Phase I Study of Safety and Immunogenicity of AMA1-C1Alhydrogel + CPG 7909 Vaccine for Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of an experimental vaccine can protect people from
      malaria and study its effects. Malaria, which affects many people in Mali and other countries
      in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading
      cause of death. Researchers at the Malaria Research and Training Center at the University of
      Bamako are working with NIH to develop an experimental vaccine against the disease. The
      vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing
      germ. CPG-7909 is a product to improve the body's reactions to vaccines.

      Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to
      stay there for the study duration, and who are not pregnant or breast feeding may be eligible
      for this study. There will be 24 participants.

      At an initial evaluation of 2 to 3 hours, patients will have a physical examination and
      undergo blood and urine tests regarding the blood, kidneys, and liver. During the study,
      patients will receive two injections of one of the two experimental malaria vaccines.
      Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients
      will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines
      they receive until the study's end. After each injection, patients will stay in the clinic
      for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined
      and report how they are feeling. Blood and urine samples will be collected at some visits.
      Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one
      injection, he or she will be asked to return to the clinic for routine visits until the
      study's end. After the first 2 months, patients will return to the clinic once a month for 30
      weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the
      vaccine is not harmful as well as to measure the vaccine's effects.

      Risks in this study include pain, swelling, and redness at the injection site; fever; and
      gastrointestinal problems. Some people have had a temporary decrease in white blood cells
      after receiving the vaccine. There is a small chance of a severe allergic reaction. However,
      researchers will closely watch patients immediately after each injection and will give
      treatment if a serious reaction occurs.

      Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...
    

Detailed description: 
      AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The primary objective of this
      Phase 1 study is to evaluate safety and reactogenicity of the vaccine in semi-immune adults
      in Mali. Secondary objectives are to evaluate the immunogenicity of the vaccine. The study is
      a double blind Phase 1 clinical trial in healthy adult volunteers. Volunteers will be
      screened and 24 participants will be enrolled and randomly assigned to one of the two groups:
      12 volunteers will receive two doses of 80 microgram AMA1-C1/Alhydrogel + 500 microgram CPG;
      12 volunteers will receive 80 microgram AMA1-C1/Alhydrogel, both at a 1-month dosing
      interval. Safety outcome measures are local and systemic (including laboratory) adverse
      events. Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay
      (ELISA) and growth inhibition assay (GIA), and will be compared between groups. Peripheral
      blood lymphocytes will be assayed for the presence of AMA-1-specific memory B cells and for
      the total number of memory B cells.
    

Intervention name(s): AMA1-C1/Alhydrogel + CPG 7909 Vaccine
Intervention type(s): Drug
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Blood Stage; Investigational; Endemic; Malaria