A Phase 4 interventional study of AVA and Raxibacumab in Infections, Bacterial, sponsored by Emergent BioSolutions. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Phase 4, Interventional, and Treatment
This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's enrollment of 573 is above the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections 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.
Non- defined as:
Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
Reproductive potential and agrees to follow one of the options listed in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP), from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit at Day 183 (at least five terminal half-lives for raxibacumab).
Exclusion Criteria:
An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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).
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
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.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
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.
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.
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.
Subjects will be administered subcutaneous (SC) 0.5 mL AVA doses on Days 1, 15, and 29 (0, 2, and 4 weeks).
Biological: AVA
Subjects will be administered SC 0.5 mL AVA doses on Days 1, 15, and 29 (0, 2, and 4 weeks), with the first AVA dose administered immediately after completion of a single intravenous (IV) infusion 40 milligram (mg)/kilogram (kg) raxibacumab dose. Subjects will be premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Biological: AVA · Biological: Raxibacumab · Drug: Diphenhydramine
Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration
Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration
Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV
Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups
Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 \[Day 1\] and Week 2 \[Day 15\] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment \[anti-PA Ab concentration at Week 4\]).
Time frame: Day 29
Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups
Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Days 57 and 183
Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups
The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a \>4-fold increase in toxin neutralizing activity \[TNA\] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay.
Time frame: Days 29, 57 and 183
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA.
Time frame: Up to Day 183
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Change From Baseline in Heart Rate at Indicated Time Points
Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Change From Baseline in Respiratory Rate at Indicated Time Points
Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Change From Baseline in Temperature at Indicated Time Points
Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Baseline and up to Day 183
Number of Participants With Hematology Parameters Outside Normal Range
Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Day 57
Number of Participants With Clinical Chemistry Parameters Outside Normal Range
Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time frame: Up to Day 57
Number of Participants With Urinalysis Parameters
Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters.
Time frame: Day 57
This study included healthy volunteers who were not previously immunized against protective antigen. 573 participants were randomized with 566 receiving study treatment and 537 completed the study.
| Milestone | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Started | 287 | 286 |
| Received study treatment | 286 | 280 |
| Completed | 272 | 265 |
| Not completed | 15 | 21 |
| Withdrew: Adverse event | 0 | 6 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 8 | 9 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Withdrawal by subject | 4 | 4 |
Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 \[Day 1\] and Week 2 \[Day 15\] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment \[anti-PA Ab concentration at Week 4\]).
| Microgram/milliliter (µg/mL) | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups | 26.516 (23.580 to 29.816) | 22.477 (20.098 to 25.137) |
Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| µg/mL | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Week 8, n=275, 267 | 50.470 (46.124 to 55.224) | 46.095 (41.860 to 50.757) |
| Week 26, n=267, 258 | 10.007 (9.243 to 10.835) | 10.231 (9.479 to 11.042) |
The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a \>4-fold increase in toxin neutralizing activity \[TNA\] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay.
| Percent of Participants | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Week 4 | 76.4 (71.1 to 81.1) | 99.3 (97.3 to 99.8) |
| Week 8 | 95.3 (92.5 to 97.5) | 98.1 (96.7 to 99.6) |
| Week 26 | 31.9 (27.6 to 38.8) | 32.0 (27.9 to 39.3) |
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA.
