Intranasal nanoemulsion adjuvanted S-2P vaccine demonstrates protection in hamsters and induces systemic, cell-mediated and mucosal immunity in mice

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1. Version published to 10.1371/journal.pone.0272594

   Nov 2, 2022
2. 

   ScreenIT

   Mar 26, 2022

   SciScore for 10.1101/2022.03.22.485323: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	Field Sample Permit: Mouse Study: Mouse immunization studies were performed at IBT Bioservices, Rockville, MD, USA under the approved IACUC animal study protocol # AP-160805. IACUC: Mouse Study: Mouse immunization studies were performed at IBT Bioservices, Rockville, MD, USA under the approved IACUC animal study protocol # AP-160805.
   Sex as a biological variable	Six-to eight-week-old female CD-1 mice were randomly assigned to each of the five groups, with 8 animals in each, except for group with two intranasal vaccinations, where 7 animals were assigned.
   Randomization	Six-to eight-week-old female CD-1 mice were randomly assigned to each of the five groups, with 8 animals in each, except for group …

   SciScore for 10.1101/2022.03.22.485323: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	Field Sample Permit: Mouse Study: Mouse immunization studies were performed at IBT Bioservices, Rockville, MD, USA under the approved IACUC animal study protocol # AP-160805. IACUC: Mouse Study: Mouse immunization studies were performed at IBT Bioservices, Rockville, MD, USA under the approved IACUC animal study protocol # AP-160805.
   Sex as a biological variable	Six-to eight-week-old female CD-1 mice were randomly assigned to each of the five groups, with 8 animals in each, except for group with two intranasal vaccinations, where 7 animals were assigned.
   Randomization	Six-to eight-week-old female CD-1 mice were randomly assigned to each of the five groups, with 8 animals in each, except for group with two intranasal vaccinations, where 7 animals were assigned.
   Blinding	not detected.
   Power Analysis	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   17 Determination of serum and BAL S-2P specific IgG and IgA by ELISA: Serum and bronchoalveolar lavage samples (BAL) were evaluated for S-2P specific IgG and IgA antibody responses by ELISA.	BAL S-2P specific IgG suggested: None S-2P specific IgG suggested: None
   At the end of 3 days, the cells were washed and plated onto PVDF ELISpot filter plates coated with anti-mouse IgG or IgA capture antibody (Mabtech, Cat# BASIC 3825-2H and BASIC 3835-2H).	anti-mouse IgG suggested: None IgA suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Following incubation, the mixture was added to monolayer of Vero cells in triplicates and incubated for 24 hours at 37°C.	Vero suggested: None
   Experimental Models: Organisms/Strains
   Sentences	Resources
   Six-to eight-week-old female CD-1 mice were randomly assigned to each of the five groups, with 8 animals in each, except for group with two intranasal vaccinations, where 7 animals were assigned.	CD-1 suggested: RRID:MGI:2686808)

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   With the caveat that IM vaccination temporarily reduced nasal colonization following vaccination, our intranasal vaccination outcomes were in line with other data generated in the same hamster model using an S-2P vaccine adjuvanted with a combination of Alum and CpG 1018,16, 17 suggesting that intranasal immunization could be as efficient as intramuscular vaccination with the potential advantage of induction of mucosal immunity that would eliminate the virus at its port of entry. The NE01 adjuvant is a clinical-stage adjuvant and has been evaluated in several clinical trials, including a phase 1 anthrax vaccine trial and a seasonal flu trial.32 NE01-adjuvanted vaccines demonstrated a remarkable safety profile and a robust mucosal and systemic immunity. Additionally, the exceptional stability (at 5°C) and ease of administration, reduces the complexities involved with ultra-low cold chain storage and needle-less administration, making this vaccine attractive to low-income countries. We believe our NE01 technology can play a role in providing safe and efficacious standalone vaccine to protect against infection and disease. In the light of the fact that billions of people had already received IM vaccines and that many vaccines are already licensed and have been used, our future development plan includes using this unique intranasal vaccine as a booster vaccine to those who had received IM vaccines fin order to boost their systemic immunity and to confer complementary mucosal immu...

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   Results from rtransparent:

   • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
   • No funding statement was detected.
   • No protocol registration statement was detected.

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   Results from scite Reference Check: We found no unreliable references.

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3. 

   Version published to 10.1101/2022.03.22.485323v1 on bioRxiv

   Mar 23, 2022