A Phase 2 interventional study of IMVAMUNE and IMVAMUNE in Smallpox, sponsored by Bavarian Nordic. Completed at 4 sites in United States. Open to participants aged 56 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Bavarian Nordic · Phase 2, Interventional, and Prevention
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-Experienced Subjects
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 120 is below the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (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.
Adequate renal function defined as:
Adequate hepatic function defined as:
Exclusion Criteria:
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
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.
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 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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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 New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A 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.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
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.
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.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Biological: IMVAMUNE
Biological: IMVAMUNE
Related Serious Adverse Events
Incidence of Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
Time frame: within 8 weeks
Unsolicited Non-serious AEs: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Time frame: within 29 days after any vaccination
Unsolicited Non-serious AEs: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time frame: within 29 days after any vaccination
Related Grade >=3 Adverse Events
Incidence of any Grade \>=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general) and unsolicited AEs
Time frame: within 29 days after any vaccination
Cardiac Signs or Symptoms
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzymes elevated above 2 x upper limit of normal range (ULN).
Time frame: within 32 weeks
Solicited Local Adverse Events
Incidence and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritus). Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Solicited General Adverse Events
Incidence of solicited general AEs (body temperature increased, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship tovaccination. Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
ELISA Response Rate
Response rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Time frame: within 32 weeks
ELISA Seroconversion Rate
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Time frame: within 32 weeks
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.
Time frame: within 32 weeks
PRNT Response Rate
Response rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Response is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Time frame: within 32 weeks
PRNT Seroconversion Rate
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
Time frame: within 32 weeks
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.
Time frame: within 32 weeks
Correlation PRNT vs ELISA Titers
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Time frame: within 32 weeks
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 62 | 58 |
| Completed | 59 | 58 |
| Not completed | 3 | 0 |
Incidence of Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
| Participants | Group 1 | Group 2 |
|---|---|---|
| Related Serious Adverse Events | 0 | 0 |
Occurrence of unsolicited non-serious AEs by Intensity
| events | Group 1 | Group 2 |
|---|---|---|
| Total | 73 | 58 |
| Grade 1 | 60 | 50 |
| Grade 2 | 9 | 7 |
| Grade 3 | 4 | 1 |
| Grade 4 | 0 | 0 |
| Missing | 0 | 0 |
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
| events | Group 1 | Group 2 |
|---|---|---|
| Unrelated/None | 32 | 26 |
| Unlikely | 6 | 2 |
| Possible | 20 | 13 |
| Probable | 8 | 5 |
| Definite | 7 | 12 |
| Missing | 0 | 0 |
| Total | 73 | 58 |
Incidence of any Grade \>=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general) and unsolicited AEs
| Participants | Group 1 | Group 2 |
|---|---|---|
| Related Grade >=3 Adverse Events | 3 | 1 |
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzymes elevated above 2 x upper limit of normal range (ULN).
| Participants | Group 1 | Group 2 |
|---|---|---|
| Any AESI | 5 | 0 |
| Any AESI with intensity >= Grade 3 | 0 | 0 |
| Any AESI assessed as related to vaccine | 0 | 0 |
Incidence and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritus). Percentages based on subjects with at least one completed diary card.
| Participants | Group 1 | Group 2 |
|---|---|---|
| Pain: Any | 46 | 36 |
| Pain: Grade >=3 | 4 | 1 |
| Erythema: Any | 49 | 37 |
| Erythema: Grade >=3 | 3 | 1 |
| Swelling: Any | 39 | 27 |
| Swelling: Grade >=3 | 0 | 0 |
| Induration: Any | 31 | 17 |
| Induration: Grade >=3 | 0 | 0 |
| Pruritis: Any | 27 | 22 |
| Pruritis: Grade >=3 | 0 | 0 |
Incidence of solicited general AEs (body temperature increased, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship tovaccination. Percentages based on subjects with at least one completed diary card.
