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Your Position: Home > Solutions for COVID-19 vaccine safety and immunogenicity evaluation

Solutions for COVID-19 vaccine safety and immunogenicity evaluation

Solutions for COVID-19 vaccine safety and immunogenicity evaluation
Background

Researchers around the world are working hard on a vaccine for COVID-19. Up until now, several vaccine candidates have entered into phase III clinical trials. Experts estimate that a fast-tracked vaccine development process could potentially bring a successful candidate to market within one year or even less. In the development of a COVID-19 vaccine, safety and immunogenicity evaluation are indispensable and well-established assays are required for fast and convenient assessment of the vaccine candidates.

Based on advanced technology platform in recombinant protein production, ACROBiosystems has developed a series of critical reagents for COVID-19 vaccine development and evaluation, including recombinant proteins, antibodies and ELISA kits. These featured products are suitable for IgG/M antibody titer detection, neutralizing antibody titer detection and antigen titer detection to accelerate the vaccine development.

Application

Scenario 1: IgG antibody titer detection

Recommended products

> Cat.No. SPN-C52H9   Product: SARS-CoV-2 S protein, His Tag, Super stable trimer (MALS & NS-EM verified)

The purity, molecular weight and polymeric form were rigorously verified by SDS-PAGE, SEC-MALS and NS-EM.

Fig 1. The purity of SARS-CoV-2 S protein, His Tag, Super stable trimer (Cat. No. SPN-C52H9) was more than 90% verified by SDS-PAGE under reducing (R) condition. The molecular weight was around 550-660 kDa confirmed by SEC-MALS. The particles are similar in size and appearance to SARS-CoV-2 trimers reported in published literature verified by negative stain electron micrography.

Bioactivity of binding to anti-SARS-CoV-2 neutralizing antibody was verified by ELISA

Fig 2. Immobilized Anti-SARS-CoV-2 Neutralizing Antibody, Human IgG1 (Cat. No. SAD-S35) at 1 μg/mL (100 μL/well) can bind SARS-CoV-2 S protein, His Tag, Super stable trimer (Cat. No. SPN-C52H9) with a linear range of 0.3-10 ng/mL

> Cat.No. SPD-C82E9   Product: Biotinylated SARS-CoV-2 (COVID-19) S protein RBD, His, Avitag™ (MALS verified)

Bioactivity of binding to anti-SARS-CoV-2 neutralizing antibody was verified by ELISA

Fig 3. Immobilized Biotinylated SARS-CoV-2 S protein RBD, His,Avitag (Cat. No. SPD-C82E9) at 1 μg/mL (100 μL/well) on Streptavidin (Cat. No. STN-N5116) precoated (0.5 μg/well) plate, can bind Monoclonal Anti-SARS-CoV-S protein RBD Antibody, Human IgG1 with a linear range of 0.1-4 ng/mL

Case Study:

Pfizer employed ACROBiosystems' featured biotinylated S protein RBD in the RBD-binding IgG assay during the phase 1/2 research. The interim report showed that the biotinylated S protein RBD from ACROBiosystems (Cat.No. SPD-C82E9)was bound to streptavidin-coated Luminex microspheres.[1]

Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. medRxiv  preprint. doi:  https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1

> Cat.No. TAS-K002   Product: Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (Spike protein RBD)

Fig 4. Immobilized SARS-CoV-2 S protein RBD at 2 μg/mL (100 μL/well) can bind Monoclonal Anti-SARS-CoV-2 Antibody, Human IgG1 in 1:50 human serum. Detection was performed using HRP-Conjugated Anti-human IgG antibody with sensitivity of 24 ng/mL

Scenario 2: Neutralizing antibody titer detection

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> Cat.No. SPD-C52H3   Product: SARS-CoV-2 (COVID-19) S protein RBD, His Tag (MALS verified)

Bioactivity of binding to anti-SARS-CoV-2 neutralizing antibody was verified by ELISA

Fig 5. Immobilized SARS-CoV-2 S protein RBD, His Tag (Cat. No. SPD-C52H3) at 1 μg/mL (100 μL/well) can bind Anti-SARS-CoV-2 RBD Neutralizing Antibody, Human IgG1 (Cat. No. SAD-S35) with a linear range of 0.1-3 ng/mL

Bioactivity of binding to ACE-2 was verified by ELISA

Fig 6. Immobilized SARS-CoV-2 S protein RBD, His Tag (Cat. No. SPD-C52H3) at 1 μg/mL (100 μL/well) can bind Human ACE2, Fc Tag (Cat. No. AC2-H5257) with a linear range of 0.2-3 ng/mL

> Cat.No. TAS-K003   Product: Anti-SARS-CoV-2 Neutralizing Antibody Titer Serologic Assay kit

Fig 7. Neutralizing titer of Anti-SARS-CoV-2 Neutralizing Antibody, Human IgG1 (Cat.No.SAD-S35) measured by Anti-SARS-CoV-2 neutralizing antibody titer serologic assay kit (Cat. No. TAS-K003).

Scenario 3: Antigen titer detection

Recommended products

> Cat.No. TAS-K011   Product: SARS-CoV-2 Spike Protein Titer Assay Kit

Fig 8. Immobilized Anti-SARS-CoV-2 Spike S1 Antibody at 2 μg/mL (100 μL/well) can bind SARS-CoV-2 Spike Protein. And then add Biotinylated Anti-SARS-CoV-2 Spike S1 Antibody at 1ug/ml. Detection was performed using HRP-conjugated streptavidin with sensitivity of 24 pg/mL

Scenario 4: Antibody isotype assay kit

ACROBiosystems has developed a serial of antibody isotype assay kits, which can be used in detecting the isotypes of anti-SARS-CoV-2 antibody IgG1, IgG2, IgG3 and IgG4. In addition, the antibody kits of different species for preclinical assay are coming soon!

