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Bacillus Anthracis (Anthrax)Phase 4NCT01641991

Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule

A Phase 4 study testing BioThrax® in people with Bacillus Anthracis (Anthrax), run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Bacillus Anthracis (Anthrax)
What is being tested?
BioThrax®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
4 sitesUnited States
Study dates
Jul 2012to Jun 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject able to provide informed consent;
  • Female or male, 18 through 65 years of age, inclusive;
  • If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus) or use acceptable contraception, initiated at least 30 days prior to the first study vaccination through 56 days after the 6 month boost vaccination in order to avoid pregnancy:
  • A woman is considered of childbearing potential unless post-menopausal (>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
  • Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other Food and Drug Administration (FDA)-approved contraceptive method
  • Be willing and able to return for all visits and blood collections for the duration of the study;
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  • Be able to understand and comply with planned study procedures;
  • Agree to complete the memory aid and to report concomitant medications and Adverse Events during the study period.
  • Further clarification of inclusion/exclusion criteria:
  • Provided a subject meets all study inclusion criteria and none of the study exclusion criteria, the following conditions will not exclude the subject from study participation:
  • History of gestational diabetes;
  • Type II diabetes controlled with diet or oral hypoglycemic medications;
  • Treated, controlled, uncomplicated hypertension;
  • History of coronary artery disease, asymptomatic (New York Heart Association [NYHA] Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least two years post-myocardial infarction, cardiac bypass surgery and/or percutaneous coronary interventions (e.g., angioplasty, stent placement) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician;
  • Cured, non-metastatic cancer (excluding hematologic malignancies), disease-free for five years;
  • Localized skin cancer, resected (including squamous cell and basal cell carcinomas). Participants with a history of melanoma must be disease-free for five years;
  • Exercise-induced bronchospasm controlled with inhaled medication(s) only;
  • Mild asthma: Subjects who have not been hospitalized for asthma in the past two years and use only inhalers to control their symptoms will be eligible. Only low to medium doses of inhaled steroids, defined as </=3 puffs a day, are allowed. Persons who require oral or parenteral steroids will not be eligible.
  • Subjects with isolated entrapment neuropathies, such as carpal tunnel syndrome, or compression neuropathies, such as lumbar radiculopathy, that are not associated with systemic disease or immune dysfunction may be eligible for enrollment. If the subject's condition has been stable for six months, surgery is not planned for the condition, the neurologic examination is normal (specifically no weakness or paresthesias), and the mononeuropathy will not interfere with the assessment of reactogenicity, the subject is eligible.
  • Subjects with vitiligo who are otherwise healthy and the vitiligo is not widespread in the area of the vaccinations may be eligible for enrollment.
  • Subjects with seasonal allergies are eligible provided the dose of nasal steroids that are used is < 800µg/day.

