Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

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1. Version published to 10.1038/s41467-022-31379-0

   Jun 27, 2022
2. 

   ScreenIT

   Mar 12, 2022

   SciScore for 10.1101/2022.03.08.22272062: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Trial oversight: The trial protocol was reviewed and approved by Abu Dhabi Health Research and Technology Ethics Committee.
   Sex as a biological variable	not detected.
   Randomization	Trial design and participants: We conducted a randomized, double-blind, controlled phase 2 trial to evaluate the immunogenicity and safety of NVSI-06-08 (Sinopharm) as a booster dose following a primary series of BBIBP-CorV (Sinopharm).
   Blinding	Both RBD-binding IgG detection and live-virus neutralization assays were carried out in a blinded manner.
   Power Analysis	Assuming that the 4-fold rise rate after booster vaccination achieve 85%, 208 participants in each arm will be required to have 80% power to conclude …

   SciScore for 10.1101/2022.03.08.22272062: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Trial oversight: The trial protocol was reviewed and approved by Abu Dhabi Health Research and Technology Ethics Committee.
   Sex as a biological variable	not detected.
   Randomization	Trial design and participants: We conducted a randomized, double-blind, controlled phase 2 trial to evaluate the immunogenicity and safety of NVSI-06-08 (Sinopharm) as a booster dose following a primary series of BBIBP-CorV (Sinopharm).
   Blinding	Both RBD-binding IgG detection and live-virus neutralization assays were carried out in a blinded manner.
   Power Analysis	Assuming that the 4-fold rise rate after booster vaccination achieve 85%, 208 participants in each arm will be required to have 80% power to conclude non-inferiority with margin of -10% and one-sided significance level of 2.5% using Miettinen and Nurminen method.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   Study outcomes: The primary immunogenicity outcome was the neutralizing response on 15 days and 30 days after booster vaccination, by evaluation of the geometric mean titers (GMTs) of neutralizing antibodies and the corresponding 4-fold rise rate (i.e., post-/pre-boost ≥4).	≥4 suggested: None
   Laboratory analyses: Spike receptor-binding domain (RBD)-specific IgG antibodies against the prototype SARS-CoV-2 strain was measured using a commercially available magnetic particle-based chemiluminescence enzyme immunoassay kit purchased from Bioscience (Chongqing) Biotechnology Co. (approved by the China National Medical Products Administration; approval numbers 20203400183).	RBD)-specific IgG suggested: None
   6 In brief, serum samples were heat-inactivated at 56 °C for 30 min, and then serially diluted by 2 fold starting from 1:4 (in detection of neutralizing antibodies against prototype SARS-CoV-2 strain) or 1:10 (in detection of neutralizing antibodies against VOCs) dilution.	antibodies against prototype SARS-CoV-2 strain suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   After that, the Vero cell suspension with a density of 1.5-2×105 cells per mL was added into the serum-virus mixture, and then the plates were incubated at 37 °C for 3 to 5 days.	Vero suggested: None

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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:

   This trial has several limitations. Firstly, among participants, the proportion of elderly persons aged ≥60 years was low, and the immune response of the BBIBP-CorV/NVSI-06-08 booster strategy in older population should be further assessed in the future. Secondary, the number of male participants were much larger than female, and the data may not well reflect the effect in women. In summary, heterologous prime-boosting vaccination with BBIBP-CorV plus NVSI-06-08 was well tolerated and immunogenic against not only SARS-CoV-2 prototype strain but also the VOCs including Omicron. It was immunogenically superior to the booster with a third dose of BBIBP-CorV. Our study provides a preferred strategy to top up the immunity in BBIBP recipients against SARS-CoV-2 and its variants. The findings also implied that hybrid-type vaccine could induce potent and broad immune activities, which may provide an effective strategy for broad-spectrum vaccine developments.

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   Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
   

   Identifier	Status	Title
   NCT05069129	Recruiting	Clinical Trial on Sequential Immunization of Recombinant COV…

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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.
   • 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.

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

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   Read the original source
3. 

   Version published to 10.1101/2022.03.08.22272062 on medRxiv

   Mar 10, 2022