DTH reaction assessment Sample Clauses

DTH reaction assessment. The DTH reaction will be measured in 2 dimensions at 48-72 hours post inoculation and compared between peptide and sterile saline and between pre-inoculation and post- inoculation. The low dose of peptide used in the DTH test is not expected to induce a long term immune response; however, any response that is induced is expected to be transitory in nature. Patients are to be monitored post-injection for 1 hour to note any local or systemic reactions to the vaccine and are required to return to the clinic within 48-72 hours after inoculation for assessment of local and/or systemic reactions. A photograph of the DTH response will be obtained for the purpose of documentation and reporting. These results will also be recorded in the response database. See Section 8.2.3 and Table 7. Additionally, patients should be given the phone number to the treatment clinic, and emergency department in case of reaction/side effects, and educated about the local and systemic signs of infection. If any adverse events occur, these will be reported per the protocol. If infection is detected, then vaccinations will be halted and the sterility of the remaining single dose vials re-confirmed. The patient will be medically treated as appropriate. Note: A ≤ Grade 1 skin reaction DTH response is required to begin study therapy. See
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Related to DTH reaction assessment

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