A Phase 4 interventional study of Anthrax Vaccine Adsorbed and Saline injection in Healthy, sponsored by Centers for Disease Control and Prevention. Completed at 5 sites in United States. Open to participants aged 18 Years to 61 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention
Anthrax Clinical Trial Objectives:
To assess whether:
Additionally for the final report we will assess whether:
This study is a 43-month prospective, randomized, double-blind, placebo-controlled comparison of immunogenicity and reactogenicity elicited by BioThrax given by different routes of administration (SQ versus IM) and dosing regimens (as many as 8 doses versus as few as 4 doses). Sterile saline is used as the placebo where doses are dropped in regimens using AVA, and in the all-placebo study group.
This study is conducted among a total of 1564 healthy adult men and women (18 to 61 years of age) at five sites in the United States. Participants were randomized into one of 6 study groups with 260 participants per group. One group receives BioThrax given as currently licensed (SQ with 6 doses followed by annual boosters); another group is given placebo IM (130 participants) or SQ (130 participants) in the currently licensed dosing regimen. The four other groups receive BioThrax IM in modified dosing regimens; placebo is given when a dose of BioThrax is omitted from the licensed dosing regimen. There are a total of 25 required visits for this study, during which all participants receive an injection of vaccine or placebo (8 injections total), have a blood sample drawn (16 or 17 total), and have an in-clinic examination for adverse events (22 total).
Immunogenicity is assessed by assaying 16 serial blood samples obtained from all participants and a 17th sample from a subset of participants before vaccination and at other specified times. Total anti-protective antigen IgG antibody (anti-PA IgG) is quantified using a standardized and validated enzyme-linked immunosorbent assay (ELISA); the primary study endpoints are 4-fold rise in antibody titer and antibody concentration relative to the pre-vaccination titers or assay reactivity threshold. A subset of serum samples is also assayed in an in vitro toxin neutralization assay (TNA) to measure the functional activity of anti-BioThrax antibodies. The kinetics of the immune response to BioThrax are examined at 3 time points in the study and blood samples from a subset of participants will be further tested in correlates of protection and immunogenetics substudies. All adverse events (AEs), including vaccine reactogenicity, are actively monitored. While all AEs will be ascertained among study participants, several endpoints will be defined based on the likelihood of their occurrence and/or their clinical importance. Of primary interest is the occurrence of local AEs such as warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. Systemic AEs such as fever, fatigue, muscle ache, headache, temperature, and painful axillary adenopathy are also evaluated.
This study is expected to provide the basis for consideration of change in route of BioThrax administration from SQ to IM and reduction in number of vaccine doses required for primary and booster immunization.
There is an interim analysis of data collected through each participant's first 7 months of this study for consideration in changing the route of BioThrax administration from SQ to IM, and elimination of the 2 week vaccine priming dose.
At the end of the study, the Sponsor will present the entire results of the trial to FDA for consideration in elimination of additional doses from the licensed BioThrax schedule. At that time, the Sponsor will also supplement these data with results from parallel non-human primate challenge studies and additional research on immunologic correlates of protection.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 1,564 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Read/sign Document; Female or male, 18 to 61 years old (up to 62nd birthday); Females must agree to exercise adequate from the time of the screening procedures to one month after the last vaccination; willingness/ability to return for all follow-up visits and blood collections for the duration of the study; ability to understand/comply with planned study procedures; agree to complete the Participant Diary (Appendix G) and to report concomitant medications and AEs during the study period; thave two intact upper arms with sufficient subcutaneous and intramuscular tissue in the deltoid regions for vaccine administration.Potential participants with a history of the following conditions remain eligible for study enrollment: gestational diabetes; treated, controlled, uncomplicated hypertension; treated hypo- or hyperthyroidism; cured nonmetastatic cancer; disease-free for 5 years (excluding hematologic ); localized skin cancer, resected (including squamous cell and basal cell carcinomas, participants with a history of melanoma must be disease-free for 5 years); exercise-induced bronchospasm; mild asthma: use of inhalers only for control of symptoms is acceptable (Persons who have required hospitalization for asthma within the previous 2 years or those who require chronic or frequent oral/parenteral will not be eligible; use of low to medium doses of inhaled steroids; history of coronary artery disease, asymptomatic ( Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least 2 years post-myocardial infarction, cardiac bypass surgery, and/or percutaneous coronary intervention (e.g., angioplasty, stent placement, etc) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician.
