Baseline variation and associations between subject characteristics and five cytokine biomarkers of vaginal safety among healthy non-pregnant women in microbicide trials

Cytokine

Volumn 55, Issue 1, 2011, Pages 134-140

  Fichorova, Raina N ^a   Lai, Jaim Jou ^b   Schwartz, Jill L ^c   Weiner, Debra H ^b   Mauck, Christine K ^c   Callahan, Marianne M ^c  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b FAMILY HEALTH INTERNATIONAL   (United States)

^c EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

Author keywords

IL 1; IL 1RA; IL 1RA to IL 1 ratio; IL 8; Nugent score

Indexed keywords

INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; INTERLEUKIN 1ALPHA; INTERLEUKIN 1BETA; INTERLEUKIN 8; MICROBICIDE;

ADULT; ARTICLE; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; CORRELATIONAL STUDY; CROSS-SECTIONAL STUDY; CYTOKINE PRODUCTION; DRUG TOLERABILITY; EDUCATIONAL STATUS; ETHNIC DIFFERENCE; FEMALE; HORMONAL CONTRACEPTION; HUMAN; HUMAN EXPERIMENT; MENSTRUAL CYCLE; NORMAL HUMAN; NUGENT SCORE; ORAL CONTRACEPTION; PAPANICOLAOU TEST; PATIENT SAFETY; PRIORITY JOURNAL; PROTEIN EXPRESSION; SCORING SYSTEM; SEXUAL BEHAVIOR; VAGINAL LAVAGE;

ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; BIOLOGICAL MARKERS; CASE-CONTROL STUDIES; CONTRACEPTIVE AGENTS; CYTOKINES; DEMOGRAPHY; FEMALE; HEALTH; HUMANS; MIDDLE AGED; PREGNANCY; VAGINA; YOUNG ADULT;

HUMAN IMMUNODEFICIENCY VIRUS 1;

EID: 79956341658     PISSN: 10434666     EISSN: 10960023     Source Type: Journal    
DOI: 10.1016/j.cyto.2011.03.016     Document Type: Article

References (64)

