Experimental infection and protection against ... - TI Pharma

44 Chapter 2
Figure 2. Mean log anti-AMA-1 titres with standard deviation for low and
high dose per adjuvant group. Anti-AMA-1 titres were determined by ELISA
for the six different groups, immunized with Alhydrogel, Montanide and
AS02 adjuvanted PfAMA1 vaccine. Dashed lines represent high dose of
PfAMA1 (50 µg), continuous lines represent low dose groups (10 µg).
Measurements were performed at baseline, 28 days after the first, second
and third immunisation (day 28, 56 and 84 respectively) and day 140 and
365.
levels of C-reactive protein remained below detection levels (indicating that the
reaction was a local response). Ultrasound examination suggested an
intramuscular and subcutaneous localisation of the fluid-filled cavity.
Systemic reactions were infrequent in the Alhydrogel and Montanide groups
and occurred mainly in the AS02 groups. The systemic adverse events occurred
within 24 hours of immunisation and usually resolved within two days. The most
prevalent systemic adverse events were headache (77.8-87.5%) and malaise
(66.7-87.5%) in the AS02 groups. Four of those volunteers reported grade 3
headache or malaise. Most of the systemic adverse events occurred after dose
2. There was no effect of antigen dose on reactogenicity. No changes in blood
pressure were noted in any of these volunteers.