Exclusion Criteria:
Prior history of anthrax or immunization against anthrax; Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex; Pregnant/plans to become pregnant for duration of study/does not agree to use adequate from the time of screening procedures to one month after last vaccination; Used cytotoxic therapy in previous 5 years; Cardiovascular disease with significant likelihood of progression over 5 years; Moderate to severe asthma, , other significant pulmonary disease; using high doses of inhaled ; Clinically recognized hepatic or renal insufficiency; Inflammatory, vasculitic, or rheumatic disease including systemic lupus erythematosis, polymyalgia rheumatica and rheumatoid arthritis, scleroderma; Known , or infection; Other conditions known to produce or be associated with immune suppression; Neuropathy or other evolving neurologic condition; Unstable/moderate to severe mental illness; Ongoing drug abuse/dependence (including alcohol); Seizure disorder; Active or history of or hematologic malignancy; current diabetes; Anyone who plans to receive within 60 days of study entry: cytotoxic therapy, experimental products, a outside this trial, therapy, parenteral immunoglobulin or blood products; Anyone who plans to receive an inactivated vaccine outside this trial within 42 days after study entry;: experimental products, a live vaccine outside this trial, immunosuppressive therapy; Anyone who received an inactivated vaccine outside this trial within 14 days prior to study entry, parenteral immunoglobulin or blood products within three months of study. In addition to conditions listed above, temporary exclusion would result from moderate or severe illness and/or oral temperature >100.4˚F within 3 days of injection or chronic condition that, in opinion of investigator, would render injection unsafe or would interfere with evaluations.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Biological: Anthrax Vaccine Adsorbed
receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Biological: Anthrax Vaccine Adsorbed
receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Biological: Anthrax Vaccine Adsorbed
receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.
Biological: Anthrax Vaccine Adsorbed
receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42
Biological: Anthrax Vaccine Adsorbed
Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.
Biological: Saline injection
Also known as: AVA, BioThrax
Local AEs
warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. The number of injections analyzable varies for each event based on the presence or absence of reported data.
Time frame: 4 weeks after each injection
Systemic AEs
Fatigue, Muscle Ache, Headache, Fever, Tender Axillary Lymphnode The number of injections analyzable varies for each event based on the presence or absence of reported data.
Time frame: 4 weeks after each injection
Anti-protective Antigen IgG Geometric Mean Concentration
Geometric mean of the Anti-PA IgG Concentration measured in μg/mL. The lower limit of quantification (LLOQ) is 3.7, results below the LLOQ have been replaced by 1/2 LLOQ (1.85) before taking the geometric mean.
Time frame: 4 weeks after the m1, m6 and m42 injections
Anti-protective Antigen IgG Geometric Mean Titer
Geometric mean of the Dilutional Titer. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by 1/2 LLOQ (29) before taking the geometric mean.
Time frame: 4 weeks after the m1, m6 and m42 injections
4-fold Rise in Anti-protective Antigen IgG Titer Response
Percent of participants who achieved a 4-fold or greater rise in anti-PA IgG Titer relative to the pre-vaccination level at month 0. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by LLOQ (58) before calculating the fold response. Thus the lowest titer that can achieve 4-fold rise is 4\*58 = 232.
Time frame: 4 weeks after the m1, m6 and m42 injections
TNA ED50 Titer
Geometric mean of the ED50. The ED50 is the reciprocal of the dilution at which patient serum neutralizes 50% of a dose of anthrax lethal toxin (ED50). The lower limit of quantification (LLOQ) for this assay is 36, results below the LLOQ have been replaced with 1/2 LLOQ (18) before taking the geometric mean. Note that this secondary endpoint was only performed on \~47% of the participants.
