Delving into the Latest Updates on Hepatitis B vaccine(ICGEB) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Anti-HBV therapeutic vaccine, Hepatitis B vaccine, NASVAC

+ [3]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis B

Inactive Indication

Hepatitis B, Chronic

Originator Organization

International Centre for Genetic Engineering and Biotechnology (ICGEB)

Active Organization

ICGEB

Inactive Organization

Abivax SA

Drug Highest PhaseApproved

First Approval Date

CU (01 Jan 2015),

Hepatitis B

Regulation-

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Gene Sequence

Sequence Code 153750

Sequence Code 10035456

An open-level, randomized and treatment-controlled clinical trial has shown that a therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (NASVAC) is endowed with antiviral and liver protecting capacity and is safer than pegylated interferon (Peg-IFN) in patients with chronic hepatitis B (CHB). The present study provides information about the role of the hepatitis B virus (HBV) genotype in this phase III clinical trial. From a total of 160 patients enrolled in this trial, the HBV genotypes of 133 patients were characterized, and NASVAC induced a stronger antiviral effect (HBV DNA reduction below 250 copies per mL) than Peg-IFN. The antiviral effects and alanine aminotransferase levels were not significantly different among different HBV genotypes in NASVAC-treated patients. However, a significantly higher proportion of genotype-D patients receiving NASVAC showed better therapeutic effects, compared to genotype-D patients receiving Peg-IFN, with a marked difference of 44%. In conclusion, NASVAC seems to be a better alternative to Peg-IFN, especially in patients with HBV genotype-D patients. This reflects the attractiveness of NASVAC in countries where genotype D is highly prevalent. The mechanisms underlying the effect of HBV genotype are being studied in a new clinical trial.

01 Mar 2023·Hepatology research : the official journal of the Japan Society of Hepatology

Intranasal therapeutic vaccine containing HBsAg and HBcAg for patients with chronic hepatitis B; 18 months follow‐up results of phase IIa clinical study

Article

Author: Tsukiyama‐Kohara, Kyoko ; Shimizu, Masahito ; Tokumoto, Yoshio ; Yoshida, Osamu ; Aguilar, Julio Cesar ; Kamishita, Taizou ; Akbar, Sheikh Mohammad Fazle ; Miyazaki, Takashi ; Al Mahtab, Mamun ; Tsuge, Masataka ; Imai, Yusuke ; Sanada, Takahiro ; Guillen, Gerardo ; Hikita, Hayato ; Hiasa, Yoichi ; Miyake, Teruki ; Kohara, Michinori

Abstract:

Aims:

HBsAg loss with anti‐HBs acquisition is considered a functional cure and ideal treatment goal for patients with CHB. Our group have reported the efficacy of therapeutic vaccine with HBsAg and HBcAg (NASVAC) by intranasal and subcutaneous injection. In this study, we investigated the safety and efficacy of newly developed CVP‐NASVAC, which contained NASVAC with mucoadhesive carboxyl vinyl polymer (CVP) in the dedicated device.

Methods:

A single dose, open‐label, phase IIa clinical trial of CVP‐NASVAC was conducted. Patients with CHB treated with nucleoside/nucleotide analogs (NAs) and HBV carriers not undergoing anti‐HBV treatment were enrolled. CVP‐NASVAC was injected through the nose for, in total, 10 times. Participants were followed‐up for 18 months, and their HBsAg reduction and anti‐HBs induction assessed as endpoints.

Results:

Among the patients with CHB treated with NAs (n = 27) and HBV carriers without NAs (n = 36), 74.1% and 75.0% exhibited reductions in their baseline HBsAg, and the mean reductions were −0.1454 log10 IU/ml (p < 0.05) and −0.2677 log10 IU/ml (p < 0.05), respectively. Anti‐HBs antibody was detected in 40.7% and 58.3% of patients treated with and without NAs, respectively. Six of 71 (9.5%) patients were functionally cured after the CVP‐NASVAC treatment.

