1. Briefly introduce the research and development background of therapeutic hepatitis B vaccine ("Bg")?
Bg is composed of recombinant hepatitis B surface antigen and human anti-hepatitis B high-titer immunoglobulin. The immunogenic antigen-antibody complex required by patent regulations is an innovative product with my country's independent intellectual property rights that has been developed since 1987 with the support of the National High-tech 863 Program. It is now supported by the "Tenth Five-Year Plan" National Major Science and Technology Project Funded by the National 863 Program, he participated in the "15th Anniversary" exhibition of the National 863 Program and received an award from the program.
This product has been studied in ducks and hepatitis B surface antigen-positive transgenic mice, and compared with synthetic peptides, simple hepatitis B antigen, and DNA vaccines encoding the S gene. The results prove that the immunogenicity of the compound It can make animals produce antibodies and cellular immunity, and has the best effect in clearing antigens.
In 1999, it cooperated with the Beijing Institute of Biological Products for research and development. Without precedent at home and abroad, it researched and formulated the production process and entered industrialization.
In 2004, it was included in the first batch of Shanghai funded projects to revitalize the city through science and education.
2. What is the progress of clinical research on "Bigram"?
The hepatitis B surface antigen-antibody immunogenicity ("Yigram") therapeutic vaccine obtained the national drug designation in August 2002 The Clinical Research Administration (SDA) approved the clinical research (approval number: 2002SL0038), and the clinical phase I trial was started at Beijing Ditan Hospital in September 2002. As a safety study, first of all, patients with B, C, D, and D symptoms must be excluded. History of hepatitis E virus infection. After screening 86 healthy people, only 22 people could be selected. All the patients were admitted to the hospital the night before the injection. After the injection, the heart, liver, kidney, blood and other indicators were observed. There were no abnormalities after the injection (the injection cycle is 4 weeks). Follow-up was conducted 2 months after the completion of the injection to ensure safety. The study found that all normal people produce antibodies against surface antigens, which can reach up to 1000 international units/ ml. Cytokine test results showed that interleukin-2 and interferon gamma were higher than before immunization in 8 cases, suggesting that ethyl gram can also induce cellular immunity. All results have been published in the authoritative international vaccine magazine Vaccine. 2005, 23: 2658-2664).
The Phase II clinical trial was conducted in a small number of patients to continue to evaluate its safety and explore the appropriate dose to produce an immune response. It started in February 2004 on 36 patients. A phase II clinical group A trial was conducted among patients with chronic hepatitis B, 12 of whom received placebo treatment. The entire trial was conducted in an internationally recognized double-blind manner, that is, blinded by statistical experts independently, including physicians, patients, scientific researchers, and testing personnel. It is not known whether the patient was injected with ethyl gram or placebo. The treatment was administered once every 4 weeks for 6 times, and the patient was followed up for 24 weeks until December 2004. The last patient in the clinical study was. The patient has completed the injection and needs to be followed up for 24 weeks. It is expected that the blindness will be unmasked at the end of May 2005.
3. Why is the clinical study of "Yi Ke" so long?
Although HBV is effective in animal experiments, patients and animals are different after all. So far, no animal (chimpanzees can be infected with hepatitis B virus, but rarely develop cirrhosis and liver cancer) can completely simulate clinical hepatitis B patients. The purpose of the research is to understand the efficacy and clarify the indications (which patients with hepatitis B are suitable for Bacillus) and contraindications (which patients are not suitable for Bacillus). Bacillus is a new class of new drugs. We must be responsible for patients and gradually accumulate treatment experience. Gradually promote. In fact, no medicine can cure all diseases, and each disease must be different from person to person.
For the safety of patients, national regulatory authorities have strict regulations on clinical research of new drugs. Requirements, if the research must be divided into clinical phases I, II, III, and IV, the time and number of cases in each phase are strictly stipulated and cannot be changed or omitted at will. Therefore, the clinical research of a new drug in a class generally requires 4- 5 years.
In addition, because chronic hepatitis B is a persistent viral infection, it is different from acute viral infections (such as colds). To gradually mobilize the immune function of the patient, a certain treatment period and follow-up period are required. As a result, the clinical trials required for ethyl acetate are longer than those for other drugs.
4. As a volunteer for Phase II clinical trials, how should I participate in clinical research?
Based on the Phase IIA clinical research, a Phase IIB clinical research plan is currently being formulated. The research plan is expected to involve about 240 people, but one-third of them will be placebo injections, because there must be a double-blind control for the results to be scientific. However, once the blindness is lifted, patients who receive the placebo injection will immediately have the right to receive the full course of treatment with the Etg injection. Each participant must also undergo systematic laboratory tests and physical examinations, and must rule out contraindications before being included in the group. By then, the II B program will be carried out in selected hospitals, not only in Beijing. It is expected that hospitals in Shanghai, Hangzhou and other cities can also participate. Once the Phase IIB clinical research plan and participating units are determined, we will announce it as soon as possible. Patients who are willing to participate can contact the nearest hospital. Those who meet the clinical trial conditions can be enrolled at the relevant hospital after signing the informed consent form.
5. Do patients entering IIB have to pay?
Once the IIB study is started, the injection Etylgram and laboratory fees will be provided by the clinical research unit. The patient does not have to bear the Etylgram drug fee and laboratory test fees except for the fees specified by the hospital.
6. Why is the marketization of Yike so slow?
The so-called marketization means that patients can buy drugs at will with a prescription. Generally, if the drug (or therapeutic vaccine) is a Class I new drug, it needs to go through three phases of clinical trials, obtain a new drug certificate, and then apply for a production license number. , so as to enter the market.
It must be noted that as an immune vaccine treatment, Ethyl Gram not only mobilizes the body's immunity to clear the virus, but may also cause certain damage to the function of the infected liver (elevated transaminase) by stimulating the body's immunity. . Although no cases of severe hepatitis have occurred in the research on therapeutic hepatitis B vaccines at home and abroad so far, in the spirit of being responsible for patients, the basic line of clinical research on hepatitis B is: “active, cautious, and in line with international standards; Study new ways to treat hepatitis B with a scientific attitude."
Reference: http://www.ganbing.org/news/20060401162443.htm