Phase i/ii randomized trial of safety and immunogenicity of LIPO-5 alone, ALVAC-HIV (vCP1452) alone, and ALVAC-HIV (vCP1452) prime/LIPO-5 boost in healthy, HIV-1-Uninfected adult participants

Clinical and Vaccine Immunology

Volumn 21, Issue 11, 2014, Pages 1589-1599

  Frey, Sharon E ^a   Peiperl, Laurence ^b   McElrath, M Juliana ^c   Kalams, Spyros ^d   Goepfert, Paul A ^e   Keefer, Michael C ^f   Baden, Lindsey R ^g   Lally, Michelle A ^h   Mayer, Kenneth ^g   Blattner, William A ⁱ   Harro, Clayton D ^j   Hammer, Scott M ^k   Gorse, Geoffrey J ^a   Hural, John ^l   Tomaras, Georgia D ^m   Levy, Yves ⁿ   Gilbert, Peter ^l   DeCamp, Allan ^l   Russell, Nina D ^o   Elizaga, Marnie ^l   Allen, Mary ^p   Corey, Lawrence ^c   more..

^a SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e University of Alabama at Birmingham   (United States)

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

^g HARVARD MEDICAL SCHOOL   (United States)

^h BROWN UNIVERSITY   (United States)

ⁱ UNIVERSITY OF MARYLAND   (United States)

^j JOHNS HOPKINS UNIVERSITY   (United States)

^k NewYork Presbyterian Hospital   (United States)

^l Fred Hutchinson Cancer Research Center   (United States)

^m DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁿ FACULTÉ DE MÉDECINE   (France)

^o BILL AND MELINDA GATES FOUNDATION   (United States)

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

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALVAC HIV VACCINE; ENV ANTIBODY; GAG ANTIBODY; GAG PROTEIN; GAMMA INTERFERON; GLYCOPROTEIN GP 120; GLYCOPROTEIN GP 41; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; LIPO 5 VACCINE; PLACEBO; POXVIRUS VECTOR; UNCLASSIFIED DRUG; VIRUS ANTIBODY; VIRUS ENVELOPE PROTEIN; VIRUS VACCINE; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTHRALGIA; ARTICLE; CHILL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG SAFETY; DRUG SCREENING; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; ENZYME LINKED IMMUNOSPOT ASSAY; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOGENICITY; INJECTION SITE INDURATION; INJECTION SITE PAIN; IRIDOCYCLITIS; LOW DRUG DOSE; LYMPHOCYTE FUNCTION; MALAISE; MALE; MULTICENTER STUDY; MYALGIA; MYELITIS; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SERODIAGNOSIS; STRUCTURAL GENE; VACCINATION; VACCINATION REACTION; VIRUS GENE; VOMITING; ACQUIRED IMMUNODEFICIENCY SYNDROME; ADOLESCENT; ADVERSE EFFECTS; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOLOGY; MIDDLE AGED; PATHOLOGY; PROCEDURES; SECRETION (PROCESS); TREATMENT OUTCOME; YOUNG ADULT;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADOLESCENT; ADULT; AIDS VACCINES; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ENZYME-LINKED IMMUNOSORBENT ASSAY; ENZYME-LINKED IMMUNOSPOT ASSAY; FEMALE; HIV ANTIBODIES; HIV-1; HUMANS; INTERFERON-GAMMA; MALE; MIDDLE AGED; PLACEBOS; TREATMENT OUTCOME; VACCINATION; YOUNG ADULT;

EID: 84914701342     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00450-14     Document Type: Article

References (44)

1. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH, MOPH-TAVEG Investigators. 2009. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N. Engl. J. Med. 361:2209-2220. http://dx.doi.org/10.1056/NEJMoa0908492.
2. Haynes BF, Gilbert PB, McElrath MJ, Zolla-Pazner S, Tomaras GD, Alam M, Evans DT, Montefiori DC, Karnasuta C, Sutthent R, Liao HX, DeVico AL, Lewis GK, Williams C, Pinter A, Fong Y, Janes H, DeCamp A, Huang Y, Rao M, Billings E, Karasavvas N, Robb ML, Ngauy V, de Souza MS, Paris R, Ferrari G, Bailer RT, Soderberg KA, Andrews C, Berman PW, Frahm N, De Rosa SC, Alpert MD, Yates NL, Shen X, Koup RA, Pitisuttithum P, Kaewkungwal J, Nitayaphan S, Rerks-Ngarm S, Michael NL, Kim JH. 2012. Immune-correlates analysis of an HIV-1 vaccine efficacy trial. N. Engl. J. Med. 366:1275-1286. http://dx.doi.org/10.1056/NEJMoa1113425.
3. Belshe R, Franchini G, Girard MP, Gotch F, Kaleebu P, Marthas ML, McChesney MB, McCullough R, Mhalu F, Salmon-Ceron D, Sekaly RP, van Rompay K, Verrier B, Wahren B, Weissenbacher M. 2004. Support for the RV144 HIV vaccine trial. Science 305:177-180. http://dx.doi.org /10.1126/science.305.5681.177b.
4. Burton DR, Desrosiers RC, Doms RW, Feinberg MB, Gallo RC, Hahn B, Hoxie JA, Hunter E, Korber B, Landay A, Lederman MM, Lieberman J, McCune JM, Moore JP, Nathanson N, Picker L, Richman D, Rinaldo C, Stevenson M, Watkins DI, Wolinsky SM, Zack JA. 2004. A sound rationale needed for phase III HIV-1 vaccine trials. Science 303:316. http://dx.doi.org/10.1126/science.1094620.
5. Letvin NL. 2009. Moving forward in HIV vaccine development. Science 326:1196-1198. http://dx.doi.org/10.1126/science.1183278.
6. Russell ND, Graham BS, Keefer MC, McElrath MJ, Self SG, Weinhold KJ, Montefiori DC, Ferrari G, Horton H, Tomaras GD, Gurunathan S, Baglyos L, Frey SE, Mulligan MJ, Harro CD, Buchbinder SP, Baden LR, Blattner WA, Koblin BA, Corey L, National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. 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. http://dx.doi.org/10.1097/01.qai.0000248356.48501.ff.
7. Pialoux G, Excler JL, Rivière Y, Gonzalez-Canali G, Feuillie V, Coulaud P, Gluckman JC, Matthews TJ, Meignier B, Kieny MP, Gonnet P, Diaz I. 1995. A prime-boost approach to HIV preventive vaccine using a recombinant canarypoxvirus expressing glycoprotein 160 (MN) followed by a recombinant glycoprotein 160 (MN/LAI). The AGIS Group and l'Agence Nationale de Recherche sur le SIDA. AIDS Res. Hum. Retroviruses 11:373-381. http://dx.doi.org/10.1089/aid.1995.11.373.
8. Fleury B, Janvier G, Pialoux G, Buseyne F, Robertson MN, Tartaglia J, Paoletti E, Kieny MP, Excler JL, Rivière Y. 1996. Memory cytotoxic T lymphocyte responses in human immunodeficiency virus type 1 (HIV-1)-negative volunteers immunized with a recombinant canarypox expressing gp 160 of HIV-1 and boosted with a recombinant gp160. J. Infect. Dis. 174:734-738. http://dx.doi.org/10.1093/infdis/174.4.734.
9. Salmon-Ceron D, Excler JL, Finkielsztejn L, Autran B, Gluckman JC, Sicard D, Matthews TJ, Meignier B, Valentin C, El Habib R, Blondeau C, Raux M, Moog C, Tartaglia J, Chong P, Klein M, Milcamps B, Heshmati F, Plotkin S. 1999. Safety and immunogenicity of a live recombinant canarypox virus expressing HIV type 1 gp120 MN MN tm/gag/ protease LAI (ALVAC-HIV, vCP205) followed by a p24EV3MN synthetic peptide (CLTB-36) administered in healthy volunteers at low risk for HIV infection. AIDS Res. Hum. Retroviruses 15:633-645. http://dx.doi.org/10.1089/088922299310935.
10. Goepfert PA, Horton H, McElrath MJ, Gurunathan S, Ferrari G, Tomaras GD, Montefiori DC, Allen M, Chiu YL, Spearman P, Fuchs JD, Koblin BA, Blattner WA, Frey S, Keefer MC, Baden LR, Corey L, NIAID HIV Vaccine Trials Network. 2005. High-dose recombinant canarypox vaccine expressing HIV-1 protein, in seronegative human subjects. J. Infect. Dis. 192:1249-1259. http://dx.doi.org/10.1086/432915.
11. Gorse GJ, Patel GB, Belshe RB. 2001. HIV type 1 vaccine-induced T cell memory and cytotoxic T lymphocyte responses in HIV type 1-uninfected volunteers. AIDS Res. Hum. Retroviruses 17:1175-1189. http://dx.doi.org/10.1089/088922201316912781.
12. Gorse GJ, Patel GB, Mandava MD, Arbuckle JA, Doyle TM, Belshe RB. 2001. Cytokine responses to human immunodeficiency virus type 1 (HIV-1) induced by immunization with live recombinant canarypox virus vaccine expressing HIV-1 genes boosted by HIV-1(SF-2) recombinant GP120. Vaccine 19:1806-1819. http://dx.doi.org/10.1016/S0264-410X(00)00378-9.
13. Belshe RB, Stevens C, Gorse GJ, Buchbinder S, Weinhold K, Sheppard H, Stablein D, Self S, McNamara J, Frey S, Flores J, Excler JL, Klein M, Habib RE, Duliege AM, Harro C, Corey L, Keefer M, Mulligan M, Wright P, Celum C, Judson F, Mayer K, McKirnan D, Marmor M, Woody G, National Institute of Allergy and Infectious Diseases Vaccine Evaluation Group AIDS, HIV Network for Prevention Trials (HIVNET). 2001. 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. 183:1343-1352. http://dx.doi.org/10.1086/319863.
14. Egan MA, Pavlat WA, Tartaglia J, Paoletti E, Weinhold KJ, Clements ML, Siliciano RF. 1995. Induction of human immunodeficiency virus type 1 (HIV-1)-specific cytolytic T lymphocyte responses in seronegative adults by a nonreplicating, host-range-restricted canarypox vector (ALVAC) carrying the HIV-1MN env gene. J. Infect. Dis. 171:1623-1627. http://dx.doi.org/10.1093/infdis/171.6.1623.
15. Clements-Mann ML, Weinhold K, Matthews TJ, Graham BS, Gorse GJ, Keefer MC, McElrath MJ, Hsieh R-H, Mestecky J, Zolla-Pazner S, Mascola J, Schwartz D, Siliciano R, Corey L, Wright PF, Belshe R, Dolin R, Jackson S, Xu S, Fast P, Walker MC, Stablein D, Excler J-L, Tartaglia J, Duliege A-M, Sinangil F, Paoletti E, Vaccine Evaluation Group NIAID AIDS. 1998. Immune responses to human immunodeficiency virus (HIV) type 1induced by canarypox expressing HIV-1MN gp120, HIV-1SF2 recombinant gp120, or both vaccines in seronegative adults. J. Infect. Dis. 177:1230-1246. http://dx.doi.org/10.1086/515288.
16. AIDS Vaccine Evaluation Group 022 Protocol Team. 2001. 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. 183:563-570. http://dx.doi.org/10.1086/318523.
17. Belshe RB, Gorse GJ, Mulligan MJ, Evans TG, Keefer MC, Excler JL, Duliege AM, Tartaglia J, Cox WI, McNamara J, Hwang KL, Bradney A, Montefiori D, Weinhold KJ. 1998. 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 12:2407-2415.
18. Evans TG, Keefer MC, Weinhold KJ, Wolff M, Montefiori D, Gorse GJ, Graham BS, McElrath MJ, Clements-Mann ML, Mulligan MJ, Fast P, Walker MC, Excler JL, Duliege AM, Tartaglia J. 1999. 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. 180:290-298. http://dx.doi.org/10.1086/314895.
19. Gupta K, Hudgens M, Corey L, McElrath MJ, Weinhold K, Montefiori DC, Gorse GJ, Frey SE, Keefer MC, Evans TG, Dolin R, Schwartz DH, Harro C, Graham B, Spearman PW, Mulligan M, Goepfert P, AIDS Vaccine Evaluation Group. 2002. Safety and immunogenicity of a hightitered 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. 29:254-261.
20. Deres K, Schild H, Wiesmuller KH, Jung G, Rammensee HG. 1989. In vivo priming of virus-specific cytotoxic T lymphocytes with synthetic lipopeptide vaccine. Nature 342:561-564. http://dx.doi.org/10.1038/342561a0.