| Participants | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Non-serious AEs | 85 | 80 |
| SAE | 5 | 3 |
SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Millimeter of mercury (mmHg) | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| SBP, Day 1, n=286, 280 | -3.4 ± 9.2 | -3.8 ± 9.6 |
| SBP, Day 29, n=283, 279 | 0.6 ± 9.9 | 1.9 ± 9.9 |
| SBP, Day 57, n=282, 275 | 1.8 ± 10.9 | 2.2 ± 10.3 |
| SBP, Day 183, n=273, 266 | 2.4 ± 10.6 | 1.5 ± 9.9 |
| DBP, Day 1, n=286, 280 | -2.7 ± 6.9 | -3.1 ± 6.8 |
| DBP, Day 29, n=283, 279 | 1.0 ± 7.3 | 1.6 ± 6.5 |
| DBP, Day 57, n=282, 275 | 1.9 ± 7.4 | 2.3 ± 7.4 |
| DBP, Day 183, n=273, 266 | 2.3 ± 8.4 | 2.5 ± 7.9 |
Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Beats per minute (bpm) | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Day 1, n=286, 280 | -0.3 ± 10.4 | -0.8 ± 10.5 |
| Day 29, n=283, 279 | -0.4 ± 10.5 | -0.4 ± 10.5 |
| Day 57, n=282, 275 | -1.2 ± 10.6 | -0.9 ± 11.2 |
| Day 183, n=273, 266 | 0.9 ± 11.7 | 0.7 ± 11.5 |
Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Breaths per minute | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Day 1, n=286, 280 | -0.4 ± 1.5 | -0.3 ± 1.5 |
| Day 29, n=283, 279 | -0.1 ± 1.4 | -0.1 ± 1.4 |
| Day 57, n=282, 276 | -0.1 ± 1.5 | -0.1 ± 1.3 |
| Day 183, n=273, 266 | -0.3 ± 1.6 | -0.2 ± 1.5 |
Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Degree celsius | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Day 1, n=286, 280 | -0.04 ± 0.26 | 0.02 ± 0.27 |
| Day 29, n=283, 279 | -0.04 ± 0.24 | -0.03 ± 0.31 |
| Day 57, n=282, 276 | -0.05 ± 0.25 | -0.02 ± 0.25 |
| Day 183, n=272, 266 | -0.04 ± 0.277 | -0.01 ± 0.26 |
Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Participants | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Eosinophils 10^9/Liter (L) Low, Week 4, n=282, 278 | 0 | 0 |
| Eosinophils 10^9/L High, Week 4, n=282, 278 | 4 | 6 |
| Eosinophils 10^9/L, Low, Week 8, n=281, 276 | 0 | 0 |
| Eosinophils 10^9/L, High, Week 8, n=281, 276 | 7 | 5 |
| Basophils 10^9/L, Low, Week 4, n=282, 278 | 0 | 0 |
| Basophils 10^9/L, High, Week 4, n=282, 278 | 0 | 0 |
| Basophils 10^9/L, Low, Week 8, n=281, 276 | 0 | 0 |
| Basophils 10^9/L, High, Week 8, n=281, 276 | 0 | 0 |
| Hematocrit percent (%) Low, Week 4, n=283, 279 | 7 | 6 |
| Hematocrit %, High, Week 4, n=283, 279 | 2 | 1 |
| Hematocrit %, Low, Week 8, n=281, 276 | 6 | 9 |
| Hematocrit %, High, Week 8, n=281, 276 | 2 | 2 |
| Hemoglobin gram/Liter (g/L) Low,Week 4,n=283, 279 | 7 | 3 |
| Hemoglobin g/L, High, Week 4, n=283, 279 | 4 | 1 |
| Hemoglobin g/L, Low, Week 8, n=281, 276 | 7 | 10 |
| Hemoglobin g/L, High, Week 8, n=281, 276 | 3 | 2 |
| Lymphocytes 10^9/L , Low, Week 4, n=282, 278 | 3 | 1 |
| Lymphocytes 10^9/L , High, Week 4, n=282, 278 | 0 | 1 |
| Lymphocytes 10^9/L, Low, Week 8, n=281, 276 | 2 | 4 |
| Lymphocytes 10^9/L, High, Week 8, n=281, 276 | 0 | 0 |