| Participants | Group 1 | Group 2 |
|---|---|---|
| Increased body temperature: Any | 2 | 1 |
| Increased body temperature: Related | 2 | 0 |
| Increased body temperature: Grade >=3 | 0 | 0 |
| Headache: Any | 19 | 22 |
| Headache: Related | 15 | 14 |
| Headache: Grade >=3 | 1 | 0 |
| Myalgia: Any | 19 | 14 |
| Myalgia: Related | 14 | 12 |
| Myalgia: Grade >=3 | 2 | 1 |
| Chills: Any | 5 | 4 |
| Chills: Related | 5 | 1 |
| Chills: Grade >=3 | 0 | 0 |
| Nausea: Any | 7 | 5 |
| Nausea: Related | 4 | 4 |
| Nausea: Grade >=3 | 0 | 0 |
| Fatigue: Any | 21 | 18 |
| Fatigue: Related | 18 | 15 |
| Fatigue: Grade >=3 | 1 | 0 |
Response rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
| percentage of subjects | Group 1 | Group 2 |
|---|---|---|
| Week 2 | 98.4 (91.2 to 100.0) | 19.0 (9.9 to 31.4) |
| Week 4 | 96.6 (88.3 to 99.6) | 19.0 (9.9 to 31.4) |
| Week 6 | 98.3 (91.1 to 100.0) | 96.6 (88.1 to 99.6) |
| Week 8 | 100.0 (93.9 to 100.0) | 100.0 (93.8 to 100.0) |
| Individual Peak | 100.0 (94.1 to 100.0) | 100.0 (93.8 to 100.0) |
| Week 32 | 94.9 (85.9 to 98.9) | 82.8 (70.6 to 91.4) |
Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
| percentage of subjects | Group 1 | Group 2 |
|---|---|---|
| Week 2 | 83.6 (71.9 to 91.8) | 1.7 (0.0 to 9.2) |
| Week 4 | 79.7 (67.2 to 89.0) | 3.4 (0.4 to 11.9) |
| Week 6 | 83.3 (71.5 to 91.7) | 82.8 (70.6 to 91.4) |
| Week 8 | 83.1 (71.0 to 91.6) | 77.6 (64.7 to 87.5) |
| Individual Peak | 90.2 (79.8 to 96.3) | 84.5 (72.6 to 92.7) |
| Week 32 | 59.3 (45.7 to 71.9) | 58.6 (44.9 to 71.4) |
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 | Group 2 |
|---|---|---|
| Week 0 | 129.0 (100.3 to 165.8) | 105.3 (71.8 to 154.5) |
| Week 2 | 622.5 (491.2 to 788.9) | 98.5 (64.8 to 150.0) |
| Week 4 | 501.2 (406.4 to 617.9) | 101.0 (66.5 to 153.3) |
| Week 6 | 804.1 (636.3 to 1016.0) | 605.8 (479.6 to 765.2) |
| Week 8 | 720.2 (577.9 to 897.6) | 505.0 (398.2 to 640.3) |
| Individual Peak | 992.4 (769.2 to 1280.3) | 645.2 (505.0 to 824.3) |
| Week 32 | 344.6 (288.9 to 411.1) | 258.1 (202.5 to 328.9) |
Response rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Response is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak response rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
| percentage of subjects | Group 1 | Group 2 |
|---|---|---|
| Week 2 | 83.6 (71.9 to 91.8) | 15.5 (7.3 to 27.4) |
| Week 4 | 81.4 (69.1 to 90.3) | 10.3 (3.9 to 21.2) |
| Week 6 | 96.7 (88.5 to 99.6) | 82.8 (70.6 to 91.4) |
| Week 8 | 89.8 (79.2 to 96.2) | 79.3 (66.6 to 88.8) |
| Individual Peak | 96.7 (88.7 to 99.6) | 84.5 (72.6 to 92.7) |
| Week 32 | 66.1 (52.6 to 77.9) | 50.0 (36.6 to 63.4) |
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (15) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual peak seroconversion rate is based on the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Percentages based on number of subjects with data available.
