HIV Vaccine Efficacy Trials: Towards the Future of HIV Prevention

Infectious Disease Clinics of North America

Volumn 21, Issue 1, 2007, Pages 201-217

  Kim, Denny ^a   Elizaga, Marnie ^a   Duerr, Ann ^a  

^a Fred Hutchinson Cancer Research Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; ALVAC HIV; ANTIRETROVIRUS AGENT; DNA VACCINE; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CLINICAL TRIAL; CYTOTOXIC T LYMPHOCYTE; DISEASE TRANSMISSION; DRUG EFFICACY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOTHERAPY; NONHUMAN; PHASE 3 CLINICAL TRIAL; QUALITY OF LIFE; REVIEW; SIMIAN IMMUNODEFICIENCY VIRUS; SURVIVAL;

AIDS VACCINES; ANTIBODIES, VIRAL; CLINICAL TRIALS; HIV INFECTIONS; HIV-1; HUMANS; RESEARCH DESIGN; RISK FACTORS; T-LYMPHOCYTES, CYTOTOXIC; VACCINES, SYNTHETIC;

EID: 34248205600     PISSN: 08915520     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.idc.2007.01.006     Document Type: Review

References (77)

1. UNAIDS. AIDS epidemic update: special report on HIV/AIDS (2006), UNAIDS, Geneva, Switzerland
2. Wawer M.J., Sewankambo N.K., Serwadda D., et al. Control of sexually transmitted diseases for AIDS prevention in Uganda: a randomised community trial. Rakai Project Study Group. Lancet 353 (1999) 525-535
3. Brenchley J.M., Schacker T.W., Ruff L.E., et al. CD4+ T cell depletion during all stages of HIV disease occurs predominantly in the gastrointestinal tract. J Exp Med 200 (2004) 749-759
4. Francis D.P., Heyward W.L., Popovic V., et al. Candidate HIV/AIDS vaccines: lessons learned from the world's first phase III efficacy trials. AIDS 17 (2003) 147-156
5. 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 194 (2006) 1661-1671
6. Flynn N.M., Forthal D.N., Harro C.D., et al. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis 191 (2005) 654-665
7. Keefer M.C., Wolff M., Gorse G.J., et al. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses 13 (1997) 1163-1177
8. Graham B.S., Keefer M.C., McElrath M.J., et al. Safety and immunogenicity of a candidate HIV-1 vaccine in healthy adults: recombinant glycoprotein (rgp) 120. A randomized, double-blind trial. NIAID AIDS Vaccine Evaluation Group. Ann Intern Med 125 (1996) 270-279
9. Dolin R., Graham B.S., Greenberg S.B., et al. The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network. Ann Intern Med 114 (1991) 119-127
10. McElrath M.J., Corey L., Montefiori D., et al. A phase II study of two HIV type 1 envelope vaccines, comparing their immunogenicity in populations at risk for acquiring HIV type 1 infection. AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses 16 (2000) 907-919
11. Wright P.F., Lambert J.S., Gorse G.J., et al. Immunization with envelope MN rgp120 vaccine in human immunodeficiency virus-infected pregnant women. J Infect Dis 180 (1999) 1080-1088
12. Migasena S., Suntharasamai P., Pitisuttithum P., et al. AIDSVAX (MN) in Bangkok injecting drug users: a report on safety and immunogenicity, including macrophage-tropic virus neutralization. AIDS Res Hum Retroviruses 16 (2000) 655-663
13. Mascola J.R., Snyder S.W., Weislow O.S., et al. Immunization with envelope subunit vaccine products elicits neutralizing antibodies against laboratory-adapted but not primary isolates of human immunodeficiency virus type 1. The National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. J Infect Dis 173 (1996) 340-348
14. Zolla-Pazner S., Alving C., Belshe R., et al. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis 175 (1997) 764-774
15. Montefiori D.C., Metch B., McElrath M.J., et al. Demographic factors that influence the neutralizing antibody response in recipients of recombinant HIV-1 gp120 vaccines. J Infect Dis 190 (2004) 1962-1969
16. Belshe R.B., Bolognesi D.P., Clements M.L., et al. HIV infection in vaccinated volunteers. JAMA 272 (1994) 431
