A Phase 1/2 interventional study of MVA Smallpox Vaccine and MVA Smallpox Vaccine in Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-05.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Prevention
The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA: Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease) response to this vaccine. Participants will be assigned to 1 of 6 study groups. Each group will include 12 subjects, 10 will receive the modified smallpox vaccine and two will receive placebo, an inactive substance. The vaccine will be administered in 1 of 3 ways: under the skin; in the muscle; or between the muscle and the skin. Groups A and B will receive Dryvax® 6-15 months after the initial MVA vaccine; groups C, D, E, and F will receive Dryvax® 6 months after the initial MVA vaccine. Study procedures will include documenting side effects for 14 days after each vaccination, electrocardiogram (picture of the hearts activity) and blood samples. Participants will be involved in study related procedures for up to 18 months.
The emergence of smallpox as a potential agent of bioterrorism has heightened concern about the vulnerability of the population to infection with this agent, and has led to proposals to undertake large scale smallpox immunization of military personnel and "first responders" in the United States, including certain health care workers. A particularly promising vaccine approach to the development of an effective, yet less reactogenic vaccine to smallpox is the use of Modified Vaccinia Ankara (MVA) as a vaccine. Despite the established efficacy of smallpox vaccination, the parameters of protective immunity against smallpox infection are incompletely understood. This is a phase I/II trial to be conducted under a placebo controlled double-blind, randomized allocation of study product. The purpose of this study is to assess the safety and immunogenicity of ACAM 3000 MVA in healthy vaccinia-naïve adult subjects. Participants will include 72 healthy, male or female, from the Boston metropolitan area. Six dose regimens will be studied initially: 10\^6 or 10\^7 tissue culture infectious dose 50 (TCID50) administered intradermally and 10\^7 or 10\^8 TCID50 administered intramuscularly or subcutaneously as 2 immunizations 1 month apart. Each arm will be comprised of 12 subjects, 10 of whom will receive ACAM3000 MVA and 2 of whom will receive placebo. A subsequent vaccinia vaccination will be offered to all patients. Consenting participants in Groups A and B will receive the vaccinia (Dryvax®) inoculation between 6 and 15 months after the initial MVA / placebo vaccination. Consenting participants in groups C, D, E and F will receive the Dryvax® inoculation approximately 6 months after the initial MVA / placebo vaccination, coinciding with planned visit 13. Assessment of safety will be carried out by observation and measurement of acute clinical and laboratory evidence of reactions or toxicity; including clinical, electrocardiographic or laboratory evidence of myopericarditis. Assessment of immunogenicity will be carried out by the measurement of humoral and cell-mediated immune response to ACAM 3000 MVA and vaccinia, performed on blood samples obtained at various times prior to and after immunization over the one year period of the study. Response to vaccinia will be assessed clinically (effect on a "take") and the results will be correlated with immune responses to MVA. Subjects will be followed for reactogenicity. Clinical assessments and blood samples will be obtained sequentially for immunogenicity determinations.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 72 is below the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (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.
General:
Laboratory:
Normal urine dipstick or urinalysis:
In addition to meeting ALL of the above criteria, FEMALE participants must meet BOTH of the following criteria:
Reproductive status: A female participant either must:
i) condoms (male or female with or without a spermicide) ii) diaphragm or cervical cap with spermicide iii) intrauterine device (IUD) iv) hormone-based therapy, e.g., contraceptive pills, Norplant, or Depo-Provera
In addition to the above criteria, female participants must meet the following criteria prior to participating in Dryvax vaccination:
Comply with one of the following methods of contraception for at least 21 days prior to vaccination and at least 2 months post vaccination.
i) Hysterectomy or tubal ligation ii) The participant is in a monogamous relationship with a male partner who has undergone successful vasectomy (Successful vasectomy as defined as microscopic documentation of azospermia or a vasectomy more than two years ago with no resultant pregnancy despite sexual activity post-vasectomy.) c) Sexual abstinence
Exclusion Criteria:
Participant has a history of any of the following:
NOTE: This criterion applies only to subjects 20 years of age and older AND only if at least one of the following applies:
a) have smoked a cigarette in the past month, and/or b) have hypertension (defined as systolic blood pressure greater than 140 mm Hg) or are on antihypertensive medication, and/or c) have a family history of coronary heart disease in male first-degree relative (father or brother) less than 55 years of age or a female first-degree relative (mother or sister) less than 65 years of age.
