"Nature" published an interim clinical trial report
A candidate RNA vaccine can induce a strong immune response
Science and Technology Daily, Beijing, August 13 (Reporter Zhang Mengran) The British "Nature" magazine published an interim report on the Phase I/II clinical trial of the new crown vaccine on the 12th, showing that the candidate RNA vaccine BNT162b1 can be induced in healthy adults aged 18-55 Strong immune response.
The world is accelerating the development of vaccines against the new coronavirus. Among them, RNA vaccines use messenger RNA to induce an immune response. "Nature" reported that the safety of the BNT162b1 vaccine is generally recognized.
BNT162b1 can encode an antigen of the new coronavirus receptor binding domain by intramuscular injection. Researchers are conducting parallel studies on multiple candidate RNA vaccines of the same kind in order to select suitable candidate vaccines for the next safety and efficacy trials.
The US Pfizer Pharmaceuticals research team recently reported the interim data of the ongoing Phase I/II clinical study of BNT162b1. Forty-five healthy adults (23 men and 22 non-pregnant women) aged 18-55 were randomly injected with 10μg (micrograms), 30μg or 100μg of BNT162b1, or a placebo. Subjects in the 10 μg group and 30 μg group also received a second dose on the 21st day. The team found that BNT162b1 was generally well tolerated, but some subjects experienced mild to moderate adverse reactions within 7 days after vaccination, including soreness at the injection site, fatigue, headache, fever, and sleep disturbance-these adverse reactions and dose size Proportionally.
The vaccine can induce a strong immune response in subjects, and the immune response level increases with the increase of the injection dose and the second injection. New coronavirus antibodies appeared 21 days after a single injection of all doses; 7 days after the second dose of 10 μg or 30 μg was injected, the new coronavirus neutralizing antibodies increased significantly. The immune response of the 30μg group was much stronger than that of the 10μg group; but the immune response of the 30μg group and the 100μg group had no significant difference after one injection. Because the subjects in the 100μg group had greater adverse reactions, they did not receive the second injection.
The neutralizing antibody level of the subjects was 1.9 to 4.6 times that of patients who recovered from the new coronavirus infection. However, although this type of comparison can be used as a benchmark for evaluating vaccine-induced immune responses and vaccine protection, phase III trials are still needed to determine the vaccine's efficacy.
This study is currently recruiting adults aged 65-85, and will also prioritize recruiting people who are more representative of diversity.