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Home > "R" Clinical Trials Conditions > rPA (Anthrax)  rPA (Anthrax)
rPA (Anthrax)
For Condition: Anthrax
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The primary objective is to determine the tolerability and safety, from days 0 to 210, of escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the action of the principle drug) given in a two-dose, intramuscular regimen to healthy adults. The secondary objective is to evaluate antibody responses to rPA, from days 0 to 210, following one of four escalating doses of vaccine given with and without Alhydrogel given in a two-dose series to healthy adults, and to compare immune responses following rPA with those following BioThrax (tm) given by either the intramuscular or SQ route. The tertiary objective is to describe the antibody kinetics following vaccination. This information will be used to determine the most probable optimal dose of rPA and/or Alhydrogel that is safe, well tolerated, and maximally immunogenic for use in future phase II trials.
Details: Anthrax is a disease caused by a germ that can infect animals or humans. Humans can become infected on the skin, in the intestines, or in the lungs. The most serious infection is one in the lungs, from which most people will die. A vaccine to protect people against anthrax has been licensed and used in the United States since 1970. For many years after its approval, the only people who needed to get the vaccine were people who worked with infected animal hides, veterinarians, and people working in laboratories that cultured anthrax germs. More recently, though, concerns that in acts of war or terrorism persons or governments may use anthrax spores as a weapon, have made us realize that other people in the United States may need to be vaccinated. Even though the anthrax vaccine currently in use is safe and works, it has some drawbacks. It was developed over 30 years ago, when the technology to make vaccines was not as good as it is today. It is given in a series of 6 shots under the skin over 18 months and requires a booster shot every year after that. It is difficult to make. Vaccines given under the skin (called subcutaneous or SQ vaccines) may lead to more minor side effects such as redness, swelling, and pain at the injection site when compared to shots given in the muscle (called intramuscular, or IM, vaccines). For these reasons, we are testing a new vaccine against anthrax made by modern technology, using fewer shots, and given in the muscle. This new vaccine is called rPA, which stands for recombinant Protective Antigen.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Active Control, Single Group Assignment
Minimum Age/Maximum Age: 18 Years/40 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Age 18 to 40 years, inclusive. - Good health as evidenced by screening evaluation within the 30 days prior to immunization. - Expressed interest and availability to fulfill the study requirements. - Signed, informed consents: screening, HIV antibody testing, stored specimen, HIPAA Authorization, and protocol-specific consents. - Agreement to avoid pregnancy for the 30 days following each vaccination by use of highly effective birth control methods. A highly effective birth control method is defined as one which results in a failure rate less than 1 percent per year when used consistently and correctly. These methods include implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, and a vasectomized partner. - Agreement to refrain from taking any experimental drug or vaccine from day -30 to day 90. EXCLUSION CRITERIA: - History of any of the following medical illnesses: Diabetes mellitus, Cancer, Heart Disease (including hospitalization for heart attack, arrhythmia, or syncope), Unconsciousness (other than a single brief concussion), Seizures (other than simple benign febrile seizures of childhood), Gastrointestinal disease (including inflammatory bowel disease, celiac disease, and ulcers), Recurrent arthritis, Immunodeficiency, Autoimmune disease (including Systemic Lupus Erythematosus), Any current illness requiring daily medication (other than vitamins, contraceptives, and topical medications), Other conditions that in the opinion of the investigator would jeopardize the safety of the subject or the evaluation of the study objectives. - Abnormal physical findings including, but not limited to, the following: Cardiac murmur (other than a functional murmur), Focal neurologic deficit, Hepatomegaly or splenomegaly, Lymphadenopathy, Jaundice, Hypertension (BP greater than 150/90 on 2 separate days), Body Mass Index above 35 or below 19, Body mass index above 35 or below 19, BMI is a measure of weight corrected for height (weight in kg/[height in meters]2). Expected BMI is in the range of 22 to 24. Morbid obesity is defined as BMI greater than 44, and a BMI under 18 may be associated with anorexia. Other physical findings that in the opinion of the investigator would jeopardize the safety of the subject or the evaluation of the study objectives. - A psychiatric condition, including schizophrenia, personality, anxiety, or affective disorders, which in the opinion of the investigator could compromise the subject's ability to participate in the trial. - Known hypersensitivity to a component of the vaccine. - Current drug or alcohol dependence as evidenced by a four-question screening interview to determine whether the subject has had medical, occupational, or family problems related to alcohol or illicit drug use during the past 12 months. These questions are derived from the Drug Abuse Screening Test (DAST-10) developed by the Addiction Research Foundation and recommended by the National Institute for Drug Abuse as a tool for family physicians who wish to routinely screen new patients for drug abuse (http://www.nida.nih.gov/Diagnosis-Treatment/Diagnosis5.html) . - History of receipt of anthrax vaccine or history of diagnosis of or exposure to any form of anthrax. - Member of the Armed Forces who deployed during Desert Storm/Desert Shield or who has been stationed in Korea or Southwest Asia since 1990, given the possibility of previous receipt of the licensed anthrax vaccine. - Positive urine pregancy test within the 24 hours prior to vaccination. - Positive blood test for HIV, hepatitis B surface antigen or hepatitis C antibody, or syphilis (defined as positive RPR and FTA). - Failure to pass the written exam. - Employment in one of the following: any industry involved in contact with ruminant animals such as working in a slaughter house or handling of animal hides or raw wool; veterinary sciences; or others where exposure to B. anthracis may occur. - Screening laboratory values that fall outside the normal range. - Receipt of an experimental vaccine or medication within the 30 days prior to receipt of the study vaccine. - Receipt of a blood product, including immunoglobulin in the 90 days prior to receipt of the study vaccine. - Anything that, in the opinion of the investigator, will compromise the participation of the subject with respect to his/her rights or risks. - Oral temperature greater than 38 degrees Celsius or other acute illness on the day of scheduled vaccination.
Total Enrollment: 80
Location and Contact Information:
University of Maryland Health Ctr - College Park
College Park, Maryland, 20742
United States
University of Maryland School of Medcn - Balt MD
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: 01-003;
Study Start Date: July 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063843
Other Anthrax Studies:
1. Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin
2. rPA (Anthrax)
3. A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
4. Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
Related Studies:
Other Anthrax Clinical Trials
Other Maryland Clinical Trials
Other College Park Clinical Trials
rPA (Anthrax)
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