21. Martinon F, Gras-Masse H, Boutillon C, Chirat F, Deprez B, Guillet JG, Gomard E, Tartar A, Levy JP. 1992. Immunization of mice with lipopeptides bypasses the prerequisite for adjuvant. Immune response of BALB/c mice to human immunodeficiency virus envelope glycoprotein. J. Immunol. 149:3416-3422.
22. Sauzet JP, Moog C, Krivine A, Martinon F, Bossus M, Gras-Masse H, Tartar A, Guillet JG, Gomard E. 1998. Adjuvant is required when using Env lipopeptide construct to induce HIV type 1-specific neutralizing antibody responses in mice in vivo. AIDS Res. Hum. Retroviruses 14:901-909. http://dx.doi.org/10.1089/aid.1998.14.901.
23. Sauzet JP, Deprez B, Martinon F, Guillet JG, Gras-Masse H, Gomard E. 1995. Long-lasting anti-viral cytotoxic T lymphocytes induced in vivo with chimeric-multirestricted lipopeptides. Vaccine 13:1339-1345. http: //dx.doi.org/10.1016/0264-410X(94)00087-4.
24. Bourgault I, Chirat F, Tartar A, Levy JP, Guillet JG, Venet A. 1994. Simian immunodeficiency virus as a model for vaccination against HIV. Induction in rhesus macaques of GAG- or NEF-specific cytotoxic T lymphocytes by lipopeptides. J. Immunol. 152:2530-2537.
25. Mortara L, Letourneur F, Villefroy P, Beyer C, Gras-Masse H, Guillet JG, Bourgault-Villada I. 2000. Temporal loss of Nef-epitope CTL recognition following macaque lipopeptide immunization and SIV challenge. Virology 278:551-561. http://dx.doi.org/10.1006/viro.2000.0671.
26. Mortara L, Letourneur F, Gras-Masse H, Venet A, Guillet JG, Bour-gault-Villada I. 1998. Selection of virus variants and emergence of virus escape mutants after immunization with an epitope vaccine. J. Virol. 72: 1403-1410.
27. Villada IB, Mortara L, Aubertin AM, Gras-Masse H, Levy JP, Guillet JG. 1997. Positive role of macaque cytotoxic T lymphocytes during SIV infection: decrease of cellular viremia and increase of asymptomatic clinical period. FEMS Immunol. Med. Microbiol. 19:81-87. http://dx.doi.org/10.1111/j.1574-695X.1997.tb01075.x.
28. Mortara L, Gras-Masse H, Rommens C, Venet A, Guillet JG, Bourgault-Villada I. 1999. Type 1 CD4(+) T cell help is required for induction of antipeptide multispecific cytotoxic T lymphocytes by a lipopeptidic vaccine in rhesus macaques. J. Virol. 73:4447-4451.
29. Daubersies P, Thomas AW, Millet P, Brahimi K, Langermans JA, Ollomo B, BenMohamed L, Slierendregt B, Eling W, Van Belkum A, Dubreuil G, Meis JF, Guérin-Marchand C, Cayphas S, Cohen J, Gras-Masse H, Druilhe P. 2000. Protection against Plasmodium falciparum malaria in chimpanzees by immunization with the conserved preerythrocytic liver-stage antigen 3. Nat. Med. 6:1258-1263. http://dx.doi.org/10.1038/81366.
30. Gahery-Segard H, Pialoux G, Charmeteau B, Sermet S, Poncelet H, Raux M, Tartar A, Lévy JP, Gras-Masse H, Guillet JG. 2000. Multiepitopic B- and T-cell responses induced in humans by a human immunodeficiency virus type 1 lipopeptide vaccine. J. Virol. 74:1694-1703. http://dx.doi.org/10.1128/JVI.74.4.1694-1703.2000.
31. Andrieu M, Loing E, Desoutter JF, Connan F, Choppin J, Gras-Masse H, Hanau D, Dautry-Varsat A, Guillet JG, Hosmalin A. 2000. Endocytosis of an HIV-derived lipopeptide into human dendritic cells followed by class I-restricted CD8(+) T lymphocyte activation. Eur. J. Immunol. 30:3256 -3265. http://dx.doi.org/10.1002/1521-4141(200011)30:113.0.CO;2-H
32. Baxby D, Paoletti E. 1992. Potential use of non-replicating vectors as recombinant vaccines. Vaccine 10:8-9. http://dx.doi.org/10.1016/0264-410X(92)90411-C.
33. Taylor J, Paoletti E. 1988. Fowlpox virus as a vector in non-avian species. Vaccine 6:466-468. http://dx.doi.org/10.1016/0264-410X(88)90091-6.
