A Phase 3 interventional study of ACAM2000 in Smallpox Vaccine Adverse Reaction, sponsored by Emergent BioSolutions. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Phase 3, Interventional, and Other
Among 49 studies in Smallpox with a site in United States — none open to participants now, 1 under way, none of them phase 3. Smallpox · United States.
Among the 49 studies in Smallpox with a site in United States, this one is the 37th largest by enrollment of the 43 interventional ones, is one of 3 that started in 2010, is one of 6 in phase 3, and was the 37th registered.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 25 is below the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →None of the 49 studies in Smallpox with a site in United States is open now.
Of the 2 Smallpox studies recruiting now, 0 (0%) set no upper age limit and 2 (100%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →49 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2010.
Median enrollment 110 across the 43 interventional studies, 5,001 across the 5 observational. Of the 44 that completed or were terminated, 21 (48%) have results posted.
28 of 49 have an industry lead sponsor. The 10 most frequent:
Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Emergent BioSolutions has 9 studies filed under Smallpox — fewer than ten, so there is no comparison to draw.
1 of the studies in Smallpox with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04957485SIGA TechnologiesStudy to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS | 2027-01-01 |
Among the 49 studies in Smallpox with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
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.
Female subjects of must use at least one of the following means of documented by a physician's letter:
Exclusion Criteria:
Subject, household contact, or other close/intimate contact:
Subject has 3 or more of the following risk factors:
Cardiovascular disease or heart condition diagnosed by a doctor at any time in the past, with or without symptoms, including:
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.
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).
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This study was a single arm study. All eligible subjects received ACAM2000.
Biological: ACAM2000
Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration
Time frame: Days 0 to 90 post-vaccination
| Milestone | Vaccination |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
| percentage of participants | ACAM200 Vaccination Dose |
|---|---|
| Vaccination complications | 52 |
| Headache | 8 |
| injection site scab | 4 |
Collected over 1 year, 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACAM200 Vaccination Dose | 0/25 (0%) | 0/25 (0%) | 15/25 (60%) |
| Event | ACAM200 Vaccination Dose |
|---|---|
| Vaccination complicationInjury, poisoning and procedural complications | 13/25 |
| HeadacheNervous system disorders | 2/25 |
| Injection site scabGeneral disorders | 1/25 |
A total of 61 subjects were screened for VA-006 study; 25 subjects satisfied the eligibility criteria and were percutaneously administered ACAM2000 vaccine, while 36 subjects were not eligible for the study and were not administered ACAM2000.
| Age, Categorical(Participants) | Vaccination |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Vaccination |
|---|---|
| Female | 4 |
| Male | 21 |
| Region of Enrollment(participants) | Vaccination |
|---|---|
| United States | 25 |
| Age(years) | Vaccination |
|---|---|
| Mean | 47 ± 9.1 |
Plan to share: Undecided
Ran from Sep 2010 to primary completion in Feb 2012, 17 months.
Results were first posted in Mar 2019, 7 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ACAM2000