| MCH picogram (pg), Low, Week 4, n=283, 279 | 2 | 1 |
| MCH pg, High, Week 4, n=283, 279 | 0 | 0 |
| MCH pg, Low, Week 8, n=281, 276 | 2 | 5 |
| MCH pg, High, Week 8, n=281, 276 | 0 | 0 |
| MCHC g/L, Low, Week 4, n=283, 279 | 3 | 3 |
| MCHC g/L, High, Week 4, n=283, 279 | 19 | 17 |
| MCHC g/L, Low, Week 8, n=281, 276 | 3 | 7 |
| MCHC g/L, High, Week 8, n=281, 276 | 16 | 12 |
| MCV femtoliters (fL), Low, Week 4, n=283, 279 | 2 | 2 |
| MCV fL, High, Week 4, n=283, 279 | 0 | 1 |
| MCV fL, Low, Week 8, n=281, 276 | 3 | 2 |
| MCV fL, High, Week 8, n=281, 276 | 0 | 0 |
| Monocytes 10^9/L , Low, Week 4, n=282, 278 | 0 | 0 |
| Monocytes 10^9/L, High, Week 4, n=282, 278 | 3 | 2 |
| Monocytes 10^9/L, Low, Week 8, n=281, 276 | 0 | 0 |
| Monocytes 10^9/L, High, Week 8, n=281, 276 | 0 | 1 |
| Neutrophils 10^9/L, Low, Week 4, n=283, 279 | 7 | 8 |
| Neutrophils 10^9/L, High, Week 4, n=283, 279 | 3 | 2 |
| Neutrophils 10^9/L, Low, Week 8, n=281, 276 | 5 | 6 |
| Neutrophils 10^9/L, High, Week 8, n=281, 276 | 1 | 6 |
| Erythrocytes 10^12/L, Low, Week 4, n=283, 279 | 6 | 4 |
| Erythrocytes 10^12/L, High, Week 4, n=283, 279 | 4 | 7 |
| Erythrocytes 10^12/L, Low, Week 8, n=281, 276 | 2 | 8 |
| Erythrocytes 10^12/L, High, Week 8, n=281, 276 | 6 | 3 |
| Leukocytes 10^9/L, Low, Week 4, n=283, 279 | 15 | 12 |
| Leukocytes 10^9/L, High, Week 4, n=283, 279 | 2 | 2 |
| Leukocytes 10^9/L, Low, Week 8, n=281, 276 | 6 | 10 |
| Leukocytes 10^9/L, High, Week 8, n=281, 276 | 1 | 5 |
| Reticulocytes 10^12/L, Low, Week 4, n=283, 279 | 1 | 0 |
| Reticulocytes 10^12/L, High, Week 4, n=283, 279 | 1 | 3 |
| Reticulocytes 10^12/L, Low, Week 8, n=281, 276 | 1 | 1 |
| Reticulocytes 10^12/L, High, Week 8, n=281, 276 | 5 | 3 |
| Platelet 10^9/L, Low, Week 4, n=282, 279 | 6 | 4 |
| Platelet 10^9/L, High, Week 4, n=282, 279 | 0 | 0 |
| Platelet 10^9/L, Low, Week 8, n=280, 276 | 4 | 4 |
| Platelet 10^9/L, High, Week 8, n=280, 276 | 1 | 0 |
Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Participants | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Albumin g/L, Low, Week 4, n=283, 279 | 6 | 2 |
| Albumin g/L, High, Week 4, n=283, 279 | 1 | 0 |
| Albumin g/L, Low, Week 8, n=282, 275 | 2 | 1 |
| Albumin g/L, High, Week 8, n=282, 275 | 0 | 0 |
| ALP units/liter (U/L), Low, Week 4, n=283, 279 | 3 | 5 |
| ALP U/L, High, Week 4, n=283, 279 | 14 | 20 |
| ALP U/L, Low, Week 8, n=282, 275 | 2 | 2 |
| ALP U/L, High, Week 8, n=282, 275 | 13 | 19 |
| ALT U/L, Low, Week 4, n=283, 279 | 45 | 44 |
| ALT U/L, High, Week 4, n=283, 279 | 7 | 4 |
| ALT U/L, Low, Week 8, n=282, 275 | 39 | 42 |
| ALT U/L, High, Week 8, n=282, 275 | 7 | 6 |
| AST U/L, Low, Week 4, n=283, 279 | 41 | 37 |
| AST U/L, High, Week 4, n=283, 279 | 7 | 5 |
| AST U/L, Low, Week 8, n=282, 275 | 38 | 34 |
| AST U/L, High, Week 8, n=282, 275 | 6 | 10 |
| D.bili micromole/Liter (µmol/L) LowWeek4,n=274,263 | 0 | 0 |
