A Phase 2 interventional study of IMVAMUNE® in Smallpox, sponsored by Bavarian Nordic. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Bavarian Nordic · Phase 2, Interventional, and Prevention
The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Additionally, the immune system's response (protection against smallpox as measured by the amount of antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All participants in this trial will be randomly and evenly assigned to one of three groups to receive two, three or four injections. Group 1 will receive the standard regime consisting of one dose at each vaccination time point, Group 2 will receive two doses at each vaccination time point and Group 3 will receive a booster vaccination 12 weeks after the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial is scheduled to last up to 75 weeks.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 87 is below the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate renal function defined as a calculated (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation.
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.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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 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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A 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.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
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.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)
Biological: IMVAMUNE®
Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)
Biological: IMVAMUNE®
One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)
Biological: IMVAMUNE®
0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
Also known as: IMVANEX®, MVA-BN® smallpox vaccine
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
Time frame: within 75 weeks
Number of Participants With AESIs
Occurrence, relationship to the trial vaccine, and intensity of any adverse event of special interest (AESI)
Time frame: within 75 weeks
Number of Participants With Related Grade >=3 Adverse Events
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited and unsolicited AEs.
Time frame: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time frame: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Time frame: within 29 days after any vaccination
Number of Participants With Solicited Local Adverse Events
Number of participants with solicited local AEs (redness, swelling, induration, pruritus, and pain) by intensity. Percentages based on subjects with at least one completed diary card. \[Injection site erythema, injection site swelling and injection site induration--all sizes measured in diameter with max severity of: 0=0, 1 = \<30 mm, 2 = ≥30 - \<100 mm, 3 = ≥100 mm. Injection site pruritus: 0=absent, 1=mild, 2=moderate, 3=severe. Injection site pain: 0=absent, 1=painful to touch, 2=painful when limb is moved, 3=spontaneously painful/prevents normal activity.\]
Time frame: within 8 days after any vaccination
Number of Participants With Solicited General AEs
Number of Participants with solicited systemic/general AEs (pyrexia, headache, myalgia, nausea, fatigue, and chills) by intensity. Percentages based on subjects with at least one completed diary card. \[Body temperature: 0 = \<99.5 F (\<37.5 C), 1 = ≥99.5 - \<100.4 F (≥37.5 - \<38.0 C), 2= ≥100.4 - \<102.2 F (≥38.0 - \<39.0 C), 3= ≥102.2 - \<104.0 F (≥39.0 - \<40.0 C), 4= ≥ 104.0 F (≥40.0 C); pyrexia is defined as oral temperature ≥ 100.4 F (≥ 38.0 C).\] \[Headache, myalgia, nausea, chills and fatigue: 0 = none, 1 = mild: easily tolerated, minimal discomfort and no interference with daily activity, 2 = moderate: some interference with daily activity, 3 = severe: prevents daily activity.\]
