A Phase 2 interventional study of LF formulation of IMVAMUNE® and FD formulation of IMVAMUNE® in Smallpox, sponsored by Bavarian Nordic. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by Bavarian Nordic · Phase 2, Interventional, and Prevention
A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 651 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.
Adequate renal function defined as a calculated (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation:
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.
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.
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.
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.
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.
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.
LF formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart
Biological: LF formulation of IMVAMUNE®
FD formulation of IMVAMUNE® 2 doses of 1 x 10E8 TCID50, s.c., 4 weeks apart
Biological: FD formulation of IMVAMUNE®
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'
Time frame: Week 6
Number of Participants With Serious Adverse Events
Occurrence, relationship to the trial vaccine and intensity of any Serious Adverse Event (SAE).
Time frame: up to 32 weeks
Number of Participants With Adverse Events of Special Interest (AESI)
Occurrence, relationship to the trial vaccine and intensity of any Adverse Event of Special Interest (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzyme troponin I elevated above 2 x the Upper Limit of Normal
Time frame: up to 32 weeks
Number of Participants With Related Grade >=3 Adverse Events
Occurrence of any Grade \>=3 Adverse Events related to the trial vaccine.
Time frame: within 29 days after vaccination
Number of Participants With Unsolicited Adverse Events
Occurrence, relationship to the trial vaccine and intensity of unsolicited treatment-emergent AEs (TEAEs).
Time frame: within 29 days after vaccination
Number of Participants With Solicited Local Averse Events
Occurrence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).
Time frame: 8 days after any vaccination
Number of Participants With Solicited General Adverse Events
Occurrence, intensity and relationship to the trial vaccines of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).
Time frame: within 8 days after any vaccination
ELISA GMTs
Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values \<DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.
Time frame: within 8 weeks
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'
Time frame: Week 6
PRNT GMTs
Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values \<DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.
Time frame: within 8 weeks
Percentage of Participants With Seroconversion by ELISA
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.
Time frame: Week 6
Percentage of Participants With Seroconversion by ELISA
Seroconversion rates at all post-baseline immunogenicity sampling time points 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. Percentages based on number of subjects with data available.
Time frame: within 8 weeks
Percentage of Participants With Seroconversion by PRNT
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.
Time frame: Week 6
Percentage of Participants With Seroconversion by PRNT
Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: within 8 weeks
ELISPOT Magnitudes of Response
Magnitudes of response of IFNγ producing T-cells measured by vaccinica-specific ELISPOT. Spot Forming Units below the detection limit are included as a value of '1'.
Time frame: within 8 weeks
Percentage of Participants With Response by ELISPOT
Response rates regarding IFNγ producing T-cells measured by vaccinia-specific ELISPOT. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.
Time frame: within 8 weeks
Percentage of Responders by ELISPOT
Responder rate measured by vaccinia specific ELISPOT. A participant was defined as a responder to the vaccine determined by ELISPOT if the participant had at least 1 post-baseline visit determined to be a response. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.
Time frame: within 8 weeks
Correlation ELISA vs PRNT Titers
Pearson Correlation Coefficient between the ELISA titers and the PRNT titers at weeks 4, 6 and 8 based on the log10 transformed titer values
Time frame: within 8 weeks
| Milestone | LF Formulation | FD Formulation |
|---|---|---|
| Started | 327 | 324 |
| Completed | 305 | 314 |
| Not completed | 22 | 10 |
| Withdrew: Request to discontinue prematurely | 1 | 1 |
| Withdrew: Subject unwilling/unable to comply | 5 | 0 |
| Withdrew: Reason precludes participation | 1 | 0 |
| Withdrew: Lost to follow-up | 13 | 6 |
| Withdrew: Other | 2 | 3 |
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'
| Titer | LF Formulation | FD Formulation |
|---|---|---|
| ELISA GMT | 875.1 (801.3 to 955.7) | 1099.6 (1014.8 to 1191.6) |
Occurrence, relationship to the trial vaccine and intensity of any Serious Adverse Event (SAE).
