The global roadmap for advancing development of vaccines against sexually transmitted infections: Update and next steps

Vaccine

Volumn 34, Issue 26, 2016, Pages 2939-2947

  Gottlieb, Sami L ^a   Deal, Carolyn D ^b   Giersing, Birgitte ^a   Rees, Helen ^c   Bolan, Gail ^d   Johnston, Christine ^e   Timms, Peter ^f   Gray Owen, Scott D ^g   Jerse, Ann E ^h   Cameron, Caroline E ⁱ   Moorthy, Vasee S ^a   Kiarie, James ^a   Broutet, Nathalie ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

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

^c UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^d CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^e UNIVERSITY OF WASHINGTON   (United States)

^f UNIVERSITY OF THE SUNSHINE COAST   (Australia)

^g UNIVERSITY OF TORONTO   (Canada)

^h UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES   (United States)

ⁱ UNIVERSITY OF VICTORIA   (Canada)

Author keywords

Roadmap; Sexually transmitted infections; STI vaccine development; Vaccines

Indexed keywords

SEXUALLY TRANSMITTED DISEASE VACCINE; UNCLASSIFIED DRUG; VACCINE;

ARTICLE; CHLAMYDIA TRACHOMATIS; HERPES SIMPLEX VIRUS; HUMAN; INCIDENCE; NEISSERIA GONORRHOEAE; PREVALENCE; PRIORITY JOURNAL; SEXUALLY TRANSMITTED DISEASE; TREPONEMA PALLIDUM; VACCINATION; CHLAMYDIA INFECTIONS; GONORRHEA; HERPES SIMPLEX; MEDICAL RESEARCH; SEXUALLY TRANSMITTED DISEASES; SYPHILIS; TRENDS;

BIOMEDICAL RESEARCH; CHLAMYDIA INFECTIONS; GONORRHEA; HERPES SIMPLEX; HUMANS; SEXUALLY TRANSMITTED DISEASES; SYPHILIS; VACCINES;

EID: 84965134111     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.03.111     Document Type: Article

References (76)

