A Recombinant Subunit Vaccine Induces a Potent, Broadly Neutralizing, and Durable Antibody Response in Macaques against the SARS-CoV-2 P.1 (Gamma) Variant
This article has been Reviewed by the following groups
Discuss this preprint
Start a discussion What are Sciety discussions?Listed in
- Evaluated articles (ScreenIT)
Abstract
No abstract available
Article activity feed
-
-
SciScore for 10.1101/2021.09.24.461759: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IACUC: Ethical Statement: The investigators adhered fully to the “Guide for the Care and Use of Laboratory Animals” by the Committee on Care of Laboratory Animal Resources Commission on Life Sciences, National Research Council. Sex as a biological variable Each group consisted of both male and female cynomolgus macaques (n = 3 for each formulation) weighing between 2.8 and 8.2 kg. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Bound IgG was detected using 1μg/mL red phycoerythrin (R-PE)-conjugated goat anti-human IgG antibodies (Jackson ImmunoResearch, Inc., West Grove, PA) and … SciScore for 10.1101/2021.09.24.461759: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IACUC: Ethical Statement: The investigators adhered fully to the “Guide for the Care and Use of Laboratory Animals” by the Committee on Care of Laboratory Animal Resources Commission on Life Sciences, National Research Council. Sex as a biological variable Each group consisted of both male and female cynomolgus macaques (n = 3 for each formulation) weighing between 2.8 and 8.2 kg. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Bound IgG was detected using 1μg/mL red phycoerythrin (R-PE)-conjugated goat anti-human IgG antibodies (Jackson ImmunoResearch, Inc., West Grove, PA) and resuspended in MAGPIX® drive fluid before being analyzed on a MAGPIX® Instrument (Luminex Corporation, Austin, TX). anti-human IgGsuggested: NoneExperimental Models: Cell Lines Sentences Resources 1 variant, hCoV-19/Japan/TY7-501/2021, TY7-501 (BIOQUAL-generated stock [lot no. 031921-1215] in Calu-3 cells from seed stock no.TY7-501 was performed with an inoculum dose of 5×105 TCID50/mL administered to each animal in volumes of 1 mL by intratracheal and intranasal injection at each site. Calu-3suggested: NoneAntibody-virus complexes were added to Vero cell monolayers in 6-well plates and incubated at 37°C for another hour followed by addition of overlay media mixed with 1% agarose. Verosuggested: NoneThe TCID50 assay was conducted by addition of 10-fold graded dilutions of samples to Vero TMPRSS2 cell monolayers. Vero TMPRSS2suggested: NoneThe serum-virus mixtures were added to a monolayer of confluent Vero E6 cells and incubated for one hour at 37°C in 5% CO2. Vero E6suggested: NoneSoftware and Algorithms Sentences Resources Recombinant S protein was purified from clarified cell culture supernatants by immunoaffinity chromatography (IAC) using the SARS-CoV-2 cross-reactive mAb CR3022 (provided by Mapp Biopharmaceutical) coupled to NHS-activated Sepharose at a concentration of 10 mg/mL. Mapp Biopharmaceuticalsuggested: NoneThe resulting MFI values were plotted against the Log10-transformed concentrations and fitted using a sigmoidal dose-response, variable slope model (GraphPad Prism, San Diego, CA). GraphPadsuggested: (GraphPad Prism, RRID:SCR_002798)All statistical analysis was completed using Graphpad Prism 9 software (San Diego, CA). Graphpad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The small size of our treatment groups (n=3) is a limitation of our study and may therefore not provide enough statistical power to strongly correlate antibody concentrations to viral load or histopathology score. Furthermore, we cannot directly compare the outcome of our study to other studies that evaluate vaccine efficacy soon after the final booster when immunity is greatest, as vaccine efficacy is known to decline over time. Likewise, we could not benchmark the efficacy of our vaccine formulation when the immunity is greatest at week 5, however, our late challenge scheme accurately reflects the current urgent need for decisions about timing and candidates for possible booster vaccinations during the pandemic situation as it provides useful information regarding the real-life durability and breadth of vaccine protection. It furthermore may shed light into the utility of protein vaccines to serve as prime or boost in combination with other vaccines. In conclusion, we show that a two-dose regimen of a prefusion-stabilized trimeric S subunit protein vaccine formulated with lyophilizable CoVaccine HT™ adjuvant reduces viral burden and high antigen doses can confer durable cross-variant immunity. Future efforts will therefore focus on developing a thermostabilized vaccine formulation in a single-vial presentation, potentially enabling facile worldwide distribution.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
-
