Evaluation of a novel vaccine (HVJ–liposome/HSP65 DNA + IL-12 DNA) against tuberculosis using the cynomolgus monkey model of TB

Okada, Masaji; Kita, Yoko; Nakajima, Takeshi; Kanamaru, Noriko; Hashimoto, Satomi; Nagasawa, T; Kaneda, Yasufumi; Yoshida, Shigeto; Nishida, Yasuko; Fukamizu, Reiko; Tsunai, Yoshie; Inoue, Ruriko; Nakatani, Hitoshi; Namie, Yumi; Yamada, Jun; Takao, Katsuyuki; Asai, Ritsuko; Asaki, Ryoko; Matsumoto, Makoto; McMurray, David N.; Cruz, Eduardo Canteiro; Tan, Esterlina V.; Abalos, Rodolfo M.; Burgos, Jasmin; Gelber, Robert H.; Sakatani, Mitsunori

doi:10.1016/j.vaccine.2007.01.014

Cited by 49 publications

(41 citation statements)

References 6 publications

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“…Previous studies in which TB vaccine candidates have been evaluated for efficacy in rhesus macaques have ended at a fixed point, 8 to 17 weeks after either aerosol (1,2,3,14,26) or intratracheal (15, 31) challenge. Longer-term studies of vaccine efficacy with postchallenge investigation periods in excess of 16 weeks have been conducted with cynomolgus macaques (22,23,25). In the latter studies, survival after challenge has provided a readout of vaccine efficacy, although only one of the four efficacy studies reported (21) was sufficiently long to allow the entire unvaccinated group to progress to end-stage disease, i.e., not survive the challenge.…”

Section: Discussionmentioning

confidence: 99%

Establishment of an Aerosol Challenge Model of Tuberculosis in Rhesus Macaques and an Evaluation of Endpoints for Vaccine Testing

Sharpe

McShane

Dennis

et al. 2010

Clin Vaccine Immunol

121

167

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The establishment of an aerosol challenge model in nonhuman primates (NHPs) for the testing of vaccines against Mycobacterium tuberculosis would assist the global effort to optimize novel vaccination strategies. The endpoints used in preclinical challenge studies to identify measures of disease burden need to be accurate and sensitive enough to distinguish subtle differences and benefits afforded by different tuberculosis (TB) vaccine regimens when group sizes are inevitably small. This study sought to assess clinical and nonclinical endpoints as potentially sensitive measures of disease burden in a challenge study with rhesus macaques by using a new protocol of aerosol administration of M. tuberculosis. Immunological and clinical readouts were assessed for utility in vaccine evaluation studies. This is the first example of TB vaccine evaluation with rhesus macaques where long-term survival was one of the primary endpoints. However, we found that in NHP vaccine efficacy studies with maximum group sizes of six animals, survival did not provide a valuable endpoint. Two approaches used in human clinical trials for the evaluation of the gamma interferon (IFN-␥) response to vaccination (enzyme-linked immunospot [ELISpot] assay and enzyme-linked immunosorbent assay [ELISA])were included in this study. The IFN-␥ profiles induced following vaccination were found not to correlate with protection, nor did the level of purified protein derivative (PPD)-specific proliferation. The only readout to reliably distinguish vaccinated and unvaccinated NHPs was the determination of lung lesion burden using magnetic resonance (MR) imaging combined with stereology at the end of the study. Therefore, the currently proposed key markers were not shown to correlate with protection, and only imaging offered a potentially reliable correlate.Tuberculosis (TB) is a reemerging infectious disease and is responsible for nearly 2 million deaths and 9 million new cases each year (36). The global TB pandemic has been exacerbated by the emergence of drug-resistant strains of Mycobacterium tuberculosis, which render treatment less effective, and by the HIV epidemic, where coinfection with HIV greatly increases the risk of reactivation of latent TB and susceptibility to active TB disease.The most effective means of controlling this global epidemic would be by prophylactic immunization. Mycobacterium bovis bacille Calmette-Guérin (BCG), the only licensed TB vaccine, is administered to neonates in high-risk populations as part of the WHO Expanded Programme on Immunization. BCG consistently protects against TB meningitis and disseminated TB in childhood (27,30), but its efficacy wanes with time, and it affords only variable protection against pulmonary disease (10). A new, more effective TB vaccine is a major global health priority and is an important part of the WHO STOP TB partnership strategy.A large international effort is under way to develop a more effective vaccine. The leading TB vaccine development strategy involves vaccination with BCG followe...