17. Evans T.G., McElrath M.J., Matthews T., et al. QS-21 promotes an adjuvant effect allowing for reduced antigen dose during HIV-1 envelope subunit immunization in humans. Vaccine 19 (2001) 2080-2091
18. Clements-Mann M.L., Weinhold K., Matthews T.J., 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 (1998) 1230-1246
19. Harro C.D., Judson F.N., Gorse G.J., et al. Recruitment and baseline epidemiologic profile of participants in the first phase 3 HIV vaccine efficacy trial. J Acquir Immune Defic Syndr 37 (2004) 1385-1392
20. Rerks-Ngarm S., Brown A.E., Khamboonruang C., et al. HIV/AIDS preventive vaccine prime-boost phase III trial: foundations and initial lessons learned from Thailand. AIDS 20 (2006) 1471-1479
21. Binley J.M., Wrin T., Korber B., et al. Comprehensive cross-clade neutralization analysis of a panel of anti-human immunodeficiency virus type 1 monoclonal antibodies. J Virol 78 (2004) 13232-13252
22. Burton D.R., Desrosiers R.C., Doms R.W., et al. HIV vaccine design and the neutralizing antibody problem. Nat Immunol 5 (2004) 233-236
23. DeBruyn G., Rossini A.J., Chiu Y.L., et al. Safety profile of recombinant canarypox HIV vaccines. Vaccine 22 (2004) 704-713
24. Gupta K., Hudgens M., Corey L., et al. Safety and immunogenicity of a high-titered canarypox vaccine in combination with rgp120 in a diverse population of HIV-1-uninfected adults. AIDS Vaccine Evaluation Group Protocol 022A. J Acquir Immune Defic Syndr 29 (2002) 254-261
25. Gorse G.J., Patel G.B., and Belshe R.B. HIV type 1 vaccine-induced T cell memory and cytotoxic T lymphocyte responses in HIV type 1-uninfected volunteers. AIDS Res Hum Retroviruses 17 (2001) 1175-1189
26. AIDS Vaccine Evaluation Group 022 Protocol Team. Cellular and humoral immune responses to a canarypox vaccine containing human immunodeficiency virus type 1 Env, Gag, and Pro in combination with rgp120. J Infect Dis 183 (2001) 563-570
27. Evans T.G., Keefer M.C., Weinhold K.J., et al. A canarypox vaccine expressing multiple human immunodeficiency virus type 1 genes given alone or with rgp120 elicits broad and durable CD8+ cytotoxic T lymphocyte responses in seronegative volunteers. J Infect Dis 180 (1999) 290-298
28. Belshe R.B., Gorse G.J., Mulligan M.J., et al. Induction of immune responses to HIV-1 by canarypox virus (ALVAC) HIV-1 and gp120 SF-2 recombinant vaccines in uninfected volunteers. NIAID AIDS Vaccine Evaluation Group. AIDS 12 (1998) 2407-2415
29. Goepfert P.A., Horton H., McElrath M.J., et al. High-dose recombinant canarypox vaccine expressing HIV-1 protein, in seronegative human subjects. J Infect Dis 192 (2005) 1249-1259
30. Russell ND, Gorse G, Baden L, et al. The HIV Vaccine Trials Network. Evaluation of the safety and immunogenicity of the EP HIV-1090 DNA vaccine in healthy, HIV-1 uninfected adults. Presented at the AIDS Vaccine 06. Amsterdam, The Netherlands, August 29-September 1, 2006.
31. Belshe R.B., Stevens C., Gorse G.J., et al. Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus type 1 vaccine with or without gp120: a phase 2 study in higher- and lower-risk volunteers. J Infect Dis 183 (2001) 1343-1352
32. Nitayaphan S., Pitisuttithum P., Karnasuta C., et al. Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults. J Infect Dis 190 (2004) 702-706
33. Trinvuthipong C. Thailand's Prime-Boost HIV Vaccine Phase III. Science 303 (2004) 954-955
34. McNeil J.G., Johnston M.I., Birx D.L., et al. Policy rebuttal. HIV vaccine trial justified. Science 303 (2004) 961
35. Van Rompay K.K., Abel K., Lawson J.R., et al. Attenuated poxvirus-based simian immunodeficiency virus (SIV) vaccines given in infancy partially protect infant and juvenile macaques against repeated oral challenge with virulent SIV. J Acquir Immune Defic Syndr 38 (2005) 124-134
