Safety of and Immune Response to a Malaria Vaccine (MSP1 42-C1) With or Without CPG 7909 Adjuvant
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to a preventive
      malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults. This study will also compare
      responses to two different doses of the malaria vaccine given with or without the adjuvant
      CPG 7909.
    

Detailed description: 
      In 2002, the World Health Organization reported a worldwide malaria incidence of
      approximately 300 million clinical cases annually, with approximately 1 million deaths
      attributed to malaria alone or in combination with other diseases. The parasite Plasmodium
      falciparum is responsible for the majority of these infections and deaths. During P.
      falciparum infection, liver cells are invaded by the parasite and asexual multiplication
      occurs. The liver cells burst, and tens of thousands of infectious particles called
      merozoites are released. A multiprotein complex on the surface of a merozoite is necessary
      for the merozoite to infect a blood cell. MSP1 42-C1 is a malaria vaccine that mimics MSP1
      42, a protein in the multiprotein complex. By introducing this "decoy" form of MSP1 42,
      infection of additional blood cells may be blocked. The adjuvant CPG 7909 is known to elicit
      cell-mediated immunity, the arm of the immune system that defends the body against
      intracellular pathogens such as P. falciparum. This study will evaluate the safety and
      immunogenicity of MSP1 42-C1/Alhydrogel at two different doses in healthy adults. The vaccine
      will be given either alone or with CPG 7909.

      This study will last at least 34 weeks. Participants will be randomly assigned to one of four
      groups:

        -  Group A participants will receive three injections of the lower dose of MSP1
           42-C1/Alhydrogel.

        -  Group B participants will receive three injections of the lower dose of MSP1
           42-C1/Alhydrogel and CPG 7909.

        -  Group C participants will receive three injections of the higher dose of MSP1
           42-C1/Alhydrogel.

        -  Group D participants will receive three injections of the higher dose of MSP1
           42-C1/Alhydrogel and CPG 7909.

      Enrollment into Groups C and D will begin only after safety review of all participants in
      Groups A and B. All participants will receive their assigned injections at study entry, Week
      4, and Week 8, and will be asked to return to the clinic the day after each vaccination for
      clinical evaluation. Participants will be asked to keep a diary for 6 days after each
      vaccination, taking note of their body temperatures and any side effects they experience.
      There will be a total of 18 study visits over 34 weeks. A clinical evaluation will occur at
      each visit. Blood collection, vital signs measurement, and urine collection will occur at
      selected visits.
    

Intervention name(s): MSP1 42-C1/Alhydrogel; CPG 7909
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant MSP1 42-C1/Alhydrogel vaccine (one of two doses); Adjuvant
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Plasmodium falciparum