Time frame: 4 weeks after the m1, m6 and m42 injections
| Milestone | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Saline Placebo IM or SQ |
|---|---|---|---|---|---|---|
| Started | 260 | 262 | 256 | 258 | 268 | 260 |
| Completed | 148 | 157 | 146 | 144 | 158 | 144 |
| Not completed | 112 | 105 | 110 | 114 | 110 | 116 |
warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. The number of injections analyzable varies for each event based on the presence or absence of reported data.
| injections | SQ Females | IM Female | SQ Males | IM Male |
|---|---|---|---|---|
| Warmth | 500 | 344 | 186 | 189 |
| Tenderness | 667 | 1398 | 410 | 1075 |
| Itching | 247 | 160 | 80 | 77 |
| Pain | 201 | 569 | 96 | 341 |
| Arm Motion Limitation | 94 | 434 | 50 | 218 |
| Erythema | 723 | 952 | 399 | 603 |
| Induration | 411 | 386 | 195 | 245 |
| Edema | 345 | 528 | 225 | 354 |
| Nodules | 409 | 161 | 133 | 98 |
| Bruise | 69 | 150 | 65 | 32 |
Fatigue, Muscle Ache, Headache, Fever, Tender Axillary Lymphnode The number of injections analyzable varies for each event based on the presence or absence of reported data.
| injections | SQ Females | IM Female | SQ Males | IM Male |
|---|---|---|---|---|
| Fatigue | 118 | 278 | 69 | 182 |
| Muscle Ache | 57 | 226 | 36 | 132 |
| Headache | 90 | 219 | 39 | 105 |
| Fever | 0 | 0 | 0 | 1 |
| Tender Axillary Adenopathy | 10 | 17 | 3 | 8 |
Geometric mean of the Anti-PA IgG Concentration measured in μg/mL. The lower limit of quantification (LLOQ) is 3.7, results below the LLOQ have been replaced by 1/2 LLOQ (1.85) before taking the geometric mean.
| μg/ml | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Anthrax Vaccine Adsorbed 754-IM | Saline Placebo IM or SQ |
|---|---|---|---|---|---|---|---|
| Month 2 | 94.3 (82.1 to 108.3) | 84.5 (73.7 to 96.8) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 46.4 (42.2 to 51.0) | 1.9 (1.9 to 2.0) |
| Month 7 | 201.1 (174.7 to 231.6) | 232.6 (202.4 to 267.3) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 206.9 (187.1 to 227.0) | 1.9 (1.9 to 2.0) |
| Month 43 | 216.8 (185.8 to 253.1) | 320.5 (276.0 to 372.1) | 254.8 (222.0 to 292.4) | 310.0 (270.5 to 355.3) | 433.2 (379.6 to 494.4) | NA (NA to NA) | 1.9 (1.8 to 1.9) |
Geometric mean of the ED50. The ED50 is the reciprocal of the dilution at which patient serum neutralizes 50% of a dose of anthrax lethal toxin (ED50). The lower limit of quantification (LLOQ) for this assay is 36, results below the LLOQ have been replaced with 1/2 LLOQ (18) before taking the geometric mean. Note that this secondary endpoint was only performed on \~47% of the participants.
| ED50 Dilutional Titer | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Anthrax Vaccine Adsorbed 754-IM | Saline Placebo IM or SQ |
|---|---|---|---|---|---|---|---|
| Month 2 | 229.1 (190.9 to 274.9) | 240.8 (196.5 to 295.2) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 165.5 (146.2 to 187.4) | 18.0 (18.0 to 18.0) |
| Month 7 | 1281.1 (1073.9 to 1528.3) | 1630.0 (1354.3 to 1961.7) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 1423.9 (1253.1 to 1617.9) | 18.1 (17.9 to 18.4) |
| Month 43 | 1015.0 (827.8 to 1244.4) | 1540.3 (1274.6 to 1861.4) | 1451.0 (1139.5 to 1847.7) | 1876.2 (1603.1 to 2195.9) | 2825.9 (2175.2 to 3671.3) | NA (NA to NA) | 18.0 (18.0 to 18.0) |
Geometric mean of the Dilutional Titer. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by 1/2 LLOQ (29) before taking the geometric mean.
