOVIRUS TYPE 5 HUMAN IMMUNODEFICIENCY VIRUS VACCINE; UNCLASSIFIED DRUG; VIRUS ENVELOPE PROTEIN;

ADULT; ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIGEN BINDING; ARTHRALGIA; ARTICLE; CELLULAR IMMUNITY; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC TEST; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSPOT ASSAY; FATIGUE; FEMALE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALAISE; MALE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; MYALGIA; NAUSEA; OUTCOME ASSESSMENT; PERIPHERAL BLOOD MONONUCLEAR CELL; RANDOMIZED CONTROLLED TRIAL; SERODIAGNOSIS; SINGLE DRUG DOSE; SYSTEMIC DISEASE; T LYMPHOCYTE; VIRUS PARTICLE; VOMITING; ADENOVIRUS; DEFECTIVE VIRUS; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOLOGY;

HUMAN ADENOVIRUS TYPE 5; HUMAN IMMUNODEFICIENCY VIRUS 1;

ADENOVIRIDAE; ADULT; AIDS VACCINES; ANTIBODIES, NEUTRALIZING; DEFECTIVE VIRUSES; DOUBLE-BLIND METHOD; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; MALE; PLACEBOS; T-LYMPHOCYTES;

EID: 78149417692     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0013579     Document Type: Article

References (44)

