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Product description



　　Publication of Clinical Trial Results

　　Politch JA, Cu-Uvin S, Moench TR, Tashima KT, Marathe JG, Guthrie KM, Cabral H, Nyhuis T, Brennan M, Zeitlin L, Spiegel HML, Mayer KH, Whaley KJ, Anderson DJ. Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66):  A Phase I randomized trial. PLoS Med, 2021;18(2):e1003495.

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　　IPCP Investigators:

　　Journal of Infectious Diseases Supplement:  Cell-Associated HIV Transmission Across Mucosal Surfaces:

　　Original and Review Articles:

　　1.         Daggett GJ Jr, Zhao C, Connor-Stroud F, Oviedo-Moreno P, Moon H, Cho MW, Moench T, Anderson DJ, Villinger F. Comparison of the vaginal environment in rhesus and cynomolgus macaques pre- and post-lactobacillus colonization.  J Med Primatol. 2017 May 9. doi: 10.1111/jmp.12264. [Epub ahead of print]

　　5.         Henry CE, Wang YY, Yang Q, Hoang T, Chattopadhyay S, Hoen T, Ensign LM, Nunn KL, Schroeder H, McCallen J, Moench T, Cone R, Roffler SR, Lai SK. Anti-PEG antibodies alter the mobility and biodistribution of densely PEGylated nanoparticles in mucus. Acta Biomater. 2016 Oct 1;43:61-70. doi: 10.1016/j.actbio.2016.07.019. Epub 2016 Jul 14.

　　18.      Cone RA. Vaginal microbiota and sexually transmitted infections that may influence transmission of cell-associated HIV.  J Infect Dis. 2014 Dec 15;210 Suppl 3:S616-21. doi: 10.1093/infdis/jiu459.

　　Other Relevant Publications:

　　1.         Abdel-Motal UM, Sarkis PT, Han T, Pudney J, Anderson DJ, Zhu Q, Marasco WA. Anti-gp120 minibody gene transfer to female genital epithelial cells protects against HIV-1 virus challenge in vitro. PLoS One 2011,6:e26473.

　　2.         Abela IA, Berlinger L, Schanz M, Reynell L, Gunthard HF, Rusert P, Trkola A.  Cell-cell transmission enables HIV-1 to evade inhibition by potent CD4bs directed antibodies.  PLoS Pathogens 2012,4:e1002634.

　　3.         Balazs AB, Chen J, Hong CM, Rao DS, Yang L, Baltimore D. Antibody-based protection against HIV infection by vectored immunoprophylaxis. Nature 2011,481:81-84.

　　4.         Belshe RB, Leone PA, Bernstein DI, Wald A, Levin MJ, Stapleton JT, et al. Efficacy results of a trial of a herpes simplex vaccine. N Engl J Med 2012,366:34-43.

　　5.         Burton DR, Hessell AJ, Keele BF, Klasse PJ, Ketas TA, Moldt B, et al. Limited or no protection by weakly or nonneutralizing antibodies against vaginal SHIV challenge of macaques compared with a strongly neutralizing antibody. Proc Natl Acad Sci U S A 2011,108:11181-11186.

　　6.         Chen W, Dimitrov DS. Monoclonal Antibody-Based Candidate Therapeutics Against HIV Type 1. AIDS Res Hum Retroviruses 2011.

　　7.         Diskin R, Scheid JF, Marcovecchio PM, West AP, Jr., Klein F, Gao H, et al. Increasing the potency and breadth of an HIV antibody by using structure-based rational design. Science,334:1289-1293.

　　8.         Gilbert P, Wang M, Wrin T, Petropoulos C, Gurwith M, Sinangil F, et al.Magnitude and breadth of a nonprotective neutralizing antibody response in an efficacy trial of a candidate HIV-1 gp120 vaccine. J Infect Dis 2010,202:595-605.

　　9.         Haigwood NL, Hirsch VM. Blocking and tackling HIV. Nat Med 2009,15:841-842.

　　10.       Hessell AJ, Poignard P, Hunter M, Hangartner L, Tehrani DM, Bleeker WK, et al. Effective, low-titer antibody protection against low-dose repeated mucosal SHIV challenge in macaques. Nat Med 2009,15:951-954.

　　11.       Hessell AJ, Rakasz EG, Tehrani DM, Huber M, Weisgrau KL, Landucci G, et al. Broadly neutralizing monoclonal antibodies 2F5 and 4E10 directed against the human immunodeficiency virus type 1 gp41 membrane-proximal external region protect against mucosal challenge by simian-human immunodeficiency virus SHIVBa-L. J Virol 2010,84:1302-1313.

