A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers

Jang, Hee-Chang; Kim, Choong Jong; Kim, Kye Hyoung; Lee, Kwang-Hee; Byun, Young-Ho; Seong, Baik-Lin; Saletti, Giulietta; Czerkinsky, Cécil; Park, Wan Beom; Park, Sang-Won; Kim, Hong Bin; Kim, Nam Joong; Oh, Myoung‐don

doi:10.1016/j.vaccine.2010.06.063

Cited by 12 publications

(8 citation statements)

References 19 publications

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“…Lyophilized virus, given at two different doses in >100 subjects, showed a 99% take rate and cellular immunogenicity similar to that of other second-generation (tissue-culture based live) smallpox vaccines with one possible case of generalized vaccinia [112]. Further phase III studies conducted in Korea showed similar immune responses, and no occurrence of severe AEs [113].…”

Section: Contemporary Vaccinesmentioning

confidence: 91%

Defending against smallpox: a focus on vaccines

Voigt

Kennedy

Poland

2016

Expert Review of Vaccines

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Smallpox has shaped human history, from the earliest human civilizations well into the 20th century. With high mortality rates, rapid transmission, and serious long-term effects on survivors, smallpox was a much-feared disease. The eradication of smallpox represents an unprecedented medical victory for the lasting benefit of human health and prosperity. Concerns remain, however, about the development and use of the smallpox virus as a biological weapon, which necessitates the need for continued vaccine development. Smallpox vaccine development is thus a much-reviewed topic of high interest. This review focuses on the current state of smallpox vaccines and their context in biodefense efforts.

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Section: Contemporary Vaccinesmentioning

confidence: 91%

Defending against smallpox: a focus on vaccines

Voigt

Kennedy

Poland

2016

Expert Review of Vaccines

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“…A third cell-culture derived VACV vaccine based on NYCBH has been studied in humans, called CJ-50300 [67,68]. The vaccine was derived by passaging a strain of NYCBH (ATCC VR-118) in MRC-5 cells without plaque purification [68].…”

Section: Cj-50300mentioning

confidence: 99%

“…The second trial was a randomized, double-blind trial of two dilutions of CJ-50300 (1 × 10 8 and 1 × 10 7 PFU/ml) at a 2:1 ratio [67]. Almost all volunteers had a successful take with one vaccination: 81 of 82 (98.7%) in the 1 × 10 8 group and 100% in the 1 × 10 7 group [67].…”

Section: Cj-50300mentioning

confidence: 99%

“…Almost all volunteers had a successful take with one vaccination: 81 of 82 (98.7%) in the 1 × 10 8 group and 100% in the 1 × 10 7 group [67]. Seroconversion rates were 99 and 100%, respectively, and cell-mediated immune responses as measured by ELISpot were not statistically different between the two groups [67]. There were no differences in AEs between the groups, and no SAEs were reported.…”

Section: Cj-50300mentioning

confidence: 99%

“…There were no differences in AEs between the groups, and no SAEs were reported. However, a woman in the 1 × 10 8 group had an exanthem that raised a concern for possible generalized vaccinia, but the lesions were culture negative [67]. A Phase III open-label, single-arm trial of CJ-50300 in VACV-naive volunteers is ongoing [203].…”

Section: Cj-50300mentioning

confidence: 99%

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Vaccinia viruses: vaccines against smallpox and vectors against infectious diseases and tumors

Walsh

Dolin

2011

Expert Review of Vaccines

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Less than 200 years after its introduction, widespread use of vaccinia virus (VACV) as a smallpox vaccine has eradicated variola virus. Along with the remarkable success of the vaccination program, frequent and sometimes severe adverse reactions to VACV were encountered. After eradication, VACV has been reserved for select populations who might be at significant risk for orthopoxvirus infections. Events over the past decade have renewed concerns over the potential use of variola virus as a biological weapon. Accordingly, interest in VACV and attenuated derivatives has increased, both as vaccines against smallpox and as vectors for other vaccines. This article will focus on new developments in the field of orthopoxvirus immunization and will highlight recent advances in the use of vaccinia viruses as vectors for infectious diseases and malignancies.

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