36. Burton D.R., Desrosiers R.C., Doms R.W., et al. Public health: a sound rationale needed for phase III HIV-1 vaccine trials. Science 303 (2004) 316
37. Rerks-Ngarm S., Pitisutithum P., Nitayaphan S., et al. ALVAC HIV/AIDSVAX B/E prime boost, the community phase III HIV-1 preventive vaccine trial: an update-2006. Aids Vaccine (2006)
38. Shaw GM. The membrane proximal external region of HIV-1 on different viral scaffolds: detection of epitope-specific neutralizing antibodies. Presented at the Conference on Retroviruses and Opportunistic Infections. Denver, February 5-8, 2006.
39. Mellors J.W., Munoz A., Giorgi J.V., et al. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med 126 (1997) 946-954
40. Quinn T.C., Wawer M.J., Sewankambo N., et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med 342 (2000) 921-929
41. Koup R.A., Safrit J.T., Cao Y., et al. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol 68 (1994) 4650-4655
42. Kent S.J., Woodward A., and Zhao A. Human immunodeficiency virus type 1 (HIV-1)-specific T cell responses correlate with control of acute HIV-1 infection in macaques. J Infect Dis 176 (1997) 1188-1197
43. Migueles S.A., Laborico A.C., Shupert W.L., et al. HIV-specific CD8+ T cell proliferation is coupled to perforin expression and is maintained in nonprogressors. Nat Immunol 3 (2002) 1061-1068
44. Zhang D., Shankar P., Xu Z., et al. Most antiviral CD8 T cells during chronic viral infection do not express high levels of perforin and are not directly cytotoxic. Blood 101 (2003) 226-235
45. Schmitz J.E., Kuroda M.J., Santra S., et al. Control of viremia in simian immunodeficiency virus infection by CD8+ lymphocytes. Science 283 (1999) 857-860
46. Schmitz J.E., Johnson R.P., McClure H.M., et al. Effect of CD8+ lymphocyte depletion on virus containment after simian immunodeficiency virus SIVmac251 challenge of live attenuated SIVmac239delta3-vaccinated rhesus macaques. J Virol 79 (2005) 8131-8141
47. Garber D.A., Silvestri G., and Feinberg M.B. Prospects for an AIDS vaccine: three big questions, no easy answers. Lancet Infect Dis 4 (2004) 397-413
48. Duerr A., Wasserheit J.N., and Corey L. HIV vaccines: new frontiers in vaccine development. Clin Infect Dis 43 (2006) 500-511
49. Spearman P. Current progress in the development of HIV vaccines. Curr Pharm Des 12 (2006) 1147-1167
50. Davis N.L., West A., Reap E., et al. Alphavirus replicon particles as candidate HIV vaccines. IUBMB Life 53 (2002) 209-211
51. Xin K.Q., Urabe M., Yang J., et al. A novel recombinant adeno-associated virus vaccine induces a long-term humoral immune response to human immunodeficiency virus. Hum Gene Ther 12 (2001) 1047-1061
52. Egan M.A., Chong S.Y., Rose N.F., et al. Immunogenicity of attenuated vesicular stomatitis virus vectors expressing HIV type 1 Env and SIV Gag proteins: comparison of intranasal and intramuscular vaccination routes. AIDS Res Hum Retroviruses 20 (2004) 989-1004
53. Corey L. The human HIV vaccine pipeline: an update. Amsterdam (the Netherlands): AIDS Vaccine. August 29-September 1, 2006.
54. Yang Y., Ertl H.C., and Wilson J.M. MHC class I-restricted cytotoxic T lymphocytes to viral antigens destroy hepatocytes in mice infected with E1-deleted recombinant adenoviruses. Immunity 1 (1994) 433-442
55. Yang Y., Nunes F.A., Berencsi K., et al. Cellular immunity to viral antigens limits E1-deleted adenoviruses for gene therapy. Proc Natl Acad Sci U S A 91 (1994) 4407-4411
56. Zhong L., Granelli-Piperno A., Choi Y., et al. Recombinant adenovirus is an efficient and non-perturbing genetic vector for human dendritic cells. Eur J Immunol 29 (1999) 964-972
57. Herrern O.B., Brett S., and Lechler R.I. Infection of mouse bone marrow-derived dendritic cells with recombinant adenovirus vectors leads to presentation of encoded antigen by both MHC class I and class II molecules-potential benefits in vaccine design. Vaccine 21 (2002) 231-242