Household contacts/sexual contacts with, or frequent and/or prolonged exposure to any of the following:
a) Children less than 12 months of age b) Pregnant women or women who are breast feeding c) Individuals with a history of eczema or atopic dermatitis d) Individuals with chronic exfoliative skin disorders or skin disorders of large magnitude (greater than 2x2 centimeters) e) Individuals with an immunosuppressive disorder such as infection, organ transplantation, or a condition requiring prolonged corticosteroid therapy
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with one or more of the following:
a) Psychoses within the past 5 years. b) Suicidal ideation occurring within 2 years prior to enrollment. Not excluded: A participant with a remote history (greater than 3 years) of a suicide attempt or suicide gesture is not excluded if the investigator finds the participant (a) to be of sound mental health; and (b) the suicide attempt was a well-defined, isolated event; and (c) the cause or inciting factor(s) no longer has relevance to the individual. A participant currently in therapy, due to a suicide attempt or gesture, or suicidal ideation, may be enrolled only when the participant's current therapist or health care provider provides documentation that the participant currently is not suicidal.
In addition to the above criteria, the following exclusion criteria apply to those participants consenting to Dryvax vaccination:
-A history of the following:
a) A calculated less than 80 mL/min based on the following formulas: i) Males: [(140 - age in years) X weight in kilograms (kg)]/(72 X serum creatinine) ii) Females: 0.85 X [(140 - age in years) X weight in kg]/(72 X serum creatinine)
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.
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.
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.
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.
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.
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.
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.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
10 subjects to receive ACAM3000 MVA dose 10\^7 TCID50 via intradermal route on days 0 and 28; 2 subjects to receive placebo via intradermal route on days 0 and 28. Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Other: Placebo · Biological: MVA Smallpox Vaccine · Biological: Live vaccinia virus vaccine
10 subjects to receive ACAM3000 MVA dose 10\^8 TCID50 via intramuscular route on days 0 and 28; 2 subjects to receive placebo via intramuscular route on days 0 and 28. Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Biological: MVA Smallpox Vaccine · Biological: Live vaccinia virus vaccine · Other: Placebo
10 subjects to receive ACAM3000 MVA dose 10\^8 TCID50 via subcutaneous route on days 0 and 28; 2 subjects to receive placebo via subcutaneous route on days 0 and 28. Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Biological: MVA Smallpox Vaccine · Other: Placebo · Biological: Live vaccinia virus vaccine
10 subjects to receive ACAM3000 MVA dose 10\^7 TCID50 via intramuscular route on days 0 and 28; 2 subjects to receive placebo via intramuscular route on days 0 and 28. Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Biological: MVA Smallpox Vaccine · Biological: Live vaccinia virus vaccine · Other: Placebo
10 subjects to receive ACAM3000 MVA dose 10\^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28; 2 subjects to receive placebo via intradermal route on days 0 and 28. Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Other: Placebo · Biological: MVA Smallpox Vaccine · Biological: Live vaccinia virus vaccine
10 subjects to receive ACAM3000 MVA dose 10\^7 TCID50 via subcutaneous (SC) route on days 0 and 28; 2 subjects to receive placebo via subcutaneous route on days 0 and 28. Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Biological: MVA Smallpox Vaccine · Other: Placebo · Biological: Live vaccinia virus vaccine
MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^7 or 10\^8 TCID50 intramuscularly (IM).
MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^7 or 10\^8 TCID50 subcutaneously (SC).
Sterile saline (0.9%) volume of 0.5 ml intradermally in the deltoid.
Sterile saline (0.9%) volume of 0.5 ml subcutaneously in the deltoid.
MVA smallpox vaccine (ACAM3000 MVA) administered in two doses approximately 28 days apart in the following dose/route combination: 10\^6 or 10\^7 TCID50 intradermally (ID).
Dryvax® smallpox vaccine administered at approximately day 180, dosage 10\^8 pfu/ml.
Sterile saline (0.9%) volume of 0.5 ml intramuscularly in the deltoid.
Number of Participants Reporting Moderate or Greater Solicited Local Reactions
Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
Time frame: 15 days after vaccination
Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions
Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
Time frame: 15 days after vaccination
Number of Participants With Hematologic Laboratory Abnormalities After Vaccination
Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Time frame: 28 days after vaccination
Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination
Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Time frame: 28 days after vaccination
Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination
Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions
Time frame: 28 days after vaccination
Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination
Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
Time frame: 28 days after vaccination
Number of Participants With Signs of Possible Myopericarditis
Number of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study
Time frame: Within 360 days after vaccination
Peak Neutralizing Antibodies to ACAM3000 MVA
Median neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Time frame: Approximately Day 42 after first vaccination
Peak Neutralizing Antibodies to Vaccinia
Median neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Time frame: Approximately Day 42 after first vaccination
Peak Binding Antibodies (ELISA) to ACAM3000 MVA
Median binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Time frame: Approximately Day 42 after first vaccination
Peak Binding Antibodies (ELISA) to Vaccinia
Median binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
Time frame: Approximately Day 42 after first vaccination
Peak T-cell Gamma Interferon Responses (ELISPOT)
Median T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10\^6 peripheral blood mononuclear cells (SFU/10\^6 PBMC).
