Examining the natural history and immune response of anthrax in infected and vaccinated individuals

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

This study looks at how anthrax affects people who are infected or exposed, as well as how well the anthrax vaccine works in healthy vaccinated individuals.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 3 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00050310 on ClinicalTrials.gov

What this trial studies

This observational study investigates the pathophysiology and immune response of individuals infected with or exposed to anthrax, as well as the immune response in healthy vaccinated individuals. Participants include those with confirmed or suspected anthrax, those exposed without symptoms, and healthy individuals vaccinated with the anthrax vaccine AVA. The study aims to gather data on disease symptoms, prevention, and treatment responses over a long-term follow-up period. Clinical procedures such as blood tests and nasal swabs will be conducted to assess the presence of anthrax bacteria and immune markers.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed or suspected anthrax infections, those exposed to anthrax, and healthy vaccinated individuals.

Not a fit: Patients with no history of exposure to anthrax and who have not been vaccinated may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of anthrax infection and improve prevention and treatment strategies.

How similar studies have performed: While this study builds on past research regarding anthrax, its specific observational approach to long-term follow-up is relatively novel.

Eligibility criteria

* INCLUSION CRITERIA:

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.

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

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Mary E Wright, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Rosemary McConnell, R.N.

Conditions Anthrax; Bacillus Infections; Natural History; Vaccinated Healthy Volunteer