SmallpoxPhase 2NCT00258947
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
A Phase 2 study testing Smallpox vaccine, LISTER strain, from chick embryo cells in people with Smallpox and Poxvirus Infection, run by Sanofi at 6 sites in France.
Trial summary
Primary Objective: To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine. Secondary Objectives: To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox, Poxvirus Infection
- What is being tested?
- Smallpox vaccine, LISTER strain, from chick embryo cells
- Type of treatment
- Vaccines
- How many people
- 230 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2005to Jan 2007
- Phase
- Phase 2
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 25 years on the day of screening
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative serum pregnancy test performed at screening (Visit 01)
- Subject entitled to national social security
- Subject registered in the French file of healthy volunteers in clinical trials
- For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least 3 months prior to screening to 3 months following trial vaccination
- For a woman, inability to bear a child or negative urine pregnancy test.
Who cannot join
- Previous smallpox vaccination confirmed by vaccination record or typical scar
- Participation in another trial in the 3 months before or during the trial period
- Acute intercurrent or chronic illness during the trial
- Breast-feeding
- Allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine
- Congenital or acquired immunodeficiency or immunosuppressive therapy or any treatment including corticosteroids
Show all 21Show fewer
- Treatment with antiviral drugs within 1 month before vaccination
- History of organ or bone marrow transplant or skin disorders
- Personal or family history of autoimmune disease or cardiac disease, including cardiac risk factors
- History or current central nervous system disease
- Ongoing acute infectious disease
- Blood or blood-derived products received in the past 6 months
- Any vaccination with a live-attenuated vaccine within the 60 days or other vaccines within 40 days preceding the trial vaccination
- Vaccination planned in the 8 weeks following the trial vaccination
- Planned or foreseeable close contact after vaccination with infants less than 12 months, or with immuno-suppressed persons, pregnant and/or lactating woman, or practice of contact or water sports after vaccination before the crust separates
- Skin wound near the vaccination site
- Apparent lack of personal hygiene
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- HIV, hepatitis B or hepatitis C seropositivity (screening tests)
- Abnormal lab values for hematological parameters or cardiac enzyme (screening tests)
- Feverish illness (oral temperature >=37.5°C, rectal equivalent temperature >=38.0°C) on the day of vaccination.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Study site
Gières
Study site
Lagord
Study site
Montpellier
Study site
Paris
Study site
Poitiers
Study site
Rouen
About this study
Official title: Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.
Primary Objective:
To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.
Secondary Objectives:
To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.
- Conditions
- Smallpox, Poxvirus Infection
- Being tested
- Smallpox vaccine, LISTER strain, from chick embryo cells
- Keywords
- Smallpox, Orthopoxvirus, Poxvirus, Vaccina Virus, LISTER Strain, Bioterrorism
- Medical subject headings
- Smallpox, Poxviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smallpox vaccine, LISTER strain, from chick embryo cellsBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2006
- Study completionJan 2007
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258947
- Sponsor's protocol ID
- VVL04
- Status last verified
- Jan 2012
- First submitted
- 24 Nov 2005
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.
- ClinicalTrials.gov ID
- NCT00258947
- Acronym / sponsor ID
- VVL04
- Conditions
- Smallpox, Poxvirus Infection
- Keywords
- Smallpox, Orthopoxvirus, Poxvirus, Vaccina Virus, LISTER Strain, Bioterrorism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 28 Nov 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.
Primary Objective:
To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.
Secondary Objectives:
To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18 to 25 years on the day of screening
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative serum pregnancy test performed at screening (Visit 01)
- Subject entitled to national social security
Key exclusion criteria (21 listed)
- Previous smallpox vaccination confirmed by vaccination record or typical scar
- Participation in another trial in the 3 months before or during the trial period
- Acute intercurrent or chronic illness during the trial
- Breast-feeding
- Allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine
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 |
|---|---|---|
| Smallpox vaccine, LISTER strain, from chick embryo cells | Biological | – |
Primary outcome
Not reported in the source record.
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 1 Feb 2012.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Smallpox vaccine, LISTER strain, from chick embryo cells in people with Smallpox and Poxvirus Infection, run by Sanofi at 6 sites in France.
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 8 inclusion and 21 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 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 1 Feb 2012.