Time frame: Approximately Day 42 after first vaccination
Peak Titer of Viral Shedding Post Dryvax Challenge
Median Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.
Time frame: Until vaccination site lesion has scabbed
Assessment of Dryvax Take Category
Restricted to participants who received Dryvax 6-15 months after MVA. A "take" is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction
Time frame: 3 weeks after Dryvax challenge
Normal healthy vaccinia-naïve young adults who reside in the greater Boston metropolitan area were recruited for this study between September 29, 2005 and April 23, 2007.
| Milestone | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Started | 10 | 10 | 10 | 10 | 10 | 10 | 12 |
| Completed | 10 | 10 | 8 | 9 | 6 | 9 | 9 |
| Not completed | 0 | 0 | 2 | 1 | 4 | 1 | 3 |
Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Erythema | 3 | 0 | 1 | 6 | 9 | 2 | 1 |
| Induration | 1 | 0 | 1 | 4 | 8 | 2 | 0 |
| Itchiness at vaccination site | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Limitation of motion | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Pain at injection site | 0 | 0 | 0 | 4 | 1 | 4 | 0 |
| Tenderness | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash | 0 | 2 | 0 | 0 | 1 | 0 | 0 |
Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Change in appetite | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Chills | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Feeling tired | 3 | 3 | 0 | 1 | 1 | 4 | 0 |
| Headache | 1 | 1 | 0 | 0 | 2 | 5 | 0 |
| Joint pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Muscle aches | 2 | 1 | 0 | 2 | 0 | 4 | 0 |
| Nausea | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Oral temperature elevated | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Underarm pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Underarm swelling | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Hemoglobin | 3 | 2 | 2 | 1 | 2 | 3 | 1 |
| White blood cells | 4 | 5 | 4 | 2 | 1 | 3 | 5 |
| Neutrophil count | 3 | 1 | 3 | 0 | 1 | 0 | 1 |
| Platelets | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Bilirubin | 0 | 0 | 2 | 0 | 1 | 1 | 1 |
| Creatinine | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| AST (SGPT) | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| ALT (SGOT) | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Alkaline Phosphatase | 0 | 1 | 0 | 2 | 5 | 1 | 3 |
Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Proteinuria | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Hematuria | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Number of Participants With Signs of Possible Myopericarditis | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Median neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
| Titers | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Peak Neutralizing Antibodies to ACAM3000 MVA | 27 (20 to 76) | 74 (52 to 113) | 68 (51 to 126) | 202 (157 to 569) | 220 (49 to 695) | 333 (177 to 584) | 20 (20 to 20) |
Median neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
| Titers | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Peak Neutralizing Antibodies to Vaccinia | 20 (20 to 20) | 20 (20 to 39) | 24 (20 to 32) | 70 (58 to 141) | 129 (41 to 274) | 179 (88 to 237) | 20 (20 to 20) |
Median binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
| Titers | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Peak Binding Antibodies (ELISA) to ACAM3000 MVA | 90 (30 to 810) | 270 (270 to 2430) | 270 (270 to 810) | 810 (810 to 7290) | 2430 (270 to 2430) | 2430 (810 to 2430) | 30 (30 to 30) |
Median binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.
| Titers | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Peak Binding Antibodies (ELISA) to Vaccinia | 90 (30 to 270) | 540 (30 to 2430) | 540 (270 to 810) | 4860 (2430 to 7290) | 540 (270 to 2430) | 2430 (810 to 2430) | 30 (30 to 30) |
Median T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10\^6 peripheral blood mononuclear cells (SFU/10\^6 PBMC).
| SFU/10^6 PBMC | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Peak T-cell Gamma Interferon Responses (ELISPOT) | 61 (0 to 89) | 373 (175 to 637) | 114 (79 to 279) | 99 (36 to 198) | 38 (14 to 137) | 185 (113 to 377) | 10 (0 to 25) |
Median Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.
