HIV InfectionsPhase 1NCT00282581
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
A Phase 1 study testing MVA Smallpox Vaccine in people with HIV Infections and Smallpox, run by Sanofi Pasteur, a Sanofi Company at 6 sites in United States.
Trial summary
The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Smallpox
- What is being tested?
- MVA Smallpox Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2006to Jul 2007
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product
- Subjects must test positive for HIV infection
- Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses.
- Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control
- subjects must be clinically stable for 6 months prior to study enrollment.
Who cannot join
- Subjects with a known or suspected history of immunodeficiency (with the exception of HIV infection)
- Subjects with history or prior exposure to a vaccinia-containing product
- subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions)
- Subjects with concomitant illnesses associated with impairment of immunologic function.
- subjects with dementia
- Subjects with malignancy.
Show all 11Show fewer
- Subjects with a known history of Cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities
- Current or past history of eczema
- known allergies to any component of MVA, including eggs or egg products, or allergies to blood products
- females must not be pregnant and using approved contraceptives.
- Morbid obesity
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2050
University of Hawaii
Honolulu, Hawaii, 96816
AltaMed Health Services Corporation
Los Angeles, California, 90022
University of Miami AIDS Clinical Research Unit
Miami, Florida, 33136
University of Miami School of Medicine
Miami, Florida, 33136
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects
The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection
Read the detailed description
This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28.
Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.
- Conditions
- HIV Infections, Smallpox
- Being tested
- MVA Smallpox Vaccine
- Keywords
- HIV, Smallpox, MVA
- Medical subject headings
- HIV Infections, Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA Smallpox VaccineBiological
Also called placebo
0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Biological: MVA Smallpox 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 posted27 Jan 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Senior managemnt decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Fischl, MD, Principal investigator, University of Miami AIDS clinical research unitRafael E Campo, MD, Principal investigator, University of MiamiCecilia Shikuma, MD, Principal investigator, University of Hawaii- HonoluluDaniel Pearce, DO, Principal investigator, AltaMed Health Services, Los AngelesJacob Lalezari, MD, Principal investigator, Quest Clinical Research, San FranciscoScott D Parker, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282581
- Sponsor's protocol ID
- H-249-004
- Status last verified
- Jan 2014
- First submitted
- 26 Jan 2006
- 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
- A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects
- ClinicalTrials.gov ID
- NCT00282581
- Acronym / sponsor ID
- H-249-004
- Conditions
- HIV Infections, Smallpox
- Keywords
- HIV, Smallpox, MVA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Senior managemnt decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 27 Jan 2006 (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 assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection
Detailed description
This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28.
Subjects will be enrolled and vaccinated in two cohorts according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Biological: MVA Smallpox Vaccine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product
- Subjects must test positive for HIV infection
- Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses.
- Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control
- subjects must be clinically stable for 6 months prior to study enrollment.
Key exclusion criteria (11 listed)
- Subjects with a known or suspected history of immunodeficiency (with the exception of HIV infection)
- Subjects with history or prior exposure to a vaccinia-containing product
- subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions)
- Subjects with concomitant illnesses associated with impairment of immunologic function.
- subjects with dementia
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 |
|---|---|---|
| MVA Smallpox VaccineAlso: placebo0.5mL of MVA3000 Smallpox Vaccine, 2 doses, separated by 28 days. | Biological | placebo |
Primary outcome
Safety
Time frame: Study Completion
1 secondary outcome
Immunogenicity
Time frame: Study Completion
Results and safety
The study was stopped early (reason given: Senior managemnt decision). 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.
Margaret Fischl, MD principal investigator
University of Miami AIDS clinical research unit
Rafael E Campo, MD principal investigator
University of Miami
Cecilia Shikuma, MD principal investigator
University of Hawaii- Honolulu
6 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 MVA Smallpox Vaccine in people with HIV Infections and Smallpox, run by Sanofi Pasteur, a Sanofi Company at 6 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 5 inclusion and 11 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 6 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 was stopped early (reason given: Senior managemnt decision). 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?
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 22 Jan 2014.