SmallpoxPhase 2NCT00466245
Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine
A Phase 2 study testing MVA Smallpox vaccine in people with Smallpox, run by Sanofi Pasteur, a Sanofi Company.
Trial summary
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- MVA Smallpox vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Jun 2006
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects must be in good general health, checked on toxicity grading table.
- for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
- for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
- Female subjects must not be pregnant or lactating.
Who cannot join
- Subjects who participated in a "first responder" program.
- any history of immunodeficiency.
- any autoimmune disease
- any history of cardiac disease
- any diagnosed risk factors for ischemic coronary disease
- any history of heart palpitations or abnormalities in cardiac rhythm.
Show all 9Show fewer
- any current or history of eczema of any description.
- Known allergy to MVA or any of its components, including eggs or egg products.
- morbid obesity
About this study
Official title: Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2 Study Assessing Safety, Tolerability, Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara Smallpox Vaccine in Adults With and Without Previous Smallpox Vaccination
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.
Read the detailed description
This study will be a randomized, double-blind, placebo-controlled out-patient study conducted in multiple centers in the United States (US). Up to 700 healthy male and female adult subjects 18 to 55 years of age (inclusive), who have been previously vaccinated or subjects who are naïve to smallpox vaccine will be enrolled. Subjects will be randomized to 1 of 8 treatment groups with 100 (or 50 placebo) subjects per group in which they will receive either ACAM3000 MVA Smallpox Vaccine (1 of 3 dose levels) or placebo on Study Days 0 and 28. All personnel associated with the trial will be blinded as to treatment, with the exception of the study pharmacist who prepares the treatment for administration to each subject. There are 2 control groups in this study. A comparison of adverse events and other safety assessments between placebo and ACAM3000 MVA Smallpox Vaccine will be performed. In addition to serving as a control for safety, the previously vaccinated subjects receiving placebo will serve as a control for antibody and T-cell responses in persons with preexisting immunity who receive ACAM3000 MVA Smallpox Vaccine. Safety, tolerability, and immunogenicity data for 110 subjects undergoing primary immunization with graded doses of ACAM3000 MVA Smallpox Vaccine will be available following completion of Acambis protocol H-249-001, an ongoing phase I clinical trial. The doses levels in this study may be changed following the availability of results from protocol H-249-001. Statistical analysis will focus on comparisons among the dose levels of ACAM3000 MVA Smallpox Vaccine and comparisons of ACAM3000 MVA Smallpox Vaccine to placebo, as appropriate. A separate analysis will be performed for previously vaccinated and naïve subjects. Descriptive statistics will be used to compare demographic and baseline clinical data between stratum.
- Conditions
- Smallpox
- Being tested
- MVA Smallpox vaccine, Placebo
- Keywords
- MVA Vaccine
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA Smallpox vaccineDrug
Two 0.5mL subcutaneous injections, separated by 28 days
PlaceboDrug
Two 0.5mL subcutaneous injections, separated by 28 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Previously vaccinated for smallpox, 1x10-8 dose Receives: Drug: MVA Smallpox vaccine |
| B | Experimental | Smallpox vaccine naive, 1x10-8 dose Receives: Drug: MVA Smallpox vaccine |
| C | Experimental | Previous smallpox vaccination, 1x10-7 dose Receives: Drug: MVA Smallpox vaccine |
| D | Experimental | Smallpox vaccine naive, 1x10-7 dose Receives: Drug: MVA Smallpox vaccine |
| E | Experimental | Previous smallpox vaccination, 1x10-6 dose Receives: Drug: MVA Smallpox vaccine |
| F | Experimental | Smallpox vaccine naive, 1x10-6 dose Receives: Drug: MVA Smallpox vaccine |
| G | Experimental | Previous smallpox vaccination, placebo dose Receives: Drug: Placebo |
| H | Experimental | Smallpox vaccine naive, placebo dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Study Completion
Secondary outcomes (1)
Immunogenicity
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 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.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466245
- Sponsor's protocol ID
- H-249-002
- Status last verified
- Jan 2014
- First submitted
- 25 Apr 2007
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2 Study Assessing Safety, Tolerability, Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara Smallpox Vaccine in Adults With and Without Previous Smallpox Vaccination
- ClinicalTrials.gov ID
- NCT00466245
- Acronym / sponsor ID
- H-249-002
- Conditions
- Smallpox
- Keywords
- MVA Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 27 Apr 2007 (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.