| Titers | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Peak Titer of Viral Shedding Post Dryvax Challenge | 497,000 (99,000 to 895,000) | 52,500 (29,000 to 191,000) | 23,000 (3,150 to 545,000) | 570 (0 to 157,000) | 11,550 (0 to 147,500) | — | 480,000 (32,500 to 2,010,000) |
Restricted to participants who received Dryvax 6-15 months after MVA. A "take" is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction
| Participants | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Category 0 | 0 | 0 | 0 | 0 | 0 | — | 0 |
| Category 1 | 0 | 0 | 0 | 0 | 0 | — | 0 |
| Category 2 | 0 | 0 | 0 | 0 | 0 | — | 0 |
| Category 3 | 2 | 4 | 7 | 6 | 9 | — | 7 |
Collected over Subjects maintained a diary card to record the occurrence of solicited symptoms (vaccine reactogenicity) for 15 days (Day 0-14) after each vaccination. Unsolicited adverse events were collected through Day 360 after the first vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10^6 TCID50 MVA ID | — | 1/10 (10%) | 10/10 (100%) |
| 10^7 TCID50 MVA IM | — | 2/10 (20%) | 10/10 (100%) |
| 10^7 TCID50 MVA SC | — | 0/10 (0%) | 8/10 (80%) |
| 10^8 TCID50 MVA SC | — | 0/10 (0%) | 10/10 (100%) |
| 10^7 TCID50 MVA ID | — | 0/10 (0%) | 10/10 (100%) |
| 10^8 TCID50 MVA IM | — | 0/10 (0%) | 10/10 (100%) |
| Saline Placebo | — | 0/12 (0%) | 12/12 (100%) |
| Event | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Haemoglobin decreasedInvestigations | 0/10 | 2/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/12 |
| AmenorrhoeaReproductive system and breast disorders | 1/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/10 | 0/12 |
| Event | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo |
|---|---|---|---|---|---|---|---|
| Injection site erythema - post dose 2General disorders | 8/10 | 1/10 | 2/8 | 8/10 | 10/10 | 4/10 | 0/11 |
| Injection site erythema - post DryvaxGeneral disorders | 2/2 | 5/5 | 7/7 | 6/6 | 7/9 | — | 7/7 |
| Injection site induration - post dose 2General disorders | 5/10 | 2/10 | 2/8 | 8/10 | 10/10 | 3/10 | 0/11 |
| Injection site induration - post DryvaxGeneral disorders | 2/2 | 5/5 | 7/7 | 6/6 | 7/9 | — | 7/7 |
| Injection site pruritus - post DryvaxGeneral disorders | 2/2 | 4/5 | 6/7 | 3/6 | 5/9 | — | 6/7 |
| Injection site pain - post DryvaxGeneral disorders | 2/2 | 3/5 | 4/7 | 1/6 | 2/9 | — | 4/7 |
| Injection site erythema - post dose 1General disorders | 7/10 | 2/10 | 4/10 | 6/10 | 9/10 | 3/10 | 3/12 |
| Injection site induration - post dose 1General disorders | 4/10 | 1/10 | 2/10 | 8/10 | 9/10 | 1/10 | 2/12 |
| Injection site pain - post dose 1General disorders | 2/10 | 5/10 | 6/10 | 8/10 | 7/10 | 9/10 | 1/12 |
| Injection site pain - post dose 2General disorders | 1/10 | 5/10 | 6/8 | 9/10 | 7/10 | 6/10 | 1/11 |
| Age, Categorical(Participants) | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 10 | 10 | 10 | 10 | 12 | 72 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 24.3 ± 3.1 | 26.9 ± 4.7 | 24 ± 3.9 | 24.7 ± 4.1 | 26.5 ± 2.2 | 24.2 ± 3.6 | 25.6 ± 3.9 | 25.2 ± 3.7 |
| Sex: Female, Male(Participants) | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 7 | 6 | 5 | 7 | 4 | 8 | 6 | 43 |
| Male | 3 | 4 | 5 | 3 | 6 | 2 | 6 | 29 |
| Region of Enrollment(participants) | 10^6 TCID50 MVA ID | 10^7 TCID50 MVA IM | 10^7 TCID50 MVA SC | 10^8 TCID50 MVA SC | 10^7 TCID50 MVA ID | 10^8 TCID50 MVA IM | Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 10 | 10 | 10 | 10 | 10 | 10 | 12 | 72 |
The record gives a start of Oct 2005, a primary completion of Apr 2008 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2009, 1 year 3 months after primary completion.
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Studies of the drug tested here: MVA-BN smallpox vaccine
National Institute of Allergy and Infectious Diseases (NIAID) →