A Phase 3 interventional study of AV7909 and BioThrax in Anthrax, sponsored by Emergent BioSolutions. Completed at 35 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Emergent BioSolutions · Phase 3, Interventional, and Prevention
This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to that induced by the currently licensed vaccine, BioThrax®, (Anthrax Vaccine Adsorbed; AVA) for post-exposure of anthrax disease.
This is a Phase 3, multicenter, randomized, double-blind, parallel-group trial designed to evaluate the lot consistency (using three consecutively manufactured lots), immunogenicity, and safety of AV7909 administered in healthy adults for an indication of postexposure prophylaxis (PEP) of anthrax.
Healthy adults between 18 and 65 years of age (inclusive) will sign and date an informed consent form and then be screened for eligibility for participation in the study 2 to 28 days prior to randomization. Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups on Day 1. Randomization will be stratified by site.
Participants will be evaluated for safety through Day 64 [or the early withdrawal visit (EWV)], as assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of Adverse Events (AE) including Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI), vital signs, and physical examinations. Adverse Events of Special Interest are adverse events associated with autoimmune disease as defined by the Center for Biologics Evaluation and Research, and might represent a safety signal for vaccine-associated autoimmunity. Reactogenicity (solicited systemic and injection site reactions) will be assessed daily by the participants using electronic diaries (e-diaries) after each vaccination.
Information on the use of medications will be collected at each study visit. In addition, blood samples for auto-antibody assessment will be taken at Day 1 predose and Day 64 (or Early Withdrawal Visit).
Participants who receive at least one dose of vaccine but who for any reason discontinue vaccinations prematurely will be asked to participate in the further planned study visits up to Day 64 for safety assessment only.
Participants who receive at least one dose of vaccine will also be asked to participate in safety follow-up phone calls occurring on Day 43, Month 4, Month 7, Month 10, and Month 13 (nominally 0.5, 3, 6, 9, and 12 months after the last vaccination) to collect information on AEs, SAEs and any potential AESIs. Based on responses at these phone contacts, participants may be asked to return to the clinic for an unscheduled visit to provide blood samples for auto-antibody testing to investigate reports of potential AESIs.
Independent safety oversight will be provided by a Data Safety Monitoring Board, which will be notified of significant AEs as determined by the Medical Monitor on an ongoing basis.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 3,689 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) 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.
Exclusion Criteria:
Woman of refusing to practice an adequate method of from at least one month before Day 1 and continuing through Month 13.
An adequate method of contraception is defined as abstinence from sexual intercourse; prior bilateral tubal ligation; monogamous relationship with a vasectomized partner (vasectomy performed at least six months prior to the participant's screening visit); or any of these forms of birth control: pill, intrauterine device (IUD), implantable or injectable contraceptive (for example, Norplant® or Depo-Provera®), removable device (for example, NuvaRing® or Evra® patch), or double-barrier method (condom with spermicide, diaphragm with spermicide). The Principal Investigator and/or designee will discuss with the participant the need to use adequate contraception consistently and correctly and document such conversation in the participant's chart. In addition, the Principal Investigator and/or designee will instruct the participant to call immediately if the selected contraception method is discontinued or if pregnancy is known or suspected.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. Groups 1 to 3 will each receive one of the three consecutively manufactured lots of AV7909, per the study visit schedule.
Biological: AV7909
Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. Groups 1 to 3 will each receive one of the three consecutively manufactured lots of AV7909, per the study visit schedule.
Biological: AV7909
Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. Groups 1 to 3 will each receive one of the three consecutively manufactured lots of AV7909, per the study visit schedule.
Biological: AV7909
Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. In Group 4, one lot of BioThrax® vaccine will be administered, per the study visit schedule.
Biological: BioThrax
AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. BioThrax is licensed for post-exposure prophylaxis of anthrax disease. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.
BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64
GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.
Time frame: Day 64 (seven weeks after second AV7909 vaccination)
Percentage of Participants in AV7909 Lot 1, Lot 2 and Lot 3 Groups Achieving a TNA NF50 ≥0.56 on Day 64
Proportion of participants with TNA NF50 ≥0.56 at Day 64 in each AV7909 study groups (Lot 1, Lot 2, Lot 3). The assessment of the immune response in each study group was pre-defined as the lower bound of the two-sided 95% CI to be ≥40% for the percentage of AV7909 participants in each of the three lots achieving a TNA NF50 ≥0.56 at seven weeks after second AV7909 vaccination (Day 64).
