SmallpoxPhase 1NCT00079820
Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults
A Phase 1 study testing ACAM3000 MVA Vaccine in people with Smallpox, run by Sanofi Pasteur, a Sanofi Company at 2 sites in United States.
Trial summary
The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in… Read more about this study
- Who is it for?
- Ages 18 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- ACAM3000 MVA Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2004to Oct 2006
- 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 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet the following to be eligible for the study:
- adult males or females who provided informed consent for the study.
- adults 18 and 31 years (inclusive).
- good general health,
- female subjects must not be pregnant or lactating and be on appropriate contraception or be a female unable to bear children.
- subjects be available for participation during the entire study.
Who cannot join
- Any of the following exclusion criteria are met, the subject is NOT eligible.
- military service prior to 1989 or after December 13th, 2002.
- history of previous smallpox vaccination
- known/suspected history of immunodeficiency, or with current radiation treatment or use of immunosuppressive or anti-neoplastic drugs.
- subjects with a household member or intimate contact with the same conditions listed above.
- known or suspected impairment of other immunologic function.
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- malignancy, including squamous cell or basal cell skin cancer at vaccination site
- active autoimmune disease.
- subjects with known eye diseases or other conditions that require the use of corticosteroid eye drops.
- known/history of cardiac disease.
- subjects who have been diagnosed with 3 or more of the following risk factors for ischemic coronary disease: a) high blood pressure b) elevated blood cholesterol levels c) diabetes or high blood sugar d) first degree relative (for example, mother, father, brother, or sister) who had a heart condition before the age of 50 e) smoke cigarettes
- subjects with a history of palpitations or abnormalities of cardiac rhythm.
- subjects with odd ECG patterns
- subjects with a ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years.
- positive or elevated creatinine kinase, CK-MB, or Troponin I laboratory test levels.
- abnormalities of clinical laboratory assessments.
- past history or current diagnosis of chronic renal disease, adverse reactions to drugs characterized by renal impairment, a serum creatinine > 1.5 mg/dL, or presence of 1+ protein in urinalysis at screening and a calculated creatinine clearance of not less than 80 mL/min.
- current diagnosis or past history of eczema.
- subjects with a household member or intimate contact with the same conditions listed above.
- presence of acute, chronic, or exfoliative skin conditions, open wounds, or burns.
- history of keloid formation.
- known allergies to MVA or to any known components (Neomycin, Gentamycin) of the vaccine.
- known allergy to eggs or egg products.
- known allergies to any component of the Dryvax® vaccine. Antibiotics in Dryvax® include neomycin, streptomycin, chlortetracycline, and polymixin B.
- known allergies to any known component of the Dryvax® diluent (i.e., glycerin and phenol).
- known allergies to any known component of VIG, (i.e., thimerosal or previous allergic reaction to immunoglobulins).
- known allergies to cidofovir or sulphur containing drugs, including probenecid, trimethoprim, and sulfonamide antibiotics.
- transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within 6 months of the screening visit.
- positive serology result for HIV, hepatitis B surface antigen, or hepatitis C.
- current diagnosis or history within six months of the screening visit of drug or alcohol abuse disorders.
- significant acute or chronic psychiatric illness.
- female subjects with a positive serum pregnancy test result
- subjects with a household member or direct contact with someone who is pregnant or lactating.
- temperature or acute illness within 3 days prior to vaccination
- inoculation with an inactivated vaccine with 14 days of Day 0 or with a live attenuated vaccine within 30 days of Day 0.
- subjects who have participated in another investigational drug or vaccine trial within 30 days of Day 0.
- subjects who are planning on donating blood or organs within 30 days of vaccination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PRA International
Lenexa, Kansas, 66219
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0093
About this study
Official title: The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination
The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated.
Historically, individuals in the US were vaccinated with a product such as Dryvax®, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine.
Read more
The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus.
The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or "pox" which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination.
- Conditions
- Smallpox
- Being tested
- ACAM3000 MVA Vaccine
- Keywords
- Smallpox, Smallpox Vaccine, Variola virus, Smallpox Virus, MODIFIED VACCINIA ANKARA, MVA, Dryvax, Dryvax vaccine, Protection against smallpox
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACAM3000 MVA VaccineBiological
Also called Dryvax smallpox vaccine
Two subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | MVA3000 Smallpox vaccine (1x10-8) with Dryvax Challenge at Day 112 Receives: Biological: ACAM3000 MVA Vaccine |
| B | Experimental | MVA3000 Smallpox vaccine (1x10-8) with no Challenge Receives: Biological: ACAM3000 MVA Vaccine |
| C | Placebo comparator | Placebo Receives: Biological: ACAM3000 MVA Vaccine |
| D | Experimental | MVA3000 Smallpox vaccine (1x10-7) with Dryvax challenge at Day 112 Receives: Biological: ACAM3000 MVA Vaccine |
| E | Experimental | MVA3000 Smallpox vaccine (1x10-6) with Dryvax challenge at Day 112 Receives: Biological: ACAM3000 MVA Vaccine |
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 posted17 Mar 2004 (estimated)
- Study startApr 2004
- Primary completionOct 2006
- Study completionOct 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 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
- NCT00079820
- Sponsor's protocol ID
- H-249-001
- Status last verified
- Jan 2014
- First submitted
- 15 Mar 2004
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination
- ClinicalTrials.gov ID
- NCT00079820
- Acronym / sponsor ID
- H-249-001
- Conditions
- Smallpox
- Keywords
- Smallpox, Smallpox Vaccine, Variola virus, Smallpox Virus, MODIFIED VACCINIA ANKARA, MVA, Dryvax, Dryvax vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 17 Mar 2004 (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 gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated.
Historically, individuals in the US were vaccinated with a product such as Dryvax®, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine.
The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus.
The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or "pox" which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: ACAM3000 MVA VaccineMVA3000 Smallpox vaccine (1x10-8) with Dryvax Challenge at Day 112 |
| B | Experimental | Biological: ACAM3000 MVA VaccineMVA3000 Smallpox vaccine (1x10-8) with no Challenge |
| C | Placebo comparator | Biological: ACAM3000 MVA VaccinePlacebo |
| D | Experimental | Biological: ACAM3000 MVA VaccineMVA3000 Smallpox vaccine (1x10-7) with Dryvax challenge at Day 112 |
| E | Experimental | Biological: ACAM3000 MVA VaccineMVA3000 Smallpox vaccine (1x10-6) with Dryvax challenge at Day 112 |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- adult males or females who provided informed consent for the study.
- adults 18 and 31 years (inclusive).
- good general health,
- female subjects must not be pregnant or lactating and be on appropriate contraception or be a female unable to bear children.
- subjects be available for participation during the entire study.
Key exclusion criteria (37 listed)
- Any of the following exclusion criteria are met, the subject is NOT eligible.
- military service prior to 1989 or after December 13th, 2002.
- history of previous smallpox vaccination
- known/suspected history of immunodeficiency, or with current radiation treatment or use of immunosuppressive or anti-neoplastic drugs.
- subjects with a household member or intimate contact with the same conditions listed above.
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 |
|---|---|---|
| ACAM3000 MVA VaccineAlso: Dryvax smallpox vaccineTwo subcutaneous injections of MVA3000 smallpox vaccine, separated by 28 days | Biological | A, B, C, D, E |
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 13 Jan 2014.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACAM3000 MVA Vaccine in people with Smallpox, run by Sanofi Pasteur, a Sanofi Company at 2 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 6 inclusion and 37 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 13 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 2 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. Some participants in this study may receive a placebo. 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.
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 13 Jan 2014.