Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients

NCT00050310 | Recruiting

• 2 other identifiers: 02011002-I-0110
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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
• medical history and physical examination
• 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
• 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.

Conditions

Anthrax; Bacillus Infections

Keywords

Anthrax; Natural History; Vaccinated Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• evaluate the natural history of anthrax and immune response to anthrax antigens over time

  This study is intended to evaluate the natural history of anthrax and the immune response to anthrax over time in four subpopulations of men, women and children with: --acute infection (confirmed or suspected) --recovering phase of infection --exposure to infection --no known or no exposure to infection but a history of anthrax vaccination (AVA) (since no children have received AVA, they will be excluded from this subgroup)

  2 years

Study Arms (4)

Acute Infection (confirmed or suspected)

adults and children with acute anthrax infection

AVA Recipient/Healthy Volunteer

healthy adults who have received AVA vaccine

Recovered

adults and children in recovering phase of anthrax infection

Suspected Exposure

adults and children with suspected exposure to anthrax

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have recovered from anthrax infection. Cohorts are based on route of infection.

You may qualify if:

• Although the study is open to participants at least 3 years old, pediatric anthrax cases are historically rare and essentially of the cutaneous type. Therefore, few, if any pediatric subjects are expected.
• Decisionally impaired subjects will be included in this study only if a Legally Authorized Representative (LAR) understands and is willing to sign a written informed consent document.
• 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
• Cutaneous Anthrax (acute or recovering infection)
• CONFIRMED:
• characteristic lesion (papule-\>vesicular-\>depressed black eschar plus or minus edema, erythema, necrosis, or ulceration)
• AND

You may not qualify if:

• Inability of subject or Legally Authorized Representative (LAR) to understand or subject not willing to sign a written informed consent document.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Dalton R. Genetic sleuths rush to identify anthrax strains in mail attacks. Nature. 2001 Oct 18;413(6857):657-8. doi: 10.1038/35099687. No abstract available.

  PMID: 11606978 BACKGROUND

• Shafazand S, Doyle R, Ruoss S, Weinacker A, Raffin TA. Inhalational anthrax: epidemiology, diagnosis, and management. Chest. 1999 Nov;116(5):1369-76. doi: 10.1378/chest.116.5.1369.

  PMID: 10559102 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Update: Investigation of bioterrorism-related anthrax and adverse events from antimicrobial prophylaxis. MMWR Morb Mortal Wkly Rep. 2001 Nov 9;50(44):973-6.

  PMID: 11724150 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mary E Wright, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemary McConnell, R.N.

CONTACT

(301) 312-1235; rosemary.mcconnell@nih.gov

Mary E Wright, M.D.

CONTACT

(301) 594-6318; marywright@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2002
• First Posted: December 4, 2002
• Study Start: October 31, 2002
• Last Updated: May 1, 2026

Record last verified: 2025-08-13

Locations

US (1)