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Adjuvant of novel coronavirus vaccine, application of adjuvant and novel coronavirus bivalent recombinant vaccine

A coronavirus and vaccine technology, applied in antiviral agents, viruses, vaccines, etc., can solve the problems of poor protection of the South African mutant strain B.1.351

Active Publication Date: 2021-12-28
BEIJING HEALTH GUARD BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the new coronavirus COVID-19, there have been some studies to obtain related vaccines. The vaccines currently on the market are all developed against the HuB strain of the new coronavirus. Therefore, the protection against the South African mutant strain B.1.351 is not good, so it is urgent to develop Vaccine effective against novel coronavirus strain B.1.351 in South Africa

Method used

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  • Adjuvant of novel coronavirus vaccine, application of adjuvant and novel coronavirus bivalent recombinant vaccine
  • Adjuvant of novel coronavirus vaccine, application of adjuvant and novel coronavirus bivalent recombinant vaccine
  • Adjuvant of novel coronavirus vaccine, application of adjuvant and novel coronavirus bivalent recombinant vaccine

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1, adjuvant configuration and optimization

[0026] 1. Adjuvant formula

[0027] Since the main components of the reference positive control MF59 adjuvant are squalene, Tween 80, and Span 85, and the buffer is a citric acid system. Sodium acetate buffer system is more stable, therefore, the adjuvant optimization of citrate buffer system and sodium acetate buffer system was carried out respectively, at the same time, SDS, Solutol HS-15 and RH40, which have similar protein protection functions as Tween 80, were added Research.

[0028] The configuration of the adjuvant The adjuvant test formula is as follows:

[0029]

[0030] Weigh squalene, Tween-80 and Span-85, or / and SDS, stir and mix evenly, as the oil phase. Add to the aqueous phase of the acetic acid-sodium acetate solution. Mix the oil phase and the water phase, stir them separately with a disperser, 1000-10000 rpm, stir for 5-20 minutes to form colostrum, and then process it through a micro-flui...

Embodiment 2

[0050] Example 2. Effect of different adjuvants on the neutralizing antibody level of the new crown vaccine

[0051] The HuB strain recombinant protein (see 2020110659137.8 for its preparation method) was mixed with different adjuvant combinations respectively, and mice were immunized. 10 in each group. Each mouse was immunized with 1ug protein in muscle. Booster immunization every two weeks. The blood of the mice was collected three weeks after the first immunization, and the supernatant was collected by centrifugation, and the neutralizing antibody titer of the pseudovirus method and the cytokine detection of the ELISPOT method were carried out. Two weeks after the second immunization, mouse sera were collected for pseudovirus neutralizing antibody detection.

[0052]

[0053] The results showed that in the serum collected two weeks after the second immunization, the neutralizing activity of the KL02 adjuvant and MF59 adjuvant groups was significantly higher than that ...

Embodiment 3

[0056] Embodiment three, the research of antigen dosage

[0057] The recombinant protein of HuB strain (see 2020110659137.8 for its preparation method) was mixed with KL02 adjuvant or aluminum hydroxide adjuvant respectively, and rhesus monkeys were immunized. Two doses were set for the KL02 adjuvant group, 4 monkeys were immunized respectively, and one dose was set for the aluminum hydroxide adjuvant group, a total of 12 rhesus monkeys. A booster immunization was given every 4 weeks for a total of three immunizations. The serum was collected after the second and third immunizations, and the live virus of the new coronavirus HuB strain was used to detect the neutralizing antibody by the new coronavirus live virus neutralizing antibody detection method.

[0058] New coronavirus live virus neutralizing antibody detection method: The cytopathic effect (cytopathic efficiency) detection method is used to detect the neutralizing antibody titer of 50% live virus. Serum samples were...

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Abstract

The invention discloses an adjuvant of a novel coronavirus COVID-19 vaccine and a developed bivalent vaccine which contains a novel coronavirus epidemic HuB strain and a South African mutant strain B.1.351 antigen. The adjuvant disclosed by the invention has the advantages of being more suitable for a stable sodium acetate buffer solution system of a COVID-19 vaccine protein, and high in neutralizing antibody and cellular immune level. On the basis, the bivalent COVID-19 vaccine invented by the invention can have a good protection effect on infection of the novel coronaviruses, especially the HuB strain, the South African mutant strain and a Delta mutant strain.

Description

technical field [0001] The invention belongs to the technical field of biology and medicine, and in particular relates to an adjuvant for a recombinant subunit vaccine of novel coronavirus and a bivalent vaccine of novel coronavirus COVID 19. Background technique [0002] The new coronavirus belongs to the new coronavirus of the genus β, with an envelope, and the particles are round or oval, often pleomorphic, with a diameter of 60-140nm. The structural proteins of the new coronavirus SARS-CoV-2 include S protein, N protein, E protein, and M protein. For SARS-CoV-2, only neutralizing antibodies directed against the S protein can neutralize the virulence of the virus and prevent the virus from infecting the body. The spike protein (Spike protein, S protein) on the coat of the coronavirus It is a key protein that recognizes host cell receptors during virus infection. The S protein is composed of two subunits, S1 and S2, of which the S1 subunit contains a receptor binding doma...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K39/215A61P31/14A61P37/04
CPCA61K39/39A61K39/12A61P31/14A61P37/04A61K2039/55511A61K2039/70C12N2770/20034
Inventor 刘永江张海江贠炳岭杨秀芬伍树明高文双银飞姜绪林
Owner BEIJING HEALTH GUARD BIOTECH
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