Malaria Vaccine in Children in Mali
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe
      and if it reduces episodes of malaria parasitemia (parasites in the blood) in children
      exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each
      year, causing from 2 million to 3 million deaths, mostly among children less than 5 in
      sub-Saharan Africa. It is the leading cause of death and illness among the general population
      of Mali in West Africa. Increasing drug resistance to the malaria parasite and widespread
      resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing
      the ability to control malaria through these strategies. A vaccine that could reduce illness
      and death from malaria would be a valuable new resource in the fight against this disease.
      AMA1-C1 is an experimental vaccine developed by the NIAID. Tests of AMA1-C1 in 87 healthy
      people in the United States and in Mali found no serious harmful side effects of the vaccine.

      Two- and three-year-old children who live in Don gu bougou or Bancoumana, Mali, and are in
      general good health may be eligible for this study. Candidates are screened with a medical
      history, physical examination, and blood and urine tests.

      Participants are randomly assigned to receive two injections (shots) of either AMA1-C1 or a
      Haemophilus influenzae type B vaccine called Hiberix® (Registered Trademark), which is
      approved and used in Mali. All shots are given in the thigh muscle. Before the first shot, a
      small blood sample is obtained to make sure the child is well and to see if he or she has
      antibodies to the malaria parasite. The second shot is given 4 weeks after the first. After
      each shot, participants are observed in the clinic for 30 minutes. They return to the clinic
      1, 2, 3, 7 and 14 days after each shot for a physical examination. Blood samples are drawn at
      some visits to check for side effects of the vaccine and to measure the response to it.

      During the rainy season after the second vaccination, subjects come to the clinic once a
      month for an examination. Any child who has been ill with a disease that could be malaria has
      a blood sample collected by fingerstick to test for malaria and to learn about the malaria
      parasites causing the infection. Every fourth visit a fingerstick sample is taken regardless
      of whether the child has been sick. If a child becomes sick at any time during the study, he
      or she will be brought to the clinic for examination a...
    

Detailed description: 
      Apical membrane antigen-1 (AMA1) is a surface protein expressed during the asexual blood
      stage of P. falciparum. It is produced as an 83-kDa polypeptide by mature schizonts in
      infected erythrocytes. In clinical studies in malaria-unexposed adults in the USA and in
      malaria-exposed adults in Mali, AMA1-C1/Alhydrogel was safe and immunogenic. This study will
      evaluate its safety and immunogenicity in malaria-exposed children living in an area of
      seasonal malaria transmission.
    

Intervention name(s): AMA1-C1/Alhydrogel Malaria Vaccine
Intervention type(s): Drug
Intervention MeSH terms: Aluminum Hydroxide
Primary purpose: Treatment
Keywords: Blood Stage; Investigational; Endemic; Malaria