AnthraxNCT00050310
Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
An observational study of Anthrax and Bacillus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Anthrax, Bacillus Infections
- Type of treatment
- Vaccines
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2002to not given
- Phase
- Observational
- 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 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who have recovered from anthrax infection. Cohorts are based on route of infection.
Who may be able to join
- Subjects at least 3 years old, 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. Women of child-bearing age or potential will not be excluded from participation but pregnancy status will be determined by serum or urine pregnancy test at time of enrollment in order to optimize subsequent evaluation and care.
- 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
Show all 38Show fewer
- 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
- --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
- 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).
- Exposed individuals who are clinically asymptomatic.
- Past or imminent vaccination in healthy (non-anthrax exposed).
- 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
- Participant agrees to stored samples.
Who cannot join
- Inability of subject or Legally Authorized Representative (LAR) to understand or subject not willing to sign a written informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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:
Read more
- People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering);
- People exposed to anthrax who have no clinical symptoms.
- 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
- 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.
Read the detailed description
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 Anthrax Vaccine Adsorbed (AVA) vaccine.
- Conditions
- Anthrax, Bacillus Infections
- Keywords
- Anthrax, Natural History, Vaccinated Healthy Volunteer
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2002 (estimated)
- Study start31 Oct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnthraxStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary E Wright, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050310
- Sponsor's protocol ID
- 020110
- Other IDs
- 02-I-0110
- Status last verified
- 6 Aug 2026
- First submitted
- 3 Dec 2002
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11606978Shafazand 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.
PubMed 10559102Centers 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.
PubMed 11724150
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Anthrax: A Study of Primary Infected, Recovered, and Exposed (SPoRE) Individuals and Evaluation of AVA Vaccinated Recipients
- ClinicalTrials.gov ID
- NCT00050310
- Acronym / sponsor ID
- 020110
- Conditions
- Anthrax, Bacillus Infections
- Keywords
- Anthrax, Natural History, Vaccinated Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 31 Oct 2002 (actual)
- First posted
- 4 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- People with confirmed or suspected anthrax (inhalational, cutaneous or gastrointestinal, either acute or recovering);
- People exposed to anthrax who have no clinical symptoms.
- 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
- 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.
Detailed description
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 Anthrax Vaccine Adsorbed (AVA) vaccine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who have recovered from anthrax infection. Cohorts are based on route of infection.
Key inclusion criteria (38 listed)
- Subjects at least 3 years old, 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. Women of child-bearing age or potential will not be excluded from participation but pregnancy status will be determined by serum or urine pregnancy test at time of enrollment in order to optimize subsequent evaluation and care.
- 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)
- --nonspecific febrile illness followed by sepsis and/or respiratory failure
Key exclusion criteria (1 listed)
- Inability of subject or Legally Authorized Representative (LAR) to understand or subject not willing to sign a written informed consent document.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the natural history of anthrax and immune response to anthrax antigens over time
Time frame: 2 years
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 11606978Dalton 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.
- Background: PubMed 10559102Shafazand 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.
- Background: PubMed 11724150Centers 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Wright, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anthrax and Bacillus Infections, 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 38 inclusion and 1 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 22 Sep 2026. 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.
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?
evaluate the natural history of anthrax and immune response to anthrax antigens over time (time frame: 2 years). 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 NCT00050310, which also lists 3 linked publications.
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 22 Sep 2026.