| D.bili µmol/L, High, Week 4, n=274, 263 | 5 | 3 |
| D.bili µmol/L, Low, Week 8, n=274, 261 | 0 | 0 |
| D.bili µmol/L, High, Week 8, n=274, 261 | 5 | 9 |
| Bili µmol/L, Low, Week 4, n=280, 279 | 5 | 4 |
| Bili µmol/L, High, Week 4, n=280, 279 | 1 | 5 |
| Bili µmol/L, Low, Week 8, n=280, 273 | 3 | 2 |
| Bili µmol/L, High, Week 8, n=280, 273 | 2 | 7 |
| Cal,millimole/Liter (mmol/L)Low,Week 4,n=283, 279 | 6 | 4 |
| Cal mmol/L, High, Week 4, n=283, 279 | 2 | 4 |
| Cal mmol/L, Low, Week 8, n=282, 275 | 12 | 10 |
| Cal mmol/L, High, Week 8, n=282, 275 | 0 | 3 |
| Chloride mmol/L, Low, Week 4, n=283, 279 | 0 | 0 |
| Chloride mmol/L, High, Week 4, n=283, 279 | 19 | 12 |
| Chloride mmol/L, Low, Week 8, n=282, 275 | 0 | 0 |
| Chloride mmol/L, High, Week 8, n=282, 275 | 12 | 9 |
| CO2 mmol/L, Low, Week 4, n=283, 279 | 7 | 11 |
| CO2 mmol/L, High, Week 4, n=283, 279 | 14 | 12 |
| CO2 mmol/L, Low, Week 8, n=282, 275 | 6 | 14 |
| CO2 mmol/L, High, Week 8, n=282, 275 | 10 | 9 |
| Creatinine µmol/L, Low, Week 4, n=283, 279 | 19 | 10 |
| Creatinine µmol/L, High, Week 4, n=283, 279 | 6 | 3 |
| Creatinine µmol/L, Low, Week 8, n=282, 275 | 20 | 10 |
| Creatinine µmol/L, High, Week 8, n=282, 275 | 7 | 5 |
| GGT U/L, Low, Week 4, n=283, 279 | 8 | 3 |
| GGT U/L, High, Week 4, n=283, 279 | 4 | 3 |
| GGT U/L, Low, Week 8, n=282, 275 | 10 | 6 |
| GGT U/L, High, Week 8, n=282, 275 | 4 | 9 |
| Glucose mmol/L, Low, Week 4, n=283, 279 | 17 | 14 |
| Glucose mmol/L, High, Week 4, n=283, 279 | 16 | 31 |
| Glucose mmol/L, Low, Week 8, n=282, 275 | 16 | 16 |
| Glucose mmol/L, High, Week 8, n=282, 275 | 21 | 12 |
| Potassium mmol/L, Low, Week 4, n=283, 279 | 3 | 2 |
| Potassium mmol/L, High, Week 4, n=283, 279 | 1 | 1 |
| Potassium mmol/L, Low, Week 8, n=282, 275 | 1 | 2 |
| Potassium mmol/L, High, Week 8, n=282, 275 | 2 | 1 |
| Magnesium mmol/L, Low, Week 4, n=283, 279 | 0 | 0 |
| Magnesium mmol/L, High, Week 4, n=283, 279 | 0 | 2 |
| Magnesium mmol/L, Low, Week 8, n=282, 275 | 0 | 1 |
| Magnesium mmol/L, High, Week 8, n=282, 275 | 0 | 0 |
| Protein g/L, Low, Week 4, n=283, 279 | 16 | 17 |
| Protein g/L, High, Week 4, n=283, 279 | 1 | 2 |
| Protein g/L, Low, Week 8, n=282, 275 | 16 | 9 |
| Protein g/L, High, Week 8, n=282, 275 | 4 | 2 |
| Sodium mmol/L, Low, Week 4, n=283, 279 | 3 | 6 |
| Sodium mmol/L, High, Week 4, n=283, 279 | 1 | 1 |
| Sodium mmol/L, Low, Week 8, n=282, 275 | 5 | 6 |
| Sodium mmol/L, High, Week 8, n=282, 275 | 2 | 1 |
| Urate µmol/L, Low, Week 4, n=283, 279 | 5 | 5 |
| Urate µmol/L, High, Week 4, n=283, 279 | 4 | 5 |
| Urate µmol/L, Low, Week 8, n=282, 275 | 9 | 7 |
| Urate µmol/L, High, Week 8, n=282, 275 | 4 | 4 |
| UN mmol/L, Low, Week 4, n=283, 279 | 3 | 4 |
| UN mmol/L, High, Week 4, n=283, 279 | 9 | 7 |
| UN mmol/L, Low, Week 8, n=282, 275 | 3 | 6 |
| UN mmol/L, High, Week 8, n=282, 275 | 8 | 7 |
Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters.