1. Newman L., Rowley J., Vander Hoorn S., Wijesooriya N., Unemo M., Low N., et al. Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLOS ONE 2015, 10:e0143304.
2. Looker K.J., Magaret A.S., Turner K.M., Vickerman P., Gottlieb S.L., Newman L.M. Global estimates of prevalent and incident herpes simplex virus type 2 infections in 2012. PLOS ONE 2015, 10:e114989.
3. Looker K.J., Magaret A.S., May M.T., Turner K.M., Vickerman P., Gottlieb S.L., et al. Global and regional estimates of prevalent and incident herpes simplex virus type 1 infections in 2012. PLOS ONE 2015, 10:e0140765.
4. Newman L., Kamb M., Hawkes S., Gomez G., Say L., Seuc A., et al. Global estimates of syphilis in pregnancy and associated adverse outcomes: analysis of multinational antenatal surveillance data. PLOS Med 2013, 10:e1001396.
5. GLOBOCAN: International Agency for Research on Cancer. Cervical cancer: estimated incidence, mortality and prevalence worldwide in 2012 2012, http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx [accessed 10.03.16].
6. Brunham R.C., Gottlieb S.L., Paavonen J. Pelvic inflammatory disease. N Engl J Med 2015, 372:2039-2048.
7. Westrom L., Joesoef R., Reynolds G., Hagdu A., Thompson S.E. Pelvic inflammatory disease and fertility. A cohort study of 1,844 women with laparoscopically verified disease and 657 control women with normal laparoscopic results. Sex Transm Dis 1992, 19:185-192.
8. Freeman E.E., Weiss H.A., Glynn J.R., Cross P.L., Whitworth J.A., Hayes R.J. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS 2006, 20:73-83.
9. Gottlieb S.L., Low N., Newman L.M., Bolan G., Kamb M., Broutet N. Toward global prevention of sexually transmitted infections (STIs): the need for STI vaccines. Vaccine 2014, 32:1527-1535.
10. Gottlieb S.L., Xu F., Brunham R.C. Screening and treating Chlamydia trachomatis genital infection to prevent pelvic inflammatory disease: interpretation of findings from randomized controlled trials. Sex Transm Dis 2013, 40:97-102.
11. Kirkcaldy R.D., Bolan G.A., Wasserheit J.N. Cephalosporin-resistant gonorrhea in North America. JAMA 2013, 309:185-187.
12. Low N., Broutet N., Adu-Sarkodie Y., Barton P., Hossain M., Hawkes S. Global control of sexually transmitted infections. Lancet 2006, 368:2001-2016.
13. Sexually transmitted infections: vaccine development for global health. Vaccine 2014, 32:1523-1640.
14. Broutet N., Fruth U., Deal C., Gottlieb S.L., Rees H. Vaccines against sexually transmitted infections: the way forward. Vaccine 2014, 32:1630-1637. Participants of the STI Vaccine Technical Consultation.
15. Dodet B. Current barriers, challenges and opportunities for the development of effective STI vaccines: point of view of vaccine producers, biotech companies and funding agencies. Vaccine 2014, 32:1624-1629.
16. Global Burden of Disease Study 2013 Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015, 386:743-800.
17. GBD 2013 Mortality and Causes of Death Collaborators Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015, 385:117-171.
18. Morrison C.S., Chen P.L., Kwok C., Baeten J.M., Brown J., Crook A.M., et al. Hormonal contraception and the risk of HIV acquisition: an individual participant data meta-analysis. PLOS Med 2015, 12:e1001778.
19. Alsallaq R.A., Schiffer J.T., Longini I.M., Wald A., Corey L., Abu-Raddad L.J. Population level impact of an imperfect prophylactic vaccine for herpes simplex virus-2. Sex Transm Dis 2010, 37:290-297.
20. Freeman E.E., White R.G., Bakker R., Orroth K.K., Weiss H.A., Buve A., et al. Population-level effect of potential HSV2 prophylactic vaccines on HIV incidence in sub-Saharan Africa. Vaccine 2009, 27:940-946.
21. Garnett G.P. The theoretical impact of vaccines that protect against sexually transmitted infections and disease. Vaccine 2014, 32(14):1536-1542.
