Methodological Issues in Sampling the Local Immune System of the Female Genital Tract in the Context of HIV Prevention Trials

American Journal of Reproductive Immunology

Volumn 65, Issue 3, 2011, Pages 368-376

  Jespers, Vicky ^a   Francis, Suzanna C ^b   Van De Wijgert, Janneke ^c   Crucitti, Tania ^a  

^a INSTITUTE OF TROPICAL MEDICINE   (Belgium)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

Clinical trials; HIV; HIV prevention; Microbicides; Mucosal immunology

Indexed keywords

ANTIGEN PRESENTING CELL; CELLULAR IMMUNITY; CLINICAL TRIAL (TOPIC); FEMALE; FEMALE GENITAL SYSTEM; FLOW CYTOMETRY; HERPES SIMPLEX VIRUS 2; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; IMMUNE SYSTEM; MUCOSAL IMMUNITY; PRIORITY JOURNAL; RECTUM BIOPSY; REVIEW; T LYMPHOCYTE; UTERINE CERVIX BIOPSY; VAGINA DISCHARGE; VAGINA FLORA; VAGINAL LAVAGE; VAGINAL MUCOSAL IMMUNITY; VIRUS TRANSMISSION;

ADMINISTRATION, INTRAVAGINAL; ANTI-HIV AGENTS; ANTI-INFECTIVE AGENTS, LOCAL; CLINICAL TRIALS AS TOPIC; FEMALE; HIV INFECTIONS; HUMANS; IMMUNITY, MUCOSAL; LACTOBACILLUS; VAGINA;

EID: 79551645529     PISSN: 10467408     EISSN: 16000897     Source Type: Journal    
DOI: 10.1111/j.1600-0897.2010.00938.x     Document Type: Review

References (34)

