SmallpoxPhase 2NCT00053508
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
A Phase 2 study testing ACAM1000 and vaccinia virus (calf lymph) smallpox vaccine: Dryvax in people with Smallpox, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.
Trial summary
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- ACAM1000 and vaccinia virus (calf lymph) smallpox vaccine: Dryvax
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2002to Sep 2003
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- in good general health.
- not pregnant and using effective birth control
- agreed to participate in entire study and comply with protocol requirements.
Who cannot join
- military service prior to 1989.
- no previous smallpox vaccination.
- no contact with with children 1 year of age or younger
- immunodeficiency individuals or close contacts who are immunodeficient
- past history or current renal disease
- diagnosis or past history of eczema
Show all 13Show fewer
- known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).
- known allergy or past allergic to blood products.
- known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
- transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.
- serology positive for HIV, hepatitis B or hepatitis C.
- current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.
- inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Radiant Research
Cincinnati, Ohio, 45236
Orlando Clinical Research Center
Orlando, Florida, 32806
Mayo Vaccine Research Group
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Read the detailed description
In addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:
- Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
- Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.
- Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.
- Conditions
- Smallpox
- Being tested
- ACAM1000, vaccinia virus (calf lymph) smallpox vaccine: Dryvax
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACAM1000Biological
Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
vaccinia virus (calf lymph) smallpox vaccine: DryvaxBiological
Also called brand name = Dryvax
group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ACAM1000 Receives: Biological: ACAM1000 |
| Group 2 | Experimental | ACAM1000 Receives: Biological: ACAM1000 |
| Group 3 | Experimental | ACAM1000 Receives: Biological: ACAM1000 |
| Group 4 | Active comparator | Dryvax Receives: Biological: vaccinia virus (calf lymph) smallpox vaccine: Dryvax |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.
Measured: Day 7, Day 10, and/or Day 15
Secondary outcomes (1)
1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups.
Measured: days 0 and 30, day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionMar 2003
- Study completionSep 2003
Why it stopped: CDC's decision to down-select vaccine development to single candidate, ACAM2000
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053508
- Sponsor's protocol ID
- H-300-002
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2003
- 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
- The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
- ClinicalTrials.gov ID
- NCT00053508
- Acronym / sponsor ID
- H-300-002
- Conditions
- Smallpox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CDC's decision to down-select vaccine development to single candidate, ACAM2000
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 31 Jan 2003 (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 examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Detailed description
In addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:
- Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
- Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.
- Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ACAM1000ACAM1000 |
| Group 2 | Experimental | Biological: ACAM1000ACAM1000 |
| Group 3 | Experimental | Biological: ACAM1000ACAM1000 |
| Group 4 | Active comparator | Biological: vaccinia virus (calf lymph) smallpox vaccine: DryvaxDryvax |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- in good general health.
- not pregnant and using effective birth control
- agreed to participate in entire study and comply with protocol requirements.
Key exclusion criteria (13 listed)
- military service prior to 1989.
- no previous smallpox vaccination.
- no contact with with children 1 year of age or younger
- immunodeficiency individuals or close contacts who are immunodeficient
- past history or current renal 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 |
|---|---|---|
| ACAM1000Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU) | Biological | Group 1, Group 2, Group 3 |
| vaccinia virus (calf lymph) smallpox vaccine: DryvaxAlso: brand name = Dryvaxgroup 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU) | Biological | Group 4 |
Primary outcome
The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.
Time frame: Day 7, Day 10, and/or Day 15
1 secondary outcome
1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups.
Time frame: days 0 and 30, day 31
Results and safety
The study was stopped early (reason given: CDC's decision to down-select vaccine development to single candidate, ACAM2000). Results are not available in the source record.
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 Director study director
Sanofi Pasteur Inc
3 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 ACAM1000 and vaccinia virus (calf lymph) smallpox vaccine: Dryvax in people with Smallpox, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.
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 3 inclusion and 13 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: stopped early, 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.
Where is the study taking place?
The record lists 3 sites in United States. 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 was stopped early (reason given: CDC's decision to down-select vaccine development to single candidate, ACAM2000). Results are not available in the source record.
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?
The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15. (time frame: Day 7, Day 10, and/or Day 15). 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.