A Phase 3 interventional study of FD MVA-BN in Smallpox, sponsored by Bavarian Nordic. Completed at 12 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Bavarian Nordic · Phase 3, Interventional, and Prevention
This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine. The vaccine will be given to healthy subjects who do not have a smallpox scar.
Approximately 1110 subjects will be randomly enrolled into one of three groups:
Group 1 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 1).
Group 2 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 2).
Group 3 will include 370 subjects, who will receive two separate injections (shot) with a short needle, given below the skin of the upper arm with 0.5 mL FD MVA-BN (Lot 3).
The primary objective of the trial is to show that the immune response elicited (produced) by three consecutively produced MVA-BN lots are statistically (numerically) comparable.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 1,129 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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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 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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
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.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
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.
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.
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.
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.
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1
Biological: FD MVA-BN
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2
Biological: FD MVA-BN
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3
Biological: FD MVA-BN
Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT)
Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20.
Time frame: Two weeks post second vaccination; approximately Week 6.
Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA)
Vaccinia-specific total antibody titers below the lower limit of quantitation are given a value 100, i.e., half of the ELISA lower limit of quantitation of 200.
Time frame: Two weeks post second vaccination; approximately Week 6.
Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT
Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for PRNT is 20.
Time frame: Two weeks post second vaccination; approximately Week 6.
Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA
Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for ELISA is 200.
Time frame: Two weeks post second vaccination; approximately Week 6.
Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers
Pearson correlation coefficient calculated on the log10 PRNT vs. ELISA titers at 2 weeks post second vaccination.
Time frame: Two weeks post second vaccination; approximately Week 6.
Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial
Occurrence is defined as the number of participants who experienced an SAE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
Time frame: Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial.
Occurrence is defined as the number of participants who experienced an event falling in the system organ class of "Cardiac disorders" per MedDRA version 22.0. Related cardiac signs and symptoms are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
Time frame: Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine
Related AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where Grade 3 is Severe and Grade 4 is Potentially Life Threatening.
Time frame: Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits.
Occurrence, Relationship and Intensity of Unsolicited AEs
Occurrence is defined as the number of participants who experienced an unsolicited AE. Related unsolicited AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
Time frame: Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits.
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Occurrence is defined as the number of participants who experienced a solicited local AE. Intensity is defined per the protocol for each local event type. For injection site erythema, swelling, and induration the intensity is graded based on the maximum diameter as Grade 1: \< 30mm, Grade 2: \>= 30 - \< 100mm, Grade 3: \>= 100mm. Intensity for pruritis is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. Intensity for injection site pain is defined as Grade 1: Painful on touch, Grade 2: Painful when moving the limb, Grade 3: Spontaneously painful/prevents normal activity. If a participant experienced the local event after both vaccinations, the maximum intensity is presented.
Time frame: During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits.
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Number of days from the start of the local event to resolution. If a participant experienced the local event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.
Time frame: Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution.
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Occurrence is defined as the number of participants who experienced a solicited general AE. Related solicited general AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the protocol for each general event type. For pyrexia (increased body temperature) grading is defined as Grade 1: ≥ 99.5 - \< 100.4°F (≥ 37.5 - \< 38.0°C), Grade 2:≥ 100.4 - \< 102.2°F (≥ 38.0 - \< 39.0°C), Grade 3:≥ 102.2 - \< 104°F (≥ 39.0 - \< 40.0°C), and Grade 4: ≥ 104°F (≥ 40.0°C). Intensity for headache, myalgia, nausea, fatigue and chills is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. If a participant experienced the general event after both vaccinations, the maximum intensity is presented.
Time frame: During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits.
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Number of days from the start of the general event to resolution. If a participant experienced the general event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.
