Influenza A Virus, H7N9 SubtypePhase 1NCT01995695
Safety and Immunogenicity of a Live Attenuated H7N9 Influenza Virus Vaccine in Healthy Adults
A Phase 1 study testing Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine and Inactivated subvirion H7N9 influenza vaccine in people with Influenza A Virus, H7N9 Subtype, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H7N9 Subtype
- What is being tested?
- Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine and Inactivated subvirion H7N9 influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2016
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, and for safety considerations and because of the need for isolation.
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Agree to storage of blood specimens for future research
- Available for the duration of the trial
- Willingness to participate in the study as evidenced by signing the informed consent document
- Female participants of child-bearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female participants will be considered being of child-bearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
Who cannot join
- Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
- Currently breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than two times the upper normal limit will be exclusionary at baseline, prior to vaccination.
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
Show all 29Show fewer
- Positive urine drug toxicology test indicating narcotic use/dependency
- Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- History of anaphylaxis
- Allergy to oseltamivir as determined by participant report
- Current diagnosis of asthma or reactive airway disease (within the past 2 years)
- History of Guillain-Barré Syndrome
- Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1)
- Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
- Positive hepatitis B virus surface antigen (HBsAg) by ELISA
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
- History of asplenia
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
- Current smoker unwilling to stop smoking for the duration of the study:
- A current smoker includes anyone stating they currently smoke any amount of a tobacco product.
- The decision to exclude a potential participant is determined by medical history and a clinician's clinical judgment based on the physical examination.
- After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
- Travel to the Southern Hemisphere within 14 days prior to study vaccination
- Travel on a cruise ship within 14 days prior to study vaccination
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
- Allergy to eggs or egg products
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Phase 1 Evaluation of the Safety and Immunogenicity of Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease in the Event of a Pandemic
H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.
Read the detailed description
H7N9 AI viruses have recently caused a large outbreak of severe respiratory disease in humans in China. A vaccine for use in the event of an H7N9 AI pandemic is an important research priority. Previous studies have shown that when subjects who received a live bird flu vaccine received a subsequent "booster" dose of inactivated bird flu vaccine, a vigorous antibody response was detected. The inactivated vaccine served as a way to probe the immune response to the initial live vaccine. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults, and to administer a booster dose of an inactivated subvirion H7N9 influenza vaccine 3 months later.
This study will enroll healthy adults who are willing to remain in an isolation unit in an inpatient clinic for several days during the study. They will be randomly assigned to receive either one dose (Group 1) or two doses (Group 2) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine, which will be delivered by a nasal spray device. Participants in both groups will receive one "booster" dose of inactivated subvirion H7N9 influenza vaccine 3 months later in an outpatient setting. All participants will be admitted to the inpatient clinic and will receive one dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine 2 days after entering the clinic. Participants will remain in the inpatient clinic for approximately 9 days after receiving the vaccine. While in the clinic, participants will undergo medical history reviews, blood collections, urine collections, physical examinations, nasal wash procedures, and vital sign measurements.
Participants in Group 1 will attend a study visit at Day 28 and undergo a medical history review, blood collection, and a nasal wash. Participants in Group 2 will be readmitted to the inpatient clinic 2 days prior to receiving a second dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine at Day 28. They will remain in the clinic for approximately 9 days after receiving the vaccine; while in the clinic, they will take part in the same study procedures as during the first inpatient visit.
All participants will attend a study visit at Day 56 and undergo a medical history review, blood collection, and a nasal wash. At Day 98, all participants will receive one "booster" dose of the inactivated subvirion H7N9 influenza vaccine, as outpatients. They will attend additional study visits on Days 101, 105, 112, 126, 154, and 180, which may include medical history reviews; physical examinations; and urine, blood, and nasal secretion collections.
- Conditions
- Influenza A Virus, H7N9 Subtype
- Being tested
- Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine, Inactivated subvirion H7N9 influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccineBiological
Participants will receive approximately 10^7.0 focus forming units (FFU) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine. The vaccine will be delivered by an Accuspray nasal spray device (0.25 mL per nostril for a total of 0.5 mL of vaccine).