Time frame: Day 64 (seven weeks after second AV7909 vaccination)
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.56 on Day 64
Percentage of AV7909 participants (from all three AV7909 study groups pooled) achieving a TNA NF50 ≥0.56 on Day 64 (seven weeks after second AV7909 vaccination). The assessment of the immune response in AV7909 participants was pre-defined as the lower bound of the two-sided 95% CI for proportion of AV7909 participants with TNA NF50 ≥0.56 at Day 64 ≥40%.
Time frame: Day 64 (seven weeks after second AV7909 vaccination)
Percentage of AV7909 Participants and BioThrax Participants With TNA NF50 ≥0.29 at Day 64
Proportion of AV7909 participants (in each AV7909 study groups) and BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. Non-inferiority of AV7909 vaccine to BioThrax vaccine at Day 64 was assessed as determined by the two-sided lower bound for the 95% CI of the difference in the percentage of AV7909 participants (three lots pooled) with a TNA NF50 ≥0.29 and the percentage of BioThrax participants with a TNA NF50 ≥0.29 being greater than -15%.
Time frame: Day 64 (seven weeks after second AV7909 vaccination; five weeks after third BioThrax vaccination)
Incidence of Serious Adverse Events
Number of AV7909 participants or BioThrax participants who received at least one vaccination and reported serious adverse event(s) (SAEs) from the time of the first vaccination on Day 1 through Day 394.
Time frame: Day 1 though Day 394
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29.
Proportion of AV7909 participants (in each AV7909 study group) who achieved TNA NF50 ≥0.15 at Day 29 (two weeks after second AV7909 vaccination). Assessment of the lower bound of the two-sided 95% CI to be ≥67% for the percentage of AV7909 participants in AV7909 study groups 1-3 (Pooled AV7909) achieving a TNA NF50 ≥0.15 on Day 29 was performed.
Time frame: Day 29 (two weeks after second AV7909 vaccination)
Incidence of Adverse Events
Number of AV7909 or BioThrax participants who received at least one vaccination and had at least one treatment-emergent adverse event reported from the time of the first vaccination on Day 1 through Day 64.
Time frame: Day 1 through Day 64
Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology)
Incidence of adverse events of special interest (AESIs; events of autoimmune etiology) from the time of the first vaccination on Day 1 through Day 394 in participants who received at least one dose of AV7909 (Lot 1, Lot 2 or Lot 3) or BioThrax vaccines.
Time frame: Day 1 through Day 394
Incidence of Solicited Systemic Reactogenicity Events
Incidence of any solicited systemic reactogenicity reaction after any AV7909 or BioThrax vaccination.
Time frame: Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)
Incidences of Solicited Injection Site Reactogenicity Events
Incidence of any solicited injection site reactogenicity reaction after any AV7909 (Lots 1, 2 or 3) or BioThrax vaccination.
Time frame: Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)
| Milestone | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Started | 1053 | 1054 | 1049 | 533 |
| Received at least one study vaccination | 1050 | 1053 | 1048 | 533 |
| Did not receive any study vaccination | 3 | 1 | 1 | 0 |
| Completed | 984 | 977 | 987 | 512 |
| Not completed | 69 | 77 | 62 | 21 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Death | 2 | 2 | 2 | 0 |
| Withdrew: Lost to follow-up | 41 | 52 | 45 | 17 |
| Withdrew: Physician decision | 2 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 16 | 21 | 11 | 4 |
| Withdrew: Other - various | 4 | 1 | 1 | 0 |
| Withdrew: Not treated | 3 | 1 | 1 | 0 |
GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.
| Titer (TNA NF50) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64 | 0.765 (0.718 to 0.814) | 0.741 (0.698 to 0.788) | 0.716 (0.673 to 0.762) | 0.330 (0.299 to 0.363) |
Proportion of participants with TNA NF50 ≥0.56 at Day 64 in each AV7909 study groups (Lot 1, Lot 2, Lot 3). The assessment of the immune response in each study group was pre-defined as the lower bound of the two-sided 95% CI to be ≥40% for the percentage of AV7909 participants in each of the three lots achieving a TNA NF50 ≥0.56 at seven weeks after second AV7909 vaccination (Day 64).