| Participants | LF Formulation | FD Formulation |
|---|---|---|
| SAE | 5 | 2 |
| SAE related to vaccine | 0 | 0 |
| SAE Grade >=3 | 3 | 1 |
Occurrence, relationship to the trial vaccine and intensity of any Adverse Event of Special Interest (AESI). AESIs were defined as any cardiac symptoms and ECG changes determined to be clinically significant or cardiac enzyme troponin I elevated above 2 x the Upper Limit of Normal
| Participants | LF Formulation | FD Formulation |
|---|---|---|
| AESI | 1 | 4 |
| Drug-related AESI | 0 | 0 |
| AESI Grade >=3 | 0 | 0 |
Occurrence of any Grade \>=3 Adverse Events related to the trial vaccine.
| Participants | LF Formulation | FD Formulation |
|---|---|---|
| Number of Participants With Related Grade >=3 Adverse Events | 0 | 1 |
Occurrence, relationship to the trial vaccine and intensity of unsolicited treatment-emergent AEs (TEAEs).
| Participants | LF Formulation | FD Formulation |
|---|---|---|
| TEAE | 313 | 310 |
| Drug-Related TEAE | 207 | 207 |
| TEAE Grade >=3 | 6 | 5 |
| Drug-Related TEAE Grade >=3 | 0 | 1 |
Occurrence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).
| participants | LF Formulation | FD Formulation |
|---|---|---|
| Injection site pain : All | 274 | 290 |
| Injection site pain : Grade >=2 | 138 | 167 |
| Injection site pain : Grade =3 | 22 | 35 |
| Injection site erythema : All | 247 | 255 |
| Injection site erythema : Grade >=2 | 140 | 181 |
| Injection site erythema : Grade =3 | 16 | 47 |
| Injection site swelling : All | 210 | 223 |
| Injection site swelling : Grade >=2 | 94 | 125 |
| Injection site swelling : Grade =3 | 10 | 23 |
| Injection site induration : All | 211 | 213 |
| Injection site induration : Grade >=2 | 73 | 96 |
| Injection site induration : Grade =3 | 5 | 6 |
| Injection site pruritus : All | 177 | 189 |
| Injection site pruritus : Grade >=2 | 38 | 47 |
| Injection site pruritus : Grade =3 | 7 | 11 |
Occurrence, intensity and relationship to the trial vaccines of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after any vaccination. Events were graded by intensity (1 = mild, 2 = moderate, 3 = severe).
| participants | LF Formulation | FD Formulation |
|---|---|---|
| Body Temperature increased : All | 23 | 33 |
| Body Temperature increased : Grade >=2 | 7 | 8 |
| Body Temperature increased : Grade =3 | 3 | 2 |
| Body Temperature increased : Related | 22 | 30 |
| Body Temperature increased : Related Grade =3 | 3 | 2 |
| Headache : All | 125 | 112 |
| Headache : Grade >=2 | 37 | 27 |
| Headache : Grade =3 | 8 | 7 |
| Headache : Related | 110 | 94 |
| Headache : Related Grade =3 | 6 | 6 |
| Myalgia : All | 68 | 59 |
| Myalgia : Grade >=2 | 24 | 18 |
| Myalgia : Grade =3 | 1 | 5 |
| Myalgia : Related | 59 | 47 |
| Myalgia : Related Grade =3 | 1 | 3 |
| Chills : All | 38 | 35 |
| Chills : Grade >=2 | 14 | 10 |
| Chills : Grade =3 | 2 | 5 |
| Chills : Related | 34 | 33 |
| Chills : Related Grade =3 | 2 | 4 |
| Nausea : All | 57 | 51 |
| Nausea : Grade >=2 | 19 | 18 |
| Nausea : Grade =3 | 4 | 2 |
| Nausea : Related | 53 | 44 |
| Nausea : Related Grade =3 | 4 | 2 |
| Fatigue : All | 113 | 102 |
| Fatigue : Grade >=2 | 39 | 39 |
| Fatigue : Grade =3 | 15 | 9 |
| Fatigue : Related | 106 | 95 |
| Fatigue : Related Grade =3 | 14 | 9 |
Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values \<DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.
