Meningococcal Infection, Group BPhase 1HOPSNCT00678652
Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
A Phase 1 study testing 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine and 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine in people with Meningococcal Infection, Group B, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infection, Group B
- What is being tested?
- 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine and 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (by physical examination and medical history) military or civilian males or females;
- Age 18-45 years;
- Able to give informed consent, understands risks and benefits of study, assents to use of blood samples for future research; understands and is willing to comply with all protocol procedures and time commitments;
- Females must have a negative urine pregnancy test on vaccination day before each dose AND agree to practice an effective birth control method as necessary, for 6 months after the first vaccination;
- Military service-members who wish to participate must obtain written permission from their immediate supervisor, department chief or equivalent, and company commander or equivalent.
Who cannot join
- Current or history of significant organ/system disease;
- History of allergy to any vaccine;
- History of allergy to aluminum hydroxide;
- Presence of significant unexplained laboratory abnormality that in the opinion of the PI may potentially confound the analysis of the study results;
- HIV seropositive or any other immunosuppressive state;
- Positive test for HBsAg or hepatitis C antibody;
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- Evidence or admission of on-going drug or alcohol abuse/dependence;
- Intention to leave the area during the study such that the volunteer would miss 1 or more study days;
- Prior receipt of any group B meningococcal outer membrane protein (OMP) vaccine or a vaccine containing meningococcal OMP;
- Has received or plans to receive any live vaccine, Investigational New Drug (IND) products or significant immunosuppressive therapy* in the 28 days prior to, or any inactivated vaccine within 14 days before initial vaccination or throughout the study, or received parenteral immunoglobulin or blood products within 3 months of study initiation;
- (Intra-articular, topical, or intranasal steroids, steroids applied to the eye, or ≤ 7 days of oral steroids are in general acceptable, depending on the formulation and condition for which they are prescribed. Inclusion of individuals receiving these medications will be made by the PI on a case by case basis)
- High levels of baseline bactericidal antibodies against the vaccine strain on screening (>1:16) and/or throat carriage of Neisseria meningitidis at time of screening;
- Positive urine pregnancy test prior to vaccination;
- Lactation from first dose through 3 months after last dose;
- Any condition in the opinion of the investigator that might interfere with the study vaccine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Center, WRAIR
Silver Spring, Maryland, 20910
About this study
Official title: Ph 1 Dose-Escalation Study of Safety and Immunogenicity of 3 Injections, at 0, 6, 2 Wks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Adm Intramuscularly to Healthy Subjects at 10, 25, 50, 75 μg With Adjuvant
The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as a potentially globally effective vaccine against group B meningococcus.
Read the detailed description
This was a Phase 1, outpatient, open-label, dose-escalating study to evaluate the safety, tolerability, and immunogenicity of 4 doses of the Group B Meningococcal HOPS-G 8570 NOMV vaccine in healthy subjects. Subjects were screened by medical history; physical exam; complete blood count; serum chemistry profile; coagulation studies including prothrombin time (PT), partial thromboplastin time (PTT), and fibrinogen; human immunodeficiency virus (HIV) test, anti-hepatitis C virus (HCV) antibodies, and hepatitis B surface antigen (HBsAg) test results; nasopharyngeal swabs for carriage of meningococci; bactericidal antibody titer to meningococci; and urinalysis; and urine pregnancy test results for females. The first 36 subjects to meet all inclusion criteria and none of the exclusion criteria were assigned to 1 of 4 dosage groups of 9 subjects each. After screening, there was a 10 to 60 day lead-in time (depending on when screening occurred) prior to vaccination during which subjects could not take or receive any experimental products. Also prior to vaccination, adverse events were recorded to establish a baseline with which to compare adverse events occurring after vaccination. Subjects kept a diary for 7 days before the first dose and for 1 day before each of the second and third doses. Immediately before each vaccination, vital signs were checked, an abbreviated physical examination was performed, each subject's throat was swabbed to assess carriage of meningococcal bacteria, and blood was drawn for immunology and safety labs. Urine was collected for analysis and females took a urine pregnancy test. The pregnancy test results had to be negative in order for a subject to be vaccinated. The vaccine with adjuvant was given intramuscularly at 0, 6, and 12 weeks (Study Days 0, 42, and 84) in doses of 10 μg, 25 μg, 50 μg, or 75 μg based on protein concentration. Vaccinations were performed in a staggered fashion with safety monitoring between groups. The 10-μg dose group was divided into 2 subgroups. Subjects in the first subgroup were vaccinated 30 minutes apart to observe subjects for the occurrence of acute side effects, and subjects in the second subgroup were vaccinated 1 week after the first. The subjects in each group were monitored for AE for at least 2 weeks prior to vaccinating the next higher dosage group. Subjects were kept in the Clinical Trials Center for 30 minutes after each vaccination for observation, and they were asked to keep a diary of symptoms for 7 days after each vaccination. AEs and SAEs were recorded at all study visits, and each AE or SAE was assessed for severity and relationship to the vaccine by the investigator.