22. Press release: The Bill & Melinda Gates Foundation to fund disease surveillance network in Africa and Asia to prevent childhood mortality and help prepare for the next epidemic 2015, http://www.gatesfoundation.org/Media-Center/Press-Releases/2015/05/Child-Health-and-Mortality-Prevention-Surveillance-Network [accessed 10.03.16].
23. Owusu-Edusei K., Chesson H.W., Gift T.L., Brunham R.C., Bolan G. Cost-effectiveness of Chlamydia vaccination programs for young women. Emerg Infect Dis 2015, 21:960-968.
24. Knipe D.M., Corey L., Cohen J.I., Deal C.D. Summary and recommendations from a National Institute of Allergy and Infectious Diseases (NIAID) workshop on "Next Generation Herpes Simplex Virus Vaccines". Vaccine 2014, 32:1561-1562.
25. World Health Organization WHO preferred product characteristics 2014, http://www.who.int/immunization/research/vaccine_preferred_product_characteristics/en/ [accessed 10.03.16].
26. World Health Organization WHO preferred product characteristics (PPC) for malaria vaccines 2014, WHO, Geneva, Switzerland, http://apps.who.int/iris/bitstream/10665/149822/1/WHO_IVB_14.09_eng.pdf [accessed 10.03.16].
27. Johnston C., Gottlieb S.L., Wald A. Status of vaccine research and development of vaccines for herpes simplex virus. Vaccine 2016, [in this issue].
28. Masese L., Baeten J.M., Richardson B.A., Bukusi E., John-Stewart G., Graham S.M., et al. Changes in the contribution of genital tract infections to HIV acquisition among Kenyan high-risk women from 1993 to 2012. AIDS 2015, 29:1077-1085.
29. Belshe R.B., Leone P.A., Bernstein D.I., Wald A., Levin M.J., Stapleton J.T., et al. Efficacy results of a trial of a herpes simplex vaccine. N Engl J Med 2012, 366:34-43.
30. Bernstein D.I., Bellamy A.R., Hook E.W., Levin M.J., Wald A., Ewell M.G., et al. Epidemiology, clinical presentation, and antibody response to primary infection with herpes simplex virus type 1 and type 2 in young women. Clin Infect Dis 2013, 56:344-351.
31. Belshe R.B., Heineman T.C., Bernstein D.I., Bellamy A.R., Ewell M., van der Most R., et al. Correlate of immune protection against HSV-1 genital disease in vaccinated women. J Infect Dis 2014, 209:828-836.
32. Bernard M.-C., Barban V., Pradezynski F., de Montfort A., Ryall R., Caillet C., et al. Immunogenicity, protective efficacy, and non-replicative status of the HSV-2 vaccine candidate HSV529 in mice and guinea pigs. PLOS ONE 2015, 10:e0121518.
33. de Bruyn G., Vargas-Cortez M., Warren T., Tyring S.K., Fife K.H., Lalezari J., et al. A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects. Vaccine 2006, 24:914-920.
34. Agyemang A.E., Magaret A.S., Selke S., Johnston C., Corey L., Wald A. HSV shedding: biomarker for disease severity and response to antivirals 2015, ID Week 2015, San Diego, CA.
35. Wald A., Bernstein D., Fife K., Lee P., Tyring S., Van Wagoner N., et al. Novel therapeutic vaccine for genital herpes reduces genital HSV-2 shedding. 53rd Interscience conference on antimicrobial agents and chemotherapy 2013.
36. Dutton J.L., Li B., Woo W.-P., Marshak J.O., Xu Y., Huang M.-L., et al. A novel DNA vaccine technology conveying protection against a lethal herpes simplex viral challenge in mice. PLOS ONE 2013, 8:e76407.
37. ®-adjuvanted HSV-2 plasmid DNA vaccine is effective for prophylactic and therapeutic use in the guinea pig model of genital herpes. Vaccine 2012, 30:7046-7051.
38. Kolb A.W., Larsen I.V., Cuellar J.A., Brandt C.R. Genomic, phylogenetic, and recombinational characterization of herpes simplex virus 2 strains. J Virol 2015, 89:6427-6434.
39. Newman R.M., Lamers S.L., Weiner B., Ray S.C., Colgrove R.C., Diaz F., et al. Genome sequencing and analysis of geographically diverse clinical isolates of herpes simplex virus 2. J Virol 2015, 89:8219-8232.
