A Phase 2 interventional study of MVA Smallpox Vaccine in Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study will look at condensed schedules. Study will randomize subjects to one of four arms.
This is a Phase II, randomized, open-label immunogenicity and safety study of different immunization schedules and delivery systems (syringe and needle vs. the Stratis™) in healthy, vaccinia-naïve adults 18 years to 40 years of age, inclusive. Approximately 352 subjects will be enrolled and randomized to one of four study arms. Study Arm A (N=88) will receive a two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) via the SC route using a syringe and needle on Day 1 and 29. Study Arm B (N=88) will receive a two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) via the SC route using a syringe and needle on Day 1 and 15. Study Arm C (N=88) will receive a two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL) via the SC route using a syringe and needle on Day 1 and 22. Study Arm D (N=88) will receive a two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL) via the SC route using the Stratis™ on Day 1 and 29. Immunogenicity assessments will be performed using ELISA and PRNT. Safety assessments will be done via solicited injection site and systemic reactions. Unsolicited AEs will be collected until 28 days post last injection and SAEs for the duration of the subjects' study participation. Safety laboratory assessments will be performed at baseline and 14 days after each vaccination. Primary outcome measures: For each subject, the peak PRNT will be defined as the highest titer among all available measurements post second vaccination; Occurrence of solicited local injection site reactions in subjects receiving vaccine via the Stratis™ compared to syringe and needle administration as collected on the memory aid and by in clinic assessment. Parent protocol to sub-study 13-0027.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 435 is above the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) 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.
If the subject is female and of childbearing potential*, she agrees to practice abstinence** or use acceptable *** through 56 days after the last vaccination in order to avoid pregnancy:
* a woman is considered of childbearing potential unless (>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
**No sexual intercourse with men (vaginal penetration by a penis, coitus)
***Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other FDA-approved contraceptive method
(ECG) with no abnormalities*
* e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two PVC's in a row, or ST elevation consistent with ischemia)
Acceptable hematology parameters:
Exclusion Criteria:
History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or , or other heart condition under the care of a doctor*
*Subjects with a not clinically relevant heart murmur, i.e., without any pathological /arrhythmias or under treatment are not excluded.
Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's (NCEP) risk assessment tool*
*NOTE that this criterion applies only to subjects 20 years of age and older AND only if at least one of the following apply:
URL for NCEP risk assessment tool: http://cvdrisk.nhlbi.nih.gov/calculator.asp (if a subject has an HDL of greater than 100mg/dl please enter 100 in the tool)
High-dose use for greater than 2 weeks duration within three months prior to vaccination or current use of medication:
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.
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.
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.
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).
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.
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
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.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
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.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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.
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.
88 subjects receive IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
Biological: MVA Smallpox Vaccine
88 subjects receive IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 15.
Biological: MVA Smallpox Vaccine
88 subjects receive IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
Biological: MVA Smallpox Vaccine
88 subjects receive IMVAMUNE® 1x10\^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ on Days 1 and 29.
Biological: MVA Smallpox Vaccine
Subjects receive two dose regimen of IMVAMUNE® (1x10\^8 TCID50/0.5 mL per dose) via the SC route using either a syringe and needle or the Stratis™ system. Arm A receives doses via syringe and needle on days 1 and 29; Arm B receives doses via syringe and needle on days 1 and 15, Arm C receives doses via syringe and needle on days 1 and 22, Arm D receives doses via Stratis on days 1 and 29.
Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination
Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.
Time frame: Day 7 through Day 31 after 2nd vaccination
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration
Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A
Time frame: 15 days after each vaccination
Geometric Mean Peak ELISA Titer After Second Vaccination
Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.
Time frame: Day 7 through 31 after the 2nd vaccination
Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as "Related", meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event.
Time frame: Day 1 after the first vaccination through 180 days after the 2nd vaccination.
Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 17JUN2013 and 23SEP2014.
| Milestone | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| Started | 115 | 96 | 104 | 120 |
| Completed | 102 | 89 | 93 | 97 |
| Not completed | 13 | 7 | 11 | 23 |
| Withdrew: Adverse event | 0 | 0 | 4 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 | 0 | 4 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 2 | 3 |
| Withdrew: Physician decision | 0 | 1 | 0 | 1 |
| Withdrew: Temporary study halt to vaccinations | 11 | 2 | 5 | 13 |
Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.
| titers | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination | 138.0 (110.1 to 172.8) | 55.1 (42.3 to 71.7) | 75.9 (58.5 to 98.4) | 103.5 (80.8 to 132.6) |
Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A
| percentage of participants | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| Pain at Injection Site | 28 | 36 | 26 | 33 |
| Itchiness at Injection Site | 6 | 10 | 17 | 12 |
| Underarm Pain | 4 | 4 | 3 | 5 |
| Underarm Swelling | 2 | 2 | 2 | 1 |
| Redness at Injection Site | 54 | 52 | 60 | 79 |
| Swelling at Injection Site | 52 | 47 | 52 | 70 |
| Any Solicited Local Symptom | 73 | 69 | 77 | 90 |
Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.
