The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans

Human Vaccines

Volumn 5, Issue 7, 2009, Pages 475-482

  Von Eschen, Kenneth ^a   Morrison, Royce ^b   Braun, Madeleine ^a   Ofori Anyinam, Opokua ^a   De Kock, Els ^a   Pavithran, Priya ^a   Koutsoukas, Marguerite ^a   Moris, Philippe ^a   Cain, Daniel ^a   Dubois, Marie Claude ^a   Cohen, Joe ^a   Ballou, W Ripley ^a,c  

^a GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^b Charles River Clinical Services Northwest Inc   (United States)

^c BILL AND MELINDA GATES FOUNDATION   (United States)

Author keywords

AS02A; Clinical trial; First time in human; Immunogenicity; Mtb32a; Mtb39a; Mtb72F; PPD negative; Safety; Tuberculosis vaccine

Indexed keywords

AS02A ADJUVANT; CD40 LIGAND; FERRITIN; GAMMA INTERFERON; IMMUNOLOGICAL ADJUVANT; INTERLEUKIN 2; RECOMBINANT PROTEIN MBT72F VACCINE; RECOMBINANT VACCINE; UNCLASSIFIED DRUG;

ADULT; AMINO TERMINAL SEQUENCE; ARTICLE; BACKACHE; BLOOD PRESSURE FLUCTUATION; BREATHING RATE; CARBOXY TERMINAL SEQUENCE; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENZYME LINKED IMMUNOSORBENT ASSAY; ENZYME LINKED IMMUNOSPOT ASSAY; EOSINOPHILIA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; IRON DEFICIENCY ANEMIA; MALAISE; MALE; MYALGIA; NAUSEA; NOSE CONGESTION; PHASE 1 CLINICAL TRIAL; PROTEIN DOMAIN; RIGOR; SIDE EFFECT; STAINING; VACCINATION;

EID: 70349551599     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.8570     Document Type: Article

References (23)

1. Sacksteder KA, Nacy CA. New tuberculosis vaccine development. Exp Opin Biol Ther 2002; 2:741-9.
2. Fine PE. Variation in protection by BCG: implications of and for heterologous immunity. Lancet 1995; 346:1339-45.
3. Chaisson RE, Martinson MA. Tuberculosis in Africa - Combating an HIV-Driven Crisis. N Engl J Med 2008; 358:1089-92.
4. Skeiky YA, Lodes MJ, Guderian JA, Mohamath R, Bement T, Alderson MR, et al. Cloning, expression and immunological evaluation of two putative secreted serine protease antigens of Mycobacterium tuberculosis. Infect Immun 1999; 67:3998-4007.
5. Garçon N, Chomez P, Van Mechelen M. GlaxoSmithKline Adjuvant Systems in vaccines: concepts; achievements and perspectives. Exp Rev Vaccines 2007; 6:723-39.
6. Skeiky YAW, Alderson MR, Ovendale PJ, Guderian JA, Brandt L, Dillon DC, et al. Differential immune response and protective efficacy induced by components of a tuberculosis polyprotein vaccine, Mtb72F, delivered as naked DNA or recombinant protein. J Immunol 2004; 172:7618-28.
7. Brandt L, Skeiky YA, Alderson MR, Lobet Y, Dalemans W, Turner OC, et al. The protective effect of the Mycobacterium bovis BCG vaccine is increased by coadministration with the Mycobacterium tuberculosis 72-kDa fusion polyprotein Mtb72F in M. tuberculosis-infected guinea pigs. Infect Immun 2004; 72:6622-32.
8. Tsenova L, Skeiky YAW, Ellison E, Dalemans W, Reed SG, et al. Anti-tuberculosis vaccine evaluation using a rabbit model. TB Vaccines for the World, Montreal, Canada 2003.
9. Reed SG, Coler RN, Dalemans W, Tan EV, Dela Cruz EC, Basaraba RJ, et al. Defined tuberculosis vaccine, Mtb72F/AS02A, evidence of protection in cynomolgus monkeys. Proc Natl Acad Sci USA 2009; Epub ahead of print: www.pnas.org/cgi/doi/10.1073/pnas.0712077106.
10. + T lymphocytes produce multiple cytokines and proliferate in vivo in humans. J Immunol 2006; 177:8185-90.
11. + T cell memory. Science 2002; 297:2060-3.
12. + T cells specific for defined antigens according to CD154 expression. Nat Med 2005; 11:1118-24.
13. Pearl JE, Saunders B, Ehlers S, Orme IM, Cooper AM. Inflammation and lymphocyte activation during mycobacterial infection in the interferon-gamma-deficient mouse. Cell Immunol 2001; 211:43-50.
14. Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, et al. Tuberculosis associated with infliximab, a tumor necrosis factor-α - neutralizing agent. N Engl J Med 2001; 345:1098-104.
15. Imperiali FG, Zaninoni A, La Maestra L, Tarsia P, Blasi F, Barcellini W. Increased Mycobacterium tuberculosis growth in HIV-1-infected human macrophages: role of tumour necrosis factor-α. Clin Exp Immunol 2001; 123:435-42.
16. Glatman-Freedman A, Casadevall A. Serum therapy for tuberculosis revisited: reappraisal of the role of antibody-mediated immunity against Mycobacterium tuberculosis. Clin Microbiol Rev 1998; 11:514-32.
17. Vandepapeliere P, Rehermann B, Koutsoukos M, Moris P, Gar&on N, Wettendorff M, Leroux-Roels G. A recombinant protein vaccine formulated with a strong novel adjuvant (AS02) can induce a CTL response in humans. Vaccine 2005; 23:2591-601.
18. Cancer Therapy Evaluation Program Common terminology criteria for AEs, Version 3.0, DCTD NCI, NIH, DHHS 2003; (http://ctep.cancer.gov), Publish Date 2003.
19. Maecker HT, Maino VC, Picker LJ. Immunofluorescence analysis of T-cell responses in health and disease. J Clin Immunol 2000; 20:391-9.
20. Maecker HT, Dunn HS, Suni MA, Khatamzas E, Pitcher CJ, Bunde T, et al. Use of overlapping peptide mixtures as antigens for cytokine flow cytometry. J Immunol Methods 2001; 255:27-40.
21. ElGhazali GE, Paulie S, Andersson G, Hansson Y, Holmquist G, Sun JB, et al. Number of interleukin-4- and interferon-gamma-secreting human T cells reactive with tetanus toxoid and the mycobacterial antigen PPD or phytohemagglutinin: distinct response profiles depending on the type of antigen used for activation. Eur J Immunol 1993; 23:2740-5.
22. Rodbard D, Frazier GR. Statistical analysis of radioligand assay data. Methods Enzymol 1975; 37:3-22.
23. Karpinski KF, Hayward S, Tryphonas H. Statistical considerations in the quantitation of serum immunoglobulin levels using the enzyme-linked immunosorbent assay (ELISA). J Immunol Methods 1987; 103:189-94.