| Titer | LF Formulation | FD Formulation |
|---|---|---|
| Week 0 | 1.1 (1.0 to 1.2) | 1.1 (1.0 to 1.2) |
| Week 2 | 56.0 (44.8 to 69.9) | 90.4 (75.9 to 107.7) |
| Week 4 | 89.6 (75.0 to 107.0) | 131.3 (115.8 to 148.9) |
| Week 6 | 875.1 (801.3 to 955.7) | 1099.6 (1014.8 to 1191.6) |
| Week 8 | 546.4 (499.4 to 597.8) | 689.0 (635.2 to 747.4) |
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'
| Titer | LF Formulation | FD Formulation |
|---|---|---|
| PRNT GMT | 81.8 (73.0 to 91.6) | 101.2 (91.0 to 112.5) |
Geometric Mean Titers (GMT) at all immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). For the calculation of GMTs all measurements are included as they provide meaningful information even if below the detection limit (DL). Disregarding these measurements would highly bias the reported GMTs. We imputed values \<DL as a value of '1' and the GMT and corresponding 95% confidence intervals were calculated.
| Titer | LF Formulation | FD Formulation |
|---|---|---|
| Week 0 | 1.1 (1.0 to 1.1) | 1.0 (1.0 to 1.1) |
| Week 2 | 7.1 (6.0 to 8.6) | 10.4 (8.7 to 12.3) |
| Week 4 | 9.3 (7.9 to 11.1) | 12.5 (10.6 to 14.7) |
| Week 6 | 81.8 (73.0 to 91.6) | 101.2 (91.0 to 112.5) |
| Week 8 | 59.7 (54.0 to 66.0) | 76.1 (69.6 to 83.2) |
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.
| percentage of subjects | LF Formulation | FD Formulation |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA | 100.0 | 100.0 |
Seroconversion rates at all post-baseline immunogenicity sampling time points 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. Percentages based on number of subjects with data available.
| percentage of subjects | LF Formulation | FD Formulation |
|---|---|---|
| Week 2 | 83.5 | 91.5 |
| Week 4 | 91.9 | 97.0 |
| Week 6 | 100.0 | 100.0 |
| Week 8 | 100.0 | 100.0 |
Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects.
| percentage of subjects | LF Formulation | FD Formulation |
|---|---|---|
| Percentage of Participants With Seroconversion by PRNT | 99.0 | 100.0 |
Seroconversion rates at all post-baseline immunogenicity sampling time points based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
| percentage of subjects | LF Formulation | FD Formulation |
|---|---|---|
| Week 2 | 80.1 | 87.3 |
| Week 4 | 84.8 | 91.5 |
| Week 6 | 99.0 | 100.0 |
| Week 8 | 100.0 | 99.7 |
Magnitudes of response of IFNγ producing T-cells measured by vaccinica-specific ELISPOT. Spot Forming Units below the detection limit are included as a value of '1'.
| Spot Forming Units | LF Formulation | FD Formulation |
|---|---|---|
| Week 0 | 1.0 (1.0 to 1.0) | 1.0 (1.0 to 1.0) |
| Week 2 | 393.0 (318.0 to 506.0) | 581.5 (416.0 to 718.0) |
| Week 4 | 88.0 (70.0 to 107.0) | 133.0 (100.0 to 170.0) |
| Week 6 | 235.0 (185.0 to 343.0) | 315.0 (232.0 to 412.0) |
| Week 8 | 145.5 (115.0 to 174.0) | 240.0 (146.0 to 284.0) |
Response rates regarding IFNγ producing T-cells measured by vaccinia-specific ELISPOT. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.