58. Ginsberg H.S. The ups and downs of adenovirus vectors. Bull N Y Acad Med 73 (1996) 53-58
59. Muruve D.A., Barnes M.J., Stillman I.E., et al. Adenoviral gene therapy leads to rapid induction of multiple chemokines and acute neutrophil-dependent hepatic injury in vivo. Hum Gene Ther 10 (1999) 965-976
60. Shiver J.W., and Emini E.A. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med 55 (2004) 355-372
61. Shiver J.W., Fu T.M., Chen L., et al. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature 415 (2002) 331-335
62. Isaacs R. Evaluating the efficacy of the Merck adenovirus serotype 5-based trivalent MRKAd5 gag/pol/nef vaccine [abstract 42]. Presented at the Program and Abstracts of AIDS Vaccine 2005. Montreal, Quebec, Canada, September 6-9, 2005.
63. Seaman M.S., Xu L., Beaudry K., et al. Multiclade human immunodeficiency virus type 1 envelope immunogens elicit broad cellular and humoral immunity in rhesus monkeys. J Virol 79 (2005) 2956-2963
64. Graham B.S., Koup R.A., Roederer M., et al. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 194 (2006) 1650-1660
65. Robinson H.L., and Weinhold K.J. Phase 1 clinical trials of the National Institutes of Health Vaccine Research Center HIV/AIDS candidate vaccines. J Infect Dis 194 (2006) 1625-1627
66. Catanzaro A.T., Koup R.A., 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 194 (2006) 1638-1649
67. Graham BS. Safety and immunogenicity of a multiclade HIV-1 recombinant adenovirus vaccine boost in prior recipients of a multiclade HIV-1 DNA vaccine. Montreal (Canada): AIDS Vaccine, 2005.
68. Morgan C, Bailer R, Metch B, et al. International seroprevalence of neutralizing antibodies against adenovirus serotypes 5 and 35. Presented at the AIDS Vaccine 2005. Montreal, Canada, September 6-9, 2005.
69. Barouch D.H., Pau M.G., Custers J.H., et al. Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity. J Immunol 172 (2004) 6290-6297
70. Sumida S.M., Truitt D.M., Kishko M.G., et al. Neutralizing antibodies and CD8+ T lymphocytes both contribute to immunity to adenovirus serotype 5 vaccine vectors. J Virol 78 (2004) 2666-2673
71. Casimiro D.R., Chen L., Fu T.M., et al. Comparative immunogenicity in rhesus monkeys of DNA plasmid, recombinant vaccinia virus, and replication-defective adenovirus vectors expressing a human immunodeficiency virus type 1 gag gene. J Virol 77 (2003) 6305-6313
72. Mascola J, Cheng C, Gall J, et al. Preclinical safety and immungenicity studies of adenovirus serotype-35-based vectors in rabbits and non-human primates. Presented at the AIDS Vaccine 06. Amsterdam, the Netherlands, August 29-September 1, 2006.
73. Vogels R., Zuijdgeest D., van Rijnsoever R., et al. Replication-deficient human adenovirus type 35 vectors for gene transfer and vaccination: efficient human cell infection and bypass of preexisting adenovirus immunity. J Virol 77 (2003) 8263-8271
74. Lemckert A.A., Sumida S.M., Holterman L., et al. Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus serotype 11 (Ad11) and Ad35 vaccine vectors in the presence of anti-ad5 immunity. J Virol 79 (2005) 9694-9701
75. Barouch D, Roberts D, Nanda A, et al. Novel adenovirus vector-based vaccines for HIV-1. Presented at the AIDS Vaccine 2006. Amsterdam, August 29-September 1, 2006.
76. Follmann D., Duerr A., Tabet S., et al. Endpoints and regulatory issues in HIV vaccine clinical trials: lessons from a workshop. J Acquir Immune Defic Syndr 44 1 (2007) 49-60
77. Gilbert P.B., DeGruttola V.G., Hudgens M.G., et al. What constitutes efficacy for a human immunodeficiency virus vaccine that ameliorates viremia: issues involving surrogate end points in phase 3 trials. J Infect Dis 188 (2003) 179-193