A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults

Journal of Infectious Diseases

Volumn 206, Issue 8, 2012, Pages 1280-1290

  Leroux Roels, Isabel ^a   Leroux Roels, Geert ^a   Clement, Frédéric ^a   Vandepapelière, Pierre ^b   Vassilev, Ventzislav ^c   Ledent, Edouard ^c   Heineman, Thomas C ^d  

^a GHENT UNIVERSITY HOSPITAL   (Belgium)

^b Neovacs SA   (France)

^c GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^d GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLYCOPROTEIN E; LIVE VACCINE; SUBUNIT VACCINE; VARICELLA ZOSTER VACCINE;

ADULT; AGED; ARTICLE; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CHILL; CONTROLLED STUDY; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FLU LIKE SYNDROME; GASTROINTESTINAL DISEASE; HERPES ZOSTER; HUMAN; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALE; MYALGIA; OPEN STUDY; PARALLEL DESIGN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN REDNESS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VACCINATION; VESICULAR RASH;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; ANTIBODIES, VIRAL; CD4-POSITIVE T-LYMPHOCYTES; CHICKENPOX VACCINE; DRUG TOXICITY; FEMALE; GLYCOPROTEINS; HERPES ZOSTER; HERPESVIRUS 3, HUMAN; HUMANS; MALE; MIDDLE AGED; VACCINATION; VACCINES, SUBUNIT; VIRAL STRUCTURAL PROTEINS; YOUNG ADULT;

EID: 84866916280     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jis497     Document Type: Article

References (33)