Time frame: Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution.
| Milestone | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Started | 377 | 375 | 377 |
| Completed | 332 | 335 | 337 |
| Not completed | 45 | 40 | 40 |
| Withdrew: Adverse event | 6 | 5 | 2 |
| Withdrew: Death | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 20 | 16 | 15 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 13 | 14 | 13 |
| Withdrew: Other reasons | 5 | 3 | 10 |
Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20.
| Titer | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) | 252.7 (231.3 to 276.0) | 269.9 (243.2 to 299.7) | 242.0 (219.5 to 266.8) |
Vaccinia-specific total antibody titers below the lower limit of quantitation are given a value 100, i.e., half of the ELISA lower limit of quantitation of 200.
| Titer | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA) | 1222 (1123.3 to 1329.4) | 1311 (1195.7 to 1437.5) | 1226.1 (1118.1 to 1344.6) |
Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for PRNT is 20.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT | 325 | 328 | 327 |
Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for ELISA is 200.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA | 323 | 325 | 326 |
Pearson correlation coefficient calculated on the log10 PRNT vs. ELISA titers at 2 weeks post second vaccination.
| Correlation Coefficient | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers | 0.657 (0.5901 to 0.7142) | 0.657 (0.5910 to 0.7142) | 0.656 (0.5893 to 0.7131) |
Occurrence is defined as the number of participants who experienced an SAE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Any Serious Adverse Event | 1 | 7 | 1 |
| Related Serious Adverse Event | 0 | 0 | 0 |
| Serious Adverse Event >= Grade 3 | 0 | 5 | 1 |
Occurrence is defined as the number of participants who experienced an event falling in the system organ class of "Cardiac disorders" per MedDRA version 22.0. Related cardiac signs and symptoms are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Any Cardiac Sign or Symptom | 1 | 2 | 1 |
| Any Related Cardiac Sign or Symptom | 0 | 0 | 0 |
| Any Cardiac Sign or Symptom >=Grade 3 | 0 | 0 | 0 |
Related AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where Grade 3 is Severe and Grade 4 is Potentially Life Threatening.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine | 2 | 0 | 1 |
Occurrence is defined as the number of participants who experienced an unsolicited AE. Related unsolicited AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Any Unsolicited AE | 88 | 110 | 98 |
| Any Related Unsolicited AE | 33 | 38 | 37 |
| Any Unsolicited AE >= Grade 3 | 6 | 8 | 7 |
Occurrence is defined as the number of participants who experienced a solicited local AE. Intensity is defined per the protocol for each local event type. For injection site erythema, swelling, and induration the intensity is graded based on the maximum diameter as Grade 1: \< 30mm, Grade 2: \>= 30 - \< 100mm, Grade 3: \>= 100mm. Intensity for pruritis is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. Intensity for injection site pain is defined as Grade 1: Painful on touch, Grade 2: Painful when moving the limb, Grade 3: Spontaneously painful/prevents normal activity. If a participant experienced the local event after both vaccinations, the maximum intensity is presented.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Any Solicited Local AEs | 338 | 348 | 344 |
| Any Redness | 271 | 283 | 272 |
| Redness Grade 1 | 84 | 110 | 87 |
| Redness Grade 2 | 143 | 131 | 156 |
| Redness Grade 3 | 44 | 42 | 29 |
| Any Swelling | 215 | 233 | 236 |
| Swelling Grade 1 | 88 | 121 | 118 |
| Swelling Grade 2 | 110 | 87 | 106 |
| Swelling Grade 3 | 17 | 25 | 12 |
| Any Induration | 215 | 226 | 229 |
| Induration Grade 1 | 98 | 126 | 123 |
| Induration Grade 2 | 106 | 92 | 100 |
| Induration Grade 3 | 11 | 8 | 6 |
| Any Pruritis | 210 | 230 | 198 |
| Pruritis Grade 1 | 160 | 181 | 159 |
| Pruritis Grade 2 | 40 | 42 | 29 |
| Pruritis Grade 3 | 10 | 7 | 10 |
| Any Injection Site Pain | 325 | 330 | 329 |
| Injection Site Pain Grade 1 | 118 | 112 | 124 |
| Injection Site Pain Grade 2 | 161 | 173 | 162 |
| Injection Site Pain Grade 3 | 46 | 45 | 43 |
Number of days from the start of the local event to resolution. If a participant experienced the local event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.
