1. Safety and Immunogenicity of an
AMA1 Malaria Vaccine in Malian
Children: Results of a Phase 1
Randomized Controlled Trial
Mahamadou, T., et al (2010)

2. What is Malaria?
Caused by a parasite, Plasmodium falciparum; malariae; ovale , that is
transmitted by mosquitoes
Results from multiplication of the parasite in red blood cells
A malaria infection is generally characterized by recurrent attacks
with the following signs and symptoms:
Moderate to severe shaking chills
High fever
Profuse sweating as body temperature falls
Kills about 1 million people each year worldwide

3. The Vaccine
A subunit vaccine, manufactured within Escherichia
coli
The vaccine utilized synthetic AMA1 (FMP2.1)
FMP2.1 was synthesized using a clone of the AMA1
gene of P. falciparum inserted into the genome of E.
Coli

4. Objective of Study
To find the optimal pediatric dose of the vaccine
FMP2.1/AS02A
To see how the immune system will react to varying
doses of the vaccine
To determine if the immune response (the production of
anti-AMA1 antibodies) is sustained
To evaluate the safety of the FMP2.1/AS02A vaccine

5. Study Setting
Study was performed in Bandiagra, Mali
97% of Malaria infections are from P. falciparum
3% are due to P. malariae
Rare cases are caused by P. ovale
The malaria season
Begins and end in December
Begins and ends in June
Malaria prevalent throughout the year

6. Methods
Participants:
100 Malian children aged 1-6 years
Blood tests were run to screen for significant current
illnesses (positive tests were excluded)
Children who were previously immunized for rabies or
other experimental vaccines were not included
Applicants were also excluded if they had taken regular
immunosuppressants, received blood products in the
past 6 months, or were allergic to substances used in
the vaccines

7. Methods (Contd.)
100 children were divided into 3 cohorts by age
Cohort 1: 20 children aged 1-2 years
Cohort 2: 40 children aged 3-4 years
Cohort 3: 40 children aged 5-6 years
Within each cohort a 3:1 ratio of experimental vaccine
to rabies vaccine was administered

8. Methods (Contd.)
Dosages
10µg/mL FMP2.1 in o.10mL AS02A
25µg/mL FMP2.1 in o.25mL AS02A
50µg/mL FMP2.1 in o.50mL AS02A
Rabies vaccine (RabAvert®)
Dosage interval
Administered at 0, 1, and 2 months

9. Anti-AMA1 Antibody Levels
Figure 3

10. Results
Figure 3 shows the increase of antibody production
when vaccine was administered
Production peaked after the third injection as predicted
The antibody levels observed within each malaria
vaccine group were not statistically significant

11. Conclusion
Phase 2 for the trial began
Dose being evaluated: 50µg/mL FMP2.1 /AS02A
Data from phase 1 was not available when phase 2 started
Highest dose with acceptable safety profile was selected
for further evaluation

12. Reference List
Mahamadou, T., et al (2010). Safety and Immunogenicity of an
AMA1 Malaria Vaccine in Malian Children: Results of a Phase 1
Randomized Controlled Trial . PLoS ONE, 5(2). Retrieved from
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.
pone.0009041
Malaria - MayoClinic.com. (2010, July 31). Mayo Clinic. Retrieved
from http://www.mayoclinic.com/health/malaria
Mali Map, Mali Maps and Travel Guides. (n.d.). Word Travels -
Travel Guide. Destination guides for the world traveller. Retrieved
from http://www.wordtravels.com/Travelguide