Time frame: within 8 days after any vaccination
CD4+ T Cell Counts
Mean CD4+ T-cell counts over time
Time frame: within 15 days after each vaccination
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Time frame: within 64 weeks
ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Time frame: Week 6
ELISA GMT 2 Weeks Following the Last Vaccination
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Time frame: Week 6 (Groups 1 and 2), Week 14 (Group 3)
ELISA GMT During Follow-up
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Time frame: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Time frame: within 64 weeks
PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Time frame: Week 6
PRNT GMT 2 Weeks Following the Last Vaccination
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Time frame: Week 6 (Groups 1 and 2), Week 14 (Group 3)
PRNT GMT During Follow-up
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Time frame: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Percentage of Participants With Seroconversion by ELISA
SC rate based on ELISA. SC 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 64 weeks
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
SC rate based on ELISA. SC 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: Week 6
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination
SC rate based on ELISA. SC 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: Week 6 (Groups 1 and 2), Week 14 (Group 3)
Percentage of Participants With Seroconversion by ELISA During Follow-up
SC rate based on ELISA. SC 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: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Percentage of Participants With Seroconversion by PRNT
SC rate based on PRNT. SC 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 64 weeks
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
SC rate based on PRNT. SC 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: Week 6
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination
SC rate based on PRNT. SC 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: Week 6 (Groups 1 and 2), Week 14 (Group 3)
Percentage of Participants With Seroconversion by PRNT During Follow-up
SC rate based on PRNT. SC 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: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Subjects were screened and enrolled at 12 sites in the US
| Milestone | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Started | 27 | 29 | 31 |
| Completed | 24 | 29 | 30 |
| Not completed | 3 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 |
| Withdrew: Incarcerated | 1 | 0 | 0 |
Occurrence, relationship and intensity of any serious AE (SAE)
| Participants | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Any SAE | 0 | 0 | 2 |
| Any SAE with intensity >= Grade 3 | 0 | 0 | 2 |
| Any SAE assessed as related to vaccine | 0 | 0 | 0 |
Occurrence, relationship to the trial vaccine, and intensity of any adverse event of special interest (AESI)
| Participants | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Any AESI | 0 | 0 | 1 |
| Any AESI with intensity >= Grade 3 | 0 | 0 | 0 |
| Any AESI assessed as related to vaccine | 0 | 0 | 0 |
Number of Participants with any Grade \>=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited and unsolicited AEs.
| Participants | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Number of Participants With Related Grade >=3 Adverse Events | 4 | 5 | 3 |
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
