SmallpoxPhase 1NCT00068198
Human Immune Responses Smallpox
A Phase 1 study testing Dryvax in people with Smallpox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to determine whether certain genetic characteristics influence the size of the sore around the vaccination site, and use blood samples from… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- Dryvax
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2004
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hematocrit greater than 34% for women, greater than 38% for men, white blood cells between 2500 and 11000/mm3 with normal differential, and platelet count equal to or greater than 150000/mm3
- Availability for followup for the planned duration of the study
- Negative urine or serum pregnancy test on day of vaccination for women
- If the subject is female, she agrees to use acceptable contraception and not become pregnant for at least seven months after vaccination
- Negative ELISA for HIV or negative Western Blot for subject who have a positive ELISA and participated in an HIV vaccine trial
- Meets the criteria for assignment into one of the three study groups
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- Willing to sign informed consent
- ALT greater than 1.5 times institutional upper limit of normal
- Negative hepatitis B surface antigen and negative antibody to hepatitis C virus
- Negative urine glucose by dipstick
- Adequate renal function defined as a serum creatinine greater than 1.5 mg/dL, urine protein greater than 100 mg/dL or less than 2+ proteinuria, and a calculated creatinine clearance greater than 55 mL/min
- Acceptable medical history by screening evaluation and brief clinical assessment
Who cannot join
- History of immunodeficiency
- Known or suspected impairment of immunologic function including but not limited to clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment
- Malignancy other than squamous cell or basal cell skin cancer
- Autoimmune disease
- Live attenuated vaccines within 60 days of study
- Known allergies to any component of the vaccine (e.g. polymyxin B sulfate, dihydrostreptomycin sulfate, chlortetracycline hydrochloride, neomycin sulfate)
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- Known allergies to any known component of VIG i.e. thimerosal or previous allergic reaction to immunoglobulins
- Acute febrile illness on the day of vaccination
- Eczema of any degree or history of eczema
- Use of immunosuppressive medication. Corticosteriod nasal sprays are permissible
- Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol
- History of "illegal" injection drug use
- Inactivated vaccine 14 days prior to vaccination
- Use of experimental agents within 30 days prior to study
- Receipt of blood products or immunoglobulin in the past 6 months
- Pregnant or lactating women
- History of chronic exfoliative skin disorders/conditions
- Any acute skin disorders of large magnitude e.g. laceration requiring sutures, burn greater than 2 x 2 cm
- Any condition that, in the opinion of the investigator, might interfere with study objectives
- Known allergies to any known component of the diluent (i.e. glycerin and phenol)
- Known allergies to cidofovir or probenecid
- Household contacts/sexual contacts with, or occupational exposure to (other than minimal contact), any of the following: 1) pregnant women, 2) children less than 12 months of age, 3) people with a history of eczema, 4) people with chronic exfoliative skin disorders/conditions or any acute skin disorders of large magnitude e.g. laceration requiring sutures, burn greater than 2 x 2 cm, or 5) people with immunodeficiency disease or use of immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Medicine
Rochester, New York, 14642
About this study
Official title: Evaluation of Human Immune Response to Smallpox Vaccine (Vaccinia Virus)
The purpose of this study is to attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to determine whether certain genetic characteristics influence the size of the sore around the vaccination site, and use blood samples from subjects in the study to make a new form of antibody that could be given to people with vaccine side effects.
Read the detailed description
Smallpox is a very serious disease that is fatal in about 1 in 3 patients. Smallpox does not exist naturally in the world, and there have been no cases of smallpox in the world since 1980. Smallpox can be prevented through the use of a very effective vaccine called vaccinia virus (Dryvax). After the world was considered free of smallpox, the production of smallpox vaccine was discontinued, but due to the recent concern that the smallpox virus may be used as a means of bioterrorism, the production of the smallpox vaccine may be restarted. Although Dryvax is known to be an effective vaccine for the prevention of smallpox, very little is known about the ability of the body to develop defenses to prevent disease (immune responses) with this vaccine. As new vaccines for preventing smallpox are developed, it will be important to compare the immune responses they cause to the responses that occur with the standard vaccine, Dryvax.
- Conditions
- Smallpox
- Being tested
- Dryvax
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DryvaxBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2003 (estimated)
- Study completionNov 2004
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 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068198
- Sponsor's protocol ID
- 02-067
- Status last verified
- May 2006
- First submitted
- 9 Sep 2003
- Last updated
- 27 Aug 2010
- Results posted
- No
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
- Evaluation of Human Immune Response to Smallpox Vaccine (Vaccinia Virus)
- ClinicalTrials.gov ID
- NCT00068198
- Acronym / sponsor ID
- 02-067
- Conditions
- Smallpox
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 2004
- First posted
- 10 Sep 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 attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine. In addition, we will try to determine whether certain genetic characteristics influence the size of the sore around the vaccination site, and use blood samples from subjects in the study to make a new form of antibody that could be given to people with vaccine side effects.
Detailed description
Smallpox is a very serious disease that is fatal in about 1 in 3 patients. Smallpox does not exist naturally in the world, and there have been no cases of smallpox in the world since 1980. Smallpox can be prevented through the use of a very effective vaccine called vaccinia virus (Dryvax). After the world was considered free of smallpox, the production of smallpox vaccine was discontinued, but due to the recent concern that the smallpox virus may be used as a means of bioterrorism, the production of the smallpox vaccine may be restarted. Although Dryvax is known to be an effective vaccine for the prevention of smallpox, very little is known about the ability of the body to develop defenses to prevent disease (immune responses) with this vaccine. As new vaccines for preventing smallpox are developed, it will be important to compare the immune responses they cause to the responses that occur with the standard vaccine, Dryvax.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Hematocrit greater than 34% for women, greater than 38% for men, white blood cells between 2500 and 11000/mm3 with normal differential, and platelet count equal to or greater than 150000/mm3
- Availability for followup for the planned duration of the study
- Negative urine or serum pregnancy test on day of vaccination for women
- If the subject is female, she agrees to use acceptable contraception and not become pregnant for at least seven months after vaccination
- Negative ELISA for HIV or negative Western Blot for subject who have a positive ELISA and participated in an HIV vaccine trial
Key exclusion criteria (22 listed)
- History of immunodeficiency
- Known or suspected impairment of immunologic function including but not limited to clinically significant liver disease, diabetes mellitus, moderate to severe kidney impairment
- Malignancy other than squamous cell or basal cell skin cancer
- Autoimmune disease
- Live attenuated vaccines within 60 days of study
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 | 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.
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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 Dryvax in people with Smallpox, run by National Institute of Allergy and Infectious Diseases (NIAID) 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?
The sponsor lists 12 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 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 27 Aug 2010.