40. Szpara M.L., Gatherer D., Ochoa A., Greenbaum B., Dolan A., Bowden R.J., et al. Evolution and diversity in human herpes simplex virus genomes. J Virol 2014, 88:1209-1227.
41. Lamers S.L., Newman R.M., Laeyendecker O., Tobian A.A., Colgrove R.C., Ray S.C., et al. Global diversity within and between human herpesvirus 1 and 2 glycoproteins. J Virol 2015, 89:8206-8218.
42. Cairns T.M., Huang Z.-Y., Gallagher J.R., Lin Y., Lou H., Whitbeck J.C., et al. Patient-specific neutralizing antibody responses to herpes simplex virus are attributed to epitopes on gD, gB, or both and can be type specific. J Virol 2015, 89:9213-9231.
43. Zhu J., Peng T., Johnston C., Phasouk K., Kask A.S., Klock A., et al. Immune surveillance by CD8αα+ skin-resident T cells in human herpes virus infection. Nature 2013, 497:494-497.
44. Wang Y., Kahane S., Cutcliffe L.T., Skilton R.J., Lambden P.R., Clarke I.N. Development of a transformation system for Chlamydia trachomatis: restoration of glycogen biosynthesis by acquisition of a plasmid shuttle vector. PLoS Pathog 2011, 7:e1002258.
45. Huang Y., Zhang Q., Yang Z., Conrad T., Liu Y., Zhong G. Plasmid-encoded Pgp5 is a significant contributor to Chlamydia muridarum induction of hydrosalpinx. PLOS ONE 2015, 10:e0124840.
46. Kokes M., Dunn J.D., Granek J.A., Nguyen B.D., Barker J.R., Valdivia R.H., et al. Integrating chemical mutagenesis and whole-genome sequencing as a platform for forward and reverse genetic analysis of Chlamydia. Cell Host Microbe 2015, 17:716-725.
47. Nguyen B., Valdivia R. A chemical mutagenesis approach to identify virulence determinants in the obligate intracellular pathogen Chlamydia trachomatis. Methods Mol Biol 2014, 1197:347-358.
48. Nguyen B.D., Valdivia R.H. Forward genetic approaches in Chlamydia trachomatis. J Vis Exp 2013, e50636.
49. Chen J., Yang Z., Sun X., Tang L., Ding Y., Xue M., et al. Intrauterine infection with plasmid-free Chlamydia muridarum reveals a critical role of the plasmid in chlamydial ascension and establishes a model for evaluating plasmid-independent pathogenicity. Infect Immun 2015, 83:2583-2592.
50. Kari L., Whitmire W.M., Olivares-Zavaleta N., Goheen M.M., Taylor L.D., Carlson J.H., et al. A live-attenuated chlamydial vaccine protects against trachoma in nonhuman primates. J Exp Med 2011, 208:2217-2223.
51. Qu Y., Frazer L.C., O'Connell C.M., Tarantal A.F., Andrews C.W., O'Connor S.L., et al. Comparable genital tract infection, pathology, and immunity in rhesus macaques inoculated with wild-type or plasmid-deficient Chlamydia trachomatis serovar D. Infect Immun 2015, 83:4056-4067.
52. Boje S., Olsen A.W., Erneholm K., Agerholm J.S., Jungersen G., Andersen P., et al. A multi-subunit Chlamydia vaccine inducing neutralizing antibodies and strong IFN-gamma CMI responses protects against a genital infection in minipigs. Immunol Cell Biol 2015, 94:185-195.
53. Statens Serum Institut Chlamydia vaccine research 2016, http://www.ssi.dk/English/RandD/Research%20areas/Vaccines/Chlamydia%20Vaccine%20Research.aspx [accessed 10.03.16].
54. Stary G., Olive A., Radovic-Moreno A.F., Gondek D., Alvarez D., Basto P.A., et al. VACCINES. A mucosal vaccine against Chlamydia trachomatis generates two waves of protective memory T cells. Science 2015, 348:aaa8205.
55. Jerse A.E. Experimental gonococcal genital tract infection and opacity protein expression in estradiol-treated mice. Infect Immun 1999, 67:5699-5708.
56. Liu Y., Islam E.A., Jarvis G.A., Gray-Owen S.D., Russell M.W. Neisseria gonorrhoeae selectively suppresses the development of Th1 and Th2 cells, and enhances Th17 cell responses, through TGF-beta-dependent mechanisms. Mucosal Immunol 2012, 5:320-331.
57. Liu Y., Egilmez N.K., Russell M.W. Enhancement of adaptive immunity to Neisseria gonorrhoeae by local intravaginal administration of microencapsulated IL-12. J Infect Dis 2013, 208:1821-1829.
