Variola Major (Smallpox)Phase 1NCT00565929
Safety, Reactogenicity and Immunogenicity of MVA in Hematopoietic Stem Cell Transplant (HSCT) Subjects
A Phase 1 study testing MVA-BN in people with Variola Major (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 compare how the body's immune system reacts to a vaccine against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety of this vaccine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Variola Major (Smallpox)
- What is being tested?
- MVA-BN
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to May 2012
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General:
- Age: 18 to 60
- Complete a written assessment of understanding prior to enrollment and verbalize understanding of all questions answered incorrectly
- Informed consent: Be able, willing, and have signed the informed consent form
- Undergone stem cell transplant more than 2 years prior to enrollment
- Current Health: Be in good general health without evidence of active malignancy and off immunosuppressant medications. Without evidence of clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results. A clinically significant condition or process includes one or more of the following:
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- An active condition that is life threatening
- A condition for which repeated injections or blood draws may pose additional risk to the participant
- A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being
- A condition or process in which signs or symptoms could be confused with reactions to vaccine
- Laboratory:
- Hematology and chemistries: Chemistries within 1.25x of the institutional normal limits for age and sex for alanine aminotransferase (ALT), aspartate aminotransferase (AST), Alkaline Phos, and Total Bilirubin. Creatinine less than or equal to 1.8 mg/dL. Platelets and Troponin I or T must be within normal range. Hemoglobin above 10.5 gm/dL for women and 11.5 gm/dL for men and white blood cells (WBC) between 3,000 and 12,500 cells/mm^3.
- Negative for Hepatitis B surface antigen and Hepatitis C virus (HCV) antibodies (If HCV antibodies are positive, and negative for HCV by polymerase chain reaction (PCR), subject is eligible)
- Negative Food and Drug Administration (FDA)-approved human immunodeficiency virus (HIV) blood test within 8 weeks prior to enrollment
- Normal urine dipstick or urinalysis:
- Negative glucose, and
- Negative or trace protein and negative or trace hemoglobin (if trace hemoglobin is present, a urinalysis is required to exclude participants with counts greater than the institutional normal range)
- In addition to meeting ALL of the above criteria, FEMALE participants must meet BOTH of the following criteria:
- Negative serum or urine Beta-human chorionic gonadotropin (HCG) pregnancy test performed within 24 hours prior to any vaccination
- Reproductive status: A female participant either must:
- not be of reproductive potential (Reproductive potential in women is defined as not having reached menopause (no menses for one year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.)
- be with a male partner(s) throughout the duration of the study who has undergone successful vasectomy (A vasectomy is considered successful if a woman reports that a male partner has (1) microscopic documentation of azospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy), or
- agree to avoid pregnancy through alternative methods and agree to consistently use contraception for at least 21 days prior to enrollment until 1 month after last vaccination. Contraception is defined as using one of the following methods: condoms (male or female with or without a spermicide), diaphragm or cervical cap with spermicide, intrauterine device (IUD), or hormone-based therapy, e.g., contraceptive pills, Norplant, or Depo-Provera.
Who cannot join
- Chronic Graft versus Host Disease (GVHD) requiring systemic immunosuppressive medication within the last 6 months.
- Immunosuppressive medications within 30 days prior to initial study vaccine administration, e.g., oral/parenteral corticosteroids, and/or cytotoxic medications. Not excluded: A participant using any of the following is not excluded: corticosteroid nasal spray for allergic rhinitis; or topical corticosteroids as prescribed by a physician for an acute, uncomplicated dermatitis; or over the counter medications (including topical corticosteroids for an acute, uncomplicated dermatitis); use of rapidly tapered steroids for an acute isolated condition, excluding asthma which is addressed separately-within 28 days prior to vaccine administration.
- Asthma that is unstable, e.g., use of oral or intravenous corticosteroids, hospitalization or intubation during the past 2 years.
- In addition, exclude a participant who routinely uses a moderate to high dose inhaled corticosteroids (e.g., more than equivalent of 264 micrograms (mcg) fluticasone; 600 mcg budesonide; 240 mcg beclomethasone; 1000 mcg flunisolide, 750 mcg triamcinolone or 200 mcg mometasone, as a daily dose).
- Receipt of immunoglobulin within 60 days prior to initial study vaccine administration.
- Receipt of live attenuated vaccines within 30 days prior to initial study vaccine administration.
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- Receipt of medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, or allergy treatment with antigen injections within 14 days prior to initial study vaccine administration.
- Participant has a history of any of the following:
- Acute febrile illness on the day of vaccination
- Eczema or atopic dermatitis (past or present)
- Acute skin disorders of large magnitude (greater than 2x2 cm), e.g., burns or lacerations
- History or presence of skin cancer at vaccination site(s)
- Heart disease including history of a myocardial infarction (MI), angina, congestive heart failure (CHF), or pericardial pathology
- Twenty percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool (http://hin.nhlbi.nih.gov/atpiii/calculator.asp).
