Last update 21 Nov 2024

Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Havax

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis A

Inactive Indication-

Originator Organization

The Company for Vaccine & Biological Production No. 1

Active Organization

The Company for Vaccine & Biological Production No. 1

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

100 Clinical Results associated with Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

100 Translational Medicine associated with Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

100 Patents (Medical) associated with Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

Literatures (Medical) associated with Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

01 Dec 2004·The Southeast Asian journal of tropical medicine and public healthQ4 · MEDICINE

Field performance of VAQTA (inactivated, purified hepatitis a vaccine) in Chinese children in Jiangsu.

Q4 · MEDICINE

Article

Author: Lu, W ; Gress, Jacqueline ; Chen, Zhixian ; Wang, Hua ; Chen, X ; Eves, Karen ; Kuter, Barbara ; Poerschke, Gabriele

In Jiangsu, 30% of children between the ages of 5 and 8 years test seropositive for hepatitis A. The safety, tolerability, and immunogenicity of a 2-dose regimen (0, 6 months) of VAQTA (0.5 ml of 25U) administered IM in 50 healthy children aged 5 to 8 years without prior serological screening was evaluated. Blood samples were collected prior to the first dose and after each additional dose of VAQTA to determine the initial anti-HAV serostatus and response rates to the vaccine. Twelve children (24%) were initially seropositive and 38 (76%) were initially seronegative. Four weeks after the primary dose of VAQTA, 34 of the 38 subjects (89.5%, 95% CI 75 to 97) were anti-HAV seropositive. The geometric mean titer was 33.1 mIU/ml (95% CI 22.4 to 49.0). After the booster dose at 6 months, all the subjects were seropositive (37/37), giving a seroconversion of 100% (95% CI: 90, 100). The geometric mean titer was 7585.8 mIU/ml (95% CI: 5623.4 to 10,471.3). Adverse experiences were generally mild and transient. Results of this study are consistent with results from a previous double-blind randomized trial of this vaccine and confirm that VAQTA is highly immunogenic, and generally well-tolerated.

13 Aug 1992·New England Journal of MedicineQ1 · MEDICINE

A Controlled Trial of a Formalin-Inactivated Hepatitis A Vaccine in Healthy Children

Q1 · MEDICINE

Article

Author: Kuter, Barbara ; Sitrin, Robert ; Shouval, Daniel ; Werzberger, Alan ; Mensch, Barbara ; Miller, William ; Wiens, Brian ; Calandra, Gary ; Lewis, John ; Provost, Philip ; Ryan, John ; Nalin, David ; Brown, Leora

BACKGROUNDAlthough inactivated hepatitis A vaccine is known to be well tolerated and immunogenic in healthy children and adults, its efficacy has yet to be established.METHODSTo evaluate the efficacy of the hepatitis A vaccine in protecting against clinically apparent disease, we conducted a double-blind, placebo-controlled trial in an Hasidic Jewish community in upstate New York that has had recurrent outbreaks of hepatitis A. At the beginning of a summer outbreak, 1037 healthy seronegative children 2 to 16 years of age were randomly assigned to receive one intramuscular injection of a highly purified, formalin-inactivated hepatitis A vaccine or placebo. A case was defined by the presence of typical signs and symptoms, a diagnostic increase in IgM antibody to hepatitis A, and a serum concentration of alanine aminotransferase at least twice the upper limit of normal. Cases occurring greater than or equal to 50 days after the injection were included in the evaluation of efficacy. The children were followed for a mean of 103 days.RESULTSA total of 519 children received vaccine, and 518 received placebo. The vaccine was well tolerated, with no serious adverse reactions. From day 50 after the injection, 25 cases of clinically apparent hepatitis A occurred in the placebo group and none in the vaccine group (P less than 0.001), confirming that the vaccine had 100 percent protective efficacy. Before day 21, seven cases occurred in the vaccine group and three cases in the placebo group. After that time, there were no cases among vaccine recipients and 34 cases among placebo recipients.CONCLUSIONSThe inactivated purified hepatitis A vaccine that we tested is well tolerated, and a single dose is highly protective against clinically apparent hepatitis A.

100 Deals associated with Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis A	VN	The Company for Vaccine & Biological Production No. 1	-

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Hepatitis A Vaccine, Purified Inactivated(Vabiotech)

Overview

Basic Info

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R&D Status

Clinical Result

Translational Medicine

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