| Dilutional Titer | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Anthrax Vaccine Adsorbed 754-IM | Saline Placebo IM or SQ |
|---|---|---|---|---|---|---|---|
| Month 2 | 1048.5 (913.1 to 1204.1) | 934.8 (815.6 to 1071.3) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 514.6 (468.1 to 565.7) | 29.7 (28.7 to 30.6) |
| Month 7 | 2211.9 (1921.8 to 2545.9) | 2545.6 (2215.1 to 2925.1) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 2257.0 (2050.1 to 2484.9) | 29.7 (28.7 to 30.8) |
| Month 43 | 2282.4 (1955.8 to 2663.5) | 3425.4 (2950.4 to 3976.9) | 2760.4 (2404.7 to 3168.6) | 3286.4 (2866.5 to 3767.8) | 4683.8 (4103.0 to 5346.8) | NA (NA to NA) | 29.0 (29.0 to 29.0) |
Percent of participants who achieved a 4-fold or greater rise in anti-PA IgG Titer relative to the pre-vaccination level at month 0. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by LLOQ (58) before calculating the fold response. Thus the lowest titer that can achieve 4-fold rise is 4\*58 = 232.
| % of participants with ≥4-fold rise | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Anthrax Vaccine Adsorbed 754-IM | Saline Placebo IM or SQ |
|---|---|---|---|---|---|---|---|
| Month 2 | 94.9 (91.3 to 97.3) | 91.9 (87.6 to 95.0) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 78.8 (75.6 to 81.8) | 0.4 (0.01 to 2.3) |
| Month 7 | 98.6 (96.1 to 99.7) | 98.6 (96.0 to 99.7) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 97.8 (96.3 to 99.0) | 0.5 (0.0 to 2.5) |
| Month 43 | 100.0 (97.5 to 100) | 100.0 (97.7 to 100.0) | 100.0 (97.4 to 100.0) | 99.3 (96.1 to 100.0) | 99.4 (96.5 to 100.0) | NA (NA to NA) | 0.0 (0.0 to 2.6) |
Collected over The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 8-SQ | 0/259 (0%) | 26/259 (10%) | 254/259 (98.1%) |
| 8-IM | 3/262 (1.1%) | 35/262 (13.4%) | 250/262 (95.4%) |
| 7-IM | 2/256 (0.8%) | 27/256 (10.5%) | 249/256 (97.3%) |
| 5-IM AVA | 1/258 (0.4%) | 35/258 (13.6%) | 253/258 (98.1%) |
| 4-IM | 0/268 (0%) | 38/268 (14.2%) | 263/268 (98.1%) |
| Saline Placebo | 1/260 (0.4%) | 27/260 (10.4%) | 200/260 (76.9%) |
| Event | 8-SQ | 8-IM | 7-IM | 5-IM AVA | 4-IM | Saline Placebo |
|---|---|---|---|---|---|---|
| Basal Cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/259 | 1/262 | 3/256 | 2/258 | 5/268 | 5/260 |
| bone fracture(s) following accidentInjury, poisoning and procedural complications | 0/259 | 1/262 | 0/256 | 4/258 | 1/268 | 0/260 |
| Hospitalized for mental disorderPsychiatric disorders | 3/259 | 4/262 | 1/256 | 0/258 | 1/268 | 4/260 |
| cholecystectomySurgical and medical procedures | 2/259 | 0/262 | 3/256 | 0/258 | 0/268 | 0/260 |
| Ceasarian section with healthy infant deliverySurgical and medical procedures | 3/259 | 2/262 | 1/256 | 2/258 | 2/268 | 0/260 |
| CholecystitisHepatobiliary disorders | 3/259 | 0/262 | 2/256 | 1/258 | 0/268 | 0/260 |
| Squamous Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/259 | 1/262 | 1/256 | 1/258 | 1/268 | 3/260 |
| appendectomy secondary to appendicitisSurgical and medical procedures | 0/259 | 1/262 | 0/256 | 0/258 | 3/268 | 3/260 |