| Days | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Redness | 7.1 ± 6.53 | 6.5 ± 5.06 | 6.6 ± 5.39 |
| Swelling | 6.7 ± 6.47 | 6 ± 5.04 | 5.9 ± 4.52 |
| Induration | 18 ± 24.04 | 13.9 ± 13.12 | 15 ± 15.01 |
| Pruritis | 5 ± 5.7 | 4.4 ± 3.24 | 4.4 ± 3.87 |
| Pain | 6.9 ± 4.41 | 7.1 ± 4.44 | 6.7 ± 3.64 |
Occurrence is defined as the number of participants who experienced a solicited general AE. Related solicited general AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the protocol for each general event type. For pyrexia (increased body temperature) grading is defined as Grade 1: ≥ 99.5 - \< 100.4°F (≥ 37.5 - \< 38.0°C), Grade 2:≥ 100.4 - \< 102.2°F (≥ 38.0 - \< 39.0°C), Grade 3:≥ 102.2 - \< 104°F (≥ 39.0 - \< 40.0°C), and Grade 4: ≥ 104°F (≥ 40.0°C). Intensity for headache, myalgia, nausea, fatigue and chills is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. If a participant experienced the general event after both vaccinations, the maximum intensity is presented.
| Participants | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Any Solicited General AEs | 253 | 267 | 266 |
| Any Related Solicited General AEs | 246 | 256 | 252 |
| Any Pyrexia | 47 | 60 | 63 |
| Pyrexia Grade 1 | 39 | 48 | 49 |
| Pyrexia Grade 2 | 7 | 8 | 13 |
| Pyrexia Grade 3 | 1 | 4 | 1 |
| Pyrexia Grade 4 | 0 | 0 | 0 |
| Any Related Pyrexia | 47 | 57 | 55 |
| Any Headache | 146 | 157 | 155 |
| Headache Grade 1 | 96 | 102 | 120 |
| Headache Grade 2 | 36 | 44 | 25 |
| Headache Grade 3 | 14 | 11 | 10 |
| Any Related Headache | 140 | 145 | 145 |
| Any Myalgia | 166 | 173 | 175 |
| Myalgia Grade 1 | 115 | 116 | 116 |
| Myalgia Grade 2 | 38 | 47 | 39 |
| Myalgia Grade 3 | 13 | 10 | 20 |
| Any Related Myalgia | 159 | 167 | 167 |
| Any Nausea | 75 | 81 | 78 |
| Nausea Grade 1 | 53 | 56 | 54 |
| Nausea Grade 2 | 16 | 19 | 18 |
| Nausea Grade 3 | 6 | 6 | 6 |
| Any Related Nausea | 73 | 73 | 67 |
| Any Fatigue | 140 | 171 | 171 |
| Fatigue Grade 1 | 82 | 111 | 99 |
| Fatigue Grade 2 | 43 | 47 | 58 |
| Fatigue Grade 3 | 15 | 13 | 14 |
| Any Related Fatigue | 135 | 163 | 161 |
| Any Chills | 58 | 54 | 57 |
| Chills Grade 1 | 43 | 28 | 38 |
| Chills Grade 2 | 10 | 22 | 13 |
| Chills Grade 3 | 5 | 4 | 6 |
| Any Related Chills | 55 | 50 | 53 |
Number of days from the start of the general event to resolution. If a participant experienced the general event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.