| events | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Unrelated/None | 4 | 4 | 13 |
| Unlikely | 1 | 2 | 1 |
| Possible | 1 | 1 | 0 |
| Probable | 0 | 0 | 1 |
| Definite | 0 | 0 | 0 |
Occurrence of unsolicited non-serious AEs by Intensity
| events | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Mild | 4 | 7 | 9 |
| Moderate | 1 | 0 | 6 |
| Severe | 1 | 0 | 0 |
Number of participants with solicited local AEs (redness, swelling, induration, pruritus, and pain) by intensity. Percentages based on subjects with at least one completed diary card. \[Injection site erythema, injection site swelling and injection site induration--all sizes measured in diameter with max severity of: 0=0, 1 = \<30 mm, 2 = ≥30 - \<100 mm, 3 = ≥100 mm. Injection site pruritus: 0=absent, 1=mild, 2=moderate, 3=severe. Injection site pain: 0=absent, 1=painful to touch, 2=painful when limb is moved, 3=spontaneously painful/prevents normal activity.\]
| Participants | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Injection Site Pain, Grade 1 | 5 | 4 | 11 |
| Injection Site Pain, Grade 2 | 10 | 11 | 10 |
| Injection Site Pain, Grade 3 | 2 | 4 | 1 |
| Injection Site Erythema, Grade 1 | 7 | 11 | 15 |
| Injection Site Erythema, Grade 2 | 1 | 0 | 3 |
| Injection Site Erythema, Grade 3 | 0 | 0 | 0 |
| Injection Site Swelling, Grade 1 | 9 | 9 | 9 |
| Injection Site Swelling, Grade 2 | 1 | 1 | 4 |
| Injection Site Swelling, Grade 3 | 0 | 0 | 0 |
| Injection Site Induration, Grade 1 | 7 | 5 | 9 |
| Injection Site Induration, Grade 2 | 1 | 1 | 1 |
| Injection Site Induration, Grade 3 | 0 | 0 | 0 |
| Injection Site Pruritus, Grade 1 | 7 | 6 | 15 |
| Injection Site Pruritus, Grade 2 | 4 | 2 | 3 |
| Injection Site Pruritus, Grade 3 | 1 | 0 | 0 |
Number of Participants with solicited systemic/general AEs (pyrexia, headache, myalgia, nausea, fatigue, and chills) by intensity. Percentages based on subjects with at least one completed diary card. \[Body temperature: 0 = \<99.5 F (\<37.5 C), 1 = ≥99.5 - \<100.4 F (≥37.5 - \<38.0 C), 2= ≥100.4 - \<102.2 F (≥38.0 - \<39.0 C), 3= ≥102.2 - \<104.0 F (≥39.0 - \<40.0 C), 4= ≥ 104.0 F (≥40.0 C); pyrexia is defined as oral temperature ≥ 100.4 F (≥ 38.0 C).\] \[Headache, myalgia, nausea, chills and fatigue: 0 = none, 1 = mild: easily tolerated, minimal discomfort and no interference with daily activity, 2 = moderate: some interference with daily activity, 3 = severe: prevents daily activity.\]
| Participants | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Pyrexia, Grade 1 | 0 | 0 | 0 |
| Pyrexia, Grade 2 | 1 | 0 | 0 |
| Pyrexia, Grade 3 | 0 | 0 | 0 |
| Headache, Grade 1 | 8 | 5 | 6 |
| Headache, Grade 2 | 1 | 3 | 3 |
| Headache, Grade 3 | 0 | 2 | 1 |
| Myalgia, Grade 1 | 6 | 6 | 8 |
| Myalgia, Grade 2 | 2 | 6 | 4 |
| Myalgia, Grade 3 | 1 | 0 | 1 |
| Chills, Grade 1 | 4 | 4 | 5 |
| Chills, Grade 2 | 2 | 2 | 1 |
| Chills, Grade 3 | 1 | 0 | 0 |
| Nausea, Grade 1 | 3 | 4 | 4 |
| Nausea, Grade 2 | 3 | 0 | 2 |
| Nausea, Grade 3 | 0 | 2 | 0 |
| Fatigue, Grade 1 | 5 | 4 | 5 |
| Fatigue, Grade 2 | 2 | 5 | 5 |
| Fatigue, Grade 3 | 2 | 2 | 1 |
Mean CD4+ T-cell counts over time
| CD4 count (cells/µL) | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Screening | 304.9 ± 104.77 | 295.3 ± 111.10 | 349.6 ± 133.71 |
| Week 2 | 337.4 ± 118.18 | 357.0 ± 157.87 | 335.7 ± 111.11 |
| Week 6 | 319.1 ± 117.91 | 365.4 ± 197.04 | 345.0 ± 96.22 |
| Week 14 | NA ± NA | NA ± NA | 351.9 ± 114.53 |
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 0 | 1.5 (0.8 to 2.6) | 1.2 (0.8 to 1.7) | 1.8 (0.9 to 3.5) |
| Week 4 | 40.0 (15.3 to 105.1) | 47.1 (20.7 to 107.1) | 41.8 (16.2 to 107.8) |
| Week 6 | 552.2 (337.1 to 904.4) | 846.1 (475.3 to 1506.1) | 726.1 (371.3 to 1419.8) |