| muscle, tendon, or ligament tear/ruptureMusculoskeletal and connective tissue disorders | 0/259 | 0/262 | 1/256 | 2/258 | 3/268 | 0/260 |
| miscarriage/spontaneous abortionReproductive system and breast disorders | 1/259 | 0/262 | 0/256 | 2/258 | 3/268 | 0/260 |
| Event | 8-SQ | 8-IM | 7-IM | 5-IM AVA | 4-IM | Saline Placebo |
|---|---|---|---|---|---|---|
| INJECTION SITE TENDERNESSGeneral disorders | 251/259 | 241/262 | 243/256 | 237/258 | 244/268 | 110/260 |
| INJECTION SITE SWELLING / LUMPGeneral disorders | 248/259 | 215/262 | 218/256 | 200/258 | 184/268 | 120/260 |
| INJECTION SITE ERYTHEMAGeneral disorders | 244/259 | 209/262 | 207/256 | 187/258 | 195/268 | 137/260 |
| INJECTION SITE PAINGeneral disorders | 226/259 | 223/262 | 224/256 | 221/258 | 222/268 | 84/260 |
| INJECTION SITE WARMTHGeneral disorders | 223/259 | 154/262 | 140/256 | 122/258 | 106/268 | 36/260 |
| HEADACHENervous system disorders | 203/259 | 173/262 | 194/256 | 181/258 | 187/268 | 177/260 |
| FATIGUEGeneral disorders | 199/259 | 187/262 | 187/256 | 177/258 | 181/268 | 158/260 |
| MYALGIAMusculoskeletal and connective tissue disorders | 197/259 | 185/262 | 188/256 | 186/258 | 195/268 | 130/260 |
| INJECTION SITE PRURITUSGeneral disorders | 186/259 | 114/262 | 101/256 | 71/258 | 73/268 | 32/260 |
| INJECTION SITE JOINT MOVEMENT IMPAIRMENTGeneral disorders | 163/259 | 179/262 | 177/256 | 176/258 | 188/268 | 42/260 |
mean study group size was 261 (range 260-268); proportions of men 48.8% to women 51.2% was not statistically different across groups or time points; mean age was 39 years; Whites accounted for 74%, Blacks for 21%, and "other" for 5% of participants; less than 5% of study population was Hispanic
| Age, Customized(participants) | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Saline Placebo IM or SQ | Total |
|---|---|---|---|---|---|---|---|
| Age <30 | 77 | 63 | 75 | 77 | 72 | 75 | 439 |
| Age 30-39 | 42 | 57 | 77 | 65 | 60 | 60 | 361 |
| Age 40-49 | 91 | 87 | 54 | 64 | 91 | 73 | 460 |
| Age 50-61 | 49 | 55 | 50 | 52 | 45 | 52 | 303 |
| Sex: Female, Male(Participants) | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Saline Placebo IM or SQ | Total |
|---|---|---|---|---|---|---|---|
| Female | 134 | 135 | 132 | 131 | 136 | 132 | 800 |
| Male | 125 | 127 | 124 | 127 | 132 | 128 | 763 |
| Race/Ethnicity, Customized(participants) | Anthrax Vaccine Adsorbed 8-SQ | Anthrax Vaccine Adsorbed 8-IM | Anthrax Vaccine Adsorbed 7-IM | Anthrax Vaccine Adsorbed 5-IM | Anthrax Vaccine Adsorbed 4-IM | Saline Placebo IM or SQ | Total |
|---|---|---|---|---|---|---|---|
| Race: White | 199 | 197 | 194 | 183 | 201 | 185 | 1159 |
| Race: Black | 47 | 48 | 49 | 62 | 59 | 59 | 324 |
| Race: Other | 13 | 17 | 13 | 13 | 8 | 16 | 80 |
| Ethnicity:Non-Hispanic | 246 | 250 | 247 | 243 | 256 | 251 | 1493 |
| Ethnicity: Hispanic | 13 | 12 | 9 | 15 | 12 | 9 | 70 |
Plan to share: No
The record gives a start of May 2002, a primary completion of Feb 2010 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
Results were first posted in May 2024, 14 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Biothrax
Centers for Disease Control and Prevention →