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

Table 3 Patient diary, local reactions

	Grade 1: mild	Grade 2: moderate	Grade 3: severe	Grade 4: extreme
Pain at injection site (including ache) but not skin discomfort	No treatment or responds to occasional treatment	Partial response to treatment	Need to use regular treatment to control pain	Hospitalization
Itching or irritation in the skin at site of injection	No treatment or responds well to treatment prescribed	Partial response to treatment	Need to use regular treatment to control symptoms	Hospitalization

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

ISSN: 1745-6215