| percentage of subjects | LF Formulation | FD Formulation |
|---|---|---|
| Week 2 | 95.0 | 97.9 |
| Week 4 | 66.0 | 80.2 |
| Week 6 | 88.0 | 94.4 |
| Week 8 | 84.0 | 92.3 |
Responder rate measured by vaccinia specific ELISPOT. A participant was defined as a responder to the vaccine determined by ELISPOT if the participant had at least 1 post-baseline visit determined to be a response. A response to the vaccine was defined as either the appearance of a positive signal for participants without a positive signal at Baseline or an increase by a factor of at least 1.7 of the SFU/1 x 10E6 PBMC compared to the Baseline SFU/1 x 10E6 PBMC for participants with a positive signal at Baseline.
| percentage of subjects | LF Formulation | FD Formulation |
|---|---|---|
| Percentage of Responders by ELISPOT | 100 | 100 |
Pearson Correlation Coefficient between the ELISA titers and the PRNT titers at weeks 4, 6 and 8 based on the log10 transformed titer values
| Pearson Correlation Coefficient | LF Formulation | FD Formulation |
|---|---|---|
| Week 4 | 0.597 (0.518 to 0.665) | 0.492 (0.401 to 0.572) |
| Week 6 | 0.646 (0.574 to 0.708) | 0.553 (0.470 to 0.627) |
| Week 8 | 0.567 (0.484 to 0.640) | 0.565 (0.484 to 0.637) |
Collected over 32 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LF Formulation | 0/327 (0%) | 5/327 (1.5%) | 115/327 (35.2%) |
| FD Formulation | 0/324 (0%) | 2/324 (0.6%) | 114/324 (35.2%) |
| Event | LF Formulation | FD Formulation |
|---|---|---|
| Subcutaneous AbscessInfections and infestations | 0/327 | 1/324 |
| AnxietyPsychiatric disorders | 0/327 | 1/324 |
| Haemolytic AnaemiaBlood and lymphatic system disorders | 1/327 | 0/324 |
| Limb InjuryInjury, poisoning and procedural complications | 1/327 | 0/324 |
| Diabetic KetoacidosisMetabolism and nutrition disorders | 1/327 | 0/324 |
| PresyncopeNervous system disorders | 1/327 | 0/324 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 1/327 | 0/324 |
| Event | LF Formulation | FD Formulation |
|---|---|---|
| Injection site indurationGeneral disorders | 77/327 | 74/324 |
| Upper respiratory tract infectionInfections and infestations | 16/327 | 19/324 |
| Injection site hemorrhageGeneral disorders | 2/327 | 17/324 |
| Viral upper respiratory tract infectionInfections and infestations | 12/327 | 8/324 |
| Injection site discolorationGeneral disorders | 5/327 | 9/324 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 6/327 | 8/324 |
| HeadacheNervous system disorders | 8/327 | 5/324 |
| Injection site painGeneral disorders | 6/327 | 7/324 |
| Injection site hematomaGeneral disorders | 5/327 | 5/324 |
| VomitingGastrointestinal disorders | 4/327 | 4/324 |
Full Analysis Set
| Age, Continuous(years) | LF Formulation | FD Formulation | Total |
|---|---|---|---|
| Mean | 27.8 ± 6.36 | 27.6 ± 6.21 | 27.7 ± 6.28 |
| Sex: Female, Male(Participants) | LF Formulation | FD Formulation | Total |
|---|---|---|---|
| Female | 178 | 170 | 348 |
| Male | 149 | 154 | 303 |
| Ethnicity (NIH/OMB)(Participants) | LF Formulation | FD Formulation | Total |
|---|---|---|---|
| Hispanic or Latino | 95 | 95 | 190 |
| Not Hispanic or Latino | 232 | 229 | 461 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LF Formulation | FD Formulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 78 | 67 | 145 |
| White | 239 | 247 | 486 |
| More than one race | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | LF Formulation | FD Formulation | Total |
|---|---|---|---|
| United States | 327 | 324 | 651 |
The record gives a start of Mar 2013, a primary completion of Jan 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2020, 6 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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