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Section: Discussionmentioning

confidence: 99%

Establishment of an Aerosol Challenge Model of Tuberculosis in Rhesus Macaques and an Evaluation of Endpoints for Vaccine Testing

Sharpe

McShane

Dennis

et al. 2010

Clin Vaccine Immunol

121

167

View full text Add to dashboard Cite

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“…A series of subsequent investigations were dedicated to macaque research to assess novel TB vaccines and drugs, as well as to gain an understanding of the pathogenesis of M. tuberculosis infection and reactivation. Figures 2 and 3 abridge the RM (13,(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43) and CM (10,15,25,(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59) models of experimental M. tuberculosis infection after the Golden Age, from 2001 to 2014.…”

Section: Historical Outlook On Macaque Modelsmentioning

confidence: 99%

“…Between 2005 and 2012, three reported studies using CM models evaluated the efficacy of TB vaccines that had been tested previously with smaller animal models, including guinea pigs and mice (44,45). The first project evaluated the efficacy of the 72f recombinant BCG vaccine and HASP65 plus interleukin-12 (IL-12)/HVJ vaccine (44), which another team of investigators also tested later in Osaka, Japan (45). Both research investigations showed that the recombinant BCG vaccines were more effective than BCG alone.…”

Section: Specific Macaque Models Of Tbmentioning

confidence: 99%

Monkey Models of Tuberculosis: Lessons Learned

Peña

2015

Infect Immun

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bThe use of animal models has been invaluable for studying the pathogenesis of Mycobacterium tuberculosis infection, as well as for testing the efficacy of vaccines and drug regimens for tuberculosis. Among the applied animal models, nonhuman primates, particularly macaques, share the greatest anatomical and physiological similarities with humans. As such, macaque models have been used for investigating tuberculosis pathogenesis and preclinical testing of drugs and vaccines. This review focuses on published major studies which illustrate how the rhesus and cynomolgus macaques have enriched and may continue to advance the field of global tuberculosis research.

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“…A DNA vaccine combination expressing mycobacterial Hsp65 and IL-12 provided high degree of protection against TB (Okada et al, 2007). The vaccine was delivered by the hemagglutinating virus of Japan (HVJ)-envelope and liposome.…”

Section: Hsps In Vaccine Development Against Tbmentioning

confidence: 99%

“…The vaccine was delivered by the hemagglutinating virus of Japan (HVJ)-envelope and liposome. This vaccine provided remarkable protection in mice and monkeys compared to the BCG vaccine, demonstrating the potential of Hsps to be used in vaccine development (Okada, 2006;Okada et al, 2007;Okada et al, 2009). A prime-boost strategy was investigated in cattle, using a combination of three DNA vaccines coding for Hsp65, Hsp70, and another mycobacterial protein Apa for priming, followed by a boost with BCG prior to experimental challenge with virulent M. bovis (Skinner et al, 2003).…”

Section: Hsps In Vaccine Development Against Tbmentioning

confidence: 99%

Heat Shock Proteins in Mycobacterium tuberculosis: Involvement in Survival and Virulence of the Pathogen

Bajaj¹,

Batra²

2012

Understanding Tuberculosis - Deciphering the Secret Life of the Bacilli

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Evaluation of a novel vaccine (HVJ–liposome/HSP65 DNA + IL-12 DNA) against tuberculosis using the cynomolgus monkey model of TB

Cited by 49 publications

References 6 publications

Establishment of an Aerosol Challenge Model of Tuberculosis in Rhesus Macaques and an Evaluation of Endpoints for Vaccine Testing

Establishment of an Aerosol Challenge Model of Tuberculosis in Rhesus Macaques and an Evaluation of Endpoints for Vaccine Testing

Monkey Models of Tuberculosis: Lessons Learned

Heat Shock Proteins in Mycobacterium tuberculosis: Involvement in Survival and Virulence of the Pathogen

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