| percentage of participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 |
|---|---|---|---|
| Percentage of Participants in AV7909 Lot 1, Lot 2 and Lot 3 Groups Achieving a TNA NF50 ≥0.56 on Day 64 | 68.9 (65.6 to 72.0) | 65.6 (62.3 to 68.8) | 64.4 (61.1 to 67.6) |
Percentage of AV7909 participants (from all three AV7909 study groups pooled) achieving a TNA NF50 ≥0.56 on Day 64 (seven weeks after second AV7909 vaccination). The assessment of the immune response in AV7909 participants was pre-defined as the lower bound of the two-sided 95% CI for proportion of AV7909 participants with TNA NF50 ≥0.56 at Day 64 ≥40%.
| percentage of participants | Pooled AV7909 |
|---|---|
| Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.56 on Day 64 | 66.3 (64.4 to 68.1) |
Proportion of AV7909 participants (in each AV7909 study groups) and BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. Non-inferiority of AV7909 vaccine to BioThrax vaccine at Day 64 was assessed as determined by the two-sided lower bound for the 95% CI of the difference in the percentage of AV7909 participants (three lots pooled) with a TNA NF50 ≥0.29 and the percentage of BioThrax participants with a TNA NF50 ≥0.29 being greater than -15%.
| percentage of participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Percentage of AV7909 Participants and BioThrax Participants With TNA NF50 ≥0.29 at Day 64 | 87.4 (85.0 to 89.6) | 86.8 (84.3 to 89.0) | 85.7 (83.2 to 88.0) | 61.4 (56.6 to 66.0) |
Number of AV7909 participants or BioThrax participants who received at least one vaccination and reported serious adverse event(s) (SAEs) from the time of the first vaccination on Day 1 through Day 394.
| Participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Incidence of Serious Adverse Events | 21 | 16 | 21 | 4 |
Proportion of AV7909 participants (in each AV7909 study group) who achieved TNA NF50 ≥0.15 at Day 29 (two weeks after second AV7909 vaccination). Assessment of the lower bound of the two-sided 95% CI to be ≥67% for the percentage of AV7909 participants in AV7909 study groups 1-3 (Pooled AV7909) achieving a TNA NF50 ≥0.15 on Day 29 was performed.
| percentage of participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 |
|---|---|---|---|
| Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29. | 98.3 (97.2 to 99.1) | 97.8 (96.6 to 98.7) | 97.4 (96.0 to 98.3) |
Number of AV7909 or BioThrax participants who received at least one vaccination and had at least one treatment-emergent adverse event reported from the time of the first vaccination on Day 1 through Day 64.
| Participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Incidence of Adverse Events | 310 | 315 | 336 | 221 |
Incidence of adverse events of special interest (AESIs; events of autoimmune etiology) from the time of the first vaccination on Day 1 through Day 394 in participants who received at least one dose of AV7909 (Lot 1, Lot 2 or Lot 3) or BioThrax vaccines.
| Participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology) | 5 | 4 | 6 | 2 |
Incidence of any solicited systemic reactogenicity reaction after any AV7909 or BioThrax vaccination.
| Participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Incidence of Solicited Systemic Reactogenicity Events | 885 | 876 | 864 | 414 |
Incidence of any solicited injection site reactogenicity reaction after any AV7909 (Lots 1, 2 or 3) or BioThrax vaccination.
