SmallpoxPhase 1NCT00042094
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
A Phase 1 study testing Cell-Cultured Smallpox Vaccine compared to Dryvax® in people with Smallpox, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- Cell-Cultured Smallpox Vaccine compared to Dryvax®
- Type of treatment
- Vaccines
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Mar 2003
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Have never received smallpox vaccine or previously received an experimental smallpox vectored vaccine (for vaccinia-naive cohorts only)
- Have been previously vaccinated within the last 10 years (vaccinia-experienced cohort only)
- Must agree to have blood samples banked for future research testing
- Have not participated in any clinical trial using investigational product within past month
- No current or past history of exfoliative skin problems
- Not have regular contact with children under 3 years of age until scab at site of vaccination has fallen off (around 21 days or 3 weeks after vaccination)
- Do not have a positive test for HIV virus, hepatitis C virus, or hepatitis B surface antigen
- Are not a health care worker caring for newborns, patients that are immunocompromised or have skin that is adversely altered
- Will not engage in direct patient care until immunization scab falls off (around 21 days or 3 weeks after vaccination) if health care worker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0084
About this study
Official title: A Phase 1 Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation (Take Rate) of a Cell-Cultured Smallpox Vaccine (CCSV) Compared to a Calf Lymph Vaccine (Dryvax®)
This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).
- Conditions
- Smallpox
- Being tested
- Cell-Cultured Smallpox Vaccine compared to Dryvax®
- Keywords
- Smallpox, Smallpox Vaccine, Vaccinia
- Medical subject headings
- Smallpox, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-Cultured Smallpox Vaccine compared to Dryvax®Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2002 (estimated)
- Study startMar 2002
- Study completionMar 2003
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042094
- Sponsor's protocol ID
- SMPX-001
- Status last verified
- Jun 2011
- First submitted
- 23 Jul 2002
- Last updated
- 30 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation (Take Rate) of a Cell-Cultured Smallpox Vaccine (CCSV) Compared to a Calf Lymph Vaccine (Dryvax®)
- ClinicalTrials.gov ID
- NCT00042094
- Acronym / sponsor ID
- SMPX-001
- Conditions
- Smallpox
- Keywords
- Smallpox, Smallpox Vaccine, Vaccinia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- DynPort Vaccine Company LLC, A GDIT CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Mar 2003
- First posted
- 26 Jul 2002 (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.
This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cell-Cultured Smallpox Vaccine compared to Dryvax® | 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 30 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cell-Cultured Smallpox Vaccine compared to Dryvax® in people with Smallpox, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site 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?
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 30 Jun 2011. 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 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 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.
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 30 Jun 2011; AzTrials last refreshed its copy on 6 Nov 2026.