Who cannot join

  • Have a prior history of anthrax or immunization against anthrax;
  • Intend to enlist in the military during the study;
  • Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex;
  • (Females only) Be pregnant, plan to become pregnant at any time between the Screening Visit through 56 days after the 6 month boost vaccination, or refuse to use/not have used an acceptable method of birth control (see Inclusion Criterion 3) from 30 days prior to the first study vaccine dose through 56 days after the 6 month boost vaccination;
  • Have received experimental products within 30 days before study entry or plan to receive experimental products at any time during the study;
  • Have received a live vaccine within 30 days before study entry or plan to receive a live vaccine prior to Day 63 of the study or within 30 days of the 6 month boost;
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  • Have received an inactivated vaccine within 14 days before study entry or plan to receive an inactivated vaccine from Day 0 to Day 42 or within 14 days of the 6 month boost;
  • Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry or plan to receive immunosuppressive therapy at any time during the study;
  • Have received cytotoxic therapy in the previous 5 years or plan to receive cytotoxic therapy at any time during the study;
  • Have received parenteral immunoglobulin or blood products within 3 months of the study or plan to receive parenteral immunoglobulin or blood products at any time during the study;
  • Have a history of Guillain-Barré Syndrome;
  • Have an active malignancy or history of metastatic or hematologic malignancy;
  • Have Type I diabetes or Type II diabetes treated with insulin;
  • Have cardiovascular disease (including any person with a history of cardiomyopathy or congestive heart failure);
  • Have moderate to severe asthma, chronic obstructive pulmonary disease or other significant pulmonary disease;
  • Have hepatic or renal insufficiency;
  • Have an autoimmune, inflammatory, vasculitic or rheumatic disease including but not limited to systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis or scleroderma;
  • Have HIV, hepatitis B or hepatitis C infection;
  • Have any other condition known to produce or be associated with immunosuppression;
  • Have neuropathy or any other evolving neurological condition;
  • Have an ongoing drug abuse/dependence (including alcohol) issues or a history of these issues within five years of enrollment;
  • Have a seizure disorder;
  • Have moderate or severe illness and/or an oral temperature >100.4 F within 3 days prior to vaccination;
  • Have a blood pressure, heart rate or respiratory rate of Grade 2 or higher;
  • Have any chronic condition that, in the opinion of the Investigator, would render vaccination unsafe or would interfere with study evaluations or completion of the study;
  • Have a total White Blood Cell (WBC) count, Absolute Neutrophil Count (ANC), hemoglobin or platelet count that is Grade 2 or higher;
  • Have a creatinine higher than the normal range;
  • Have an Alanine Aminotransferase (ALT) of >/= 1.2 x Upper Limit of Normal;
  • Have a value higher than trace for glucose and/or protein on urinalysis;
  • Have a history of hospitalization for psychiatric illness, suicide attempt, or confinement for danger to self or others, within the past 10 years. (Subjects with a psychiatric disorder [not meeting exclusion criteria, e.g. attention-deficit hyperactivity disorder] that is controlled for a minimum of 3 months and the investigator has determined that the subject's mental status will not compromise the subject's ability to comply with protocol requirements may be enrolled);
  • Be taking any of the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate;
  • Be taking more than one antidepressant drug not included in the list above (subjects taking only one antidepressant drug [not listed in excluded psychiatric drugs] who are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study provided the investigator determines the subject's mental status will not compromise the subject's ability to comply with protocol requirements);
  • Have donated blood within 30 days of enrollment or plans to donate blood during the study.
  • Have a tattoo in the area of the vaccination sites which will interfere with the assessment of injection site reactogenicity.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory Children's Center - Pediatric Infectious Diseases

    Atlanta, Georgia, 30322-1014

  • Cincinnati Children's Hospital Medical Center - Infectious Diseases

    Cincinnati, Ohio, 45229-3026

  • Baylor College of Medicine - Molecular Virology and Microbiology

    Houston, Texas, 77030-3411

  • Group Health Research Institute - Seattle

    Seattle, Washington, 98101-1466

Other trials in United States

About this study

Official title: A Randomized Trial for the Assessment of Immunogenicity and Safety of Four Different Dosing Regimens of BioThrax® for Post-Exposure Prophylaxis for Anthrax in Adults

A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a major biothreat.

Read the detailed description

This is a Phase IV, randomized, open-label immunogenicity and safety study to evaluate four dosing regimens of BioThrax® for Post-Exposure Prophylaxis (PEP) for anthrax. BioThrax® will be administered as a subcutaneous (SC) injection for the primary series and will be administered as an intramuscular (IM) injection for the boost. The four dosing regimens are: 0.50mL BioThrax® on Days 0, 14, and 6 month boost; 0.50mL BioThrax® on Days 0, 28 and 6 month boost; 0.50mL BioThrax® on Days 0, 14, 28 and 6 month boost and 0.25mL BioThrax® on Days 0, 14, and 28, 6 month boost with 0.50ml IM Approximately 300 subjects will be randomized 1:1:1:1 to one of the four study arms. Enrollment will be stratified by gender, with approximately equal numbers of males and females (18 through 65 years) enrolled into each dosing regimen. The Primary objective is to evaluate the immunogenicity of the four dosing regimens of BioThrax® using the Toxin Neutralization Assay (TNA). The secondary objective is to evaluate the safety of the four dosing regimens of BioThrax®.

