Delving into the Latest Updates on Recombinant hepatitis B vaccine(Shenzhen Kangtai Biological Products Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Genetically engineered subunit vaccine

Synonyms

Recombinant Hepatitis B Vaccine (Saccharomyces cerevisiae)

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis B

Inactive Indication-

Originator Organization

Shenzhen Kangtai Biological Products Co., Ltd.

Active Organization

Shenzhen Kangtai Biological Products Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 1998),

Hepatitis B

Regulation-

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CONTEXTAlternative schedules are needed to provide greater immunogenicity in adults who fail to respond to the standard hepatitis B (HB) vaccine regimen.OBJECTIVETo evaluate the immunogenicity and safety of high antigen content HB vaccine formulations administered to non-responders after routine primary vaccination.DESIGN SETTING, AND PARTICIPANTSThis was a phase III, double-blind, controlled clinical trial in China. We enrolled healthy participants (16-60 years old) seronegative for HB surface (HBs) antigen after primary vaccination, who had HBs antibody (anti-HBs) titres <10 mIU/ml at 28 days following routine vaccination with licensed HB vaccine containing 10 μg of antigen. Participants were randomised (2:2:1) to receive three booster doses of HB vaccine formulations containing 60 μg, 30 μg or 10 μg of antigen per dose 28 days apart. Blood samples were obtained pre-vaccination and 28 days after each dose to assess immunogenicity. Reactogenicity and safety were evaluated up to 28 days after each vaccine dose.RESULTSSeroconversion rates were ≥ 92.1% and ≥ 87.1% as from the second dose of the 60 μg and 30 μg HB vaccine formulations, respectively, with geometric mean concentrations (GMCs) of ≥ 286.0 mIU/ml and ≥ 164.0 mIU/ml. In the 10 μg HB vaccine group the seroconversion rates were ≥ 83.0% and the GMCs ≥ 110.1 mIU/ml as from the second vaccine dose. All HB vaccine formulations were well tolerated: 352/1091 (32.3%) participants reported at least one injection-site or systemic adverse reaction (145/434 [33.4%] from the 60μg group; 138/435 [31.7%] from the 30 μg group and 69/222 [31.1%] from the 10 μg group). Most reactions were mild or moderate and resolved within 24h. No serious adverse events were reported.CONCLUSIONBooster vaccination with a three-dose schedule of a high antigen content HB vaccine formulation was immunogenic and well tolerated in healthy adults. Clinicaltrialsgov Identifier: NCT01203319.

01 Apr 2009·Zhongguo yi miao he mian yi

[Immunoreaction levels of revaccination in healthy population with hepatitis B vaccine].

Article

Author: Huang, Zhen-Yu ; Mao, Dong-Bo ; Zhu, Jian-Qiong

OBJECTIVETo observe and compare the immunoreaction levels of revaccination with different hepatitis B vaccine in healthy population of different age groups.METHODSMulti-stage random sampling method was used, 2 to 4 years old, 6 to 8 years old, 13 to 15 years old and 16 to 40 years old healthy people had been sampled in five towns according to different district. Screened those people's HBV serologic markers by ELISA, the person whose HBV serologic markers were all negative and had been vaccinated three doses of hepatitis B vaccine would be the revaccination recipients. Six kinds of recombinant Hepatitis B vaccine (yeast-derived or CHO cells) with 5 microg, 10 microg and 20 microg were used for the recipients on a 0-1-6 month schedule.RESULTSSuccessful rates of revaccination and the median of antibody levels (mIU/ml) in the recipients were 94.34% and 226.53 in 5 microg yeast-derived vaccine group, 86.46% and 175.36 in 10 microg yeast-derived vaccine group, 97.39% and 331.44 in 10 microg CHO cells vaccine group, 91.30% and 439.01 in 10 microg Hansenula yeast-derived vaccine group, 99.20% and 386.66 in 20 microg CHO cells vaccine group, 89.04% and 372.97 in 20 microg yeast-derived vaccine group, 98.25% and 353.42 in 2 to 4 years old group, 96.80% and 320.31 in 6 to 8 years old group, 94.67% and 262.12 in 13 to 15 years old group, 87.76% and 305.24 in 16 to 40 years old group.CONCLUSIONAge, vaccine and dose were the most important factors to affect the immunoreaction levels of revaccination. There was an age-specific decline in immunogenicity, the immunoreaction levels of revaccination will be improved by changing vaccine.

01 Aug 1993·Infection Control & Hospital EpidemiologyQ4 · MEDICINE

Efficacy of Immunization with a Combination of Serum and Recombinant Hepatitis B Vaccines

Q4 · MEDICINE

Article

Author: Pearl, W ; Ortiz, A A ; Pearl, K K

AbstractObjective:To evaluate the efficacy of giving a third dose of recombinant hepatitis B vaccine to healthcare workers who already had received two doses of serum-derived vaccine, which is no longer available in the United States.Design:Volunteers who already had received two standard doses of serum-derived vaccine were given a third dose of either serum or recombinant vaccine in a double-blind fashion. Antibodies to hepatitis B surface antigen were measured at the time of the third immunization, three months later, and one year after the third immunization.Setting:U.S. Army Medical Center, El Paso, Texas.Patients:One hundred healthy healthcare workers.Results:Three months after receiving the third immunization, the serum vaccine group had significantly higher titers than the recombinant vaccine group (P= 0.018). One year after receiving the third immunization, those who received the combined regimen had a mean hepatitis B surface antibody titer less than half that of those who received three doses of serum-derived vaccine. However, both regimens resulted in titers that are considered to confer immunity.Conclusions:A regimen that combines serum and recombinant hepatitis B vaccines may not produce as high an antibody level as three doses of the same vaccine. Those who began immunization with serum vaccine and concluded with recombinant vaccine should be monitored for an accelerated drop in serum antibodies.

100 Deals associated with Recombinant hepatitis B vaccine(Shenzhen Kangtai Biological Products Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Recombinant hepatitis B vaccine(Shenzhen Kangtai Biological Products Co., Ltd.)	J07BC01	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hepatitis B	China	Shenzhen Kangtai Biological Products Co., Ltd.	01 Jan 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Preclinical	-	Shenzhen Kangtai Biological Products Co., Ltd.	01 Nov 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01203319 (CTgov)	Phase 2/3	Hepatitis B	1,091	60mcg/1.0ml recombinant hepatitis B vaccine (60mcg/1.0ml Recombinant Hepatitis B Vaccine)	wfdueeipeu(ufirepsdqn) = kimyqusqan nevqybjpza (vceifsqjhk, ffdoroyfgw - ixrtafutwm) View more	-	23 Apr 2012
				30mcg/1.0ml recombinant hepatitis B vaccine (30mcg/1.0ml Recombinant Hepatitis B Vaccine)	wfdueeipeu(ufirepsdqn) = wluytsgsfj nevqybjpza (vceifsqjhk, ayjvfhpstz - rqsjxdzucl) View more