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Plasmodium Falciparum MalariaPhase 1NCT00587249

ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

A Phase 1 study testing Malaria ICC-1132 and Alhydrogel in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum Malaria
What is being tested?
Malaria ICC-1132 and Alhydrogel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
Jul 2002to Jul 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • -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
Show all 26Show fewer
  • -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
  • History of immediate-type hypersensitivity reaction to any vaccine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Malaria ICC-1132, Alhydrogel
Keywords
Malaria, Plasmodium falciparium, Hepatitis B Core Antigen, Circumsporozoite Epitopes
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Malaria ICC-1132Biological

    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.

  • AlhydrogelBiological

    Aluminum hydroxide gel.

Study groups in NCT00587249
Study groupRoleWhat they receive
3Experimental50 mcg of ICC-1132 with alhydrogel adjuvant.
Receives: Biological: Malaria ICC-1132; Biological: Alhydrogel
2Experimental20 mcg of ICC-1132 with alhydrogel adjuvant.
Receives: Biological: Malaria ICC-1132; Biological: Alhydrogel
1Experimental10 mcg of ICC-1132 with alhydrogel adjuvant.
Receives: Biological: Malaria ICC-1132; Biological: Alhydrogel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Duration of study.

Secondary outcomes (1)

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2008 (estimated)
  2. Study startJul 2002
  3. Primary completionJul 2005
  4. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00587249
Sponsor's protocol ID
01-416
Other IDs
CVD 16000
Status last verified
Mar 2013
First submitted
3 Jan 2008
Last updated
12 Apr 2013
Results posted
No

Publications

  • 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.

    PubMed 18253503

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Malaria ICC-1132 and Alhydrogel in people with Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Duration of study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00587249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.

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