34. Russell ND, Hudgens MG, Ha R, Havenar-Daughton C, McElrath MJ. 2003. Moving to human immunodeficiency virus type 1 vaccine efficacy trials: defining T cell responses as potential correlates of immunity. J. Infect. Dis. 187:226-242. http://dx.doi.org/10.1086/367702.
35. Goepfert PA, Tomaras GD, Horton H, Montefiori D, Ferrari G, Deers M, Voss G, Koutsoukos M, Pedneault L, Vandepapeliere P, McElrath MJ, Spearman P, Fuchs JD, Koblin BA, Blattner WA, Frey S, Baden LR, Harro C, Evans T, NIAID HIV Vaccine Trials Network. 2007. Durable HIV-1 antibody and T-cell responses elicited by an adjuvanted multiprotein recombinant vaccine in uninfected human volunteers. Vaccine 25: 510-518. http://dx.doi.org/10.1016/j.vaccine.2006.07.
36. Tomaras GD, Yates NL, Liu P, Qin L, Fouda GG, Chavez LL, Decamp AC, Parks RJ, Ashley VC, Lucas JT, Cohen M, Eron J, Hicks CB, Liao HX, Self SG, Landucci G, Forthal DN, Weinhold KJ, Keele BF, Hahn BH, Greenberg ML, Morris L, Karim SS, Blattner WA, Montefiori DC, Shaw GM, Perelson AS, Haynes BF. 2008. Initial B-cell responses to transmitted human immunodeficiency virus type 1: virion-binding immunoglobulinM(IgM) and IgG antibodies followed by plasma anti-gp41 antibodies with ineffective control of initial viremia. J. Virol. 82:12449-12463. http://dx.doi.org/10.1128/JVI.01708-08.
37. Moodie Z, Huang Y, Gu L, Hural J, Self SG. 2006. Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials. J. Immunol. Methods 315:121-132. http://dx.doi.org/10.1016/j.jim.2006.07.015.
38. Agresti A, Coull BA. 1998. Approximate is better than "Exact" for interval estimation of binomial proportions. Am. Stat. 52:553-563.
39. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR, HPTN 052 Study Team. 2011. Prevention of HIV-1 infection with early antiretroviral therapy. N. Engl. J. Med. 365: 493-505. http://dx.doi.org/10.1056/NEJMoa1105243.
40. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D, CAPRISA 004 Trial Group. 2010. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 329:1168 -1174. http://dx.doi.org/10.1126/science.1193748. (Erratum, 333: 524, 2011. http://dx.doi.org/10.1126/science.333.6042.524-c.)
41. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapía M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernández T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallás EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV, iPrEx Study Team. 2010. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N. Engl. J. Med. 363:2587-2599. http://dx.doi.org/10.1056/NEJMoa1011205.
42. Durier C, Launay O, Meiffrédy V, Saïdi Y, Salmon D, Lévy Y, Guillet JG, Pialoux G, Aboulker JP. 2006. Clinical safety of HIV lipopeptides used as vaccines in healthy volunteers and HIV-infected adults. AIDS 20:1039-1049. http://dx.doi.org/10.1097/01.aids.0000222077.68243.22.
43. Salmon-Céron D, Durier C, Desaint C, Cuzin L, Surenaud M, Hamouda NB, Lelièvre JD, Bonnet B, Pialoux G, Poizot-Martin I, Aboulker JP, Lévy Y, Launay O, for the ANRS VAC18 trial group. 2010. Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo controlled ANRS trial. AIDS 24:2211-2223. http://dx.doi.org/10.1097/QAD.0b013e32833ce566.
44. Cleghorn F, Pape JW, Schechter M, Bartholomew C, Sanchez J, Jack N, Metch BJ, Hansen M, Allen M, Cao H, Montefiori DC, Tomaras GD, Gurunathan S, Eastman DJ, do Lago RF, Jean S, Lama JR, Lawrence DN, Wright PF, 026 Protocol Team, NIAID HIV Vaccine Trials Network. 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. http://dx.doi.org/10.1097/QAI.0b013e318149297d.