58. Stupiansky N.W., Van Der Pol B., Williams J.A., Weaver B., Taylor S.E., Fortenberry J.D. The natural history of incident gonococcal infection in adolescent women. Sex Transm Dis 2011, 38:750-754.
59. Ezewudo M.N., Joseph S.J., Castillo-Ramirez S., Dean D., Del Rio C., Didelot X., et al. Population structure of Neisseria gonorrhoeae based on whole genome data and its relationship with antibiotic resistance. PeerJ 2015, 3:e806.
60. McClure R., Nudel K., Massari P., Tjaden B., Su X., Rice P.A., et al. The gonococcal transcriptome during infection of the lower genital tract in women. PLOS ONE 2015, 10:e0133982.
61. Hobbs M.M., Anderson J.E., Balthazar J.T., Kandler J.L., Carlson R.W., Ganguly J., et al. Lipid A's structure mediates Neisseria gonorrhoeae fitness during experimental infection of mice and men. MBio 2013, 4:e00892-e913.
62. Lawn J.E., Blencowe H., Waiswa P., Amouzou A., Mathers C., Hogan D., et al. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet 387, 2016, 587-603.
63. D'Angelo-Scott H, Cutler J, Friedman D, Hendriks A, Jolly AM. Social networkinvestigation of a syphilis outbreak in Ottawa, Ontario. Can J Infect Dis MedMicrobiol 2015;26:268-72.
64. Mayor S. Syphilis and gonorrhoea increase sharply in England. BMJ2015;350:h3457.
65. Read P, Fairley CK, Chow EP. Increasing trends of syphilis among men who havesex with men in high income countries. Sex Health 2015;12:155-63.
66. Centurion-Lara A, Castro C, Barrett L, Cameron C, Mostowfi M, Van VoorhisWC, et al. Treponema pallidum major sheath protein homologue Tpr K is atarget of opsonic antibody and the protective immune response. J Exp Med1999;189:647-56.
67. Centurion-Lara A, Giacani L, Godornes C, Molini BJ, Brinck Reid T, Lukehart SA.Fine analysis of genetic diversity of the tpr gene family among treponemalspecies, subspecies and strains. PLoS Negl Trop Dis 2013;7:e2222.
68. Centurion-Lara A, Godornes C, Castro C, Van Voorhis WC, Lukehart SA. The tprKgene is heterogeneous among Treponema pallidum strains and has multiplealleles. Infect Immun 2000;68:824-31.
69. Giacani L, Molini BJ, Kim EY, Godornes BC, Leader BT, Tantalo LC, et al. Anti-genic variation in Treponema pallidum: TprK sequence diversity accumulatesin response to immune pressure during experimental syphilis. J Immunol2010;184:3822-9.
70. Cameron CE, Brouwer NL, Tisch LM, Kuroiwa JM. Defining the interactionof the Treponema pallidum adhesin Tp0751 with laminin. Infect Immun2005;73:7485-94.
71. Houston S, Hof R, Francescutti T, Hawkes A, Boulanger MJ, Cameron CE.Bifunctional role of the Treponema pallidum extracellular matrix bindingadhesin Tp0751. Infect Immun 2011;79:1386-98.
72. Houston S, Hof R, Honeyman L, Hassler J, Cameron CE. Activation and pro-teolytic activity of the Treponema pallidum metalloprotease, pallilysin. PLoSPathog 2012;8:e1002822.
73. Houston S, Taylor JS, Denchev Y, Hof R, Zuerner RL, Cameron CE. Conserva-tion of the host-interacting proteins Tp0750 and pallilysin among treponemesand restriction of proteolytic capacity to Treponema pallidum. Infect Immun2015;83:4204-16.
74. Cejkova D, Strouhal M, Norris SJ, Weinstock GM, Smajs D. A retrospectivestudy on genetic heterogeneity within Treponema strains: subpopulations aregenetically distinct in a limited number of positions. PLoS Negl Trop Dis2015;9:e0004110.
75. Nechvatal L, Petrosova H, Grillova L, Pospisilova P, Mikalova L, Strnadel R, et al.Syphilis-causing strains belong to separate SS14-like or Nichols-like groupsas defined by multilocus analysis of 19 Treponema pallidum strains. Int J MedMicrobiol 2014;304:645-53.
76. Fernandez-Romero JA, Deal C, Herold BC, Schiller J, Patton D, Zydowsky T, et al.Multipurpose prevention technologies: the future of HIV and STI protection.Trends Microbiol 2015;23:429-36.