Immunity research needs

As emphasized above, two important workshops held in 2001 identified a number of data gaps and research needs to advance the state-of-the-science for assessing the potential for dit.161719 30 Moreover, participants in a 2003 roundtable discussion emphasized that a number of important research efforts are currently underway in the areas of DIT, examining immune system responses following developmental exposures to known immunotoxicants.38... 

Another question is whether an endpoint reflecting the status of CMI should be included in any DIT protocol.1719 For the measurement of CMI, roundtable participants suggested that a validated DTH or T-cell responses to anti-CD3 be evaluated.38 The DTH assay is considered by the NTP as part of the Tier II test panel.3 Although reports indicate that the delayed-type hypersensitivity (DTH) response can be assessed in weanling rats.41 roundtable participants agreed that data are lacking as to whether cell-mediated immune (CMI) assessments in younger animals are feasible.38 Ultimately, the characterization of a validated endpoint which measures CMI, and the determination of whether such an endpoint should be an essential part of a DIT framework remain critical research needs. 

Adkinson, Jr., N.F. et al., Task force report future research needs for the prevention and management of immune-mediated drug hypersensitivity reactions, J. Allergy Clin. Immunol., 109, S461, 2002. 

Adverse events after immunization—the need for improved research, surveillance, and communication... 

However, research for new effective products needs a long time, and the development of any orphan vaccine should be broadly supported by measures to increase the awareness of immunization benefits at three levels - the decision-makers, the care-givers, and the patients. 

Further research is needed to more effectively assess risks to developing humans. For pharmaceuticals, more information is needed to determine whether an effect on a biomarker from an adult study can be applied to set safe levels in juveniles information on biomarker expression in juveniles is lacking. It is also not known whether juvenile humans are more sensitive to immune system perturbations than adults, although ani-... 

It has been reported that IgG from fhe milk of healthy mothers has nucleotide-hydrolyzing activity that is not related to the activity of known enzymes (Semenov et ah, 2004). Human milk appears to contain a mixture of antibodies, some hydrolyzing ATP/AMP and others hydrolyzing only AMP (Semenov et ah, 2004). It has been suggested that these antibodies neutralize bacterial and viral DNA and RNA by forming complexes with them (Semenov et ah, 2004). Although these antibodies may play a protective role in breast milk and enhance the passive immunity of neonates, more research is needed to fully defermine their biological role (Semenov et ah, 2004). 

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