Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 99 |
| Updated: | 1/17/2019 |
| Start Date: | March 4, 2002 |
| Contact: | Rosemary McConnell, R.N. |
| Email: | rosemary.mcconnell@fnlcr.nih.gov |
| Phone: | (301) 761-6645 |
Natural History of Anthrax: A Study of Primary Infected, Recovered, and Exposed (SPoRE) Individuals and Evaluation of AVA Vaccinated Recipients
This study will examine pathophysiology and immune response of anthrax in infected or exposed
individuals to learn more about the disease symptoms, prevention and response to treatment.
In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine
Adsorbed) in healthy, non-infected individuals.
The following individuals may be eligible for this study:
1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal,
either acute or recovering);
2. People exposed to anthrax who have no clinical symptoms.
3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA.
Those enrolled in the study will undergo the following tests and procedures.
Infected and exposed individuals:
- Symptomatic participants will have the following clinical procedures if medically
necessary:
- a) blood tests for cell counts, chemistries and evidence of anthrax bacteria;
- b) nasal swab to test for evidence of anthrax
- c) chest X-ray;
- d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen);
- e) echocardiogram to examine the heart
- f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and
radio waves to examine the infected area of skin and soft tissue for patients with
cutaneous anthrax.
- All subjects (with or without symptoms) will have the following research procedures:
- a) blood tests to examine immune response to anthrax;
- b) throat swab to test for evidence of anthrax
- c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then
allowed to drain for collection in a cup;
- d) induced sputum to test for presence of and immune response to anthrax. A mask with a
saline mist is placed over the subject s mouth and nose, causing the subject to cough
and produce sputum from the lungs. The sputum is collected in a cup this is for
individuals 18 and older who do not undergo bronchoscopy, described below.
- Participants 18 years of age and older may have the following optional research
procedures:
- a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated
individuals above);
- b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local
anesthetic;
- c) bronchoalveolar lavage. This 15- to 30-minute procedure is done in the intensive care
unit. The mouth, nasal passages, throat and airways are numbed with lidocaine and a thin
flexible tube is passed through the nose into the lung airways. Samples of cells and
secretions are obtained by rinsing (lavage) the airways with salt water. The fluid is
analyzed for infection, inflammatory cells and inflammatory chemicals.
All infected and exposed individuals will have periodic medical history and physical exam
evaluations and be offered treatment or prophylaxis (treatment to prevent infection) with
antibiotics, according to the guidelines of the Centers for Disease Control and Prevention
(CDC). Patients will be monitored for at least 24 months after antibiotic treatment, or
longer if circumstances warrant.
Non-infected, vaccinated individuals
1. medical history and physical examination
2. blood tests-- between 10 and 50 ml (2-10 teaspoons) of blood will be drawn at a time,
and not more than 450 ml will be taken in a 6-week period. Based on the blood test
results, other optional research procedures may be requested
3. leukapheresis to collect white blood cells and plasmapheresis to collect plasma (the
liquid part of the blood). For both of these procedures, blood is collected through a
needle placed in an arm vein. The blood flows into a special machine that separates it
into its components by spinning. The desired components (white cells or plasma) are
removed and the rest of the blood is returned to the body through the same needle or a
second needle in the other arm.
individuals to learn more about the disease symptoms, prevention and response to treatment.
In addition, it will evaluate immune response to the anthrax vaccine AVA (Anthrax Vaccine
Adsorbed) in healthy, non-infected individuals.
The following individuals may be eligible for this study:
1. People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal,
either acute or recovering);
2. People exposed to anthrax who have no clinical symptoms.
3. Healthy people who have not been exposed to anthrax and have been vaccinated with AVA.
Those enrolled in the study will undergo the following tests and procedures.
Infected and exposed individuals:
- Symptomatic participants will have the following clinical procedures if medically
necessary:
- a) blood tests for cell counts, chemistries and evidence of anthrax bacteria;
- b) nasal swab to test for evidence of anthrax
- c) chest X-ray;
- d) computed tomography (CT) scan (special X-rays to examine the lungs or abdomen);
- e) echocardiogram to examine the heart
- f) magnetic resonance imaging (MRI), a special imaging test using a magnetic field and
radio waves to examine the infected area of skin and soft tissue for patients with
cutaneous anthrax.
- All subjects (with or without symptoms) will have the following research procedures:
- a) blood tests to examine immune response to anthrax;
- b) throat swab to test for evidence of anthrax
- c) nasopharyngeal wash to test for anthrax. Water is sprayed into the nostrils and then
allowed to drain for collection in a cup;
- d) induced sputum to test for presence of and immune response to anthrax. A mask with a
saline mist is placed over the subject s mouth and nose, causing the subject to cough
and produce sputum from the lungs. The sputum is collected in a cup this is for
individuals 18 and older who do not undergo bronchoscopy, described below.
- Participants 18 years of age and older may have the following optional research
procedures:
- a) leukapheresis or plasmapheresis (see description under non-infected, vaccinated
individuals above);
- b) lymph node biopsy. A sample of lymph node tissue is surgically removed under local
anesthetic;
- c) bronchoalveolar lavage. This 15- to 30-minute procedure is done in the intensive care
unit. The mouth, nasal passages, throat and airways are numbed with lidocaine and a thin
flexible tube is passed through the nose into the lung airways. Samples of cells and
secretions are obtained by rinsing (lavage) the airways with salt water. The fluid is
analyzed for infection, inflammatory cells and inflammatory chemicals.