- Known allergy to eggs.
- History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. Not excluded: A participant who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Bleeding disorder diagnosed by a doctor and that is clinically active, e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions. Not excluded: A participant who states he/she has easy bruising or bleeding, but does not carry a formal diagnosis, and has had intramuscular (IM) injections and blood draws without any adverse experience, is not excluded.
- Active Seizure disorder. Not excluded: A participant with a history of a seizure disorder whose last seizure was over 1 year ago.
- Psychiatric condition that precludes compliance with the protocol.
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
- Female participants: Participant is pregnant and or breast-feeding.
- Currently taking investigational agents. Not excluded: participation in a study where the participant is not receiving an investigational agent or the participant is in the follow up phase of a study and the investigational agent was given more than 3 months prior.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital - Infectious Diseases
Boston, Massachusetts, 02115-6110
About this study
Official title: MVA-BN (IMVAMUNE®) Immunization in Persons Who Have Undergone Prior Hematopoietic Stem Cell Transplant (HSCT): A Phase I, Placebo-Controlled Study of the Safety, Reactogenicity and Immunogenicity of MVA Immunization
The purpose of this study is to compare how the body's immune system reacts to a vaccine against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety of this vaccine. Study participants will include 24 adults, ages 18-60 years, who have undergone a stem cell transplant more than 2 years ago. Study procedures will include a physical exam, blood samples, heart activity assessments, and urine samples. Participants will be assigned to 1 of 2 possible study vaccine groups. The participants will receive 1 of 2 possible vaccine doses or placebo (substance containing no medication) 28 days apart. Participants will make at least 8 visits to the clinic during the course of the study; additional visits may be needed if the participant experiences side effects from the vaccine. Participants may be involved in study related procedures for about 6 months.
Read the detailed description
In the event of a smallpox outbreak, or threat of one, mass immunization of all vulnerable individuals would take place. This would include persons with immunodeficiency as seen post Hematopoietic Stem Cell Transplant (HSCT). The current Food and Drug Administration (FDA) approved smallpox vaccine (Dryvax®) is a live replicating virus (vaccinia) and is contraindicated in both immunocompromised persons and those in close physical contact with them. The Modified Vaccinia Ankara (MVA), specifically IMVAMUNE® has been developed as a safer, less reactogenic vaccine against smallpox. Study participants will include 24 male or female participants, from 18 to 60 years of age. This study assesses the safety, reactogenicity and immunogenicity of 2 doses of MVA-BN (IMVAMUNE®) given to persons who have undergone an HSCT more than 2 years prior to study participation. There are 2 arms in the study, each receiving 2 doses 28 days apart of either 1 x 10^7 or 1 x 10^8 tissue culture infectious dose 50 (TCID50). Each arm will be comprised of 12 subjects, 10 of whom will receive IMVAMUNE® and 2 of whom will receive placebo under a double blind, randomized allocation. Subjects will be followed for safety and reactogenicity. Clinical assessments will be performed and blood samples will be obtained sequentially for safety and immunogenicity determinations. All subjects will complete a memory aid for 15 days after each vaccination to record oral temperature and note the occurrence of solicited and unsolicited adverse events as well as any medication use. Adverse events will be collected for 56 days after each vaccination. Serious adverse events and concomitant medications will be collected throughout the entire study period. Study staff will assess subjects clinically at days 14 and 28 after each vaccination and on days 42, 56, 84, and 180. Hematology and blood chemistry studies including hemoglobin, white blood cell and platelet counts and kidney and liver function tests will be obtained. Electrocardiogram and Troponin I or T will be obtained prior to first vaccination and on days 14 and 28 after each immunization and at day 180. Clinical laboratory assays will be conducted in the clinical laboratory at both the Brigham and Women's Hospital or the Dana Farber Cancer Institute. The primary objective of this study is to determine the safety and reactogenicity of MVA in persons who have undergone allogeneic HSCT more than 2 years prior to study participation. The secondary objective of this study is to determine the immunogenicity of MVA in persons who have undergone HSCT more than 2 years prior to study participation. Immunogenicity will be determined by humoral immune responses and cell mediated immune responses.
- Conditions
- Variola Major (Smallpox)
- Being tested
- Placebo, MVA-BN
- Keywords
- Variola major, smallpox, vaccine, hematopoietic stem cell transplant
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Sterile saline (0.9%).
