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Table 4 Grade 2 and Grade 3 adverse events

From: Direct venous inoculation of Plasmodium falciparum sporozoites for controlled human malaria infection: a dose-finding trial in two centres

Group

Grade 2*

Grade 3*

ID 2500 (n = 6)

Fatigue (2)

None

Fever (1)

Headache (2)

Tachycardia (2)

High ALT (1)

IV 50 (n = 3)

Fever (1)

None

IV 200 (n = 3)

Fever (1)

None

Headache (1)

Tachycardia (1)

IV 800 (n = 9)

None

Lymphopenia (1)

IV 3200 (n = 9)

Fatigue (2)

None

Fever (2)

DVI 3200 (n = 6)

Anxiety (2)

High CRP (1)

Contusion (1)

Common cold (1)

Fatigue (1)

Fever (4)

Fever (2)

Headache (3)

High ALT (2)

High AST (1)

High CRP (1)

Insomnia (1)

Low potassium (1)

Lymphopenia (3)

Malaise (1)

Menstrual cramps (1)

Myalgia (4)

Nausea (2)

Neutropenia (1)

Stye (1)

Vomiting (2)

Weakness (1)

Total N

47

7

  1. Note that volunteers in the verification group underwent a more extensive blood-sampling scheme for laboratory parameters. Laboratory parameters were graded using an adapted U.S. FDA toxicity scale.
  2. *Symptom (N), ID: intradermal, IV: intravenous, DVI: direct venous inoculation (verification group).