| Week 12 | NA (NA to NA) | NA (NA to NA) | 193.1 (90.9 to 410.5) |
| Week 14 | NA (NA to NA) | NA (NA to NA) | 1591.2 (1158.1 to 2186.3) |
| Week 30/38 | 34.6 (12.2 to 98.5) | 30.8 (11.3 to 83.5) | 143.3 (67.6 to 303.9) |
| Week 56/64 | 25.2 (8.4 to 75.7) | 27.5 (9.6 to 79.2) | 116.2 (57.9 to 233.2) |
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 and 3 Combined | Group 2 |
|---|---|---|
| ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined)) | 644.6 (422.7 to 983.0) | 846.1 (475.3 to 1506.1) |
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| ELISA GMT 2 Weeks Following the Last Vaccination | 552.2 (337.1 to 904.4) | 846.1 (475.3 to 1506.1) | 1591.2 (1158.1 to 2186.3) |
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
| Titer | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 30/38 | 34.6 (12.2 to 98.5) | 30.8 (11.3 to 83.5) | 143.3 (67.6 to 303.9) |
| Week 56/64 | 25.2 (8.4 to 75.7) | 27.5 (9.6 to 79.2) | 116.2 (57.9 to 233.2) |
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 0 | NA (NA to NA) | NA (NA to NA) | 1.2 (0.8 to 1.9) |
| Week 4 | 3.9 (1.9 to 8.1) | 4.8 (2.5 to 9.2) | 10.1 (4.8 to 21.1) |
| Week 6 | 78.9 (49.9 to 124.8) | 100.3 (59.8 to 168.4) | 95.9 (54.6 to 168.3) |
| Week 12 | NA (NA to NA) | NA (NA to NA) | 35.5 (19.6 to 64.5) |
| Week 14 | NA (NA to NA) | NA (NA to NA) | 281.1 (166.6 to 474.1) |
| Week 30/38 | 6.2 (2.6 to 14.8) | 11.5 (5.6 to 23.5) | 41.5 (22.6 to 75.9) |
| Week 56/64 | 6.2 (2.5 to 15.4) | 10.6 (5.3 to 21.2) | 45.3 (26.0 to 79.0) |
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 and 3 Combined | Group 2 |
|---|---|---|
| PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined)) | 88.1 (61.3 to 126.6) | 100.3 (59.8 to 168.4) |
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| PRNT GMT 2 Weeks Following the Last Vaccination | 78.9 (49.9 to 124.8) | 100.3 (59.8 to 168.4) | 281.1 (166.6 to 474.1) |
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
| Titer | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 30/38 | 6.2 (2.6 to 14.8) | 11.5 (5.6 to 23.5) | 41.5 (22.6 to 75.9) |
| Week 56/64 | 6.2 (2.5 to 15.4) | 10.6 (5.3 to 21.2) | 45.3 (26.0 to 79.0) |
SC rate based on ELISA. SC 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 | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 4 | 75.0 (50.9 to 91.3) | 82.6 (61.2 to 95.0) | 69.2 (48.2 to 85.7) |
| Week 6 | 100.0 (83.2 to 100.0) | 100.0 (85.2 to 100.0) | 92.3 (74.9 to 99.1) |
| Week 12 | NA (NA to NA) | NA (NA to NA) | 84.6 (65.1 to 95.6) |
| Week 14 | NA (NA to NA) | NA (NA to NA) | 100.0 (86.8 to 100.0) |
| Week 30/38 | 77.8 (52.4 to 93.6) | 72.7 (49.8 to 89.3) | 83.3 (62.6 to 95.3) |
| Week 56/64 | 66.7 (41.0 to 86.7) | 68.2 (45.1 to 86.1) | 83.3 (62.6 to 95.3) |
SC rate based on ELISA. SC 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 | Group 1 and 3 Combined | Group 2 |
|---|---|---|
| Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined)) | 95.7 (85.2 to 99.5) | 100.0 (85.2 to 100.0) |
SC rate based on ELISA. SC 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 | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination | 100.0 (83.2 to 100.0) | 100.0 (85.2 to 100.0) | 100.0 (86.8 to 100.0) |
SC rate based on ELISA. SC 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 | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 30/38 | 77.8 (52.4 to 93.6) | 72.7 (49.8 to 89.3) | 83.3 (62.6 to 95.3) |
| Week 56/64 | 66.7 (41.0 to 86.7) | 68.2 (45.1 to 86.1) | 83.3 (62.6 to 95.3) |
SC rate based on PRNT. SC 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 | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 4 | 60.0 (36.1 to 80.9) | 69.6 (47.1 to 86.8) | 80.8 (60.6 to 93.4) |