MVA-BNBiological
The smallpox vaccine is a liquid frozen solution formulated to contain 0.605 mg Tris and 4.090 mg sodium chloride (NaCl) per 0.5 mL dose. The concentration of the virus will be 1 X 10^8 tissue culture infectious dose 50 (TCID 50) per 0.5 mL dose and may be diluted in a solution of 0.9% saline prior to vaccination. Smallpox vaccine administered in 2 doses approximately 28 days apart in one of the following doses: 1X10^7 or 1X10^8 TCID 50.
| Study group | Role | What they receive |
|---|---|---|
| Group A: MVA-BN 1 X 10^7 TCID 50 | Experimental | 10 participants to receive vaccine dose 1X10^7 TCID 50; 2 participants to receive placebo. Receives: Drug: Placebo; Biological: MVA-BN |
| Group B: MVA-BN 1 X 10^8 TCID 50 | Experimental | 10 participants to receive vaccine dose 1X10^8 TCID 50; 2 participants to receive placebo. Receives: Drug: Placebo; Biological: MVA-BN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: acute reactogenicity, both local and systemic; and hematologic and clinical chemistry laboratory values.
Measured: Day 0-180.
Secondary outcomes (1)
Immunogenicity: humoral and cell-mediated immune responses.
Measured: Screening, Days 14 and 28 after 1st vaccination; Days 0, 14, 28, 56, and 152 after 2nd vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionMay 2012
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 Variola Major (Smallpox)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565929
- Sponsor's protocol ID
- 07-0042
- Other IDs
- 5U54AI057159-10
- Status last verified
- Sep 2012
- First submitted
- 29 Nov 2007
- Last updated
- 2 Aug 2013
- Results posted
- No
Publications
Walsh SR, Wilck MB, Dominguez DJ, Zablowsky E, Bajimaya S, Gagne LS, Verrill KA, Kleinjan JA, Patel A, Zhang Y, Hill H, Acharyya A, Fisher DC, Antin JH, Seaman MS, Dolin R, Baden LR. Safety and immunogenicity of modified vaccinia Ankara in hematopoietic stem cell transplant recipients: a randomized, controlled trial. J Infect Dis. 2013 Jun 15;207(12):1888-97. doi: 10.1093/infdis/jit105. Epub 2013 Mar 12.
PubMed 23482644
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MVA-BN (IMVAMUNE®) Immunization in Persons Who Have Undergone Prior Hematopoietic Stem Cell Transplant (HSCT): A Phase I, Placebo-Controlled Study of the Safety, Reactogenicity and Immunogenicity of MVA Immunization
- ClinicalTrials.gov ID
- NCT00565929
- Acronym / sponsor ID
- 07-0042
- Conditions
- Variola Major (Smallpox)
- Keywords
- Variola major, smallpox, vaccine, hematopoietic stem cell transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Nov 2007 (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 compare how the body's immune system reacts to a vaccine against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety of this vaccine. Study participants will include 24 adults, ages 18-60 years, who have undergone a stem cell transplant more than 2 years ago. Study procedures will include a physical exam, blood samples, heart activity assessments, and urine samples. Participants will be assigned to 1 of 2 possible study vaccine groups. The participants will receive 1 of 2 possible vaccine doses or placebo (substance containing no medication) 28 days apart. Participants will make at least 8 visits to the clinic during the course of the study; additional visits may be needed if the participant experiences side effects from the vaccine. Participants may be involved in study related procedures for about 6 months.
Detailed description
In the event of a smallpox outbreak, or threat of one, mass immunization of all vulnerable individuals would take place. This would include persons with immunodeficiency as seen post Hematopoietic Stem Cell Transplant (HSCT). The current Food and Drug Administration (FDA) approved smallpox vaccine (Dryvax®) is a live replicating virus (vaccinia) and is contraindicated in both immunocompromised persons and those in close physical contact with them. The Modified Vaccinia Ankara (MVA), specifically IMVAMUNE® has been developed as a safer, less reactogenic vaccine against smallpox. Study participants will include 24 male or female participants, from 18 to 60 years of age. This study assesses the safety, reactogenicity and immunogenicity of 2 doses of MVA-BN (IMVAMUNE®) given to persons who have undergone an HSCT more than 2 years prior to study participation. There are 2 arms in the study, each receiving 2 doses 28 days apart of either 1 x 10^7 or 1 x 10^8 tissue culture infectious dose 50 (TCID50). Each arm will be comprised of 12 subjects, 10 of whom will receive IMVAMUNE® and 2 of whom will receive placebo under a double blind, randomized allocation. Subjects will be followed for safety and reactogenicity. Clinical assessments will be performed and blood samples will be obtained sequentially for safety and immunogenicity determinations. All subjects will complete a memory aid for 15 days after each vaccination to record oral temperature and note the occurrence of solicited and unsolicited adverse events as well as any medication use. Adverse events will be collected for 56 days after each vaccination. Serious adverse events and concomitant medications will be collected throughout the entire study period. Study staff will assess subjects