Phase I randomised clinical trial of an HIV-1 CN54, clade C, trimeric envelope vaccine candidate delivered vaginally

PLoS ONE

Volumn 6, Issue 9, 2011, Pages

  Lewis, David J ^a   Fraser, Carol A ^a   Mahmoud, Abdel N ^a   Wiggins, Rebecca C ^b   Woodrow, Maria ^a   Cope, Alethea ^a   Cai, Chun ^b   Giemza, Rafaela ^a   Jeffs, Simon A ^c   Manoussaka, Maria ^a   Cole, Tom ^a   Cranage, Martin P ^a   Shattock, Robin J ^a   Lacey, Charles J ^b  

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b UNIVERSITY OF YORK   (United Kingdom)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPOL 974P; GLYCOPROTEIN GP 140; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; PLACEBO; PROTEIN CN54; UNCLASSIFIED DRUG; VIRUS ENVELOPE PROTEIN; GP140 ENVELOPE PROTEIN, HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G;

ADULT; ANTIGEN PRESENTATION; APPLICATION SITE REACTION; ARTICLE; CELLULAR IMMUNITY; CLADISTICS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG UPTAKE; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL TOXICITY; GEL; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; IMMUNIZATION; IMMUNOGENICITY; INFECTION; MENSTRUAL CYCLE; NEUROTOXICITY; NUCLEOTIDE SEQUENCE; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; REPEAT PROCEDURE; REPRODUCTIVE TOXICITY; TREATMENT DURATION; ADOLESCENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOLOGY; INTRAVAGINAL DRUG ADMINISTRATION; MIDDLE AGED; PHASE 1 CLINICAL TRIAL;

HUMAN IMMUNODEFICIENCY VIRUS 1;

ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; AIDS VACCINES; ENV GENE PRODUCTS, HUMAN IMMUNODEFICIENCY VIRUS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HIV ANTIBODIES; HUMANS; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; MIDDLE AGED; YOUNG ADULT;

EID: 80053599510     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0025165     Document Type: Article

References (27)