Inactivated subvirion H7N9 influenza vaccineBiological
Participants will receive 30 mcg of the inactivated subvirion H7N9 vaccine by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: One Vaccine Dose and One Booster Vaccine Dose | Experimental | Participants will receive one dose of live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine at study entry. They will then receive one dose of inactivated subvirion H7N9 influenza vaccine on Day 98. Receives: Biological: Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 influenza vaccine |
| Group 2: Two Vaccine Doses and One Booster Vaccine Dose | Experimental | Participants will receive two doses of live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine: one dose at study entry and one dose on Day 28. They will then receive one dose of inactivated subvirion H7N9 influenza vaccine on Day 98. Receives: Biological: Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Measured: Measured through Day 9 (Group 1) or Day 37 (Group 2)
Area under the curve (AUC) of nasal virus shedding after each dose of vaccine, as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Measured: Measured through Day 180
Vaccine virus shedding on one or more days on Days 2 through 9 as assessed by culture or real-time reverse transcriptase polymerase chain reaction (rRT-PCR)
Measured: Measured through Day 9
Evidence of a 4-fold or greater increase in either hemagglutination inhibition (HAI) or microneutralization (MN) antibody comparing pre-vaccination to either Day 29 or Day 56 post-dose two samples
Measured: Measured through Day 56
Development of serum antibody assessed by either HAI or MN assays
Measured: Measured through Day 180
Secondary outcomes (3)
Development of a significant increase in nasal secretion HA-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA)
Measured: Measured through Day 180
Development of greater than 200 influenza-specific interferon-gamma-secreting cells per million lymphocytes as assessed by enzyme-linked immunosorbent spot (ELISPOT) on Day 28 after immunization
Measured: Measured through Day 28
Detection of influenza-specific immunoglobulin G (IgG) or IgA secreting B cells on Day 7 following vaccination assessed by antibody secreting cells (ASC) assay
Measured: Measured through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2016
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 Influenza A Virus, H7N9 SubtypeStudies 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- John Treanor, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995695
- Sponsor's protocol ID
- URMC 13-001
- Status last verified
- Jul 2016
- First submitted
- 21 Nov 2013
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sobhanie M, Matsuoka Y, Jegaskanda S, Fitzgerald T, Mallory R, Chen Z, Luke C, Treanor J, Subbarao K. Evaluation of the Safety and Immunogenicity of a Candidate Pandemic Live Attenuated Influenza Vaccine (pLAIV) Against Influenza A(H7N9). J Infect Dis. 2016 Mar 15;213(6):922-9. doi: 10.1093/infdis/jiv526. Epub 2015 Dec 9.
PubMed 26655841
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of the Safety and Immunogenicity of Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease in the Event of a Pandemic
- ClinicalTrials.gov ID
- NCT01995695
- Acronym / sponsor ID
- URMC 13-001
- Conditions
- Influenza A Virus, H7N9 Subtype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- University of Rochester
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- First posted
- 26 Nov 2013 (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.
H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.
Detailed description
H7N9 AI viruses have recently caused a large outbreak of severe respiratory disease in humans in China. A vaccine for use in the event of an H7N9 AI pandemic is an important research priority. Previous studies have shown that when subjects who received a live bird flu vaccine received a subsequent "booster" dose of inactivated bird flu vaccine, a vigorous antibody response was detected. The inactivated vaccine served as a way to probe the immune response to the initial live vaccine. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults, and to administer a booster dose of an inactivated subvirion H7N9 influenza vaccine 3 months later.
This study will enroll healthy adults who are willing to remain in an isolation unit in an inpatient clinic for several days during the study. They will be randomly assigned to receive either one dose (Group 1) or two doses (Group 2) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine, which will be delivered by a nasal spray device. Participants in both groups will receive one "booster" dose of inactivated subvirion H7N9 influenza vaccine 3 months later in an outpatient setting. All participants will be admitted to the inpatient clinic and will receive one dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine 2 days after entering the clinic. Participants will remain in the inpatient clinic for approximately 9 days after receiving the vaccine. While in the clinic, participants will undergo medical history reviews, blood collections, urine collections, physical examinations, nasal wash procedures, and vital sign measurements.
Participants in Group 1 will attend a study visit at Day 28 and undergo a medical history review, blood collection, and a nasal wash. Participants in Group 2 will be readmitted to the inpatient clinic 2 days prior to receiving a second dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine at Day 28. They will remain in the clinic for approximately 9 days after receiving the vaccine; while in the clinic, they will take part in the same study procedures as during the first inpatient visit.