| Participants | AVA Alone | AVA+Raxibacumab |
|---|---|---|
| Amorphous crystals 1+ | 1 | 5 |
| Amorphous crystals 2+ | 7 | 1 |
| Amorphous crystals 3+ | 0 | 3 |
| Amorphous crystals 4+ | 3 | 4 |
| Amorphous crystals trace | 1 | 2 |
| Bacteria 1+ | 1 | 2 |
| Bacteria 2+ | 2 | 1 |
| Bacteria 3+ | 0 | 1 |
| Bacteria 4+ | 1 | 0 |
| Bacteria few | 2 | 1 |
| Bacteria many | 1 | 0 |
| Bacteria mod | 1 | 2 |
| Bacteria Occ | 3 | 7 |
| Bacteria rare | 5 | 8 |
| Bacteria trace | 2 | 3 |
| Bilirubin 1+ | 2 | 3 |
| Bilirubin negative | 196 | 188 |
| Bilirubin small | 0 | 2 |
| Ca Ox Crystals few | 0 | 2 |
| Ca Ox Crystals rare | 2 | 3 |
| Choriogonadotropin Beta negative | 24 | 16 |
| Choriogonadotropin Beta positive | 1 | 0 |
| Clarity, clear | 38 | 44 |
| Clarity, cloudy | 8 | 2 |
| Clarity turbid | 1 | 0 |
| Color amber | 2 | 5 |
| Color colorless | 1 | 1 |
| Color light-red | 0 | 1 |
| Color light-yellow | 6 | 2 |
| Color yellow | 74 | 71 |
| Crystals Ca-Ox | 9 | 17 |
| Erythrocytes 0-2 | 107 | 104 |
| Erythrocytes 10-25 | 3 | 0 |
| Erythrocytes 2-5 | 2 | 6 |
| Erythrocytes 25-50 | 0 | 1 |
| Erythrocytes 5-10 | 1 | 2 |
| Erythrocytes 50-99 | 1 | 0 |
| Erythrocytes innumerable | 0 | 1 |
| Erythrocytes less than 1 | 10 | 4 |
| Erythrocytes Tntc | 1 | 0 |
| Glucose positive | 1 | 0 |
| Glucose negative | 257 | 257 |
| Hemoglobin + | 13 | 18 |
| Hemoglobin ++ | 0 | 3 |
| Hemoglobin +++ | 1 | 2 |
| Hemoglobin large | 4 | 2 |
| Hemoglobin mod | 3 | 6 |
| Hemoglobin negative | 174 | 166 |
| Hemoglobin small | 13 | 13 |
| Hemoglobin trace | 2 | 1 |
| Ketone bodies negative | 114 | 106 |
| Ketone bodies trace | 0 | 4 |
| Ketones + | 1 | 1 |
| Ketones ++ | 1 | 0 |
| Ketones ++++ | 0 | 2 |
| Ketones mod | 1 | 0 |
| Ketones negative | 255 | 247 |
| Ketones trace | 0 | 7 |
| Leukocyte Cell Clumps Occ | 1 | 0 |
| Leukocyte Cell Clumps rare | 1 | 1 |
| Leukocyte Esterase 1+ | 4 | 2 |
| Leukocyte Esterase 2+ | 1 | 1 |
| Leukocyte Esterase 3+ | 1 | 0 |
| Leukocyte Esterase large | 10 | 7 |
| Leukocyte Esterase Mod | 1 | 3 |
| Leukocyte Esterase Moderate | 1 | 4 |
| Leukocyte Esterase negative | 162 | 159 |
| Leukocyte Esterase small | 5 | 7 |
| Leukocyte Esterase trace | 13 | 10 |
| Leukocyte + | 5 | 0 |
| Leukocyte ++ | 1 | 0 |
| Leukocyte +++ | 1 | 1 |
| Leukocyte 0-2 | 105 | 99 |
| Leukocyte 10-25 | 2 | 2 |
| Leukocyte 2-5 | 6 | 7 |
| Leukocyte 25-50 | 0 | 1 |
| Leukocyte 5-10 | 2 | 4 |
| Leukocyte less than 1 | 8 | 5 |
| Leukocyte large | 4 | 5 |
| Leukocyte mod | 1 | 5 |
| Leukocyte negative | 187 | 188 |
| Leukocyte small | 2 | 5 |
| Leukocyte trace | 9 | 7 |
| Mucous threads 2+ | 0 | 1 |
| Mucous Threads few | 24 | 25 |
| Mucous Threads many | 2 | 1 |
| Mucous Threads Mod | 1 | 2 |
| Mucous Threads trace | 1 | 2 |
| Nitrite negative | 190 | 190 |
| Nitrite positive | 8 | 3 |
| Occult Blood 1+ | 1 | 0 |
| Occult Blood 2+ | 1 | 2 |
| Occult Blood 3+ | 0 | 1 |
| Occult Blood large | 5 | 3 |
| Occult Blood mod | 1 | 5 |
| Occult Blood moderate | 2 | 7 |
| Occult Blood negative | 163 | 148 |
| Occult Blood small | 22 | 21 |
| Occult Blood trace | 3 | 6 |
| Protein + | 7 | 10 |
| Protein ++ | 2 | 0 |
| Protein ++++ | 0 | 1 |
| Protein 1+ | 3 | 4 |
| Protein large | 1 | 0 |
| Protein negative | 244 | 238 |
| Protein non-heam | 1 | 0 |
| Protein trace | 12 | 15 |
| Specific Gravity <=1.005 | 1 | 5 |
| Specific Gravity >=1.030 | 3 | 6 |