1. UNAIDS. in: ; 2010. http://www.unaids.org.
2. UNAIDS, UNAIDS Global Facts and Figures 2006. in: 2006 (). http://www.data.unaids.org.
3. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 329:1168-1174.
4. Fichorova R.N., Bajpai M., Chandra N., Hsiu J.G., Spangler M., Ratnam V., et al. Interleukin (IL)-1, IL-6, and IL-8 predict mucosal toxicity of vaginal microbicidal contraceptives. Biol Reprod 2004, 71:761-769.
5. Hillier S.L., Moench T., Shattock R., Black R., Reichelderfer P., Veronese F. In vitro and in vivo: the story of nonoxynol 9. J Acquir Immune Defic Syndr 2005, 39:1-8.
6. Lard-Whiteford S.L., Matecka D., O'Rear J.J., Yuen I.S., Litterst C., Reichelderfer P. Recommendations for the nonclinical development of topical microbicides for prevention of HIV transmission: an update. J Acquir Immune Defic Syndr 2004, 36:541-552.
7. Cutler B., Justman J. Vaginal microbicides and the prevention of HIV transmission. Lancet Infect Dis 2008, 8:685-697.
8. Fichorova R.N. Guiding the vaginal microbicide trials with biomarkers of inflammation. J Acquir Immune Defic Syndr 2004, 37(Suppl. 3):184-193.
9. Alfano M., Poli G. Role of cytokines and chemokines in the regulation of innate immunity and HIV infection. Mol Immunol 2005, 42:161-182.
10. Mauck C.K., Ballagh S.A., Creinin M.D., Weiner D.H., Doncel G.F., Fichorova R.N., et al. Six-day randomized safety trial of intravaginal lime juice. J Acquir Immune Defic Syndr 2008, 49:243-250.
11. Cummins J.E., Christensen L., Lennox J.L., Bush T.J., Wu Z., Malamud D., et al. Mucosal innate immune factors in the female genital tract are associated with vaginal HIV-1 shedding independent of plasma viral load. AIDS Res Hum Retroviruses 2006, 22:788-795.
12. Spear G.T., Sha B.E., Saarloos M.N., Benson C.A., Rydman R., Massad L.S., et al. Chemokines are present in the genital tract of HIV-seropositive and HIV-seronegative women: correlation with other immune mediators. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18:454-459.
13. Fichorova R.N., Tucker L.D., Anderson D.J. The molecular basis of nonoxynol-9-induced vaginal inflammation and its possible relevance to human immunodeficiency virus type 1 transmission. J Infect Dis 2001, 184:418-428.
14. O'Neil L.A., Greene C. Signal transduction pathways activated by the IL-1 receptor family: ancient signaling machinery in mammals, insects and plants. J Leuko Biol 1998, 63:650-657.
15. Arend W.P. The balance between IL-1 and IL-1Ra in disease. Cytokine Growth Factor Rev 2002, 13:323-340.
16. Goletti D., Kinter A.L., Hardy E.C., Poli G., Fauci A.S. Modulation of endogenous IL-1 beta and IL-1 receptor antagonist results in opposing effects on HIV expression in chronically infected monocytic cells. J Immunol 1996, 156:3501-3508.
17. Witkin S.S., Linhares I.M., Gerber S., Caetano M.E., Segurado A.C. Interleukin-1 receptor antagonist gene polymorphism and circulating levels of human immunodeficiency virus type 1 RNA in Brazilian women. J Virol 2001, 75:6242-6244.
18. Fichorova R.N., Anderson D.J. Differential expression of immunobiological mediators by immortalized human cervical and vaginal epithelial cells. Biol Reprod 1999, 60:508-514.
19. Gabay C., Smith M.F., Eidlen D., Arend W.P. Interleukin 1 receptor antagonist (IL-1Ra) is an acute-phase protein. J Clin Invest 1997, 99:2930-2940.
20. Mukaida N. Interleukin-8: an expanding universe beyond neutrophil chemotaxis and activation. Int J Hematol 2000, 72:391-398.
21. Spear G.T., Zariffard M.R., Cohen M.H., Sha B.E. Vaginal IL-8 levels are positively associated with Candida albicans and inversely with lactobacilli in HIV-infected women. J Reprod Immunol 2008, 78:76-79.
22. Narimatsu R., Wolday D., Patterson B.K. IL-8 increases transmission of HIV type 1 in cervical explant tissue. AIDS Res Hum Retroviruses 2005, 21:228-233.
23. Al-Harthi L., Kovacs A., Coombs R.W., Reichelderfer P.S., Wright D.J., Cohen M.H., et al. A menstrual cycle pattern for cytokine levels exists in HIV-positive women: implication for HIV vaginal and plasma shedding. AIDS 2001, 15:1535-1543.
24. Gumbi PP, Nkwanyana NN, Bere A, Burgers WA, Gray CM, Williamson A-L, et al. 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. 2008; 82: 8529-8536.
