A Phase 2 interventional study of IMVAMUNE and IMVAMUNE in Smallpox, sponsored by Bavarian Nordic. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by Bavarian Nordic · Phase 2, Interventional, and Prevention
The study was preformed to evaluate the persistence of antibodies following vaccination with MVA-BN and to assess the immunological memory response induced by a booster vaccination with MVA-BN in subjects two years after their participation in trial POX-MVA-005 (NCT00316524) in which they had received one or two doses of MVA-BN.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 304 is above 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.
Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)
Adequate renal function defined as:
Adequate hepatic function defined as:
Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only
Exclusion Criteria:
Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)
Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only
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 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).
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.
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).
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.
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.
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.
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.
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 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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Group 1 Initially Vaccinia Naive Subjects 2 doses of MVA-BN in prior study (POX-MVA-005) 1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50
Biological: IMVAMUNE
Group 2 Initially Vaccinia Naive Subjects 1 dose of MVA-BN and 1x Placebo in prior study (POX-MVA-005) 1 booster dose of MVA-BN (POX-MVA-023) IMVAMUNE: 1x 10E8_TCID50
Biological: IMVAMUNE
Group 4 Vaccinia Experienced 1 booster dose of MVA-BN in prior study (POX-MVA-005) Blood draw, Screening Visit only (POX-MVA-023)
Procedure: Blood Draw Only
Individual Peak Booster Rate by ELISA (Percentage of Participants)
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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 booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
Time frame: within 4 weeks
Booster Rate by ELISA (Percentage of Participants)
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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. Percentages based on number of subjects with data available.
Time frame: within 26 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 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.
Time frame: within 26 weeks
Booster Rate by PRNT (Percentage of Participants)
Booster rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
Time frame: within 26 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 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.
Time frame: within 26 weeks
Correlation PRNT vs ELISA Titers
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Time frame: within 26 weeks
Number of Participants With Related Serious Adverse Events
Number of participants with Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
Time frame: within 26 weeks
Number of Participants With Unsolicited Non-serious Adverse Events
Number of participants with any, grade \>=3, and related non-serious unsolicited adverse events
Time frame: within 29 days after any vaccination
Number of Participants With Related Grade >= 3 Unsolicited Adverse Events
Number of participants with Grade \>=3 Unsolicited Adverse Event probably, possibly, or definitely related to the study vaccine
Time frame: within 29 days after vaccination
Number of Participants With Solicited Local Adverse Events
Number of participants with and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritis). Percentages based on subjects with a completed diary card.
Time frame: within 8 days after vaccination
Number of Participants With Solicited General Adverse Events
Number of participants with solicited general AEs (body temperature increased, headache, myalgia, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with a completed diary card.
Time frame: within 8 days after vaccination
| Milestone | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose | Vaccinia Experienced, Boosted, Blood Draw Only |
|---|---|---|---|
| Started | 92 | 91 | 121 |
| Booster vaccination | 75 | 77 | 0 |
| Completed | 74 | 77 | 121 |
| Not completed | 18 | 14 | 0 |
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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 booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
| percentage of subjects | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Individual Peak Booster Rate by ELISA (Percentage of Participants) | 100.0 (95.2 to 100.0) | 100.0 (95.3 to 100.0) |
Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an 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. Percentages based on number of subjects with data available.
| percentage of subjects | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Week 1 | 100.0 (95.2 to 100.0) | 98.7 (93.0 to 100.0) |
| Week 2 | 100.0 (95.2 to 100.0) | 100.0 (95.3 to 100.0) |
| Week 4 | 100.0 (95.1 to 100.0) | 100.0 (95.3 to 100.0) |
| Week 26 | 98.6 (92.4 to 100.0) | 100.0 (95.3 to 100.0) |
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 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.
| Titer | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Screening | 24.23 (15.20 to 38.62) | 5.89 (3.63 to 9.57) |
| Week 1 | 737.93 (597.37 to 911.58) | 490.33 (368.48 to 652.46) |
| Week 2 | 1688.20 (1381.55 to 2062.91) | 1608.89 (1285.90 to 2013.00) |
| Week 4 | 1255.21 (1029.02 to 1531.13) | 1210.59 (974.01 to 1504.62) |
| Individual peak | 1821.57 (1496.13 to 2217.80) | 1723.74 (1376.87 to 2158.01) |
| Week 26 | 461.78 (381.16 to 559.46) | 382.91 (301.66 to 486.03) |
Booster rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
| percentage of subjects | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Week 1 | 92.0 (83.4 to 97.0) | 85.7 (75.9 to 92.6) |
| Week 2 | 98.7 (92.8 to 100.0) | 96.1 (89.0 to 99.2) |
| Week 4 | 94.6 (86.7 to 98.5) | 90.9 (82.2 to 96.3) |
| Individual peak | 98.7 (92.8 to 100.0) | 98.7 (93.0 to 100.0) |
| Week 26 | 88.7 (79.0 to 95.0) | 76.6 (65.6 to 85.5) |
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 4 weeks (measurements at Weeks 1, 2, and 4). Titers below the detection limit are included with a value of '1'.
