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 2 Patient diary, general symptoms

	Grade 1: mild	Grade 2: moderate	Grade 3: severe	Grade 4: extreme
Chills/rigors	Mild hot/cold flushes requiring blanket or occasional painkillers/antipyretics	Limiting daily activity > 6 h or need regular painkillers/antipyretics	Uncontrollable shaking, treatment from doctor needed	Hospitalization
Malaise/tiredness	Normal activity reduced – not bad enough to go to bed	Fatigue such that 0.5 days in bed for 1 or 2 days	Fatigue such that is in bed all day or 0.5 day for more than 2 days	Hospitalization
General muscle aches	No limitation of activity	Muscle tenderness, limited activity, e.g., difficulty climbing stairs	Severe limitation, e.g., cannot climb stairs	Hospitalization
Headache	No treatment or responds to usual treatment like paracetamol	Occasional treatment like paracetamol needed	Strong pain killers needed (with prescription)	Hospitalization
Nausea	Intake maintained	Intake reduced at most 3 days	Minimal intake 3 days or more	Hospitalization
Vomiting	Less than 4 × a day or lasting less than 1 week	At least 4 x a day or lasting 1 week or more	Unable to keep any food of fluids down	Hospitalization

General symptoms 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

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