ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

Completed · Phase 1

Conditions studied: Plasmodium Falciparum Malaria

In brief

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.

Key facts

Study ID

NCT00587249

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Starts

2002-07-01

Expected to finish

2005-07-01

Last updated by the study team

2013-04-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female 18 to 45 years of age.
• Willingness to participate in this study as evidenced by a signed, written informed consent.
• An informed consent written exam score of at least 70%.
• If female, willingness to avoid pregnancy and practice adequate birth control from the time of study enrollment until at least 2 months after the third vaccination.
• Agrees to refrain from blood donation during the course of the study.
• Agrees to be available for all scheduled study visits (vaccinations and follow-up).
• Agrees not to participate in concurrent vaccine or drug trials other than those evaluating Apovia's ICC-1132.

You may not qualify if…

• 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
• History of cancer (except basal call carcinoma of the skin and cervical carcinoma in situ)
• Evidence of liver or other reticuloendothelial disease, as indicated by any of the following:
• 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)
• Females <10.5 g/dL or >18 g/dL
• Males <11.5 g/dL or >20 g/dL History of greater than or equal to 2 hospitalizations for invasive bacterial infections (pneumonia, meningitis) History of hemoglobinopathy such as sickle cell disease or thalassemia Diagnosis of collagen vascular disease such as lupus or dermatomyositis Positive serology for HIV antibody
• History of diabetes mellitus or a 3-hour fasting blood glucose >125 mg/dL
• Evidence of pulmonary disease as indicated by any of the following:
• 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
• Is required to take a daily medication other than vitamins, levothyroxine, birth control pills, hormone replacement therapy for menopause, or the following medications for attention deficit hyperactivity disorder (pemoline [Cylert], methylphenidate HC1 [Ritalin, Ritalin-SR, Concerta], dextroamphetamine sulfate [Dexedrine, Adderall], bupropion HC1 [Wellbutrin, Wellbutrin-SR])
• Receives allergy shots or uses allergy medications chronically
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol
• Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• Pregnancy (positive urine pregnancy test immediately prior to each dose, or positive serum pregnancy test during screening) or breastfeeding
• Temperature >38 degrees C (100.4 degrees F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis on vaccination day; subjects may be rescheduled to enter the trial after illness has resolved, as per protocol
• Use of investigational drugs, products or devices within 30 days prior to study drug administration
• Vaccination with live vaccine within 30 days or killed vaccine within 2 weeks
• History of malaria infection or vaccination with candidate malaria vaccine
• Allergy to aminoglycosides, tetracycline, or related antibiotics such as gentamicin, kanamycin or doxycycline
• Weight less than 110 pounds
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol

Where it is running

• University of Maryland Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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