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Table 3 Patient diary, local reactions

From: iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy

 Grade 1:
mild
Grade 2:
moderate
Grade 3:
severe
Grade 4:
extreme
Pain at injection site (including ache) but not skin discomfortNo treatment or responds to occasional treatmentPartial response to treatmentNeed to use regular treatment to control painHospitalization
Itching or irritation in the skin at site of injectionNo treatment or responds well to treatment prescribedPartial response to treatmentNeed to use regular treatment to control symptomsHospitalization
  1. Local reactions at the injection site (pain, itching) are scored on a grade 1–4 scale at 12 h and 24 h post immunization. This is repeated every 24 h up to and including day 7. In case there is any redness, fluid-filled blisters, blood-fluid blisters or hard swelling of the skin, the patient is instructed to measure and note their diameter in centimeters