All infected and exposed individuals will have periodic medical history and physical exam
evaluations and be offered treatment or prophylaxis (treatment to prevent infection) with
antibiotics, according to the guidelines of the Centers for Disease Control and Prevention
(CDC). Patients will be monitored for at least 24 months after antibiotic treatment, or
longer if circumstances warrant.
Non-infected, vaccinated individuals
1. medical history and physical examination
2. blood tests-- between 10 and 50 ml (2-10 teaspoons) of blood will be drawn at a time,
and not more than 450 ml will be taken in a 6-week period. Based on the blood test
results, other optional research procedures may be requested
3. leukapheresis to collect white blood cells and plasmapheresis to collect plasma (the
liquid part of the blood). For both of these procedures, blood is collected through a
needle placed in an arm vein. The blood flows into a special machine that separates it
into its components by spinning. The desired components (white cells or plasma) are
removed and the rest of the blood is returned to the body through the same needle or a
second needle in the other arm.
The intentional use of Bacillus anthracis in 2001 as a bioterrorism weapon with fatal
consequences renewed interest in past epidemiologic and animal research about pathogenesis
and posed new dilemmas about diagnosis and treatment. Cases in the October 2001 US outbreak
were theoretically exposed via one dispersal method: aerosolization of Ames strain spores.
While some developed the cutaneous anthrax form, others sustained the more serious
inhalational disease. Inhaled spores are known to travel to alveolar macrophages and then
onto the mediastinal lymph nodes where germination to the bacterium form and toxin release
are thought to occur. Infective dose, significance of dormant spores after long-term
antibiotic therapy, spectrum of disease and even precise cause of death remain unknown. This
observational, prospective natural history study was developed during the 2001 outbreak and
is set up to follow participants from the time of exposure through post-recovery (greater
than ten years). Healthy vaccinated participants have been included to evaluate serum titers
and cell markers in relation to dose and frequency of AVA vaccine.
consequences renewed interest in past epidemiologic and animal research about pathogenesis
and posed new dilemmas about diagnosis and treatment. Cases in the October 2001 US outbreak
were theoretically exposed via one dispersal method: aerosolization of Ames strain spores.
While some developed the cutaneous anthrax form, others sustained the more serious
inhalational disease. Inhaled spores are known to travel to alveolar macrophages and then
onto the mediastinal lymph nodes where germination to the bacterium form and toxin release
are thought to occur. Infective dose, significance of dormant spores after long-term
antibiotic therapy, spectrum of disease and even precise cause of death remain unknown. This
observational, prospective natural history study was developed during the 2001 outbreak and
is set up to follow participants from the time of exposure through post-recovery (greater
than ten years). Healthy vaccinated participants have been included to evaluate serum titers
and cell markers in relation to dose and frequency of AVA vaccine.
- INCLUSION CRITERIA:
Subjects of any age, including pregnant women, are eligible for inclusion if they meet one
of the five criteria listed below, are hemodynamically and clinically stable, and agree to
stored samples.
1. Inhalation Anthrax (acute or recovering infection)
CONFIRMED:
--nonspecific febrile illness followed by sepsis and/or respiratory failure
AND
--B anthracis isolation (via culture) from any site OR 2 supportive lab tests
OR SUSPECTED:
--nonspecific febrile illness followed by sepsis and/or respiratory failure with no
alternative diagnosis
AND
--one supportive lab test OR direct epidemiological link to a confirmed environmental
exposure
2. Cutaneous Anthrax (acute or recovering infection)
CONFIRMED:
--characteristic lesion (papule->vesicular->depressed black eschar plus or minus
edema, erythema, necrosis or ulceration)
AND
--B anthracis isolation (culture) from any site OR 2 supportive lab tests
SUSPECTED:
--Characteristic lesion with no alternative diagnosis
AND
--one supportive lab test OR direct epidemiological link to a confirmed environmental
exposure
3. Gastrointestinal Anthrax (acute or recovering infection)
CONFIRMED:
--Severe abdominal pain often associated with bloody vomiting/diarrhea followed by
fever/septicemia
AND
--B anthracis isolation (culture) from any site OR 2 supportive lab tests
SUSPECTED:
--Severe abdominal pain often associated with bloody vomiting/diarrhea followed by
fever/septicemia with no alternative diagnosis
AND
--1 supportive lab test OR direct epidemiological link to a confirmed environmental
exposure
These definitions were subsequently updated by the CDC in 2010 to accept clinically
compatible symptoms plus one of the following: a positive culture, a positive
immunohistochemical stain for antigen, a 4-fold increase in anti-PA IgG or a positive
documented exposure with detection of DNA via PCR (26).
4. Exposed individuals who are clinically asymptomatic.
5. Past or imminent vaccination in healthy (non-anthrax exposed).
6. Hemodynamically and clinically stable at time of evaluation at NIH.
- Hemodynamically: stable vital signs
- Clinically: no obvious signs of disease progression (e.g. worsening pleural
effusions or increasing cutaneous edema)
- acute/newly recovered patients must be receiving standard antimicrobial therapy
7. Participant agrees to stored samples.
EXCLUSION CRITERIA:
Inability to sign informed consent or lack of designated Health Power of Attorney.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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