Experimental infection and protection against ... - TI Pharma

Long-term protection against malaria after experimental sporozoite inoculation 203
Any Adverse
event frequency
Protected (n=4) Delayed patency (n=2) Controls (n=5)
Mean
duration ±
SD (days) frequency
Mean
duration ±
SD (days) frequency
Mean
duration ±
SD (days)
Abdominal pain 1 1.0±0
Arthralgia 2 1.8±0
Chills 2 0.8±0.6
Fatigue 3 5.0±5.3 2 5.6±4.1 5 5.3±3.1
Fever 1 0.1±0 2 2.0±0.5 2 1.3±1.0
Headache 3 0.7±0.3 2 1.6±1.5 3 1.7±2.0
Itching 2 1.5±2.0 2 3.6±3.6 3 3.4±2.4
Malaise 2 3.2±2.1
Myalgia 1 1.0±0 1 3.0±0 3 1.9±1.9
Nausea 2 0.1±0.09 1 3.0±0 2 0.5±0.5
Vomiting 1 0.04±0
Any 4 1.8±3.1 2 2.7±2.8 5 5.7±2.2
Grade 3 adverse event
Fatigue 2 9.0±1.8 1 7.9±0
Fever 2 1.8±0.6
Itching 1 0.1±0
Malaise 2 3.2±2.1
Any 1 0.1±0 2 9.0±1.8 2 8.4±2.7
Table 2. Number of individuals reporting possibly or probably related solicited
adverse events in immune volunteers, volunteers with delayed patency and control
volunteers. Unrelated adverse events were myalgia after sports, headache related to
exams, common cold, a possible vasovagal reaction without collapse and a fracture of
the scaphoid bone.
The four protected volunteers reported several mild to moderate adverse
events, of which short episodes of headache was the most common symptom
(1-3 episodes per volunteer). Interestingly, one of these volunteers reported
fever up to 38.0°C measured sub-lingual 19 days after the challenge infection.
The two volunteers with delayed patency reported adverse events similar to
those in the control group. The number of adverse events reported per
volunteer over time is shown in Figure 3.
Four of five control volunteers developed parasitemia detected by thick smear
within the expected time frame of 7-12 days post-infection and were treated per
protocol [9]. One control volunteer presumptively received anti-malarial
treatment on day 9.3 in the absence of a parasite-positive blood-smear but
based on clinical malaria symptoms and elevated d-dimer levels [1180 ng/ml), a
pre-defined safety criterion. All control volunteers, including the latter,
developed asexual blood-stage parasitemia detectable by Q-PCR retrospective-