A phase 2 study to assess the MVA smallpox vaccine in previously vaccinated and vaccine- naive subjects at three dose levels.
Detailed description
This study will be a randomized, double-blind, placebo-controlled out-patient study conducted in multiple centers in the United States (US). Up to 700 healthy male and female adult subjects 18 to 55 years of age (inclusive), who have been previously vaccinated or subjects who are naïve to smallpox vaccine will be enrolled. Subjects will be randomized to 1 of 8 treatment groups with 100 (or 50 placebo) subjects per group in which they will receive either ACAM3000 MVA Smallpox Vaccine (1 of 3 dose levels) or placebo on Study Days 0 and 28. All personnel associated with the trial will be blinded as to treatment, with the exception of the study pharmacist who prepares the treatment for administration to each subject. There are 2 control groups in this study. A comparison of adverse events and other safety assessments between placebo and ACAM3000 MVA Smallpox Vaccine will be performed. In addition to serving as a control for safety, the previously vaccinated subjects receiving placebo will serve as a control for antibody and T-cell responses in persons with preexisting immunity who receive ACAM3000 MVA Smallpox Vaccine. Safety, tolerability, and immunogenicity data for 110 subjects undergoing primary immunization with graded doses of ACAM3000 MVA Smallpox Vaccine will be available following completion of Acambis protocol H-249-001, an ongoing phase I clinical trial. The doses levels in this study may be changed following the availability of results from protocol H-249-001. Statistical analysis will focus on comparisons among the dose levels of ACAM3000 MVA Smallpox Vaccine and comparisons of ACAM3000 MVA Smallpox Vaccine to placebo, as appropriate. A separate analysis will be performed for previously vaccinated and naïve subjects. Descriptive statistics will be used to compare demographic and baseline clinical data between stratum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MVA Smallpox vaccinePreviously vaccinated for smallpox, 1x10-8 dose |
| B | Experimental | Drug: MVA Smallpox vaccineSmallpox vaccine naive, 1x10-8 dose |
| C | Experimental | Drug: MVA Smallpox vaccinePrevious smallpox vaccination, 1x10-7 dose |
| D | Experimental | Drug: MVA Smallpox vaccineSmallpox vaccine naive, 1x10-7 dose |
| E | Experimental | Drug: MVA Smallpox vaccinePrevious smallpox vaccination, 1x10-6 dose |
| F | Experimental | Drug: MVA Smallpox vaccineSmallpox vaccine naive, 1x10-6 dose |
| G | Experimental | Drug: PlaceboPrevious smallpox vaccination, placebo dose |
| H | Experimental | Drug: PlaceboSmallpox vaccine naive, placebo dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subjects must be in good general health, checked on toxicity grading table.
- for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago.
- for vaccine naive subjects- must be between the ages of 18 and 32, and have never been vaccinated for smallpox.
- Female subjects must not be pregnant or lactating.
Key exclusion criteria (9 listed)
- Subjects who participated in a "first responder" program.
- any history of immunodeficiency.
- any autoimmune disease
- any history of cardiac disease
- any diagnosed risk factors for ischemic coronary disease
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 |
|---|---|---|
| MVA Smallpox vaccineTwo 0.5mL subcutaneous injections, separated by 28 days | Drug | A, B, C, D, E, F |
| PlaceboTwo 0.5mL subcutaneous injections, separated by 28 days | Drug | G, H |
Primary outcome
Safety
Time frame: Study Completion
1 secondary outcome
Immunogenicity
Time frame: Study Completion
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 22 Jan 2014.
- 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 Monitor study director
Sanofi Pasteur Inc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA Smallpox vaccine in people with Smallpox, run by Sanofi Pasteur, a Sanofi Company.
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 4 inclusion and 9 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Safety (time frame: Study Completion). 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 22 Jan 2014.