| Week 6 | 100.0 (83.2 to 100.0) | 100.0 (85.2 to 100.0) | 96.2 (80.4 to 99.9) |
| Week 12 | NA (NA to NA) | NA (NA to NA) | 96.2 (80.4 to 99.9) |
| Week 14 | NA (NA to NA) | NA (NA to NA) | 100.0 (86.8 to 100.0) |
| Week 30/38 | 72.2 (46.5 to 90.3) | 81.8 (59.7 to 94.8) | 91.7 (73.0 to 99.0) |
| Week 56/64 | 66.7 (41.0 to 86.7) | 72.7 (49.8 to 89.3) | 95.8 (78.9 to 99.9) |
SC rate based on PRNT. SC 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 | Group 1 and 3 Combined | Group 2 |
|---|---|---|
| Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined)) | 97.8 (88.5 to 99.9) | 100.0 (85.2 to 100.0) |
SC rate based on PRNT. SC 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 | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination | 100.0 (83.2 to 100.0) | 100.0 (85.2 to 100.0) | 100.0 (86.8 to 100.0) |
SC rate based on PRNT. SC 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 | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| Week 30/38 | 72.2 (46.5 to 90.3) | 81.8 (59.7 to 94.8) | 91.7 (73.0 to 99.0) |
| Week 56/64 | 66.7 (41.0 to 86.7) | 72.7 (49.8 to 89.3) | 95.8 (78.9 to 99.9) |
Collected over within 75 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (Standard Regimen) | 0/27 (0%) | 0/27 (0%) | 5/27 (18.5%) |
| Group 2 (Double Dose Regimen) | 0/29 (0%) | 0/29 (0%) | 6/29 (20.7%) |
| Group 3 (Booster Regimen) | 0/31 (0%) | 2/31 (6.5%) | 10/31 (32.3%) |
| Event | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| PancreatitisGastrointestinal disorders | 0/27 | 0/29 | 1/31 |
| DepressionPsychiatric disorders | 0/27 | 0/29 | 1/31 |
| Event | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) |
|---|---|---|---|
| HyperbilirubinaemiaHepatobiliary disorders | 1/27 | 0/29 | 0/31 |
| FuruncleInfections and infestations | 1/27 | 0/29 | 0/31 |
| Herpes zosterInfections and infestations | 1/27 | 0/29 | 0/31 |
| Upper respiratory tract infectionInfections and infestations | 1/27 | 0/29 | 0/31 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/27 | 0/29 | 0/31 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 1/27 | 0/29 | 0/31 |
| RhinitisInfections and infestations | 0/27 | 1/29 | 0/31 |
| Skin bacterial infectionInfections and infestations | 0/27 | 1/29 | 0/31 |
| Blood creatinine increasedInvestigations | 0/27 | 1/29 | 1/31 |
| Neck painMusculoskeletal and connective tissue disorders | 0/27 | 1/29 | 0/31 |
| Age, Continuous(years) | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) | Total |
|---|---|---|---|---|
| Mean | 35.1 ± 7.66 | 33.1 ± 6.67 | 36.6 ± 5.43 | 35 ± 6.68 |
| Sex: Female, Male(Participants) | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) | Total |
|---|---|---|---|---|
| Female | 4 | 5 | 3 | 12 |
| Male | 23 | 24 | 28 | 75 |
| Race/Ethnicity, Customized(Participants) | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) | Total |
|---|---|---|---|---|
| American Indian or Alaskan Native | 0 | 0 | 0 | 0 |
| Oriental/Asian | 0 | 0 | 0 | 0 |
| Black/African American | 16 | 18 | 16 | 50 |
| Native Hawaiian/Other Pacific Islander | 0 | 0 | 1 | 1 |
| White/Caucasian | 10 | 10 | 14 | 34 |
| Other | 1 | 1 | 0 | 2 |
| Hispanic or Latino | 5 | 4 | 3 | 12 |
| Not Hispanic or Latino | 22 | 25 | 28 | 75 |
| Region of Enrollment(participants) | Group 1 (Standard Regimen) | Group 2 (Double Dose Regimen) | Group 3 (Booster Regimen) | Total |
|---|---|---|---|---|
| United States | 27 | 29 | 31 | 87 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2014 to primary completion in May 2017, 36 months.
Results were first posted in Apr 2020, 2 years 10 months after primary completion.
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Studies of the drug tested here: MVA-BN smallpox vaccine