| titers | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| Geometric Mean Peak ELISA Titer After Second Vaccination | 1259.8 (1093.0 to 1451.9) | 741.4 (625.0 to 879.6) | 1021.0 (878.1 to 1187.1) | 1351.8 (1130.0 to 1617.1) |
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as "Related", meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event.
| participants | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE | 1 | 0 | 1 | 0 |
Collected over Solicited events were collected for 15 days after each vaccination, unsolicited non-serious AEs through 28 days after last vaccination, and SAEs through 180 days after last vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: IMVAMUNE Days 1+29, Syringe and Needle | — | 2/116 (1.7%) | 114/116 (98.3%) |
| Arm B: IMVAMUNE Days 1+15, Syringe and Needle | — | 1/96 (1%) | 94/96 (97.9%) |
| Arm C: IMVAMUNE Days 1+22, Syringe and Needle | — | 1/103 (1%) | 103/103 (100%) |
| Arm D: IMVAMUNE Days 1+29, Stratis | — | 1/120 (0.8%) | 119/120 (99.2%) |
| Event | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| Jaw fractureInjury, poisoning and procedural complications | 0/116 | 1/96 | 0/103 | 0/120 |
| Type I hypersensitivityImmune system disorders | 0/116 | 0/96 | 1/103 | 0/120 |
| Acute myocardial infarctionCardiac disorders | 1/116 | 0/96 | 0/103 | 0/120 |
| Intentional overdoseInjury, poisoning and procedural complications | 1/116 | 0/96 | 0/103 | 0/120 |
| Large intestinal obstructionGastrointestinal disorders | 0/116 | 0/96 | 0/103 | 1/120 |
| Event | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis |
|---|---|---|---|---|
| INJECTION SITE PAINGeneral disorders | 108/116 | 84/96 | 96/103 | 115/120 |
| INJECTION SITE ERYTHEMAGeneral disorders | 82/116 | 66/96 | 81/103 | 114/120 |
| INJECTION SITE OEDEMAGeneral disorders | 74/116 | 67/96 | 74/103 | 112/120 |
| INJECTION SITE PRURITUSGeneral disorders | 67/116 | 44/96 | 52/103 | 86/120 |
| MALAISEGeneral disorders | 56/116 | 59/96 | 49/103 | 61/120 |
| MYALGIAMusculoskeletal and connective tissue disorders | 42/116 | 49/96 | 46/103 | 49/120 |
| AXILLARY PAINGeneral disorders | 17/116 | 21/96 | 18/103 | 28/120 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 18/116 | 20/96 | 17/103 | 21/120 |
| NAUSEAGastrointestinal disorders | 20/116 | 15/96 | 19/103 | 20/120 |
| CHILLSGeneral disorders | 10/116 | 16/96 | 13/103 | 21/120 |
All participants are included in the baseline analysis population
| Age, Categorical(Participants) | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 115 | 96 | 104 | 120 | 435 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis | Total |
|---|---|---|---|---|---|
| Mean | 27.2 ± 5.6 | 27.1 ± 5.4 | 27.2 ± 5.0 | 27.9 ± 5.2 | 27.4 ± 5.3 |
| Sex: Female, Male(Participants) | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis | Total |
|---|---|---|---|---|---|
| Female | 61 | 49 | 59 | 60 | 229 |
| Male | 54 | 47 | 45 | 60 | 206 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 10 | 4 | 12 | 7 | 33 |
| Not Hispanic or Latino | 104 | 92 | 92 | 113 | 401 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 7 | 3 | 7 | 12 | 29 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 20 | 15 | 17 | 18 | 70 |
| White | 81 | 70 | 74 | 86 | 311 |
| More than one race | 6 | 8 | 4 | 4 | 22 |
| Unknown or Not Reported | 1 | 0 | 1 | 0 | 2 |
| Region of Enrollment(participants) | Arm A: IMVAMUNE Days 1+29, Syringe and Needle | Arm B: IMVAMUNE Days 1+15, Syringe and Needle | Arm C: IMVAMUNE Days 1+22, Syringe and Needle | Arm D: IMVAMUNE Days 1+29, Stratis | Total |
|---|---|---|---|---|---|
| United States | 115 | 96 | 104 | 120 | 435 |
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Studies of the drug tested here: MVA-BN smallpox vaccine
National Institute of Allergy and Infectious Diseases (NIAID) →