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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00587249 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Plasmodium Falciparum Malaria |
Biological: Alhydrogel Biological: Malaria ICC-1132 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase I Trial of ICC-1132, a Candidate Vaccine Against Plasmodium Falciparum Malaria Based on a Viral-like Particle Comprising Recombinant Hepatitis B Core Antigen and Circumsporozoite Epitopes, to Assess Vaccine Safety and Immunogenicity in Healthy Adult Volunteers |
| Enrollment: | 75 |
| Study Start Date: | July 2002 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 3
50 mcg of ICC-1132 with alhydrogel adjuvant.
|
Biological: Alhydrogel
Aluminum hydroxide gel.
Biological: Malaria ICC-1132
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.
|
|
Experimental: 1
10 mcg of ICC-1132 with alhydrogel adjuvant.
|
Biological: Alhydrogel
Aluminum hydroxide gel.
Biological: Malaria ICC-1132
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.
|
|
Experimental: 2
20 mcg of ICC-1132 with alhydrogel adjuvant.
|
Biological: Alhydrogel
Aluminum hydroxide gel.
Biological: Malaria ICC-1132
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-Evidence of renal disease, as indicated by any of the following: Creatinine >1.5 mg/dL within the 7 days before first vaccination RBC or WBC casts in urine Urine protein greater than or equal to 1 plus on urinalysis
-Evidence of cardiovascular disease, as indicated by any of the following: BP >150/90 mmHg in two measurements on different days Hospitalization for heart attack, arrhythmia, or syncope Murmur (other than a functional murmur) detected on physical examination
Positive serology for hepatitis B surface antigen Positive serology for hepatitis C antibody AST or ALT more than 1.5 times normal within the 7 days before first vaccination Hepatosplenomegaly, jaundice, or lymphadenopathy on physical examination
-Evidence of neurological disease, as indicated by any of the following: History of seizures (other than febrile seizures as a child <5 years old) History of unconsciousness (other than a single brief "concussion") Recurrent severe headaches or a diagnosis of migraine headaches Focal neurological deficit on physical examination suggesting a pathologic process
-Evidence of gastrointestinal disease, as indicated by any of the following: Recurrent diarrhea (>5 episodes during the past 6 months, each lasting at least 3 days, with at least one week between episodes) Frequent indigestion or heartburn that requires daily antacids or other medical therapy Diagnosed by a doctor as having uncontrolled irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, or stomach or intestinal ulcers Blood in the stool during the past year (other than occasional small amount from straining or hemorrhoids)
-Evidence of hematologic, rheumatologic, or immunologic disease, as indicated by any of the following: WBC <3.0 x 10^3/mm^3 or >13.5 x 10^3/ mm^3 within the 7 days before first vaccination Absolute neutraophil count <1500/ mm^3 within the 7 days before first vaccination Hemoglobin (within the 7 days before first vaccination)
History of asthma requiring the use of oral medications or metered dose inhalers in the previous 12 months Wheezes, rales, or prolonged expiratory phase on auscultation of the lungs
Contacts and Locations
More Information
| Responsible Party: | Robert Johnson, HHS/NIAID/DMID |
| ClinicalTrials.gov Identifier: | NCT00587249 History of Changes |
| Other Study ID Numbers: | 01-416, CVD 16000 |
| Study First Received: | January 3, 2008 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration |
|
Malaria, Plasmodium falciparium, Hepatitis B Core Antigen, Circumsporozoite Epitopes |
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Aluminum Hydroxide Adjuvants, Immunologic |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |