Rabies vaccine

Rabies Vaccine (human diploid cell) for Human Use, freeze-dried - HDCV

Rabies is a viral zoonosis with great harm. It has the highest fatality rate (100 %) in history. Rabies has a long history and has long been described and recorded in ancient Egypt and the Spring and Autumn Period in China.

Rabies is popular in most countries among the world. The World Health Organization estimates that 55,000 people worldwide died of rabies annually, 99 % of which occur in developing countries, while Asia is the region with the most serious rabies epidemic in the world, accounting for about 56 % of the total number of cases worldwide. Rabies poses a great potential threat to more than 2 billion people living in epidemic areas in Asia.

The second generation “Gold Standard”rabies vaccine for human use

China's rabies vaccine embraces the "human" era

1.Production with healthy human cell, innovated processing, highly purified

2.Fast acting, and the average antibody level in 14th days is nearly 40 times ofseroconversion level

3.The duration of immunization lasts for 8 years

4.Less than 1% of ADRs,good safety

HDC Matrix Vaccine: Made from Healthy Human Cell, Good Safety

HDC Matrix Vaccine:Made from Healthy Human Cell, free of xenobiotic pollution

Comparison of Human-derived and Animal-derived Matrix Vaccines

“General Principles for Evaluation of Cell Matrix for Vaccine Production” by Drug Review Center

As the main raw material for vaccine production, the quality of cell matrix directly effects the quality and yield of vaccine, especially the safety of vaccine. Human diploid cells have been used in vaccine production for more than 30 years, proving to be safe and effective , without tumorigenicity. Potential dangers exist in vaccine production with animal cell, such as viruses and other transmissible factors, cellular DNA and growth-promoting proteins.

Exclusive patented process The excellent second generation of “gold standard” rabies vaccine

Imported raw materials, innovated processing, highly purified

Imported raw materials --------------------------Highly purified HDCV Innovation, upgrade and purification based on the first generation HDCVNo antibiotic Quality uniformity-stable quality standards higher than international standards

Bioreactor microcarrier culture

The culture environment is automatically detected, and the product quality is uniform and stable None pollution risk, none antibiotics added

Purification: Molecular sieve column chromatography

Effectively remove impurities and highly purification The removal rate is as high as 99 %

Good immunogenicity and long duration of immunity

Good immunogenicity, fast acting

Average antibody level ( GMT )in day 42 is nearly 75 times of seroconversion level

antibody level GMT(IU/ml)

The antibody seroconversion rate can reach to 100% in day 14

antibody seroconversion rate （100%）

In 2008, a phase III clinical trial of Kangh HDCV was conducted by Jiangsu Center for Disease Control and Prevention,including 1200 subjects aged 10 to 60 years with high-risk rabies infection, randomly divided into groups, of which 60 subjects were vaccinated with HDCV according to the post-exposure procedure.

The duration of immunity was as long as 8 years

8 years after the vaccination, the average antibody level ( GMT ) was still as high as 1.31 lU / ml

antibody levelGMT(IU/ml)

In 2016, the Lianshui Center for Disease Control and Prevention in Jiangsu Province randomly selected 60 volunteers who had participated in the Phase I clinical trial of Kangh HDCV and not immunized rabies vaccine during this period to conduct the 8 years’ immune persistence observation. The test results showed that after 8 years of vaccination with Kangh HDCV, 46.67% of the volunteers were still at the positive level of antibody (>0.5IU/ml), and the GMT was 1.31 IU/ml. After one dose of booster vaccination, the GMT rapidly increased to 30.61 IU /ml.

High safety, low incidence of adverse reactions

The incidence of adverse reactions was less than 1 %

immunize with Kangh HDCV after post-exposure

The common adverse reactions include:
Pain and induration at injection site, rash, headache and nausea

In 2016, the canine injury clinic of Shijiazhuang Center for Disease Control and Prevention took 1040 patients who vaccinated with Kangh HDCV as the research objects to conduct a safety statistical study. The results showed that the total number of adverse reactions was 9 cases, no adverse reactions of grade 1 or above occurred, and the adverse reaction rate was as low as 0.87 %.

Applicable to whole population

Adults, children and the elderly have high safety and low adverse reaction rate after vaccination

In 2015, the canine injury clinic of Urumqi Center for Disease Control and Prevention took Kangh HDCV recipients as the research object to observe and analyze the safety after vaccination. A total of 372 cases were included, divided into children group, normal group and elderly group. The results showed that the total adverse reaction rate was low, and there was no significant difference in the incidence of local and systemic adverse reactions among the groups (P > 0.05). No adverse reactions above grade 1 occurred after inoculation, and all adverse reactions could relieveby self within 72 hours.