| Days | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Pyrexia | 2.3 ± 1.87 | 1.9 ± 1.91 | 1.9 ± 1.92 |
| Headache | 3.2 ± 2.85 | 3.1 ± 2.49 | 3.2 ± 3.59 |
| Myalgia | 4.1 ± 2.8 | 4 ± 3.27 | 4.1 ± 3.3 |
| Nausea | 2.6 ± 2.98 | 2.7 ± 2.76 | 2.7 ± 2.5 |
| Fatigue | 3.9 ± 5.16 | 3.1 ± 2.7 | 3.6 ± 3.57 |
| Chills | 2.3 ± 2.01 | 2.3 ± 2.71 | 2.3 ± 2.19 |
Collected over Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GP 1: Two Doses of FD MVA-BN--Lot 1 | 0/377 (0%) | 1/377 (0.3%) | 347/377 (92%) |
| GP 2: Two Doses of FD MVA-BN--Lot 2 | 2/375 (0.5%) | 7/375 (1.9%) | 353/375 (94.1%) |
| GP 3: Two Doses of FD MVA-BN--Lot 3 | 0/377 (0%) | 1/377 (0.3%) | 349/377 (92.6%) |
| Event | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| DeathGeneral disorders | 0/377 | 2/375 | 0/377 |
| ColitisGastrointestinal disorders | 0/377 | 1/375 | 0/377 |
| Foot deformityMusculoskeletal and connective tissue disorders | 0/377 | 1/375 | 0/377 |
| Groin abscessInfections and infestations | 0/377 | 1/375 | 0/377 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/377 | 1/375 | 0/377 |
| Panic attackPsychiatric disorders | 0/377 | 1/375 | 0/377 |
| Alcoholic pancreatitisGastrointestinal disorders | 0/377 | 0/375 | 1/377 |
| DepressionPsychiatric disorders | 1/377 | 0/375 | 0/377 |
| Event | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 |
|---|---|---|---|
| Injection site painGeneral disorders | 325/377 | 330/375 | 329/377 |
| Injection site erythemaGeneral disorders | 271/377 | 283/375 | 272/377 |
| Injection site swellingGeneral disorders | 215/377 | 233/375 | 236/377 |
| Injection site pruritisGeneral disorders | 210/377 | 230/375 | 198/377 |
| Injection site indurationGeneral disorders | 215/377 | 226/375 | 229/377 |
| MyalgiaMusculoskeletal and connective tissue disorders | 166/377 | 173/375 | 175/377 |
| FatigueGeneral disorders | 140/377 | 171/375 | 171/377 |
| HeadacheNervous system disorders | 146/377 | 157/375 | 155/377 |
| NauseaGastrointestinal disorders | 75/377 | 81/375 | 78/377 |
| PyrexiaGeneral disorders | 47/377 | 60/375 | 63/377 |
The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.
| Age, Categorical(Participants) | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 377 | 375 | 377 | 1129 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| Mean | 30.7 ± 7.31 | 30.6 ± 7.29 | 30.7 ± 7.50 | 30.7 ± 7.36 |
| Sex: Female, Male(Participants) | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| Female | 210 | 213 | 207 | 630 |
| Male | 167 | 162 | 170 | 499 |
| Ethnicity (NIH/OMB)(Participants) | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 28 | 20 | 25 | 73 |
| Not Hispanic or Latino | 348 | 354 | 349 | 1051 |
| Unknown or Not Reported | 1 | 1 | 3 | 5 |
| Race (NIH/OMB)(Participants) | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 | 8 |
| Asian | 17 | 13 | 13 | 43 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 0 | 2 |
| Black or African American | 58 | 55 | 59 | 172 |
| White | 292 | 295 | 293 | 880 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 9 | 8 | 24 |
| Region of Enrollment(participants) | GP 1: Two Doses of FD MVA-BN--Lot 1 | GP 2: Two Doses of FD MVA-BN--Lot 2 | GP 3: Two Doses of FD MVA-BN--Lot 3 | Total |
|---|---|---|---|---|
| United States | 377 | 375 | 377 | 1129 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2019 to primary completion in Jan 2020, 6 months.
Results were first posted in May 2021, 1 year 4 months after primary completion.
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