- Conditions
- Meningococcal Infection, Group B
- Being tested
- 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- Keywords
- Meningococcal vaccine, Neisseria meningitidis
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineBiological
10 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
25 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineBiological
25 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
50 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineBiological
50 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
75 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineBiological
75 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
| Study group | Role | What they receive |
|---|---|---|
| 10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant Receives: Biological: 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
| 25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant Receives: Biological: 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
| 50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant Receives: Biological: 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
| 75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant Receives: Biological: 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Measured: 18 weeks. Days 0, 14, 56, 84, 98 and 126
Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine
Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 2nd dose of vaccine
Measured: 42+7 days (visit 7)
Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine
Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 3rd dose of vaccine
Measured: 84+7 days (visit 11)
Secondary outcomes (1)
Total Antibody Response to the Parent Strain of Group B Meningococcus
Assess and characterize bactericidal activity and total antibody response against the vaccine strain and other strains of Group B Meningococcus induced by 3 injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Measured: 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meningococcal Infection, Group BStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul B Keiser, M.D., Principal investigator, WRAIR, Division of Bacterial and Rickettsial Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678652
- Sponsor's protocol ID
- WRAIR 1395
- Other IDs
- HSRRB Log A-14553, MIDRP AM0035_07_WR, S-15-08
- Acronym
- HOPS
- Status last verified
- Dec 2017
- First submitted
- 8 May 2008
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph 1 Dose-Escalation Study of Safety and Immunogenicity of 3 Injections, at 0, 6, 2 Wks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Adm Intramuscularly to Healthy Subjects at 10, 25, 50, 75 μg With Adjuvant
- ClinicalTrials.gov ID
- NCT00678652
- Acronym / sponsor ID
- HOPS / WRAIR 1395
- Conditions
- Meningococcal Infection, Group B
- Keywords
- Meningococcal vaccine, Neisseria meningitidis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 18 Dec 2017
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 determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other genetically modified strains as a potentially globally effective vaccine against group B meningococcus.
Detailed description
This was a Phase 1, outpatient, open-label, dose-escalating study to evaluate the safety, tolerability, and immunogenicity of 4 doses of the Group B Meningococcal HOPS-G 8570 NOMV vaccine in healthy subjects. Subjects were screened by medical history; physical exam; complete blood count; serum chemistry profile; coagulation studies including prothrombin time (PT), partial thromboplastin time (PTT), and fibrinogen; human immunodeficiency virus (HIV) test, anti-hepatitis C virus (HCV) antibodies, and hepatitis B surface antigen (HBsAg) test results; nasopharyngeal swabs for carriage of meningococci; bactericidal antibody titer to meningococci; and urinalysis; and urine pregnancy test results for females. The first 36 subjects to meet all inclusion criteria and none of the exclusion criteria were assigned to 1 of 4 dosage groups of 9 subjects each. After screening, there was a 10 to 60 day lead-in time (depending on when screening occurred) prior to vaccination during which subjects could not take or receive any experimental products. Also prior to vaccination, adverse events were recorded to establish a baseline with which to compare adverse events occurring after vaccination. Subjects kept a diary for 7 days before the first dose and for 1 day before each of the second and third doses. Immediately before each vaccination, vital signs were checked, an abbreviated physical examination was performed, each subject's throat was swabbed to assess carriage of meningococcal bacteria, and blood was drawn for immunology and safety labs. Urine was collected for analysis and females took a urine pregnancy test. The pregnancy test results had to be negative in order for a subject to be vaccinated. The vaccine with adjuvant was given intramuscularly at 0, 6, and 12 weeks (Study Days 0, 42, and 84) in doses of 10 μg, 25 μg, 50 μg, or 75 μg based on protein concentration. Vaccinations were performed in a staggered fashion with safety monitoring between groups. The 10-μg dose group was divided into 2 subgroups. Subjects in the first subgroup were vaccinated 30 minutes apart to observe subjects for the occurrence of acute side effects, and subjects in the second subgroup were vaccinated 1 week after the first. The subjects in each group were monitored for AE for at least 2 weeks prior to vaccinating the next higher dosage group. Subjects were kept in the Clinical Trials Center for 30 minutes after each vaccination for observation, and they were asked to keep a diary of symptoms for 7 days after each vaccination. AEs and SAEs were recorded at all study visits, and each AE or SAE was assessed for severity and relationship to the vaccine by the investigator.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Biological: 10 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineThree Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant |
| 25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Biological: 25 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineThree Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant |
| 50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Biological: 50 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineThree Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant |
| 75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine | Experimental | Biological: 75 μg Group B Meningococcal 8570 HOPS-G NOMV VaccineThree Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy (by physical examination and medical history) military or civilian males or females;
- Age 18-45 years;
- Able to give informed consent, understands risks and benefits of study, assents to use of blood samples for future research; understands and is willing to comply with all protocol procedures and time commitments;
- Females must have a negative urine pregnancy test on vaccination day before each dose AND agree to practice an effective birth control method as necessary, for 6 months after the first vaccination;
- Military service-members who wish to participate must obtain written permission from their immediate supervisor, department chief or equivalent, and company commander or equivalent.
Key exclusion criteria (15 listed)
- Current or history of significant organ/system disease;
- History of allergy to any vaccine;
- History of allergy to aluminum hydroxide;
- Presence of significant unexplained laboratory abnormality that in the opinion of the PI may potentially confound the analysis of the study results;
- HIV seropositive or any other immunosuppressive state;
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 |
|---|---|---|
| 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine10 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study | Biological | 10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
| 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine25 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study | Biological | 25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
| 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine50 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study | Biological | 50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
| 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine75 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study | Biological | 75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine |
Primary outcome
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Time frame: 18 weeks. Days 0, 14, 56, 84, 98 and 126
Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine
Time frame: 42+7 days (visit 7)
Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 2nd dose of vaccine
Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine
Time frame: 84+7 days (visit 11)
Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 3rd dose of vaccine
1 secondary outcome
Total Antibody Response to the Parent Strain of Group B Meningococcus
Time frame: 126 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Paul B Keiser, M.D. principal investigator
WRAIR, Division of Bacterial and Rickettsial Diseases
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 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine and 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine in people with Meningococcal Infection, Group B, run by U.S. Army Medical Research and Development Command 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 5 inclusion and 15 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 18 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections (time frame: 18 weeks. Days 0, 14, 56, 84, 98 and 126). The study lists 3 primary outcomes in all. 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 18 Dec 2017.