Assessment of the safety and immunogenicity of 2 novel vaccine platforms for HIV-1 prevention: A randomized trial

Annals of Internal Medicine

Volumn 164, Issue 5, 2016, Pages 313-322

  Baden, Lindsey R ^a   Karita, Etienne ^b   Mutua, Gaudensia ^c   Bekker, Linda Gail ^d   Gray, Glenda ^e   Page Shipp, Liesl ^f   Walsh, Stephen R ^a   Nyombayire, Julien ^b   Anzala, Omu ^c   Roux, Surita ^d   Laher, Fatima ^e   Innes, Craig ^f   Seaman, Michael S ^g   Cohen, Yehuda Z ^h   Peter, Lauren ^g   Frahm, Nicole ⁱ   McElrath, M Juliana ⁱ   Hayes, Peter ^j   Swann, Edith ^k   Grunenberg, Nicole ⁱ   Grazia Pau, Maria ^l   Weijtens, Mo ^l   Sadoff, Jerry ^l   Dally, Len ^m   Lombardo, Angela ⁿ   Gilmour, Jill ^j   Cox, Josephine ⁿ   Dolin, Raphael ^g   Fast, Patricia ⁿ   Barouch, Dan H ^g   Laufer, Dagna S ⁿ   Johnson, Jennifer ^o   Kleinjan, Jane ^o   Ingabire, Rosine ^o   Nyasani, Delvin ^o   Crida, Danielle ^o   Mamba, Musawenkosi ^o   Mngadi, Kathy ^o   Dominguez, David J ^o   Yanosick, Katherine E ^o   Cormier, Emmanuel ^o   Hural, John ^o   Stevens, Gwynn ^o   Adams, Elizabeth ^o   Kublin, James ^o   Hendriks, Jenny ^o   Sayeed, Eddy ^o   Ackland, James ^o   Anas, Kamaal ^o   Zackariah, Devika ^o   Vooijs, Dani ^o   Chinyenze, Kundai ^o   Matsoso, Mabela ^o   Park, Harriet ^o   Welsh, Sabrina ^o   more..

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b Projet San Francisco   (Rwanda)

^c UNIVERSITY OF NAIROBI   (Kenya)

^d Institute of Infectious Disease and Molecular Medicine   (South Africa)

^e Perinatal HIV Research Unit   (South Africa)

^f AURUM INSTITUTE   (South Africa)

^g HARVARD MEDICAL SCHOOL   (United States)

^h ROCKEFELLER UNIVERSITY   (United States)

ⁱ Fred Hutchinson Cancer Research Center   (United States)

^j CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

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

^l Janssen Research and Development   (Netherlands)

^m EMMES CORPORATION   (United States)

ⁿ INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

^o NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; ENVA PROTEIN; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; NEUTRALIZING ANTIBODY; PLACEBO; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; VIRUS ENVELOPE PROTEIN;

ADULT; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; CELLULAR IMMUNITY; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMORAL IMMUNITY; IMMUNOGENICITY; INFECTION PREVENTION; KENYA; MULTICENTER STUDY; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RWANDA; SEROCONVERSION; SINGLE DRUG DOSE; SOUTH AFRICA; T LYMPHOCYTE; UNITED STATES; VACCINATION; VACCINATION REACTION; VIRAL GENE DELIVERY SYSTEM; VIRUS IMMUNITY; ADENOVIRIDAE; ADOLESCENT; AFRICA; ANTIBODY PRODUCTION; CLINICAL TRIAL; GENE VECTOR; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOLOGY; MALE; MIDDLE AGED; YOUNG ADULT;

ADENOVIRIDAE; ADOLESCENT; ADULT; AFRICA, EASTERN; AIDS VACCINES; ANTIBODY FORMATION; DOUBLE-BLIND METHOD; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; GENETIC VECTORS; HIV INFECTIONS; HIV-1; HUMANS; IMMUNITY, CELLULAR; IMMUNITY, HUMORAL; MALE; MIDDLE AGED; SOUTH AFRICA; UNITED STATES; YOUNG ADULT;

EID: 84959300660     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M15-0880     Document Type: Article

References (23)

1. Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, et al; Step Study Protocol Team. Efficacy assessment of a cellmediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008; 372:1881-93. [PMID: 19012954] doi:10.1016/S0140-6736(08) 61591-3
2. Flynn NM, Forthal DN, Harro CD, Judson FN, Mayer KH, Para MF; rgp120 HIV Vaccine Study Group. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis. 2005;191:654-65. [PMID: 15688278]
3. Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, et al; HVTN 505 Study Team. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013;369:2083-92. [PMID: 24099601] doi:10.1056/NEJMoa1310566
4. McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, et al; Step Study Protocol Team. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet. 2008;372:1894-905. [PMID: 19012957] doi:10.1016/S0140-6736 (08)61592-5
5. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, et al; MOPH-TAVEG Investigators. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009;361:2209-20. [PMID: 19843557] doi:10.1056/NEJMoa0908492
6. Baden LR, Blattner WA, Morgan C, Huang Y, Defawe OD, Sobieszczyk ME, et al; NIAID HIV Vaccine Trials Network 044 Study Team. Timing of plasmid cytokine (IL-2/Ig) administration affects HIV-1 vaccine immunogenicity in HIV-seronegative subjects. J Infect Dis. 2011;204:1541-9. [PMID: 21940420] doi:10.1093/infdis/jir615
7. Bart PA, Goodall R, Barber T, Harari A, Guimaraes-Walker A, Khonkarly M, et al; EuroVacc Consortium. EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium. Vaccine. 2008; 26:3153-61. [PMID: 18502002] doi:10.1016/j.vaccine.2008.03.083
8. McCormack S, StöhrW, Barber T, Bart PA, Harari A, Moog C, et al. EV02: a phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone. Vaccine. 2008;26:3162-74. [PMID: 18502003] doi:10.1016/j.vaccine.2008.02 .072
9. Nicholson O, Dicandilo F, Kublin J, Sun X, Quirk E, Miller M, et al; for the Merck V520-018/HIV Vaccine Trials Network 050 Study Team. Safety and immunogenicity of the MRKAd5 gag HIV type 1 vaccine in a worldwide phase 1 study of healthy adults. AIDS Res Hum Retroviruses. 2010. [PMID: 20854108]
10. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, et al; Vaccine Research Center 006 Study Team. 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;194:1638-49. [PMID: 17109335]
11. Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, et al; Merck V526-001 Study Group. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol. 2009;16:1285-92. [PMID: 19605598] doi:10.1128/CVI.00144-09
12. Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, et al; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008;46:1769-81. [PMID: 18433307] doi:10.1086/587993
13. Barouch DH, Kik SV, Weverling GJ, Dilan R, King SL, Maxfield LF, et al. International seroepidemiology of adenovirus serotypes 5, 26, 35, and 48 in pediatric and adult populations. Vaccine. 2011;29: 5203-9. [PMID: 21619905] doi:10.1016/j.vaccine.2011.05.025
14. Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, Novitsky V, et al. 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. 2010;28:950-7.[PMID:19925902]doi:10.1016/j.vaccine .2009.10.145
15. Baden LR, Walsh SR, Seaman MS, Tucker RP, Krause KH, Patel A, et al. First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 ENV vaccine (IPCAVD 001). J Infect Dis. 2013;207:240-7. [PMID: 23125444] doi:10.1093/infdis/jis670
16. Barouch DH, Liu J, Peter L, Abbink P, Iampietro MJ, Cheung A, et al. Characterization of humoral and cellular immune responses elicited by a recombinant adenovirus serotype 26 HIV-1 Env vaccine in healthy adults (IPCAVD 001). J Infect Dis. 2013;207:248-56. [PMID: 23125443] doi:10.1093/infdis/jis671
17. Keefer MC, Gilmour J, Hayes P, Gill D, Kopycinski J, Cheeseman H, et al. A phase I double blind, placebo-controlled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults. PLoS One. 2012;7:e41936. [PMID: 22870265] doi:10.1371/journal.pone.0041936
18. Geisbert TW, Bailey M, Hensley L, Asiedu C, Geisbert J, Stanley D, et al. Recombinant adenovirus serotype 26 (Ad26) and Ad35 vaccine vectors bypass immunity to Ad5 and protect nonhuman primates against ebolavirus challenge. J Virol. 2011;85:4222-33. [PMID: 21325402] doi:10.1128/JVI.02407-10
19. Radosevic K, Rodriguez A, Lemckert AA, van der Meer M, Gillissen G, Warnar C, et al. The Th1 immune response to Plasmodium falciparum circumsporozoite protein is boosted by adenovirus vectors 35 and 26 with a homologous insert. Clin Vaccine Immunol. 2010;17:1687-94. [PMID: 20826614] doi:10.1128/CVI.00311-10
20. Ouédraogo A, Tiono AB, Kargougou D, Yaro JB, Ouédraogo E, Kaboré Y, et al. A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age. PLoS One. 2013;8:e78679. [PMID: 24244339] doi:10.1371/journal.pone .0078679
21. Radosevic K, Wieland CW, Rodriguez A, Weverling GJ, Mintardjo R, Gillissen G, et al. Protective immune responses to a recombinant adenovirus type 35 tuberculosis vaccine in two mouse strains: CD4 and CD8 T-cell epitope mapping and role of gamma interferon. Infect Immun. 2007;75:4105-15. [PMID: 17526747]
22. Creech CB, Dekker CL, Ho D, Phillips S, Mackey S, Murray-Krezan C, et al. Randomized, placebo-controlled trial to assess the safety and immunogenicity of an adenovirus type 35-based circumsporozoite malaria vaccine in healthy adults. Hum Vaccin Immunother. 2013;9:2548-57. [PMID: 23955431] doi:10.4161/hv.26038
23. Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. Evaluation and recommendations on good clinical laboratory practice guidelines for phase I-III clinical trials. PLoS Med. 2009;6: e1000067. [PMID: 19536325] doi:10.1371/journal.pmed.1000067