25. Cone R.A., Hoen T., Wong X., Abusuwwa R., Anderson D.J., Moench T.R. Vaginal microbicides: detecting toxicities in vivo that paradoxically increase pathogen transmission. BMC Infect Dis 2006, 6:90.
26. D'Cruz O.J., Uckun F.M. Preclinical evaluation of a dual-acting microbicidal prodrug WHI-07 in combination with vanadocene dithiocarbamate in the female reproductive tract of rabbit, pig, and cat. Toxicol Pathol 2007, 35:910-927.
27. Galen B.T., Martin A.P., Hazrati E., Garin A., Guzman E., Wilson S.S., et al. A comprehensive murine model to evaluate topical vaginal microbicides: mucosal inflammation and susceptibility to genital herpes as surrogate markers of safety. J Infect Dis 2007, 195:1332-1339.
28. Petricevic L., Unger F.M., Viernstein H., Kiss H. Randomized, double-blind, placebo-controlled study of oral lactobacilli to improve the vaginal flora of postmenopausal women. Eur J Obstet Gynecol Reprod Biol 2008, 141:54-57.
29. Van Damme L., Ramjee G., Alary M., Vuylsteke B., Chandeying V., Rees H., et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial. Lancet 2002, 360:971-977.
30. Anton G., Rid J., Mylonas I., Friese K., Weissenbacher E.R. Evidence of a TH1-shift of local vaginal inflammatory response during bacterial vaginosis. Infection 2008, 36:147-152.
31. Bollen L.J., Blanchard K., Kilmarx P.H., Chaikummao S., Connolly C., Wasinrapee P., et al. No increase in cervicovaginal proinflammatory cytokines after Carraguard use in a placebo-controlled randomized clinical trial. J Acquir Immune Defic Syndr 2008, 47:253-257.
32. Schwartz J.L., Mauck C., Lai J.J., Creinin M.D., Brache V., Ballagh S.A., et al. Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study. Contraception 2006, 74:133-140.
33. Cummins J.E., Doncel G.F. Biomarkers of cervicovaginal inflammation for the assessment of microbicide safety. Sex Transm Dis 2009, 36:S84-S91.
34. Fichorova R.N., Richardson-Harman N., Alfano M., Belec L., Carbonneil C., Chen S., et al. Biological and technical variables affecting immunoassay recovery of cytokines from human serum and simulated vaginal fluid: a multicenter study. Anal Chem 2008, 80:4741-4751.
35. Cauci S., Guaschino S., De Aloysio D., Driussi S., De Santo D., Penacchioni P., et al. Interrelationships of interleukin-8 with interleukin-1beta and neutrophils in vaginal fluid of healthy and bacterial vaginosis positive women. Mol Hum Reprod 2003, 9:53-58.
36. Keller M.J., Guzman E., Hazrati E., Kasowitz A., Cheshenko N., Wallenstein S., et al. Elicits a decline in genital tract immune mediators without compromising intrinsic antimicrobial activity. AIDS 2000, 2007(21):467-476.
37. Belec L., Gherardi R., Payan C., Prazuck T., Malkin J.E., Tevi-Benissan C., et al. Proinflammatory cytokine expression in cervicovaginal secretions of normal and HIV-infected women. Cytokine 1995, 7:568-574.
38. Anderson D.J., Williams D.L., Ballagh S.A., Barnhart K., Creinin M.D., Newman D.R., et al. Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid. Am J Reprod Immunol 2009, 61:121-129.
39. Tjiong M.Y., van der Vange N., ter Schegget J.S., Burger M.P., ten Kate F.W., Out T.A. Cytokines in cervicovaginal washing fluid from patients with cervical neoplasia. Cytokine 2001, 14:357-360.
40. Schwartz J.L., Lai J.J., Creinin M., Bradley L., Thomas M., Mauck C., et al. A randomized Phase I safety study. In: Microbicides 2006 2006, Cape Town, South Africa.
41. Amsel R., Totten P.A., Spiegel C.A., Chen K.C., Eschenbach D., Holmes K.K. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Med 1983, 74:14-22.
42. Gallo M.F., Behets F.M., Steiner M.J., Hobbs M.M., Hoke T.H., Van Damme K., et al. Prostate-specific antigen to ascertain reliability of self-reported coital exposure to semen. Sex Transm Dis 2006, 33:476-479.
43. Haimovici F., Anderson D.J. Detection of semen in cervicovaginal secretions. J Acquir Immune Defic Syndr Hum Retrovirol 1995, 8:236-238.
44. Fraser I.S., Lahteenmaki P., Elomaa K., Lacarra M., Mishell D.R., Alvarez F., et al. Variations in vaginal epithelial surface appearance determined by colposcopic inspection in healthy, sexually active women. Hum Reprod 1999, 14:1974-1978.
