Phase IIb trial of in vivo electroporation mediated dual-plasmid hepatitis B virus DNA vaccine in chronic hepatitis B patients under lamivudine therapy

doi:10.3748/wjg.v23.i2.306

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Jan 14, 2017 (publication date) through Sep 8, 2024

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Clinical Trials Study

World J Gastroenterol. Jan 14, 2017; 23(2): 306-317
Published online Jan 14, 2017. doi: 10.3748/wjg.v23.i2.306

Table 1 Characteristics of the modified intent-to-treat population

Characteristic	Vacc. (n = 107)	Ctr. (n = 115)	P value
Demographics
Age, median (IQR)	28.9 (23.1-37.1)	29.3 (24.0-35.4)	0.950
Male sex, n (%)	86 (78.9)	86 (74.1)	0.400
Weight (kg), median (IQR)	62.5 (56.0-70.0)	63.0 (56.0-70.0)	0.907
Genotype B, n (%)	42/107 (39.3)	39/115 (33.9)	0.409
Week 0 laboratory results
ALT (IU/L), median (IQR)	119.0 (94.0-167.5)	136.0 (102.6-195.3)	0.066
HBV DNA (log₁₀ IU/mL), median (IQR)	8.1 (7.7-8.3)	8.1 (7.5-8.4)	0.953²
HBeAg (COI), median (IQR)	852.0 (223.5-1093.0)	926.6 (508.5-1076.0)	0.197²
HBsAg (IU/mL), median (IQR)	10261.0 (3953.0-24089.0)	8637.0 (2748.0-24436.0)	0.754²
Week 12 laboratory results¹
HBV DNA (log₁₀ IU/mL), median (IQR)	3.5 (2.6-4.5)	3.4 (2.6-4.6)	0.754²
HBeAg (COI), median (IQR)	147.4 (15.6-650.0)	45.9 (11.9-1011.0)	0.605²
HBsAg (IU/mL) median (IQR)	4072.0 (1608.0-8514.0)	3023.5 (1167.0-11194.0)	0.460²

¹The time point when the injection of study agent started;

²Analyzed with Wilcoxon Rank Sum test. mITT: Modified intent-to-treat; LAM: Lamivudine; IQR: Interquartile ranges; ALT: Alanine aminotransferase; COI: Semi-quantification by S/CO [the signal value ratio of sample (S) to the control (CO)]; Vacc.: LAM + vaccine arm; Ctr.: LAM + placebo arm.

Citation: Yang FQ, Rao GR, Wang GQ, Li YQ, Xie Y, Zhang ZQ, Deng CL, Mao Q, Li J, Zhao W, Wang MR, Han T, Chen SJ, Pan C, Tan DM, Shang J, Zhang MX, Zhang YX, Yang JM, Chen GM. Phase IIb trial of in vivo electroporation mediated dual-plasmid hepatitis B virus DNA vaccine in chronic hepatitis B patients under lamivudine therapy. World J Gastroenterol 2017; 23(2): 306-317
URL: https://www.wjgnet.com/1007-9327/full/v23/i2/306.htm
DOI: https://dx.doi.org/10.3748/wjg.v23.i2.306