ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

NCT00587249 | Completed Phase 1

• 2 other identifiers: 01-416CVD 16000
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plasmodium Falciparum Malaria

Keywords

Malaria, Plasmodium falciparium, Hepatitis B Core Antigen, Circumsporozoite Epitopes

Outcome Measures

Primary Outcomes (1)

• Provide a preliminary assessment of the safety of ICC-1132 plus alhydrogel in healthy adults and to determine if there are any probable or definitive SAEs.

  Duration of study.

Secondary Outcomes (1)

• Immunogenicity of ICC-1132 plus alhydrogel in healthy human subjects.

  Serum will be collected at the time of each immunization and at 14 and 28 days after each immunization. Day 84 following the 2nd immunization and at Day 56 after the 3rd vaccination and possibly at Day 168 after the 3rd vaccination.

Study Arms (3)

3

EXPERIMENTAL

50 mcg of ICC-1132 with alhydrogel adjuvant.

Biological: Malaria ICC-1132; Biological: Alhydrogel

2

EXPERIMENTAL

20 mcg of ICC-1132 with alhydrogel adjuvant.

Biological: Malaria ICC-1132; Biological: Alhydrogel

1

EXPERIMENTAL

10 mcg of ICC-1132 with alhydrogel adjuvant.

Biological: Malaria ICC-1132; Biological: Alhydrogel

Interventions

Malaria ICC-1132 BIOLOGICAL

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.

1; 2; 3

Alhydrogel BIOLOGICAL

Aluminum hydroxide gel.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Gregson AL, Oliveira G, Othoro C, Calvo-Calle JM, Thorton GB, Nardin E, Edelman R. Phase I trial of an alhydrogel adjuvanted hepatitis B core virus-like particle containing epitopes of Plasmodium falciparum circumsporozoite protein. PLoS One. 2008 Feb 6;3(2):e1556. doi: 10.1371/journal.pone.0001556.

  PMID: 18253503 RESULT

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 7, 2008
• Study Start: July 1, 2002
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: April 12, 2013

Record last verified: 2013-03

Locations

US (1)