| Titer | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Screening | 1.23 (0.99 to 1.52) | 1.06 (0.95 to 1.18) |
| Week 1 | 53.61 (37.05 to 77.59) | 28.58 (18.56 to 43.99) |
| Week 2 | 125.26 (89.51 to 175.27) | 80.69 (54.37 to 119.75) |
| Week 4 | 64.26 (43.19 to 95.61) | 48.96 (31.72 to 75.57) |
| Individual Peak | 165.97 (124.21 to 221.77) | 116.79 (82.42 to 165.49) |
| Week 26 | 49.29 (32.40 to 74.98) | 25.62 (15.84 to 41.44) |
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
| Pearson correlation coefficient | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Week 1 | 0.591 | 0.690 |
| Week 2 | 0.491 | 0.655 |
| Week 4 | 0.476 | 0.592 |
| Week 26 | 0.568 | 0.550 |
Number of participants with Serious Adverse Events (SAEs) probably, possibly or definitely related to the trial vaccine
| Participants | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Number of Participants With Related Serious Adverse Events | 0 | 0 |
Number of participants with any, grade \>=3, and related non-serious unsolicited adverse events
| Participants | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Any event | 40 | 38 |
| Any event with intensity >= Grade 3 | 4 | 5 |
| Any event assessed as related to vaccine | 11 | 9 |
Number of participants with Grade \>=3 Unsolicited Adverse Event probably, possibly, or definitely related to the study vaccine
| Participants | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Number of Participants With Related Grade >= 3 Unsolicited Adverse Events | 1 | 0 |
Number of participants with and intensity of solicited local AEs (pain, erythema, swelling, induration, and pruritis). Percentages based on subjects with a completed diary card.
| Participants | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Pain: Any | 58 | 64 |
| Pain: Grade >=3 | 1 | 3 |
| Erythema: Any | 60 | 65 |
| Erythema: Grade >=3 | 0 | 2 |
| Swelling: Any | 51 | 48 |
| Swelling: Grade >=3 | 0 | 2 |
| Induration: Any | 58 | 58 |
| Induration: Grade >=3 | 0 | 1 |
| Pruritis: Any | 30 | 36 |
| Pruritis: Grade >=3 | 1 | 0 |
Number of participants with solicited general AEs (body temperature increased, headache, myalgia, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with a completed diary card.
| Participants | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| Body temperature increased: Any | 3 | 4 |
| Body temperature increased: Grade >=3 | 0 | 0 |
| Body temperature increased: Related Grade >=3 | 0 | 0 |
| Headache: Any | 19 | 25 |
| Headache: Grade >=3 | 2 | 1 |
| Headache: Related Grade >=3 | 1 | 1 |
| Myalgia: Any | 17 | 19 |
| Myalgia: Grade >=3 | 1 | 1 |
| Myalgia: Related Grade >=3 | 1 | 0 |
| Nausea: Any | 6 | 12 |
| Nausea: Grade >=3 | 0 | 0 |
| Nausea: Related Grade >=3 | 0 | 0 |
| Fatigue: Any | 22 | 27 |
| Fatigue: Grade >=3 | 2 | 0 |
| Fatigue: Related Grade >=3 | 2 | 0 |
Collected over 7 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | 0/75 (0%) | 2/75 (2.7%) | 35/75 (46.7%) |
| Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose | 0/77 (0%) | 0/77 (0%) | 25/77 (32.5%) |
| Event | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| GastroenteritisInfections and infestations | 1/75 | 0/77 |
| ConcussionInjury, poisoning and procedural complications | 1/75 | 0/77 |
| Event | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose |
|---|---|---|
| NasopharyngitisInfections and infestations | 20/75 | 9/77 |
| HeadacheNervous system disorders | 5/75 | 7/77 |
| Injection site warmthGeneral disorders | 3/75 | 3/77 |
| LymphadenopathyBlood and lymphatic system disorders | 0/75 | 3/77 |
| PalpitationsCardiac disorders | 2/75 | 1/77 |
| ToothacheGastrointestinal disorders | 2/75 | 0/77 |
| Injection site irritationGeneral disorders | 2/75 | 0/77 |
| MigraineNervous system disorders | 2/75 | 1/77 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/75 | 1/77 |
| Aphthous stomatitisGastrointestinal disorders | 0/75 | 2/77 |
Persistence Set i.e. subjects previously vaccinated in study POX-MVA-005 with a blood draw at the screening visit of study POX-MVA-023
| Age, Continuous(years) | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose | Vaccinia Experienced, Boosted, Blood Draw Only | Total |
|---|---|---|---|---|
| Mean | 27.7 ± 5.8 | 27.7 ± 4.5 | 44.9 ± 6.6 | 34.6 ± 10.2 |
| Sex: Female, Male(Participants) | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose | Vaccinia Experienced, Boosted, Blood Draw Only | Total |
|---|---|---|---|---|
| Female | 50 | 55 | 67 | 172 |
| Male | 42 | 36 | 54 | 132 |
| ELISA Long-Term Persistence(Titer) | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose | Vaccinia Experienced, Boosted, Blood Draw Only | Total |
|---|---|---|---|---|
| Geometric mean | 23.33 (1 to 1877) | 6.20 (1 to 262) | 134.65 (1 to 1103) | 31.52 (1 to 1877) |
| PRNT Long-Term Persistence(Titer) | Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose | Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose | Vaccinia Experienced, Boosted, Blood Draw Only | Total |
|---|---|---|---|---|
| Geometric mean | 1.26 (1 to 226) | 1.05 (1 to 67) | 10.28 (1 to 4382) | 2.75 (1 to 4382) |
This study is completed, as verified in Feb 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