Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host)
      that enters the human body through the bite of an infected mosquito. The purpose of this
      study is to find out about the safety of an experimental malaria vaccine and whether the
      vaccine causes humans to produce antibodies (proteins made by the body's immune system to
      help control or prevent infection). Four strengths of the vaccine will be tested. The lowest
      strength of the vaccine will be tested before the next higher strength is tested. Each dosage
      (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6
      months. Two people in each dosage group will receive injections of a placebo (contains no
      medication). Participants will include 80 healthy adults between 18 and 40 years of age.
      Multiple blood draws will occur over the duration of the study. Participants will be involved
      in study related procedures for approximately 13 months.
    

Detailed description: 
      This study is a phase I, double-blinded, placebo-controlled, dosage-escalation study of the
      safety and immunogenicity of EBA-175 RII-NG malaria vaccine administered intramuscularly. The
      vaccine is a recombinant Plasmodium falciparum (Pf) erythrocyte-binding antigen 175 kDa
      Region II-nonglycosylated (EBA-175 RII-NG) adsorbed to aluminum phosphate adjuvant. The study
      is being conducted at Baylor College of Medicine, Houston, Texas. Eighty healthy subjects,
      between the ages of 18 and 40 years, males and females, will be recruited from Houston,
      Texas, and will participate in the study for approximately 13 months. Subjects will be
      randomized to receive 3 doses of the vaccine or saline placebo by the intramuscular route in
      a 9:1 ratio at 0, 1 and 6 months. The safety and immunogenicity of ascending dosages of the
      vaccine will be assessed. Eighteen subjects will receive vaccine at each of the following
      dosage levels: 5, 20, 80 and 160 micrograms. Two subjects will receive placebo for each
      dosage level. Dosage escalation will proceed only after review of the 2-week safety data of
      the 2 initial doses of the prior dosage level. The primary study objective is to assess the
      safety and reactogenicity (tolerability) of ascending dosages of EBA-175 RII-NG vaccine among
      healthy subjects given in 3 intramuscular doses at 0, 1 and 6 months. The secondary study
      objective is to evaluate the immunogenicity of the EBA-175 RII-NG vaccine by measuring
      anti-EBA-175 RII-NG antibodies using enzyme-linked immunosorbent assay (ELISA), anti-parasite
      antibodies by indirect fluorescence antibody test (IFAT), inhibition of binding of EBA-175
      RII-NG to red blood cells (RBCs), and inhibition of Pf growth in vitro.
    

Intervention name(s): Aluminum Phosphate; Placebo; EBA-175 RII-NG Malaria Vaccine
Intervention type(s): Biological; Drug; Biological
Intervention description(s): 1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant; dosage 500 micrograms.; 0.5 mL normal saline placebo. Sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride).; White, translucent, cloudy, nonparticulate liquid suspension. Recombinant Plasmodium falciparum erythrocyte-binding antigen 175 kDa Region II-nonglycosylated (EBA-175 RII-NG) absorbed to aluminum phosphate adjuvant; dosage levels 5, 20, 80, and 160 micrograms.
Intervention MeSH terms: Aluminum phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: malaria, falciparum, Plasmodium falciparum malaria, vaccine