All participants will attend a study visit at Day 56 and undergo a medical history review, blood collection, and a nasal wash. At Day 98, all participants will receive one "booster" dose of the inactivated subvirion H7N9 influenza vaccine, as outpatients. They will attend additional study visits on Days 101, 105, 112, 126, 154, and 180, which may include medical history reviews; physical examinations; and urine, blood, and nasal secretion collections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: One Vaccine Dose and One Booster Vaccine Dose | Experimental | Biological: Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine, Biological: Inactivated subvirion H7N9 influenza vaccineParticipants will receive one dose of live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine at study entry. They will then receive one dose of inactivated subvirion H7N9 influenza vaccine on Day 98. |
| Group 2: Two Vaccine Doses and One Booster Vaccine Dose | Experimental | Biological: Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine, Biological: Inactivated subvirion H7N9 influenza vaccineParticipants will receive two doses of live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine: one dose at study entry and one dose on Day 28. They will then receive one dose of inactivated subvirion H7N9 influenza vaccine on Day 98. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, and for safety considerations and because of the need for isolation.
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
- Agree to storage of blood specimens for future research
- Available for the duration of the trial
- Willingness to participate in the study as evidenced by signing the informed consent document
Key exclusion criteria (29 listed)
- Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
- Currently breastfeeding
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than two times the upper normal limit will be exclusionary at baseline, prior to vaccination.
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
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 |
|---|---|---|
| Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccineParticipants will receive approximately 10^7.0 focus forming units (FFU) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine. The vaccine will be delivered by an Accuspray nasal spray device (0.25 mL per nostril for a total of 0.5 mL of vaccine). | Biological | Group 1: One Vaccine Dose and One Booster Vaccine Dose, Group 2: Two Vaccine Doses and One Booster Vaccine Dose |
| Inactivated subvirion H7N9 influenza vaccineParticipants will receive 30 mcg of the inactivated subvirion H7N9 vaccine by intramuscular injection. | Biological | Group 1: One Vaccine Dose and One Booster Vaccine Dose, Group 2: Two Vaccine Doses and One Booster Vaccine Dose |
Primary outcome
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study
Time frame: Measured through Day 9 (Group 1) or Day 37 (Group 2)
Area under the curve (AUC) of nasal virus shedding after each dose of vaccine, as assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Time frame: Measured through Day 180
Vaccine virus shedding on one or more days on Days 2 through 9 as assessed by culture or real-time reverse transcriptase polymerase chain reaction (rRT-PCR)
Time frame: Measured through Day 9
Evidence of a 4-fold or greater increase in either hemagglutination inhibition (HAI) or microneutralization (MN) antibody comparing pre-vaccination to either Day 29 or Day 56 post-dose two samples
Time frame: Measured through Day 56
Development of serum antibody assessed by either HAI or MN assays
Time frame: Measured through Day 180
3 secondary outcomes
Development of a significant increase in nasal secretion HA-specific antibody assessed by enzyme-linked immunosorbent assay (ELISA)
Time frame: Measured through Day 180
Development of greater than 200 influenza-specific interferon-gamma-secreting cells per million lymphocytes as assessed by enzyme-linked immunosorbent spot (ELISPOT) on Day 28 after immunization
Time frame: Measured through Day 28
Detection of influenza-specific immunoglobulin G (IgG) or IgA secreting B cells on Day 7 following vaccination assessed by antibody secreting cells (ASC) assay
Time frame: Measured through Day 7
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 Jul 2016.
- Derived from this study: PubMed 26655841Sobhanie M, Matsuoka Y, Jegaskanda S, Fitzgerald T, Mallory R, Chen Z, Luke C, Treanor J, Subbarao K. Evaluation of the Safety and Immunogenicity of a Candidate Pandemic Live Attenuated Influenza Vaccine (pLAIV) Against Influenza A(H7N9). J Infect Dis. 2016 Mar 15;213(6):922-9. doi: 10.1093/infdis/jiv526. Epub 2015 Dec 9.
Related trials for Influenza A Virus, H7N9 Subtype
RecruitingPhase 1/2
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
Avian Influenza A Virus
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.
John Treanor, M.D. principal investigator
University of Rochester
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 Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine and Inactivated subvirion H7N9 influenza vaccine in people with Influenza A Virus, H7N9 Subtype, 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 6 inclusion and 29 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 Jul 2016. 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?
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring (inpatient) phase of the study (time frame: Measured through Day 9 (Group 1) or Day 37 (Group 2)). The study lists 5 primary outcomes in all. 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 NCT01995695, 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 27 Jul 2016.