| Participants | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Incidences of Solicited Injection Site Reactogenicity Events | 961 | 961 | 967 | 500 |
Collected over Day 1 through Day 394.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AV7909 Lot 1 | 2/1,050 (0.2%) | 21/1,050 (2%) | 194/1,050 (18.5%) |
| AV7909 Lot 2 | 2/1,053 (0.2%) | 16/1,053 (1.5%) | 199/1,053 (18.9%) |
| AV7909 Lot 3 | 2/1,048 (0.2%) | 21/1,048 (2%) | 204/1,048 (19.5%) |
| BioThrax | 0/533 (0%) | 4/533 (0.8%) | 171/533 (32.1%) |
| Event | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 3/1050 | 2/1053 | 0/1048 | 1/533 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/1050 | 0/1053 | 2/1048 | 0/533 |
| Completed suicidePsychiatric disorders | 0/1050 | 2/1053 | 0/1048 | 0/533 |
| LymphadenitisBlood and lymphatic system disorders | 0/1050 | 0/1053 | 0/1048 | 1/533 |
| PneumoniaInfections and infestations | 1/1050 | 0/1053 | 0/1048 | 1/533 |
| SialoadenitisInfections and infestations | 0/1050 | 0/1053 | 0/1048 | 1/533 |
| Vascular disordersRespiratory, thoracic and mediastinal disorders | 0/1050 | 0/1053 | 0/1048 | 1/533 |
| ThrombosisRespiratory, thoracic and mediastinal disorders | 0/1050 | 0/1053 | 0/1048 | 1/533 |
| Coronary artery diseaseCardiac disorders | 0/1050 | 0/1053 | 1/1048 | 0/533 |
| Myocardial infarctionCardiac disorders | 0/1050 | 0/1053 | 1/1048 | 0/533 |
| Event | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax |
|---|---|---|---|---|
| Injection site indurationGeneral disorders | 24/1050 | 26/1053 | 20/1048 | 122/533 |
| Injection site painGeneral disorders | 46/1050 | 53/1053 | 45/1048 | 49/533 |
| Injection site pruritusGeneral disorders | 10/1050 | 8/1053 | 14/1048 | 42/533 |
| Injection site bruisingGeneral disorders | 18/1050 | 9/1053 | 16/1048 | 27/533 |
| Vaccination complicationInjury, poisoning and procedural complications | 32/1050 | 42/1053 | 41/1048 | 26/533 |
| Procedural headacheInjury, poisoning and procedural complications | 24/1050 | 32/1053 | 31/1048 | 26/533 |
| Injection site swellingGeneral disorders | 7/1050 | 6/1053 | 11/1048 | 24/533 |
| Injection site warmthGeneral disorders | 9/1050 | 5/1053 | 14/1048 | 23/533 |
| Musculoskeletal procedural complicationInjury, poisoning and procedural complications | 28/1050 | 33/1053 | 30/1048 | 19/533 |
| Injection site erythemaGeneral disorders | 8/1050 | 5/1053 | 16/1048 | 17/533 |
Intent-to-Treat Population (i.e., number of randomized participants) is used for baseline analysis.
| Age, Continuous(years) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax | Total |
|---|---|---|---|---|---|
| Mean | 39.2 ± 13.1 | 39.4 ± 13.0 | 39.1 ± 12.9 | 38.7 ± 12.4 | 39.2 ± 12.9 |
| Age, Customized(Participants) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax | Total |
|---|---|---|---|---|---|
| 18-30 years | 323 | 335 | 334 | 169 | 1161 |
| 31-50 years | 472 | 448 | 460 | 254 | 1634 |
| 51-65 years | 255 | 270 | 254 | 110 | 889 |
| Sex: Female, Male(Participants) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax | Total |
|---|---|---|---|---|---|
| Female | 620 | 588 | 618 | 293 | 2119 |
| Male | 430 | 465 | 430 | 240 | 1565 |
| Race/Ethnicity, Customized(Participants) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax | Total |
|---|---|---|---|---|---|
| Race : American Indian or Alaska Native | 4 | 4 | 5 | 2 | 15 |
| Race : Asian | 17 | 17 | 23 | 14 | 71 |
| Race : Black or African American | 168 | 186 | 187 | 88 | 629 |
| Race : Native Hawaiian or Other Pacific Islander | 2 | 4 | 3 | 1 | 10 |
| Race : White | 827 | 818 | 807 | 416 | 2868 |
| Race : More than One Race | 22 | 20 | 14 | 9 | 65 |
| Race : Other | 8 | 3 | 5 | 1 | 17 |
| Race : Unknown | 2 | 1 | 4 | 2 | 9 |
| Ethnicity: Not Hispanic or Latino | 859 | 890 | 897 | 425 | 3071 |
| Ethnicity: Hispanic or Latino | 175 | 154 | 140 | 98 | 567 |
| Ethnicity: Unknown | 4 | 2 | 8 | 4 | 18 |
| Ethnicity: Not Reported | 12 | 7 | 3 | 6 | 28 |
| Region of Enrollment(Participants) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax | Total |
|---|---|---|---|---|---|
| United States | 1050 | 1053 | 1048 | 533 | 3684 |
| Body Mass Index(kg/m^2) | AV7909 Lot 1 | AV7909 Lot 2 | AV7909 Lot 3 | BioThrax | Total |
|---|---|---|---|---|---|
| Mean | 27.0 ± 4.3 | 27.3 ± 4.3 | 27.2 ± 4.4 | 27.3 ± 4.2 | 27.2 ± 4.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2019 to primary completion in Aug 2020, 16 months.
Results were first posted in Dec 2021, 1 year 4 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: AV7909