SmallpoxPhase 1NCT00189969
Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
A Phase 1 study testing Elstree-BN in people with Smallpox, run by Bavarian Nordic at 1 site in Germany.
Trial summary
The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- Elstree-BN
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2003to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Free of obvious health problems
- Negative HIV test
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus
- Hematocrit ≥ 38%; white blood cells between 4.0 and 10.0 / nl with differential blood count without clinical finding; and platelets between 150 and 400 / nl
- ALT < 1.5 times institutional upper limit of normal
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- Negative urine glucose by dipstick or urinalysis
- Adequate renal function defined as a serum creatinine < 1.5 mg/dL; urine protein < 100 mg/dL or < 2+ proteinuria; and a calculated creatinine clearance > 55 mL/min.
- For women, negative pregnancy test at screening and within 24 hours prior to vaccination.
- If the volunteer is female and of childbearing potential, she agrees to use acceptable contraception.
Who cannot join
- Pregnancy or breast-feeding
- Known or suspected history of smallpox vaccination
- Typical vaccinia scar
- Vaccinia specific antibodies at screening
- History of immunodeficiency
- Known or suspected impairment of immunologic function
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- Use of immunosuppressive medication or radiation therapy
- Any history of atopic disease
- Eczema of any degree or history of eczema
- Chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude
- Any malignancy including leukemia or lymphoma
- Presence of any infectious disease or a history or evidence of autoimmune disease
- History or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
- History of drug or chemical abuse
- Administration of inactivated vaccine 14 days prior to vaccination
- Any immune modifying therapy within 4 weeks prior to vaccination
- Administration of live attenuated vaccines within 60 days prior to vaccination
- Receipt of blood products or immunoglobulin in the past 6 months
- Subjects with acute febrile illness within one week prior to vaccination or subjects who may be in the incubation period of an infectious disease
- Household contacts/sexual contacts with, or occupational exposure to any of the following:
- Pregnant women
- Children <12 months of age
- People with current or history of atopic dermatitis
- People with chronic exfoliative skin disorders/conditions or any acute skin disorders
- People with immunodeficiency disease, malignancies or use of immunosuppressive medications
- History of anaphylaxis or severe allergic reaction
- Hypersensitivity to egg or chick protein
- Known allergies to any component of the vaccine or its diluent
- Known allergies to any known component of VIG
- Known allergies to cidofovir or probenecid
- Abnormalities suggestive of any underlying disease, detected at routine tests prior to study inclusion
- Use of any investigational or non-registered drug or vaccine starting 30 days preceding the study vaccine and ending at conclusion visit
- History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor.
- Three or more of the following risk factors: An immediate family member who has had onset of ischemic heart disease before age 50 years, elevated blood pressure, elevated blood cholesterol, diabetes or nicotine abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate Take Rate, Immunogenicity and Safety of Bavarian Nordic's Smallpox Vaccine Elstree-BN Administered to Healthy Vaccinia-Naive Subjects in the Age of 18-32 Years
The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.
- Conditions
- Smallpox
- Being tested
- Elstree-BN
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elstree-BNBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a typical pock ("take") which is associated historically with protection against variola within one week after vaccination.
Secondary outcomes (3)
Occurrence, relationship and intensity of any serious adverse event at any time during the study / any non-serious adverse event within 4 weeks after vaccination.
ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.
Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andreas Schroedter, M.D., Principal investigator, Focus Clinical Drug Development GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189969
- Sponsor's protocol ID
- POX-ELS-001
- Status last verified
- Apr 2006
- First submitted
- 13 Sep 2005
- Last updated
- 21 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate Take Rate, Immunogenicity and Safety of Bavarian Nordic's Smallpox Vaccine Elstree-BN Administered to Healthy Vaccinia-Naive Subjects in the Age of 18-32 Years
- ClinicalTrials.gov ID
- NCT00189969
- Acronym / sponsor ID
- POX-ELS-001
- Conditions
- Smallpox
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Feb 2006
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent
- Free of obvious health problems
- Negative HIV test
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus
- Hematocrit ≥ 38%; white blood cells between 4.0 and 10.0 / nl with differential blood count without clinical finding; and platelets between 150 and 400 / nl
Key exclusion criteria (34 listed)
- Pregnancy or breast-feeding
- Known or suspected history of smallpox vaccination
- Typical vaccinia scar
- Vaccinia specific antibodies at screening
- History of immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elstree-BN | Biological | – |
Primary outcome
Occurrence of a typical pock ("take") which is associated historically with protection against variola within one week after vaccination.
3 secondary outcomes
Occurrence, relationship and intensity of any serious adverse event at any time during the study / any non-serious adverse event within 4 weeks after vaccination.
ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.
Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Schroedter, M.D. principal investigator
Focus Clinical Drug Development GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elstree-BN in people with Smallpox, run by Bavarian Nordic at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a typical pock ("take") which is associated historically with protection against variola within one week after vaccination.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2006.