Being tested
BioThrax®
Keywords
Bacillus anthracis, anthrax, vaccine, BioThrax®, dose-sparing
Medical subject headings
Anthrax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioThrax®Biological

    BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups

  • BioThrax®Biological

    BioThrax® will be administered as: Arm A: 0.50mL SC injection on Days 0 and 14; Arm B: 0.50mL SC injection on Days 0 and 28; Arm C: 0.50mL SC injection on Days 0, 14 and 28; Arm D: 0.25 mL SC injection on Days 0, 14 and 28.

Study groups in NCT01641991
Study groupRoleWhat they receive
Arm B: 0.50mL BioThrax®ExperimentalBioThrax® 0.50mL subcutaneously on Days 0, 28 and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects
Receives: Biological: BioThrax®
Arm C: 0.50mL BioThrax®ExperimentalBioThrax® 0.50mL subcutaneously on Days 0, 14, 28 and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects
Receives: Biological: BioThrax®
Arm D: 0.25mL BioThrax®ExperimentalBioThrax® 0.25mL subcutaneously on Days 0,14, and 28,and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects
Receives: Biological: BioThrax®
Arm A: 0.50mL BioThrax®ExperimentalBioThrax® 0.50 ml subcutaneously on Days 0, 14, and 0.50mL BioThrax® intramuscular 6 month boost; 75 subjects
Receives: Biological: BioThrax®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.

    Measured: Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100

Secondary outcomes (18)

  1. Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (4.64) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.

    Measured: Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.

  2. Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity

    Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Day 0

  3. Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity

    Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Day 14

  4. Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity

    Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Day 28

  5. Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity

    Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Month 6

  6. Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)

    Participants were given a ruler with the memory aid to measure the occurrence of edema (swelling) and erythema (redness) daily for at least 8 days after each vaccination. Participants are counted in this outcome measure if they had measurements of greater than 120 mm in the 8-day period after at least one vaccination, first separately for edema and erythema, and in the last category, edema and/or erythema, if they had either or both reactions of greater than 120 mm.

    Measured: Days 0-7 after each vaccination

  7. TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (0.03) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.

    Measured: Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.

  8. Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. To determine the group peak GMC, the highest antibody concentration assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of subjects' peak concentrations was calculated along with the 95% confidence intervals.

    Measured: Day 7 through Day 100

  9. Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.

    Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Day 0

  10. Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.

    Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Day 14

  11. Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.

    Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Day 28

  12. Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.

    Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.

    Measured: Days 0-7 after vaccination at Month 6

  13. Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity

    Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.

    Measured: Day 0-7 after vaccination at Day 0

  14. Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity

    Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.

    Measured: Day 0-7 after vaccination at Day 14

  15. Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity

    Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.

    Measured: Day 0-7 after vaccination at Day 28

  16. Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity

    Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.

    Measured: Day 0-7 after vaccination at Month 6

  17. Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. A participant met the threshold of a 4-fold rise in anti-PA IgG antibody concentration if the post vaccination concentration was an increase by 4-fold or more from the baseline (Day 0) concentration.

    Measured: Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.

  18. TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100

    Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. To determine the group peak GMT, the highest titer assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of each subjects' peak titers was calculated along with the 95% confidence intervals.

    Measured: Day 7 through Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMar 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01641991
Sponsor's protocol ID
11-0024
Other IDs
N01AI80006C
Status last verified
Apr 2014
First submitted
5 Jul 2012
Last updated
28 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BioThrax® in people with Bacillus Anthracis (Anthrax), run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites 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 21 inclusion and 34 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer (time frame: Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100). 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 NCT01641991.

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 28 May 2014.

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