45. Nugent R.P., Krohn M.A., Hillier S.L. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 1991, 29:297-301.
46. Myer L., Denny L., Telerant R., Souza M., Wright T.C., Kuhn L. Bacterial vaginosis and susceptibility to HIV infection in South African women: a nested case-control study. J Infect Dis 2005, 192:1372-1380.
47. van de Wijgert J.H., Morrison C.S., Brown J., Kwok C., Van Der Pol B., Chipato T., et al. Disentangling contributions of reproductive tract infections to HIV acquisition in African Women. Sex Transm Dis 2009, 36:357-364.
48. Genc M.R., Witkin S.S., Delaney M.L., Paraskevas L.R., Tuomala R.E., Norwitz E.R., et al. A disproportionate increase in IL-1beta over IL-1ra in the cervicovaginal secretions of pregnant women with altered vaginal microflora correlates with preterm birth. Am J Obstet Gynecol 2004, 190:1191-1197.
49. Genc M.R., Onderdonk A.B., Vardhana S., Delaney M.L., Norwitz E.R., Tuomala R.E., et al. Polymorphism in intron 2 of the interleukin-1 receptor antagonist gene, local midtrimester cytokine response to vaginal flora, and subsequent preterm birth. Am J Obstet Gynecol 2004, 191:1324-1330.
50. Fichorova R.N., Zhou F., Ratnam V., Atanassova V., Jiang S., Strick N., et al. Anti-human immunodeficiency virus type 1 microbicide cellulose acetate 1,2-benzenedicarboxylate in a human in vitro model of vaginal inflammation. Antimicrob Agents Chemother 2005, 49:323-335.
51. Trifonova R.T., Pasicznyk J.M., Fichorova R.N. Biocompatibility of solid-dosage forms of anti-human immunodeficiency virus type 1 microbicides with the human cervicovaginal mucosa modeled ex vivo. Antimicrob Agents Chemother 2006, 50:4005-4010.
52. Van Damme L., Govinden R., Mirembe F.M., Guedou F., Solomon S., Becker M.L., et al. Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med 2008, 359:463-472.
53. Halpern V., Ogunsola F., Obunge O., Wang C.-H., Onyejepu N., Oduyebo O., et al. PLoS ONE 2008, 3:e3784.
54. Mauck C.K., Doncel G.F. Biomarkers of semen in the vagina: applications in clinical trials of contraception and prevention of sexually transmitted pathogens including HIV. Contraception 2007, 75:407-419.
55. McCluggage W.G., Ganesan R., Hirschowitz L., Miller K., Rollason T.P. Ectopic prostatic tissue in the uterine cervix and vagina: report of a series with a detailed immunohistochemical analysis. Am J Surg Pathol 2006, 30:209-215.
56. Nucci M.R., Ferry J.A., Young R.H. Ectopic prostatic tissue in the uterine cervix: a report of four cases and review of ectopic prostatic tissue. Am J Surg Pathol 2000, 24:1224-1230.
57. Wallace C., Creager A.J., Cappellari J.O., Bergman S. Ectopic prostatic tissue in the uterine cerrix. Am J Surg Pathol 2001, 25:1215-1216.
58. Gargiulo A.R., Fichorova R.N., Politch J.A., Hill J.A., Anderson D.J. Detection of implantation-related cytokines in cervicovaginal secretions and peripheral blood of fertile women during ovulatory menstrual cycles. Fertil Steril 2004, 82(Suppl. 3):1226-1234.
59. Ryckman K.K., Simhan H.N., Krohn M.A., Williams S.M. Cervical cytokine network patterns during pregnancy: the role of bacterial vaginosis and geographic ancestry. J Reprod Immunol 2009, 79:174-182.
60. Ryckman K.K., Simhan H.N., Krohn M.A., Williams S.M. Predicting risk of bacterial vaginosis: the role of race, smoking and corticotropin-releasing hormone-related genes. Mol Hum Reprod 2009, 15:131-137.
61. Ryckman K.K., Williams S.M., Krohn M.A., Simhan H.N. Racial differences in cervical cytokine concentrations between pregnant women with and without bacterial vaginosis. J Reprod Immunol 2008, 78:166-171.
62. Simhan HN, Ryckman KK, Williams SM, Krohn MA. Genetic regulation of cervical antiinflammatory cytokine concentrations during pregnancy. Am J Obstet Gynecol 2008;199: 163 e161-163 e111.
63. Goepfert A.R., Varner M., Ward K., Macpherson C., Klebanoff M., Goldenberg R.L., et al. Differences in inflammatory cytokine and Toll-like receptor genes and bacterial vaginosis in pregnancy. Am J Obstet Gynecol 2005, 193:1478-1485.
64. Brydon L., Wright C.E., O'Donnell K., Zachary I., Wardle J., Steptoe A. Stress-induced cytokine responses and central adiposity in young women. Int J Obes (London) 2008, 32:443-450.