　　12.       Huang J, Ofek G, Laub L, Louder MK, Doria-Rose NA, Longo NS, et al.  Broad and potent neutralization of HIV-1 by a gp41-specific human antibody.  Nature 2012,491:406-12.

　　13.       Klein F, Halper-Stromberg A, Horwitz JA, Gruell H, Scheid JF, Bournazos S, et al.  HIV therapy by a combination of broadly neutralizing antibodies in humanized mice.  Nature 2012, in press.

　　14.       Li Z, Palaniyandi S, Zeng R, Tuo W, Roopenian DC, Zhu X. Transfer of IgG in the female genital tract by MHC class I-related neonatal Fc receptor (FcRn) confers protective immunity to vaginal infection. Proc Natl Acad Sci U S A 2011,108:4388-4393.

　　15.       Malbec M, Porrot F, Rua R, Horwitz J, Klein F, Halper-Stromberg A, Scheid JF, Eden C, Mouquet H, Nussenzweig MC, Schwartz O.  Broadly neutralizing antibodies that inhibit HIV-1 cell to cell transmission.  J Exp Med 2013 [Epub ahead of print]

　　16.       McGhee JR. A mucosal gateway for vaccines. Nat Biotechnol 2011,29:136-138.

　　17.       NIH News.  NIH-led scientists find antibodies that prevent most HIV strains from infecting human cells.  Bethesda:  NIAID, NIH:  2010.

　　18.       Owen DH, Katz DF.  A vaginal fluid simulant.  Contraception  1999,59:91-5.

　　19.       PATH and the Coalition Advancing Multipurpose Innovations.  Saving Lives with Multipurpose Prevention Technologies:  Turning Ideas into Solutions for Sexual and Reproductive Health. Seattle: 2010.

　　20.       Pejchal R, Doores KJ, Walker LM, Khayat R, Huang PS, Wang SK, et al. A potent and broad neutralizing antibody recognizes and penetrates the HIV glycan shield. Science 2011,334:1097-1103.

　　21.       Pejchal R, Walker LM, Stanfield RL, Phogat SK, Koff WC, Poignard P, et al.  Structure and function of broadly reactive antibody PG16 reveal an H3 subdomain that mediates potent neutralization of HIV-1.  Proc Natl Acad Sci USA 2010,107:11483-8.

　　22.       Stamatatos L, Morris L, Burton DR, Mascola JR. Neutralizing antibodies generated during natural HIV-1 infection: good news for an HIV-1 vaccine? Nat Med 2009,15:866-870.

　　23.       Veselinovic M, Neff CP, Mulder LR, Akkina R.  Topical gel formulation of broadly neutralizing anti-HIV-1 monoclonal antibody VRC01 confers protection against HIV-1 vaginal challenge in a humanized mouse model.  Virology 2012,432:505-510.

　　25.       Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, et al. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature 2011,477:466-470.

　　26.       Walker LM, Phogat SK, Chan-Hui PY, Wagner D, Phung P, Goss JL, et al. Broad and potent neutralizing antibodies from an African donor reveal a new HIV-1 vaccine target. Science 2009,326:285-289.

　　27.       West AP, Galimidi RP, Gnanapragasam PNP, Bjorkman PJ.  Single-chain Fv-based anti-HIV proteins:  potential and limitations.  J Virol  2012,86:195-202.

　　28.       Whaley KJ, Morton J, Hume S, Hiatt E, Bratcher B, Klimyuk V, Hiatt A, Pauly M, Zeitlin L.  Emerging antibody-based products.  Curr Top Microbiol Immunol 2012,Jul 8. [Epub ahead of print]

　　29.       Wu X, Wang C, O’Dell S, Li Y, Keele BF, Yang Z, Imamichi H, Doria-Rose N, Hoxie JA, Connors M, Shaw GM, Wyatt RT, Mascola JR.  Selection pressure on HIV-1 envelope by broadly neutralizing antibodies to the conserved CD4-binding site.  J Virol 2012,86:5844-56.

　　30.       Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, et al. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science 2010,329:856-861.

　　31.       Ye L, Zeng R, Bai Y, Roopenian DC, Zhu X. Efficient mucosal vaccination mediated by the neonatal Fc receptor. Nat Biotechnol 2011,29:158-163.

　　32.       Zhang MY, Borges AR, Ptak RG, Wang Y, Dimitrov AS, Alam SM, et al. Potent and broad neutralizing activity of a single chain antibody fragment against cell-free and cell-associated HIV-1. MAbs 2010,2:266-274.

　　33.       Zhou T, Georgiev I, Wu X, Yang ZY, Dai K, Finzi A, et al. Structural basis for broad and potent neutralization of HIV-1 by antibody VRC01. Science 2010,329:811-817.