| Squamous Epithelial Cells 0-2 | 8 | 3 |
| Squamous Epithelial Cells 2-5 | 2 | 5 |
| Squamous Epithelial Cells 5-10 | 2 | 2 |
| Squamous Epithelial Cells <1 | 9 | 8 |
| Turbidity clear | 15 | 15 |
| Turbidity cloudy | 2 | 3 |
| Turbidity hazy | 19 | 16 |
| Urobilinogen <2.0 | 113 | 111 |
| Urobilinogen less than 2.0 | 33 | 31 |
| Urobilinogen normal | 47 | 46 |
| Transitional Epithelial Cells <1 | 2 | 0 |
Collected over On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AVA Alone | 1/286 (0.3%) | 5/286 (1.7%) | 85/286 (29.7%) |
| Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation | 1/280 (0.4%) | 3/280 (1.1%) | 80/280 (28.6%) |
| Event | AVA Alone | Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion | AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation |
|---|---|---|---|
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 2/286 | — | 0/280 |
| Bile Duct StoneHepatobiliary disorders | 0/286 | — | 1/280 |
| CholecystitisHepatobiliary disorders | 0/286 | — | 1/280 |
| CholelithiasisHepatobiliary disorders | 0/286 | — | 1/280 |
| BronchitisInfections and infestations | 0/286 | — | 1/280 |
| Completed SuicidePsychiatric disorders | 0/286 | — | 1/280 |
| AsphyxiaRespiratory, thoracic and mediastinal disorders | 0/286 | — | 1/280 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/286 | — | 1/280 |
| Toxicity To Various AgentsInjury, poisoning and procedural complications | 1/286 | — | 0/280 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 1/286 | — | 0/280 |
| Event | AVA Alone | Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion | AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation |
|---|---|---|---|
| Infusion Related ReactionInjury, poisoning and procedural complications | 0/286 | 4/6 | 1/280 |
| UrticariaSkin and subcutaneous tissue disorders | 0/286 | 1/6 | 2/280 |
| HypersensitivityImmune system disorders | 0/286 | 1/6 | 0/280 |
| Injection Site ReactionGeneral disorders | 18/286 | 0/6 | 18/280 |
| Injection Site ErythemaGeneral disorders | 11/286 | 0/6 | 13/280 |
| HeadacheNervous system disorders | 6/286 | 0/6 | 9/280 |
| Injection Site PainGeneral disorders | 6/286 | 0/6 | 8/280 |
| NauseaGastrointestinal disorders | 6/286 | 0/6 | 4/280 |
| Urinary Tract InfectionInfections and infestations | 6/286 | 0/6 | 2/280 |
| Upper Respiratory Tract InfectionInfections and infestations | 3/286 | 0/6 | 4/280 |
The Intent to Treat (ITT) Population comprised of all randomized participants
| Age, Continuous(Years) | AVA Alone | AVA+Raxibacumab | Total |
|---|---|---|---|
| Mean | 36.2 ± 12.78 | 36.1 ± 12.06 | 36.2 ± 12.42 |
| Sex: Female, Male(Participants) | AVA Alone | AVA+Raxibacumab | Total |
|---|---|---|---|
| Female | 150 | 142 | 292 |
| Male | 137 | 144 | 281 |
| Race/Ethnicity, Customized(Participants) | AVA Alone | AVA+Raxibacumab | Total |
|---|---|---|---|
| White | 216 | 221 | 437 |
| Black or African American | 61 | 56 | 117 |
| American Indian or Alaska Native | 7 | 1 | 8 |
| Asian | 2 | 5 | 7 |
| Multiple | 1 | 2 | 3 |
| Unknown | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2015 to primary completion in Jan 2017, 22 months.
Results were first posted in Jan 2018, 1 year after primary completion.
Of 18 phase 4 interventional studies under Bacterial Infections, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 22 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Raxibacumab