Safety, tolerability, and immunogenicity of the novel antituberculous vaccine RUTI: Randomized, placebo-controlled phase II clinical trial in patients with latent tuberculosis infection

PLoS ONE

Volumn 9, Issue 2, 2014, Pages

  Nell, Andre S ^a   D'Lom, Eva ^a   Bouic, Patrick ^b   Sabaté, Montserrat ^c   Bosser, Ramon ^d   Picas, Jordi ^e   Amat, Mercè ^e   Churchyard, Gavin ^f   Cardona, Pere Joan ^e,g  

^a PAREXEL INTERNATIONAL   (United States)

^b Stellenbosch University Synexa Life Sciences   (South Africa)

^c TFS Develop   (Spain)

^d Janus Development SL   (Spain)

^e Archivel Farma   (Spain)

^f AURUM INSTITUTE   (South Africa)

^g UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL VACCINE; ISONIAZID; PLACEBO; RUTI VACCINE; UNCLASSIFIED DRUG; BCG VACCINE;

ADULT; ANTIGENICITY; ARTICLE; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HOSPITALIZATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMORAL IMMUNITY; IMMUNOGENICITY; INFECTION; INFESTATION; INJECTION SITE ABSCESS; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE NODULE; INJECTION SITE PAIN; INJECTION SITE SWELLING; INJECTION SITE ULCER; INJURY; INOCULATION; LATENT TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RETINA DETACHMENT; RHINOPHARYNGITIS; SELF REPORT; SKIN DISEASE; SOFT TISSUE DISEASE; THORAX DISEASE; VASCULAR DISEASE; CLINICAL TRIAL; COMPLICATION; FOLLOW UP; HUMAN IMMUNODEFICIENCY VIRUS; IMMUNOLOGY; ISOLATION AND PURIFICATION; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MULTICENTER STUDY; PROGNOSIS; SAFETY; VACCINATION; VIROLOGY;

ADULT; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HIV; HIV INFECTIONS; HUMANS; LATENT TUBERCULOSIS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; SAFETY; TUBERCULOSIS VACCINES; VACCINATION;

EID: 84896278047     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0089612     Document Type: Article

References (22)

1. World Health Organization. Global tuberculosis control: epidemiology s, financing: WHO report 2011.
2. Parrish NM, Dick JD, Bishai WR (1998) Mechanisms of latency in Mycobacterium tuberculosis. Trends Microbiol 6: 107-112. (Pubitemid 28123330)
3. Harris A MD, Graham. (2004) TB/HIV a clinical manual. 2nd Edition. WHO.
4. Comstock GW (1999) How much isoniazid is needed for prevention of tuberculosis among immunocompetent adults? Int J Tuberc Lung Dis 3: 847-850.
5. Cardona PJ (2010) Revisiting the natural history of tuberculosis. The inclusion of constant reinfection, host tolerance, and damage-response frameworks leads to a better understanding of latent infection and its evolution towards active disease. Arch Immunol Ther Exp (Warsz) 58: 7-14.
6. Cardona PJ (2006) RUTI: a new chance to shorten the treatment of latent tuberculosis infection. Tuberculosis (Edinb) 86: 273-289.
7. Cardona PJ (2009) A dynamic reinfection hypothesis of latent tuberculosis infection. Infection 37: 80-86.
8. Vilaplana C, Montane E, Pinto S, Barriocanal AM, Domenech G, et al. (2010) Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI. Vaccine 28: 1106-1116.
9. Hoft DF, Blazevic A, Abate G, Hanekom WA, Kaplan G, et al. (2008) A new recombinant bacille Calmette-Guerin vaccine safely induces significantly enhanced tuberculosis-specific immunity in human volunteers. J Infect Dis 198: 1491-1501.
10. van Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, et al. (2010) Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine 28: 3571-3581.
11. van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, et al. (2011) Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine 29: 2100-2109.
12. Giralt M, Domingo P, Villarroya F (2011) Adipose tissue biology and HIV-infection. Best Pract Res Clin Endocrinol Metab 25: 487-499.
13. Von Eschen K, Morrison R, Braun M, Ofori-Anyinam O, De Kock E, et al. (2009) The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans. Hum Vaccin 5: 475-482.
14. Castro P, Plana M, Gonzalez R, Lopez A, Vilella A, et al. (2009) Influence of a vaccination schedule on viral load rebound and immune responses in successfully treated HIV-infected patients. AIDS Res Hum Retroviruses 25: 1249-1259.
15. Agger EM, Andersen P (2001) Tuberculosis subunit vaccine development: on the role of interferon-gamma. Vaccine 19: 2298-2302. (Pubitemid 32234231)
16. Kaufmann SH, Baumann S, Nasser Eddine A (2006) Exploiting immunology and molecular genetics for rational vaccine design against tuberculosis. Int J Tuberc Lung Dis 10: 1068-1079. (Pubitemid 44519343)
17. Flynn JL (2004) Immunology of tuberculosis and implications in vaccine development. Tuberculosis (Edinb) 84: 93-101.
18. Hanekom WA, Dockrell HM, Ottenhoff TH, Doherty TM, Fletcher H, et al. (2008) Immunological outcomes of new tuberculosis vaccine trials: WHO panel recommendations. PLoS Med 5: e145.
19. Lin PL, Dietrich J, Tan E, Abalos RM, Burgos J, et al. The multistage vaccine H56 boosts the effects of BCG to protect cynomolgus macaques against active tuberculosis and reactivation of latent Mycobacterium tuberculosis infection. J Clin Invest 122: 303-314.
20. Guirado E, Gil O, Caceres N, Singh M, Vilaplana C, et al. (2008) Induction of a specific strong polyantigenic cellular immune response after short-term chemotherapy controls bacillary reactivation in murine and guinea pig experimental models of tuberculosis. Clin Vaccine Immunol 15: 1229-1237.
21. Hawkridge T, Scriba TJ, Gelderbloem S, Smit E, Tameris M, et al. (2008) Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in healthy adults in South Africa. J Infect Dis 198: 544-552.
22. Sander CR, Pathan AA, Beveridge NE, Poulton I, Minassian A, et al. (2009) Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in Mycobacterium tuberculosis-infected individuals. Am J Respir Crit Care Med 179: 724-733.