| percentage of subjects | Group 1 | Group 2 |
|---|---|---|
| Week 2 | 73.8 (60.9 to 84.2) | 10.3 (3.9 to 21.2) |
| Week 4 | 71.2 (57.9 to 82.2) | 8.6 (2.9 to 19.0) |
| Week 6 | 90.0 (79.5 to 96.2) | 77.6 (64.7 to 87.5) |
| Week 8 | 86.4 (75.0 to 94.0) | 74.1 (61.0 to 84.7) |
| Individual Peak | 95.1 (86.3 to 99.0) | 77.6 (64.7 to 87.5) |
| Week 32 | 55.9 (42.4 to 68.8) | 41.4 (28.6 to 55.1) |
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Individual peak is defined as the maximum post-Baseline antibody titer within 8 weeks (end of active trial phase). Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 | Group 2 |
|---|---|---|
| Week 0 | 11.9 (7.4 to 19.1) | 11.3 (6.5 to 19.4) |
| Week 2 | 111.4 (72.0 to 172.2) | 9.2 (5.3 to 15.8) |
| Week 4 | 79.5 (52.1 to 121.3) | 11.3 (6.8 to 18.7) |
| Week 6 | 210.3 (146.1 to 302.7) | 126.7 (82.4 to 194.8) |
| Week 8 | 144.9 (96.1 to 218.6) | 99.5 (63.8 to 155.1) |
| Individual Peak | 257.6 (178.6 to 371.5) | 139.6 (89.2 to 218.5) |
| Week 32 | 47.0 (31.1 to 71.1) | 27.6 (17.0 to 44.8) |
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
| Pearson correlation coefficient | Group 1 | Group 2 |
|---|---|---|
| Week 2 | 0.704 (0.546 to 0.810) | 0.489 (0.261 to 0.661) |
| Week 4 | 0.569 (0.362 to 0.718) | 0.492 (0.264 to 0.664) |
| Week 6 | 0.660 (0.484 to 0.781) | 0.697 (0.531 to 0.808) |
| Week 8 | 0.600 (0.402 to 0.740) | 0.616 (0.421 to 0.752) |
| Week 32 | 0.500 (0.276 to 0.668) | 0.654 (0.472 to 0.778) |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/62 (0%) | 2/62 (3.2%) | 21/62 (33.9%) |
| Group 2 | 0/58 (0%) | 2/58 (3.4%) | 21/58 (36.2%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/62 | 2/58 |
| CellulitisInfections and infestations | 1/62 | 0/58 |
| Non-cardiac chest painGeneral disorders | 1/62 | 0/58 |
| Event | Group 1 | Group 2 |
|---|---|---|
| Injection site haematomaGeneral disorders | 1/62 | 5/58 |
| Neutrophil count decreasedInvestigations | 1/62 | 4/58 |
| Injection site noduleGeneral disorders | 4/62 | 2/58 |
| DiarrhoeaGastrointestinal disorders | 1/62 | 3/58 |
| Application site haematomaGeneral disorders | 0/62 | 3/58 |
| SinusitisInfections and infestations | 3/62 | 0/58 |
| Upper respiratory tract infectionInfections and infestations | 3/62 | 2/58 |
| DizzinessNervous system disorders | 3/62 | 1/58 |
| ContusionInjury, poisoning and procedural complications | 0/62 | 2/58 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/62 | 2/58 |
Safety Analysis Set
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 64.6 ± 5.41 | 62.6 ± 5.85 | 63.7 ± 5.70 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 37 | 40 | 77 |
| Male | 25 | 18 | 43 |
The record gives a start of Jun 2009, a primary completion of Aug 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 8 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: MVA-BN smallpox vaccine