Conclusions:

Anti‐HBs induction and HBsAg reduction was observed after CVP‐NASVAC treatment in some patients with CHB. The CVP‐NASVAC is a safe treatment, which might expect to achieve functional cure for patients with CHB.

01 Mar 2023·Annals of hepatology

Impaired anti-HBV vaccine response in non-cirrhotic chronic HCV is not overcome by double dose regimen: randomized control trial

Article

Author: Zitelli, Patricia M ; Medeiros, Roseane P ; Oliveira, Claudia P ; Mazo, Daniel F ; Lopes, Marta H ; Terrault, Norah A ; Carrilho, Flair J ; Dodge, Jennifer ; Pessoa, Mário G

INTRODUCTION AND OBJECTIVES:

Some studies suggest chronic HCV infection diminishes responses to the anti-HBV vaccine. We evaluated the efficacy of double versus standard dose HBV vaccination among HCV patients without cirrhosis.

PATIENTS AND METHODS:

141 adults with untreated chronic HCV were randomized to HBV vaccination with double dose (40μg) or standard dose (20μg) at 0, 1 and 6 months; 70 healthy HCV-negative patients given standard dose served as controls. Vaccine response was defined by anti-HBs ≥10 mIU/mL.

RESULTS:

128 patients (60 double, 68 standard doses) completed the study. Patients were of median age 52 years, 61% female, 60% fibrosis <2 of 4, and 76% genotype 1 with median 6-log _{10 IU}/mL HCV RNA. Overall seroprotection rate was 76.7% (95% CI: 65-87) in the 40μg versus 73.5% (95% CI: 63-84) in the 20μg dose HCV-positive groups (p =0.68) and 91.2% (95%CI:84-99) in HCV-negative controls (p =0.011 and 0.003, respectively). In multivariate logistic regression, vaccine dose (double vs. standard dose) was not associated with vaccine response (OR=0.63, p =0.33). Of 32 HCV-infected patients who were non-responders to 3- doses, 25 received the fourth dose of vaccine. The fourth dose seroconversion rate for the 40μg and 20μg groups were 45.5% and 21.4%, respectively.

CONCLUSIONS:

In HCV-infected patients without cirrhosis, impaired responses to HBV vaccination cannot be overcome by the use of double dose HBV vaccination, but adding a fourth dose of vaccine for non-responders may be an effective strategy. Other adjuvant measures are needed to enhance seroconversion rates in these patients.

TRIAL REGISTER:

U 1111-1264-2343 (www.ensaiosclinicos.gov.br).

100 Deals associated with Hepatitis B vaccine(ICGEB)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07BC01	DB11627

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B	CU	-	01 Jan 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Phase 3	AU	Abivax SA	01 Dec 2014
Hepatitis B, Chronic	Phase 3	NZ	Abivax SA	01 Dec 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2023	Not Applicable	Hepatitis B, Chronic HBcAg-specific CTL	-	NASAL ADMINISTRATIVE THERAPEUTIC VACCINE	eftzjhtoef(zfraakspps) = kxkkrlbudt mpupiaobpn (qyouywkfjb ) View more	-	10 Nov 2023
				Nucleos(t)ide analogues (NAs)	eftzjhtoef(zfraakspps) = vaietmjosq mpupiaobpn (qyouywkfjb ) View more
JPRN-jRCTs061180100 (IRB#18EC003, EASL2020)	Not Applicable	Hepatitis B, Chronic HBsAg \| HBcAg \| anti-HBs ... View more	-	NASVAC	rygwkpybcx(rpnbushnmo) = akivilvrdg yhscfwapvp (feptrxlpzh )	Positive	27 Aug 2020
				Nucleos(t)ide analogs (NAs)	rygwkpybcx(rpnbushnmo) = hhqyfgllgn yhscfwapvp (feptrxlpzh )