clinically at days 14 and 28 after each vaccination and on days 42, 56, 84, and 180. Hematology and blood chemistry studies including hemoglobin, white blood cell and platelet counts and kidney and liver function tests will be obtained. Electrocardiogram and Troponin I or T will be obtained prior to first vaccination and on days 14 and 28 after each immunization and at day 180. Clinical laboratory assays will be conducted in the clinical laboratory at both the Brigham and Women's Hospital or the Dana Farber Cancer Institute. The primary objective of this study is to determine the safety and reactogenicity of MVA in persons who have undergone allogeneic HSCT more than 2 years prior to study participation. The secondary objective of this study is to determine the immunogenicity of MVA in persons who have undergone HSCT more than 2 years prior to study participation. Immunogenicity will be determined by humoral immune responses and cell mediated immune responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: MVA-BN 1 X 10^7 TCID 50 | Experimental | Drug: Placebo, Biological: MVA-BN10 participants to receive vaccine dose 1X10^7 TCID 50; 2 participants to receive placebo. |
| Group B: MVA-BN 1 X 10^8 TCID 50 | Experimental | Drug: Placebo, Biological: MVA-BN10 participants to receive vaccine dose 1X10^8 TCID 50; 2 participants to receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Age: 18 to 60
- Complete a written assessment of understanding prior to enrollment and verbalize understanding of all questions answered incorrectly
- Informed consent: Be able, willing, and have signed the informed consent form
- Undergone stem cell transplant more than 2 years prior to enrollment
- Current Health: Be in good general health without evidence of active malignancy and off immunosuppressant medications. Without evidence of clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results. A clinically significant condition or process includes one or more of the following:
Key exclusion criteria (22 listed)
- Chronic Graft versus Host Disease (GVHD) requiring systemic immunosuppressive medication within the last 6 months.
- Immunosuppressive medications within 30 days prior to initial study vaccine administration, e.g., oral/parenteral corticosteroids, and/or cytotoxic medications. Not excluded: A participant using any of the following is not excluded: corticosteroid nasal spray for allergic rhinitis; or topical corticosteroids as prescribed by a physician for an acute, uncomplicated dermatitis; or over the counter medications (including topical corticosteroids for an acute, uncomplicated dermatitis); use of rapidly tapered steroids for an acute isolated condition, excluding asthma which is addressed separately-within 28 days prior to vaccine administration.
- Asthma that is unstable, e.g., use of oral or intravenous corticosteroids, hospitalization or intubation during the past 2 years.
- Receipt of immunoglobulin within 60 days prior to initial study vaccine administration.
- Receipt of live attenuated vaccines within 30 days prior to initial study vaccine administration.
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 |
|---|---|---|
| PlaceboSterile saline (0.9%). | Drug | Group A: MVA-BN 1 X 10^7 TCID 50, Group B: MVA-BN 1 X 10^8 TCID 50 |
| MVA-BNThe smallpox vaccine is a liquid frozen solution formulated to contain 0.605 mg Tris and 4.090 mg sodium chloride (NaCl) per 0.5 mL dose. The concentration of the virus will be 1 X 10^8 tissue culture infectious dose 50 (TCID 50) per 0.5 mL dose and may be diluted in a solution of 0.9% saline prior to vaccination. Smallpox vaccine administered in 2 doses approximately 28 days apart in one of the following doses: 1X10^7 or 1X10^8 TCID 50. | Biological | Group A: MVA-BN 1 X 10^7 TCID 50, Group B: MVA-BN 1 X 10^8 TCID 50 |
Primary outcome
Safety: acute reactogenicity, both local and systemic; and hematologic and clinical chemistry laboratory values.
Time frame: Day 0-180.
1 secondary outcome
Immunogenicity: humoral and cell-mediated immune responses.
Time frame: Screening, Days 14 and 28 after 1st vaccination; Days 0, 14, 28, 56, and 152 after 2nd vaccination.
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 2 Aug 2013.
- Results publication: PubMed 23482644Walsh SR, Wilck MB, Dominguez DJ, Zablowsky E, Bajimaya S, Gagne LS, Verrill KA, Kleinjan JA, Patel A, Zhang Y, Hill H, Acharyya A, Fisher DC, Antin JH, Seaman MS, Dolin R, Baden LR. Safety and immunogenicity of modified vaccinia Ankara in hematopoietic stem cell transplant recipients: a randomized, controlled trial. J Infect Dis. 2013 Jun 15;207(12):1888-97. doi: 10.1093/infdis/jit105. Epub 2013 Mar 12.
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 MVA-BN in people with Variola Major (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 23 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 2 Aug 2013. 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.
What does the primary outcome measure?
Safety: acute reactogenicity, both local and systemic; and hematologic and clinical chemistry laboratory values. (time frame: Day 0-180.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565929, 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 2 Aug 2013.