1. UNAIDS (2007) AIDS Epidemic Update 2007. Available: http://www.unaids.org/.
2. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, et al. (2009) Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med 361: 2209-2220.
3. Robinson HL, Montefiori DC, Johnson RP, Manson KH, Kalish ML, et al. (1999) Neutralizing antibody-independent containment of immunodeficiency virus challenges by DNA priming and recombinant pox virus booster immunizations. Nat Med 5: 526-534.
4. Barouch DH, Santra S, Kuroda MJ, Schmitz JE, Plishka R, et al. (2001) Reduction of simian-human immunodeficiency virus 89.6P viremia in rhesus monkeys by recombinant modified vaccinia virus Ankara vaccination. J Virol 75: 5151-5158.
5. Shiver JW, Fu TM, Chen L, Casimiro DR, Davies ME, et al. (2002) Replicationincompetent adenoviral vaccine vector elicits effective anti-immunodeficiencyvirus immunity. Nature 415: 331-335.
6. Letvin NL, Mascola JR, Sun Y, Gorgone DA, Buzby AP, et al. (2006) Preserved CD4+ central memory T cells and survival in vaccinated SIV-challenged monkeys. Science 312: 1530-1533.
7. Kent SJ, Zhao A, Best SJ, Chandler JD, Boyle DB, et al. (1998) Enhanced T-cell immunogenicity and protective efficacy of a human immunodeficiency virus type 1 vaccine regimen consisting of consecutive priming with DNA and boosting with recombinant fowlpox virus. J Virol 72: 10180-10188.
8. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis 194: 1638-1649.
9. Kostense S, Koudstaal W, Sprangers M, Weverling GJ, Penders G, et al. (2004) Adenovirus types 5 and 35 seroprevalence in AIDS risk groups supports type 35 as a vaccine vector. AIDS 18: 1213-1216.
10. Thorner AR, Vogels R, Kaspers J, Weverling GJ, Holterman L, et al. (2006) Age dependence of adenovirus-specific neutralizing antibody titers in individuals from sub-Saharan Africa. J Clin Microbiol 44: 3781-3783.
11. Nwanegbo E, Vardas E, Gao W, Whittle H, Sun H, et al. (2004) Prevalence of neutralizing antibodies to adenoviral serotypes 5 and 35 in the adult populations of The Gambia, South Africa, and the United States. Clin Diagn Lab Immunol 11: 351-357.
12. Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, et al. (2010) International epidemiology of human pre-existing adenovirus (Ad) type-5, type- 6, type-26 and type-36 neutralizing antibodies: correlates of high Ad5 titers and implications for potential HIV vaccine trials. Vaccine 28: 950-957.
13. Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 7: e1000251.
14. Rasmussen H, Rasmussen C, Lempicki M, Durham R, Brough D, et al. (2002) TNFerade Biologic: preclinical toxicology of a novel adenovector with a radiation-inducible promoter, carrying the human tumor necrosis factor alpha gene. Cancer Gene Ther 9: 951-957.
15. Brough DE, Lizonova A, Hsu C, Kulesa VA, Kovesdi I (1996) A gene transfer vector-cell line system for complete functional complementation of adenovirus early regions E1 and E4. J Virol 70: 6497-6501.
16. Butman BT, Lizonova A, Brough DE, Sowers JM, Sheets R, et al. (2006) Comprehensive characterization of the 293-ORF6 cell line. Dev Biol (Basel) 123: 225-233; discussion 265-226.
17. Bull M, Lee D, Stucky J, Chiu YL, Rubin A, et al. (2007) Defining blood processing parameters for optimal detection of cryopreserved antigen-specific responses for HIV vaccine trials. J Immunol Methods 322: 57-69.
18. Li F, Malhotra U, Gilbert PB, Hawkins NR, Duerr AC, et al. (2006) Peptide selection for human immunodeficiency virus type 1 CTL-based vaccine evaluation. Vaccine 24: 6893-6904.
19. McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, et al. (2008) HIV- 1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 372: 1894-1905.
20. Horton H, Thomas EP, Stucky JA, Frank I, Moodie Z, et al. (2007) 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: 39-54.
21. Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 194: 1650-1660.
22. Goepfert PA, Tomaras GD, Horton H, Montefiori D, Ferrari G, et al. (2007) Durable HIV-1 antibody and T-cell responses elicited by an adjuvanted multiprotein recombinant vaccine in uninfected human volunteers. Vaccine 25: 510-518.
23. Tomaras GD, Yates NL, Liu P, Qin L, Fouda GG, et al. (2008) 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 82: 12449-12463.
24. Montefiori DC (2004) Evaluating neutralizing antibodies against HIV, SIV and SHIV in luciferase gene assays. In: Coligan JE, Kruisbeek AM, Margulies DH, Shevach EM, Strober W, et al., eds. Current protocols in immunology: John Wiley & Sons. pp 12.11.11-12.11.15.
25. Li M, Gao F, Mascola JR, Stamatatos L, Polonis VR, et al. (2005) Human immunodeficiency virus type 1 env clones from acute and early subtype B infections for standardized assessments of vaccine-elicited neutralizing antibodies. J Virol 79: 10108-10125.
26. Sprangers MC, Lakhai W, Koudstaal W, Verhoeven M, Koel BF, et al. (2003) Quantifying adenovirus-neutralizing antibodies by luciferase transgene detection: addressing preexisting immunity to vaccine and gene therapy vectors. J Clin Microbiol 41: 5046-5052.
27. Benjamini Y, Drai D, Elmer G, Kafkafi N, Golani I (2001) Controlling the false discovery rate in behavior genetics research. Behav Brain Res 125: 279-284.
28. Moodie Z, Price L, Gouttefangeas C, Mander A, Janetzki S, et al. (2010) Response definition criteria for ELISPOT assays revisited. Cancer Immunol Immunother 59: 1489-1501.
29. Westfall PH, Young SS (1993) Resampling-based multiple testing: examples and methods for P-value adjustment. New York/Chichester UK: John Wiley & Sons.
30. Agresti A, Coull BA (1998) Approximate is better than ''exact'' for interval estimation of binomial proportions. Am Stat 52: 199-256.
31. Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, et al. (2008) 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: 1881-1893.
32. Koup RA, Lamoreaux L, Zarkowsky D, Bailer RT, King CR, et al. (2009) Replication-defective adenovirus vectors with multiple deletions do not induce measurable vector-specific T cells in human trials. J Virol 83: 6318-6322.
33. Asmuth DM, Brown EL, DiNubile MJ, Sun X, del Rio C, et al. (2010) Comparative cell-mediated immunogenicity of DNA/DNA, DNA/adenovirus type 5 (Ad5), or Ad5/Ad5 HIV-1 clade B gag vaccine prime-boost regimens. J Infect Dis 201: 132-141.
34. Cox KS, Clair JH, Prokop MT, Sykes KJ, Dubey SA, et al. (2008) DNA gag/ adenovirus type 5 (Ad5) gag and Ad5 gag/Ad5 gag vaccines induce distinct Tcell response profiles. J Virol 82: 8161-8171.
35. Churchyard G, Keefer M, Morgan C, Adams E, Hural J, et al. (2007) A phase IIA trial to evaluate a multiclade HIV-1 DNA vaccine followed by a multiclade rAd5 HIV-1 vaccine boost in HIV-1 uninfected adults. HVTN Conference: Washington, D.C.
36. Kibuuka H, Kimutai R, Maboko L, Sawe F, Schunk MS, et al. (2010) A phase 1/2 study of a multiclade HIV-1 DNA plasmid prime and recombinant adenovirus serotype 5 boost vaccine in HIV-Uninfected East Africans (RV 172). J Infect Dis 201: 600-607.
37. Jaoko W, Karita E, Kayitenkore K, Omosa-Manyonyi G, Allen S, et al. (2010) Safety and immunogenicity study of multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa. PLoS One: In press.
38. Cleghorn F, Pape JW, Schechter M, Bartholomew C, Sanchez J, et al. (2007) Lessons from a multisite international trial in the Caribbean and South America of an HIV-1 Canarypox vaccine (ALVAC-HIV vCP1452) with or without boosting with MN rgp120. J Acquir Immune Defic Syndr 46: 222-230.
39. Goepfert PA, Horton H, McElrath MJ, Gurunathan S, Ferrari G, et al. (2005) High-dose recombinant Canarypox vaccine expressing HIV-1 protein, inseronegative human subjects. J Infect Dis 192: 1249-1259.
40. Russell ND, Graham BS, Keefer MC, McElrath MJ, Self SG, et al. (2007) Phase 2 study of an HIV-1 canarypox vaccine (vCP1452) alone and in combination with rgp120: negative results fail to trigger a phase 3 correlates trial. J Acquir Immune Defic Syndr 44: 203-212.
41. Harro CD, Robertson MN, Lally MA, O'Neill LD, Edupuganti S, et al. (2009) Safety and immunogenicity of adenovirus-vectored near-consensus HIV type 1 clade B gag vaccines in healthy adults. AIDS Res Hum Retroviruses 25: 103-114.
42. Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, et al. (2008) Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis 46: 1769-1781.
43. Cheng C, Gall JG, Nason M, King CR, Koup RA, et al. (2010) Differential specificity and immunogenicity of adenovirus type 5 neutralizing antibodies elicited by natural infection or immunization. J Virol 84: 630-638.
44. Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, et al. (2010) Priming immunization with DNA augments immunogenicity of recombinant adenoviralvectors for both HIV-1 specific antibody and T-cell responses. PLoS One 5: e9015.