1. Haase AT, (2010) Targeting early infection to prevent HIV-1 mucosal transmission. Nature 464: 217-223.
2. Li Q, Skinner PJ, Ha SJ, Duan L, Mattila TL, et al. (2009) Visualizing antigen-specific and infected cells in situ predicts outcomes in early viral infection. Science 323: 1726-1729.
3. Miller CJ, Li Q, Abel K, Kim EY, Ma ZM, et al. (2005) Propagation and dissemination of infection after vaginal transmission of simian immunodeficiency virus. J Virol 79: 9217-9227.
4. The GlaxoSmithKline vaccine HPV-007 study group (2009) Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 374: 1975-1985.
5. Ogra LP, Ogra SS, (1973) Local antibody response to poliovaccine in the human female genital tract. J Immunol 110: 1307-1311.
6. Klavinskis LS, Bergmeier LA, Gao L, Mitchell E, Ward RG, et al. (1996) Mucosal or targeted lymph node immunization of macaques with a particulate SIVp27 protein elicits virus-specific CTL in the genito-rectal mucosa and draining lymph nodes. J Immunol 157: 2521-2527.
7. Wassen L, Schon K, Holmgren J, Jertborn M, Lycke N, (1996) Local intravaginal vaccination of the female genital tract. Scand J Immunol 44: 408-414.
8. Kozlowski PA, Cu-Uvin S, Neutra MR, Flanigan TP, (1997) Comparison of the oral, rectal, and vaginal immunization routes for induction of antibodies in rectal and genital tract secretions of women. Infec Immun 65: 1387-1394.
9. Kozlowski PA, Williams SB, Lynch RM, Flanigan TP, Patterson RR, et al. (2002) Differential induction of mucosal and systemic antibody responses in women after nasal, rectal, or vaginal immunization: influence of the menstrual cycle. J Immunol 169: 566-574.
10. Johannson EL, Wassen L, Holmgren J, Jertborn M, Rudin A, (2001) Nasal and vaginal vaccination have differential effects on antibody responses in vaginal and cervical secretions in humans. Infec Immun 69: 7481-7486.
11. Wang Y, Abel K, Lantz K, Krieg AM, McChesney MB, et al. (2005) The Toll-like receptor 7 (TLR7) agonist, imiquimod, and the TLR9 agonist, CpG ODN, induce antiviral cytokines and chemokines but do not prevent vaginal transmission of simian immunodeficiency virus when applied intravaginally to rhesus macaques. J Virol 79: 14355-14370.
12. Cranage MP, Fraser CA, Stevens Z, Huting J, Chang M, et al. (2010) Repeated vaginal administration of trimeric HIV-1 clade C gp140 induces serum and mucosal antibody responses. Mucosal Immunol 3: 57-68.
13. Curran RM, Donnelly L, Morrow RJ, Fraser C, Andrews G, et al. (2009) Vaginal delivery of the recombinant HIV-1 clade-C trimeric gp140 envelope protein CN54gp140 within novel rheologically structured vehicles elicits specific immune responses. Vaccine 27: 6791-6798.
14. Currier JR, Kuta EG, Turk E, Earhart LB, Loomis-Price L, et al. (2002) A panel of MHC class I restricted viral peptides for use as a quality control for vaccine trial ELISPOT assays. J Immunol Methods 260: 157-172.
15. Pialoux G, Hocini H, Perusat S, Silberman B, Salmon-Ceron D, et al. (2008) Phase 1 study of a candidate vaccine based on recombinant HIV-1 gp160 (MN/LAI) administered by the mucosal route to HIV-seronegative volunteers: the ANRS VAC14 study. Vaccine 26: 2657-2666.
16. Barberini F, Correr S, De Santis F, Motta PM, (1991) The epithelium of the rabbit vagina: a microtopographical study by light, transmission and scanning electron microscopy. Arch Histol Cytol 54: 365-378.
17. Cranage MP, Fraser CA, Cope A, McKay PF, Seaman MS, et al. (2011) Antibody responses after intravaginal immunisation with trimeric HIV-1CN54 clade C gp140 in Carbopol gel are augmented by systemic priming or boosting with an adjuvanted formulation. Vaccine 29: 1421-1430.
18. Krashias G, Simon A-K, Wegmann F, Kok WL, Ho LP, et al. (2010) Potent adaptive immune responses induced against HIV-1 gp140 and influenza virus HA by a polyanionic carbomer. 28: 2482-2489.
19. Raux M, Finkielsztejn L, Salmon-Ceron D, Bouchez H, Excler JL, et al. (1999) Comparison of the distribution of IgG and IgA antibodies in serum and various mucosal fluids of HIV type1-infected subjects. AIDS Res Hum Retroviruses 15: 1365-1376.
20. Mestecky J, Moldoveanu Z, Smith PD, Hel Z, Alexander RC, (2009) Mucosal immunology of the genital and gastrointestinal tracts and HIV-1 infection. J Reprod Immunol 83: 196-200.
21. Mestecky J, Wright P, Lopalco L, Staats HF, Kozlowski PA, et al. (2011) Scarcity or absence of humoral immune responses in the plasma or cervicovaginal lavage fluids of heavily HIV-1-exposed but persistently seronegative women. AIDS Res Hum Retroviruses 27: 469-486.
22. Tudor D, Derrien M, Diomede L, Drillet AS, Houimel M, et al. (2009) HIV-1 gp41-specific monoclonal mucosal IgAs derived from highly exposed but IgG-seronegative individuals block HIV-1 epithelial transcytosis and neutralize CD4(+) cell infection: an IgA gene and functional analysis. Mucosal Immunology 2: 412-426.
23. Safaeian M, Kemp T, Falk RT, Rodriguez AC, Hildesheim A, et al. (2009) Determinants and correlation of systemic and cervical concentrations of total IgA and IgG. Cancer Epidemiol Biomarkers Prev 18: 2672-2676.
24. Kaul R, Thottingal P, Kimani J, Kiama P, Waigwa CW, et al. (2003) Quantitative ex vivo analysis of functional virus-specific CD8 T lymphocytes in the blood and genital tract of HIV-infected women. AIDS 17: 1139-1144.
25. Gumbi PP, Nkwanyana NN, Bere A, Burgers WA, Gray CM, et al. (2008) Impact of mucosal inflammation on cervical human immunodeficiency virus (HIV-1)-specific CD8 T-cell responses in the female genital tract during chronic HIV infection. J Virol 82: 8529-8536.
26. Bere A, Denny L, Burgers WA, Passmore J-A, (2010) Polyclonal expansion of cervical cytobrush-derived T cells to investigate HIV-specific responses in the female genital tract. Immunology 133: 23-33.
27. Boskey ER, Moench TR, Hees PS, Cone RA, (2003) A self-sampling method to obtain large volumes of undiluted cervicovaginal secretions. Sex Transm Dis 30: 107-109.