Cat. No.Product Description
TAS-K014Anti-SARS-CoV-2 IgG1 Titer Serologic Assay Kit (S Protein RBD)
TAS-K015Anti-SARS-CoV-2 IgG2 Titer Serologic Assay Kit (S Protein RBD)
TAS-K016Anti-SARS-CoV-2 IgG3 Titer Serologic Assay Kit (S Protein RBD)
TAS-K017Anti-SARS-CoV-2 IgG4 Titer Serologic Assay Kit (S Protein RBD)
Product list

Proteins

MoleculeCat. No.Product Description
ACE2 proteinAC2-H52H8Human ACE2 / ACEH Protein, His Tag (MALS verified)
AC2-H82E6Biotinylated Human ACE2 / ACEH Protein, His,Avitag™ (MALS verified)
AC2-H5257Human ACE2 / ACEH Protein, Fc Tag (MALS verified)
AC2-H82F9Biotinylated Human ACE2 / ACEH Protein, Fc,Avitag™
S trimer proteinSPN-C52H9SARS-CoV-2 S protein, His Tag, Super stable trimer (MALS & NS-EM verified)
SPN-C82E9Biotinylated SARS-CoV-2 S protein, His,Avitag™, Super stable trimer (MALS verified)
SPN-C52H3SARS-CoV-2 S protein (D614G), His Tag, Super stable trimer (MALS verified)
SPN-C82E3Biotinylated SARS-CoV-2 S protein (D614G), His,Avitag™, Super stable trimer (MALS verified)
S protein RBDSPD-C52H3SARS-CoV-2 (COVID-19) S protein RBD, His Tag (MALS verified)
SPD-C82E9Biotinylated SARS-CoV-2 (COVID-19) S protein RBD, His,Avitag™ (MALS verified)
SPD-C5259SARS-CoV-2 (COVID-19) S protein RBD, Mouse IgG2a Fc Tag(MALS verified)
SPD-C82AaBiotinylated SARS-CoV-2 (COVID-19) S protein RBD, Mouse IgG1 Fc,Avitag™(MALS verified)
S1 proteinS1N-C52H4SARS-CoV-2 (COVID-19) S1 protein, His Tag (MALS verified)
S1N-C82E8Biotinylated SARS-CoV-2 (COVID-19) S1 protein, His,Avitag™ (MALS verified)
S1N-C5256SARS-CoV-2 (COVID-19) S1 protein (D614G), His Tag
S1N-C82E3Biotinylated SARS-CoV-2 (COVID-19) S1 protein (D614G), His,Avitag™
S1 protein NTDS1D-C52H6SARS-CoV-2 (COVID-19) S1 protein NTD, His Tag
S1 protein CTDS1D-C52H3SARS-CoV-2 (COVID-19) S1 protein CTD, His Tag (MALS-verified)
S2 proteinS2N-C52H5SARS-CoV-2 (COVID-19) S2 protein, His Tag
Nucleocapsid proteinNUN-C5227SARS-CoV-2 (COVID-19) Nucleocapsid protein, His Tag
NUN-C82E8Biotinylated SARS-CoV-2 (COVID-19) Nucleocapsid protein, His,Avitag™

Kits

CategoryCat. No.Product Description
Neutralizing antibody titer assay kitTAS-K003Anti-SARS-CoV-2 neutralizing antibody titer serologic assay kit
IgG/M antibody titer assay kitTAS-K007Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (S protein trimer)
TAS-K001Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (S protein S1)
TAS-K002Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (S protein RBD)
TAS-K008Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (Nucleocapsid Protein)
TAS-K009Anti-SARS-CoV-2 Total Antibody Titer Serologic Assay kit(antigen sandwich)
TAS-K012Anti-SARS-CoV-2 Antibody IgM Serologic Assay kit (S protein S1)
TAS-K013Anti-SARS-CoV-2 Antibody IgM Serologic Assay kit (S RBD protein)
Antigen titer assay kitTAS-K010SARS-CoV-2 Nucleocapsid Protein Titer Assay Kit
TAS-K011SARS-CoV-2 Spike Protein Titer Assay Kit
Antibody isotype assay kitTAS-K014Anti-SARS-CoV-2 IgG1 Titer Serologic Assay Kit (S Protein RBD)
TAS-K015Anti-SARS-CoV-2 IgG2 Titer Serologic Assay Kit (S Protein RBD)
TAS-K016Anti-SARS-CoV-2 IgG3 Titer Serologic Assay Kit (S Protein RBD)
TAS-K017Anti-SARS-CoV-2 IgG4 Titer Serologic Assay Kit (S Protein RBD)

Antibodies

MoleculeCat. No.Product Description
S protein RBDSAD-S35Anti-SARS-CoV-2 Spike RBD Neutralizing Antibody, Human IgG1 (AS35)
SPD-M128Anti-SARS-CoV-2 RBD Potent Neutralizing Antibody, Mouse/Human Chimeric mAb, Human IgG1 (AM128)
S1 proteinS1N-M122Anti-SARS-CoV-2 Spike RBD Antibody, Chimeric mAb, Human IgG1 (AM122)
S1N-M130Anti-SARS-CoV-2 Spike RBD Antibody, Chimeric mAb, Human IgG1 (AM130)
Reference:
[1] Mulligan et al., (2020). Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. medRxiv, doi: https://doi.org/10.1101/2020.06.30.20142570 )

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