ICC-1132 - Candidate Vaccine Against P Falciparum Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the safety and immune responses (the body's
      defense system) to an investigational malaria vaccine called ICC-1132. Three different doses
      of the vaccine will be studied in 3 groups of people, and the results will be compared. The
      study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an
      injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood
      samples will be collected approximately 15 times for laboratory studies. Volunteers will
      record their temperature twice per day. Volunteers will complete a daily symptom diary for 7
      days after each vaccination. Volunteers will participate in the study for up to 13 months.
    

Detailed description: 
      This is a Phase I, dose-escalating clinical trial of a candidate malaria vaccine, ICC-1132.
      The primary objective is to assess and compare the safety, reactogenicity, and immunogenicity
      of 3 intramuscular injections of ICC-1132. The vaccine is absorbed to alhydrogel adjuvant.
      Three dose levels, 10 mcg, 20 mcg, and 50 mcg, will be compared. Vaccine will be injected
      intramuscularly on study days 0, 56 +/- 4 and 168 +/- 14, with the exception of the 10 mcg
      dose cohort which will receive only 2 injections, 1 each at 0 and 2 months. The study was
      originally designed as a blinded, dose-escalating trial comparing 3 doses (10, 20, and 50
      mcg) of ICC-1132 in saline to 3 doses of ICC-1132 + alhydrogel (10, 20, and 50 mcg). Prior to
      removing the saline formulated ICC-1132 from the trial, the first 16 eligible volunteers were
      assigned to the 10 mcg cohort, with 8 receiving ICC-1132 in saline and 8 receiving ICC-1132 +
      alhydrogel. The next 3 eligible volunteers were assigned to the 20 mcg cohort and were
      randomly assigned to receive ICC-1132 in saline or ICC-1132 + alhydrogel. The study will
      continue with vaccinations using only the alhydrogel formulation of the vaccine. Subjects
      will be observed for immediate localized or systemic reactions for 30 minutes before being
      released from the clinic. Vital signs and a post-vaccination arm check will be performed
      approximately 30 minutes after vaccine administration. Subjects will return to the outpatient
      clinic for clinical examinations at 24 +/- 6 and 48 +/- 6 hours, and at days 7 +/- 1, 14 +/-
      2, and 28 +/- 4 after each vaccination. Volunteers will complete a daily symptom diary for 7
      days after each vaccination. Additional follow up visits will be done 84 +/- 7 days after the
      second vaccine and 56 +/- 7 days after the third vaccine. A telephone interview will be done
      at day 4 +/- 1 after each immunization and 168 +/- 14 days after the third immunization.
      Participants will be involved in study related procedures for up to 393 days.
    

Intervention name(s): Malaria ICC-1132; Alhydrogel
Intervention type(s): Biological; Biological
Intervention description(s): ICC-1132, a candidate malaria vaccine, with alhydrogel will be in 2 ml glass vials containing ICC-1132 at either 40 mcg/ml or 100 mcg/ml concentration formulated with alhydrogel at 1mg/ml. Each vial will contain approximately 0.8 ml solution to permit recovery of 0.5 ml for injection. When shaken, the solution is off-white to greyish-white turbid liquid free of foreign particulate matter.; Aluminum hydroxide gel.
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria, Plasmodium falciparium, Hepatitis B Core Antigen, Circumsporozoite Epitopes