1. Anderson DJ, Politch JA, Nadolski AM, Blaskewicz CD, Pudney J, Mayer KH: Targeting Trojan Horse leukocytes for HIV prevention. AIDS 2010; 24:163-187.
2. Iqbal SM, Kaul R: Mucosal Innate Immunity as a Determinant of HIV Susceptibility. Am J Reprod Immunol 2008; 59:44-54.
3. Hillier SL: The vaginal microbial ecosystem and resistance to HIV. AIDS Res Hum Retroviruses 1998; 14(Suppl 1):S17-S21.
4. Thurman AR, Doncel GF: Innate immunity and inflammatory response to Trichomonas vaginalis and bacterial vaginosis: relationship to HIV acquisition. Am J Reprod Immunol 2010; Jul 30. [Epub ahead of print].
5. Ward H, Ronn M: Contribution of sexually transmitted infections to the sexual transmission of HIV. Curr Opin HIV AIDS 2010; 5:305-310.
6. UNAIDS/WHO: AIDS Epidemic Update. December 2009. Joint United Nations Programme on HIV/AIDS and World Health Organization. UNAIDS/05 19E, 2005, Geneva, 2009.
7. Karim QA: Effectiveness of 1% tenofovir vaginal microbicide gel in South African women: results of the CAPRISA 004 trial. Oral abstract TUSS0502 2010.
8. Karim QA, Karim SSA, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany ABM, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D and on behalf of the CAPRISA 004 Trial Group: Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Sci Exp Published Online 19 July 2010 Science DOI: 10 1126/science 1193748 2010.
9. Buchbinder SP, Mehrotra DV, Duerr A, Fitzgerald DW, Mogg R, Li D, Gilbert PB, Lama JR, Marmor M, Del Rio C, McElrath MJ, Casimiro DR, Gottesdiener KM, Chodakewitz JA, Corey L, Robertson MN: Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 2008; 372:1881-1893.
10. McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R, Buchbinder SP, Robertson MN, Mehrotra DV, Self SG, Corey L, Shiver JW, Casimiro DR: HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 2008; 372:1894-1905.
11. Jespers V, Harandi AM, Hinkula J, Medaglini D, Le Grand R, Stahl-Hennig C, Bogers W, El Habib R, Wegmann F, Fraser C, Cranage M, Shattock RJ, Spetz AL: Assessment of mucosal immunity to HIV-1. Expert Rev Vaccines 2010; 9:381-394.
12. van de Wijgert J, Altini L, Jones H, de Kock A, Young T, Williamson AL, Hoosen A, Coetzee N: Two methods of self-sampling compared to clinician sampling to detect reproductive tract infections in Gugulethu, South Africa. Sex Transm Dis 2006; 33:516-523.
13. Boskey ER, Moench TR, Hees PS, Cone RA: A self-sampling method to obtain large volumes of undiluted cervicovaginal secretions. Sex Transm Dis 2003; 30:107-109.
14. Gok M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, Voorhorst F, Belien JA, Babovic M, Snijders PJ, Meijer CJ: HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ 2010; 340:c1040.
15. Brink AA, Meijer CJ, Wiegerinck MA, Nieboer TE, Kruitwagen RF, van Kemenade F, Fransen Daalmeijer N, Hesselink AT, Berkhof J, Snijders PJ: High concordance of results of testing for human papillomavirus in cervicovaginal samples collected by two methods, with comparison of a novel self-sampling device to a conventional endocervical brush. J Clin Microbiol 2006; 44:2518-2523.
16. Jones HE, Wiegerinck MA, Nieboer TE, Mol BW, Westhoff CL: Women in the Netherlands prefer self-sampling with a novel lavaging device to clinician collection of specimens for cervical cancer screening. Sex Transm Dis 2008; 35:916-917.
17. Cohen CR, Moscicki AB, Scott ME, Ma Y, Shiboski S, Bukusi E, Daud I, Rebbapragada A, Brown J, Kaul R: Increased levels of immune activation in the genital tract of healthy young women from sub-Saharan Africa. AIDS 2010; 24:2069-2074.
18. Jespers VA, Van Roey JM, Beets GI, Buve AM: Dose-ranging phase 1 study of TMC120, a promising vaginal microbicide, in HIV-negative and HIV-positive female volunteers. J Acquir Immune Defic Syndr 2007; 44:154-158.
19. Kashuba A: Do systemic and genital tract tenofovir concentrations predict HIV seroconversion in the CAPRISA 004 tenofovir gel trial? Oral abstract TUSS0503. Oral abstract TUSS0503 2010.
20. Richardson-Harman N, Lackman-Smith C, Fletcher PS, Anton PA, Bremer JW, Dezzutti CS, Elliott J, Grivel JC, Guenthner P, Gupta P, Jones M, Lurain NS, Margolis LB, Mohan S, Ratner D, Reichelderfer P, Roberts P, Shattock RJ, Cummins JE Jr: Multisite comparison of anti-human immunodeficiency virus microbicide activity in explant assays using a novel endpoint analysis. J Clin Microbiol 2009; 47:3530-3539.
21. Belec L, Meillet D, Levy M, Georges A, Tevi-Benissan C, Pillot J: Dilution assessment of cervicovaginal secretions obtained by vaginal washing for immunological assays. Clin Diagn Lab Immunol 1995; 2:57-61.
22. Fichorova RN, Richardson-Harman N, Alfano M, Belec L, Carbonneil C, Chen S, Cosentino L, Curtis K, Dezzutti CS, Donoval B, Doncel FG, Donaghay M, Grivel JC, Guzman E, Hayes M, Herold B, Hillier S, Lackman-Smith C, Landay A, Margolis L, Mayer KH, Pasicznyk JM, Pallansch-Cokonis M, Poli G, Reichelderfer P, Roberts P, Rodriguez I, Saidi H, Sassi RR, Shattock R, Cummins JE Jr: 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.
23. Ryckman KK, Simhan HN, Krohn MA, Williams SM: Cervical cytokine network patterns during pregnancy: the role of bacterial vaginosis and geographic ancestry. J Reprod Immunol 2009; 79:174-182.
24. Wira CR, Fahey JV, Ghosh M, Patel MV, Hickey DK, Ochiel DO: Sex hormone regulation of innate immunity in the female reproductive tract: the role of epithelial cells in balancing reproductive potential with protection against sexually transmitted pathogens. Am J Reprod Immunol 2010; 63:544-565.
25. Gill N, Davies EJ, Ashkar AA: The role of toll-like receptor ligands/agonists in protection against genital HSV-2 infection. Am J Reprod Immunol 2008; 59:35-43.
26. Delany S, Rosas R, Mlaba N, Clayton T, Akpomiemie G, Legoff J, Capovilla A, Belec L, Stevens W, Mayaud P: Comparison of cervicovaginal lavage, cervicovaginal lavage enriched with cervical swab, and vaginal tampon for the detection of HIV-1 RNA and HSV-2 DNA in genital secretions. J Acquir Immune Defic Syndr 2008; 49:406-409.
27. Mehra V, Musib R, Schito ML: Towards developing standardized protocols for evaluation of cellular mucosal immune responses - recommendations from a DAIDS/NIH workshop, June 15-16, 2009. Vaccine 2010; 28:4689-4694.
28. Kloverpris H, Fomsgaard A, Handley A, Ackland J, Sullivan M, Goulder P: Dimethyl sulfoxide (DMSO) exposure to human peripheral blood mononuclear cells (PBMCs) abolish T cell responses only in high concentrations and following coincubation for more than two hours. J Immunol Methods 2010; 356:70-78.
29. Oishi K, Noguchi H, Yukawa H, Miyazaki T, Kato R, Kitagawa Y, Ueda M, Hayashi S: Cryopreservation of mouse adipose tissue-derived stem/progenitor cells. Cell Transplant 2008; 17:35-41.
30. Anderson DJ, Pudney J, Schust DJ: Caveats associated with the use of human cervical tissue for HIV and microbicide research. AIDS 2010; 24:1-4.
31. Cohen CR, Plummer FA, Mugo N, Ma Y, Shiboski S, Bukusi E, Daud I, Rebbapragada A, Brown J, Kaul R: Increased interleukin-10 in the the endocervical secretions of women with non-ulcerative sexually transmitted diseases: a mechanism for enhanced HIV-1 transmission? AIDS 1999; 13:327-332.
32. Keller MJ, Herold BC: Impact of microbicides and sexually transmitted infections on mucosal immunity in the female genital tract. Am J Reprod Immunol 2006; 56:356-363.
33. Franklin RD, Kutteh WH: Characterization of immunoglobulins and cytokines in human cervical mucus: influence of exogenous and endogenous hormones. J Reprod Immunol 1999; 42:93-106.
34. Mehta S, Giovannucci E, Mugusi FM, Spiegelman D, Aboud S, Hertzmark E, Msamanga GI, Hunter D, Fawzi WW: Vitamin D status of HIV-infected women and its association with HIV disease progression, anemia, and mortality. PLoS ONE 2010; 5:e8770.