Page History

Is it appropriate to use NHOID in this example where you are testing anti-RSV epitope IgG antibody in the patient? The bug is In this assessment, the microbe is not the subject of the observation, this is measuring the host/subject immune response.This example is been tweaked to include NHOID, see the orginal IS example 5 in the SDTMIG 3.4: IS Example 5.

In reference to the published examples where NHOID is used, observations are made and tests are run on the microbe itself - the results tell you something about and relevant to the microbe:

• is it susceptible to an antibiotics? (MS)
• does it have some mutations or sequence changes in its genome? (GF)
• can the subject antibody stop it from infecting cells? (IS)
• for all of the above, you are running tests that have a direct impact on the microbe, or the observations/assessments tell you something about the microbe, but not necessarily about the host/subject.

In the below example, this is a use-case where the subject's humoral immune responses are measured by the quantification of anti-RSV IgG antibody toward vaccine-delivered RSV antigens (proteins B and Z), the observations (results) are about the study subject's protective antiviral antibody levels which indicates how he responds to the vaccine stimulation. It doesn't tell you anything about the bugs. Normally and traditionally, the model would look like example 1. However, in reality, what needs to be collected and modeled is Example 2.

Having NHOID in example 2 helps to identify the specific strains from which the vaccine is derived, but this is beyond the scope of how NHOID is defined and used.

Question: Can we expand the scope of NHOID in this case? Can NHOID be used for instances where assessments are conducted to assess direct subject immune responses to a microbe or microbial-derived products via vaccination or antigen-stimulation tests, where NHOID can be used to describe more in detail the microbial taxonomic level information? Any concerns? This scope expansion can be devalued case by case be limited for IS for now (because we have only seen use-cases in IS).

Example 1: Without NHOID, in the example below, all you know is that two types of vaccine-delivered RSV antigens had successfully stimulated antibody responses in this subject. Where do you map the info that the antibody targets (in ISBDAGNT), HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B, and HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z, are actually from two different strains of RSV virus?

• HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN B is from the strain Human respiratory syncytial virus MinA    
• HUMAN RESPIRATORY SYNCYTIAL VIRUS-PROTEIN Z is from the strain Human respiratory syncytial virus (strain RSP112/Sweden/02-03)   

Example 2: With NHOID, but this is stretching the scope of this variable.

13668

13668

13669