Safety and Immunogenicity of an AMA1 Malaria Vaccine in Malian  Children: Results of a Phase 1  Randomized Controlled Tria...
What is Malaria?Caused by a parasite, Plasmodium falciparum; malariae; ovale , that istransmitted by mosquitoesResults fro...
The VaccineA subunit vaccine, manufactured within EscherichiacoliThe vaccine utilized synthetic AMA1 (FMP2.1)FMP2.1 was sy...
Objective of StudyTo find the optimal pediatric dose of the vaccineFMP2.1/AS02A  To see how the immune system will react t...
Study SettingStudy was performed in Bandiagra, Mali  97% of Malaria infections are from P. falciparum  3% are due to P. ma...
MethodsParticipants:  100 Malian children aged 1-6 years  Blood tests were run to screen for significant current  illnesse...
Methods (Contd.)100 children were divided into 3 cohorts by age  Cohort 1: 20 children aged 1-2 years  Cohort 2: 40 childr...
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  R...
Anti-AMA1 Antibody LevelsFigure 3
ResultsFigure 3 shows the increase of antibody productionwhen vaccine was administered  Production peaked after the third ...
ConclusionPhase 2 for the trial began  Dose being evaluated: 50µg/mL FMP2.1 /AS02A    Data from phase 1 was not available ...
Reference ListMahamadou, T., et al (2010). Safety and Immunogenicity of anAMA1 Malaria Vaccine in Malian Children: Results...
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Malaria

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Malaria

  1. 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. 2. What is Malaria?Caused by a parasite, Plasmodium falciparum; malariae; ovale , that istransmitted by mosquitoesResults from multiplication of the parasite in red blood cellsA malaria infection is generally characterized by recurrent attackswith the following signs and symptoms: Moderate to severe shaking chills High fever Profuse sweating as body temperature fallsKills about 1 million people each year worldwide
  3. 3. The VaccineA subunit vaccine, manufactured within EscherichiacoliThe vaccine utilized synthetic AMA1 (FMP2.1)FMP2.1 was synthesized using a clone of the AMA1gene of P. falciparum inserted into the genome of E.Coli
  4. 4. Objective of StudyTo find the optimal pediatric dose of the vaccineFMP2.1/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. 5. Study SettingStudy 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. ovaleThe malaria season Begins and end in December Begins and ends in June Malaria prevalent throughout the year
  6. 6. MethodsParticipants: 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. 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 yearsWithin each cohort a 3:1 ratio of experimental vaccineto rabies vaccine was administered
  8. 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. 9. Anti-AMA1 Antibody LevelsFigure 3
  10. 10. ResultsFigure 3 shows the increase of antibody productionwhen 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. 11. ConclusionPhase 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. 12. Reference ListMahamadou, T., et al (2010). Safety and Immunogenicity of anAMA1 Malaria Vaccine in Malian Children: Results of a Phase 1Randomized Controlled Trial . PLoS ONE, 5(2). Retrieved fromhttp://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0009041Malaria - MayoClinic.com. (2010, July 31). Mayo Clinic. Retrievedfrom http://www.mayoclinic.com/health/malariaMali Map, Mali Maps and Travel Guides. (n.d.). Word Travels -Travel Guide. Destination guides for the world traveller. Retrievedfrom http://www.wordtravels.com/Travelguide

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