SmallpoxPhase 2NCT00026611
A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
A Phase 2 study testing Dryvax vaccine in people with Smallpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given. The world was declared free of smallpox in 1980. General routine vaccinations for smallpox were stopped in the U.S. in 1971. 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?
- Dryvax vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Dec 2001
- 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 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are between 18 and 32 years of age.
- Give written informed consent.
- Are available for follow-up for 2.5 months.
- Have an acceptable medical history by screening evaluation and brief clinical assessment.
- Are HIV-negative.
- Agree to use acceptable contraception and to not get pregnant during the study.
Who cannot join
- Patients may not be eligible for this study if they:
- Have a suppressed immune system.
- Have participated in an HIV vaccine trial.
- Have liver disease, diabetes, or kidney problems.
- Have malignant skin cancer.
- Have autoimmune disease.
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- Have used medication that suppresses the immune system.
- Have had psychiatric or medical problems or have job responsibilites that will keep them from participating in the study.
- Use illegal intravenous drugs.
- Have received any live vaccines within 60 days of study start.
- Have used experimental therapies within 30 days before study start.
- Have been vaccinated with certain experimental vaccines.
- Have a vaccination scar but have no record of having a vaccine.
- Have received a smallpox vaccine.
- Have taken blood products or immunoglobulin in the past 6 months.
- Have a fever on the day of vaccination.
- Have certain skin disorders, including eczema, exfoliative skin, lacerations that require stitches or burns larger than 2 x 2 cm.
- Live with, have sexual contact with, or work with anyone who is pregnant, less than a year old, has eczema, has certain skin disorders, has a disease or takes medication that suppresses the immune system.
- Have a condition that, in the opinion of the investigator, might interfere with the study.
- Are allergic to any parts of the vaccine.
- Are allergic to thimerosal, immunoglobulins, cidofovir, or probenecid.
- Are pregnant or breast feeding.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland
Baltimore, Maryland
Baylor College of Medicine
Houston, Texas, 77030
University of Rochester
Rochester, New York, 14642
St. Louis University
St Louis, Missouri
About this study
Official title: A Multicenter, Double-Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given.
The world was declared free of smallpox in 1980. General routine vaccinations for smallpox were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of healthcare workers was also discontinued. The only people who presently receive this vaccine are people who work with vaccinia virus or monkeypox virus. Because the world was considered free of smallpox infections, this vaccine was no longer produced; there is a limited supply available in the United States.
Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study will look at the ability to dilute the vaccine making more doses available in the event of a smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox with various doses of Dryvax, followed by revaccination with the same dose, if required, in volunteers 18-32 years of age with a negative history of smallpox vaccination.
- Conditions
- Smallpox
- Being tested
- Dryvax vaccine
- Keywords
- Vaccine prophylaxis
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dryvax vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2001 (estimated)
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026611
- Sponsor's protocol ID
- DMID 01-632
- Status last verified
- Mar 2010
- First submitted
- 12 Nov 2001
- Last updated
- 27 Aug 2010
- Results posted
- No
Publications
Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R, Nolan CM, Belshe RB; National Institute of Allergy and Infectious Diseases Smallpox Vaccine Study Group. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med. 2002 Apr 25;346(17):1265-74. doi: 10.1056/NEJMoa020534. Epub 2002 Mar 28.
PubMed 11923490
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Dose-Response Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
- ClinicalTrials.gov ID
- NCT00026611
- Acronym / sponsor ID
- DMID 01-632
- Conditions
- Smallpox
- Keywords
- Vaccine prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 13 Nov 2001 (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 see how many people respond to a smallpox vaccine when a sore forms where the shot was given.
The world was declared free of smallpox in 1980. General routine vaccinations for smallpox were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of healthcare workers was also discontinued. The only people who presently receive this vaccine are people who work with vaccinia virus or monkeypox virus. Because the world was considered free of smallpox infections, this vaccine was no longer produced; there is a limited supply available in the United States.
Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study will look at the ability to dilute the vaccine making more doses available in the event of a smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox with various doses of Dryvax, followed by revaccination with the same dose, if required, in volunteers 18-32 years of age with a negative history of smallpox vaccination.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Are between 18 and 32 years of age.
- Give written informed consent.
- Are available for follow-up for 2.5 months.
- Have an acceptable medical history by screening evaluation and brief clinical assessment.
- Are HIV-negative.
Key exclusion criteria (22 listed)
- Have a suppressed immune system.
- Have participated in an HIV vaccine trial.
- Have liver disease, diabetes, or kidney problems.
- Have malignant skin cancer.
- Have autoimmune 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 |
|---|---|---|
| Dryvax vaccine | 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 27 Aug 2010.
- Background: PubMed 11923490Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R, Nolan CM, Belshe RB; National Institute of Allergy and Infectious Diseases Smallpox Vaccine Study Group. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med. 2002 Apr 25;346(17):1265-74. doi: 10.1056/NEJMoa020534. Epub 2002 Mar 28.
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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.
4 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 Dryvax vaccine in people with Smallpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 7 inclusion and 22 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
On the ClinicalTrials.gov record for NCT00026611, which also lists 1 linked publication.
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 27 Aug 2010.