1. Gershon AA, Gershon MD, Breuer J, Levin MJ, Oaklander AL, Griffiths PD. Advances in the understanding of the pathogenesis and epidemiology of herpes zoster. J Clin Virol 2010; 48(Suppl 1):S2-7.
2. Johnson RW. Herpes zoster and postherpetic neuralgia. Expert Rev Vaccines 2010; 9:21-6.
3. Oxman MN, Levin MJ. Vaccination against herpes zoster and postherpetic neuralgia. J Infect Dis 2008; 197(Suppl 2):S228-36. (Pubitemid 351590176)
4. Yawn BP, Wollan PC, Kurland MJ, St Sauver JL, Saddier P. Herpes zoster recurrences more frequent than previously reported. Mayo Clin Proc 2011; 86:88-93.
5. Oxman MN. Zoster vaccine: current status and future prospects. Clin Infect Dis 2010; 51:197-213.
6. Oxman MN, Gershon AA, Poland GA. Zoster vaccine recommendations: the importance of using a clinically valid correlate of protection. Vaccine 2011; 29:3625-7.
7. McElhaney JE. Prevention of infectious diseases in older adults through immunization: the challenge of the senescent immune response. Expert Rev Vaccines 2009; 8:593-606.
8. Levin MJ, Gershon AA, Dworkin RH, Brisson M, Stanberry L. Prevention strategies for herpes zoster and post-herpetic neuralgia. J Clin Virol 2010; 48(Suppl 1):S14-9.
9. Gelb LD. Reducing the incidence and severity of herpes zoster and PHN with zoster vaccination. J Am Osteopath Assoc 2009; 109: S18-21.
10. Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005; 352:2271-84.
11. Tseng HF, Smith N, Harpaz R, Bialek SR, Sy LS, Jacobsen SJ. Herpes zoster vaccine in older adults and the risk of subsequent herpes zoster disease. JAMA 2011; 305:160-6.
12. Levin MJ, Oxman MN, Zhang JH, et al. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis 2008; 197:825-35. (Pubitemid 351417005)
13. Clark TG, Cassidy-Hanley D. Recombinant subunit vaccines: potentials and constraints. Dev Biol (Basel) 2005; 121:153-63. (Pubitemid 41717534)
14. Arvin AM, Kinney-Thomas E, Shriver K, et al. Immunity to varicellazoster viral glycoproteins, gp I (gp 90/58) and gp III (gp 118), and to a nonglycosylated protein, p 170. J Immunol 1986; 137:1346-51.
15. Brunell PA, Novelli VM, Keller PM, Ellis RW. Antibodies to the three major glycoproteins of varicella-zoster virus: search for the relevant host immune response. J Infect Dis 1987; 156:430-5. (Pubitemid 17139383)
16. Grose C. Glycoproteins encoded by varicella-zoster virus: biosynthesis, phosphorylation, and intracellular trafficking. Annu Rev Microbiol 1990; 44:59-80.
17. Harper DR, Kangro HO, Heath RB. Antibody responses in recipients of varicella vaccine assayed by immunoblotting. J Med Virol 1990; 30:61-7. (Pubitemid 20041474)
18. Jacquet A, Haumont M, Massaer M, et al. Immunogenicity of a recombinant varicella-zoster virus gE-IE63 fusion protein, a putative vaccine candidate against primary infection and zoster reactivation. Vaccine 2002; 20:1593-602. (Pubitemid 34169800)
19. Garcon N, Chomez P, Van Mechelen M. GlaxoSmithKline Adjuvant Systems in vaccines: concepts, achievements and perspectives. Expert Rev Vaccines 2007; 6:723-39. (Pubitemid 47607848)
20. Vandepapeliere P, Horsmans Y, Moris P, et al. Vaccine adjuvant systems containing monophosphoryl lipid A and QS21 induce strong and persistent humoral and T cell responses against hepatitis B surface antigen in healthy adult volunteers. Vaccine 2008; 26:1375-86.
21. Coffman RL, Sher A, Seder RA. Vaccine adjuvants: putting innate immunity to work. Immunity 2010; 33:492-503.
22. Kester KE, Cummings JF, Ofori-Anyinam O, et al. Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS, S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis 2009; 200: 337-46.
23. Leroux-Roels I, Koutsoukos M, Clement F, et al. Strong and persistent CD4+ T-cell response in healthy adults immunized with a candidate HIV-1 vaccine containing gp120, Nef, and Tat antigens formulated in three Adjuvant Systems. Vaccine 2010; 28:7016-24.
24. Haumont M, Jacquet A, Massaer M, et al. Purification, characterization and immunogenicity of recombinant varicella-zoster virus glycoprotein gE secreted by Chinese hamster ovary cells. Virus Res 1996; 40:199-204.
25. Moris P, van der Most R, Leroux-Roels I, et al. H5N1 influenza vaccine formulated with AS03 A induces strong cross-reactive and polyfunctional CD4 T-cell responses. J Clin Immunol 2011; 31: 443-54.
26. Asanuma H, Sharp M, Maecker HT, Maino VC, Arvin AM. Frequencies of memory T cells specific for varicella-zoster virus, herpes simplex virus, and cytomegalovirus by intracellular detection of cytokine expression. J Infect Dis 2000; 181:859-66. (Pubitemid 30194466)
27. Weinberg A, Zhang JH, Oxman MN, et al. Varicella-zoster virusspecific immune responses to herpes zoster in elderly participants in a trial of a clinically effective zoster vaccine. J Infect Dis 2009; 200:1068-77.
28. Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, et al. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ≥60 years of age. Vaccine 2012; 30:904-10.
29. Trannoy E, Berger R, Hollander G, et al. Vaccination of immunocompetent elderly subjects with a live attenuated Oka strain of varicella zoster virus: a randomized, controlled, dose-response trial. Vaccine 2000; 18:1700-6. (Pubitemid 30109532)
30. Asante KP, Abdulla S, Agnandji S, Lyimo J, Vekemans J, Soulanoudjingar S, et al. Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. Lancet ID 2011; 11:741-9.
31. Van Braeckel E, Bourguignon P, Koutsoukos M, Clement F, Janssens MCaarletti I, et al. An adjuvanted polyprotein HIV-1 vaccine induces polyfunctional cross-reactive CD4+ T cell responses in seronegative volunteers. Clin Infect Dis 2011; 52:522-31.
32. Leroux-Roels I, Forgus S, De Boever F, Clement F, Demoitié MA, Mettens P, et al. Improved CD4(+) T cell responses to Mycobacterium tuberculosis in PPD-negative adults by M72/AS01 as compared to the M72/AS02 and Mtb72F/AS02 tuberculosis candidate vaccine formulations: A randomized trial. Vaccine 2012; [Epub ahead of print].
33. Insinga RP, Itzler RF, Pellisier JM, Saddier P, Nikas AA. The incidence of herpes zoster in a United States administrative database. J Gen Intern Med 2005; 20:748-53. (Pubitemid 41141008)