Immune response to COVID ‐19 vaccination is attenuated by poor disease control and antimyeloma therapy with vaccine driven divergent T‐cell response

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1. Version published to 10.1111/bjh.18066

   Feb 17, 2022
2. 

   ScreenIT

   Oct 28, 2021

   SciScore for 10.1101/2021.10.21.21265158: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: & RUDY LREC 17/SC/0501), an established online rare disease platform with online dynamic consent and patient reported data11. Recruitment: To ensure reaching our recruitment target rapidly, multiple pathways for recruitment were employed.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   immunomodulatory drugs - thalidomide, lenalidomide, pomalidomide; anti-CD38 antibody (daratumumab, Isatuximab); and anti-BCMA targeted treatment – (belantamab),	anti-CD38 suggested: None anti-BCMA suggested: None
   Laboratory assessments: Collected serum samples were tested for antibodies against …

   SciScore for 10.1101/2021.10.21.21265158: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: & RUDY LREC 17/SC/0501), an established online rare disease platform with online dynamic consent and patient reported data11. Recruitment: To ensure reaching our recruitment target rapidly, multiple pathways for recruitment were employed.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   immunomodulatory drugs - thalidomide, lenalidomide, pomalidomide; anti-CD38 antibody (daratumumab, Isatuximab); and anti-BCMA targeted treatment – (belantamab),	anti-CD38 suggested: None anti-BCMA suggested: None
   Laboratory assessments: Collected serum samples were tested for antibodies against SARS-CoV2 nucleocapsid (N) or spike (S) protein.	SARS-CoV2 nucleocapsid ( N suggested: None
   SARS-CoV2 N protein antibodies were measured by turbidimetry (Abbott), with samples that produced values of >1.4IU/ml considered to be positive.	SARS-CoV2 N protein suggested: None
   SARS-CoV2 S protein antibodies were measured by turbidimetry (Abbott) (IgG serology only), with a cut-off value of 50IU/ml considered to be a positive result.	SARS-CoV2 S protein suggested: (PhosphoSolutions Cat# CoV2-5G8, RRID:AB_2868396)
   We combined humoral and T cell outcomes responses to generate 4 independent groups: combined positive Anti-S antibody and IGRA reactivity compared with those with either Anti-S antibody or IGRA reactivity and those with double negative results.	Anti-S suggested: None
   Software and Algorithms
   Sentences	Resources
   SARS-CoV2 N protein antibodies were measured by turbidimetry (Abbott), with samples that produced values of >1.4IU/ml considered to be positive.	Abbott suggested: (Abbott, RRID:SCR_010477)

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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:

   But a small proportion of patients (6%) are antibody and IGRA negative who require salvage strategies to Strengths and weaknesses of the study: The strength of the study is confirmation of an immune response in heterogeneously vaccinated patients with longer than recommended duration between first and second dose. Our humoral response results are comparable to data reported so far. We have generated a large dataset of T cell response alongside humoral response in myeloma patients. Our data has also been generated in a comparable demographic to the UK myeloma population. Studies use different platforms to generate both antibody and T cell results which makes direct comparability difficult. This dataset, although very reassuring, requires longitudinal follow up. Although further vaccine doses are planned for this patient population, attrition of immune response over time due to ongoing therapy or underlying disease is a concern. A major limitation of this study is the limited sample size of participants with poor humoral and T cell responses. Further, our study is limited by the missing data on chemotherapy and myeloma status from the clinical notes for all participants. We partially addressed this by adding self-reported myeloma status where clinical data were not required and when we compared using only clinical record data, the findings were similar. Therefore, further follow up to determine whether immune response wanes over time and whether use of particular therapies have...

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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.
   • 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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3. 

   Version published to 10.1101/2021.10.21.21265158v1 on medRxiv

   Oct 25, 2021