HealthyPhase 4KAVI-VZV-001NCT02514018
Pilot Study to Describe Immune Responses of Healthy Women Following Immunization With Varicella Zoster Virus Vaccine
A Phase 4 study testing Live-attenuated varicella-zoster virus vaccine in people with Healthy, run by University of Toronto at 1 site in Kenya.
Trial summary
The re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when used as a vaccine vector in conjunction with HIV to generate durable immunity systemically and at the mucosa. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Live-attenuated varicella-zoster virus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2015to Jul 2017
- Phase
- Phase 4
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females, as assessed by a medical history, physical examination and laboratory tests;
- Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
- VZV-seropositive, as assessed by the Vitek Immunodiagnostic Assay System (VIDAS) assay.
- Ability to comply with the study requirements and available for follow-up for the planned duration of the study.
- In the opinion of the Principal Investigator or designee, the volunteer has understood the information provided and signed the consent document.
- Willing to undergo HIV testing, HIV counseling and to receive HIV test results three times during the study.
- For women with potential to become pregnant, willing to use effective contraception or barrier methods, such as oral, patch, injectable, implant, ring contraceptives or intrauterine device to avoid pregnancy during the study (spermicide are not allowed).
Who cannot join
- Any relevant abnormality on history or examination that, in the opinion of the Principal Investigator or designee, is clinically significant, and/or:
- A high risk for HIV-acquisition defined by the experience of any of the follow situations:
- Had unprotected vaginal or anal sex with a known HIV-1-infected person, a person known to be at high risk for HIV or a casual partner (i.e., no continuing, established relationship) within the previous 6 months;
- Engaged in sex work for money or drugs within the previous 6 months;
- Used injection drugs in the last 12 months;
- Abuse of illicit or prescribed drugs, including alcohol;
Show all 23Show fewer
- Acquired one of the following sexually transmitted infection: chlamydia, gonorrhoea and syphilis in the last 12 months;
- More than 1 sexual partner within the last 6 months;
- New sexual partner within the last 3 months.
- Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to therapy (2 consecutive attempts by study team).
- Confirmed HIV-1 or HIV-2 infection.
- Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the Principal Investigator or designee, would make the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal, cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic, respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency status and rectal problems).
- Significant laboratory abnormalities, including coagulation (International Normalised Ratio- INR <1.0 or > 1.5).
- A positive pregnancy test or breast-feeding at screening; for the participants with reproductive potential, unwilling to use an effective method of preventing pregnancy during the study.
- Receipt of vaccine within the previous 2 months or planned receipt at any time until 6 months after vaccination with live-attenuated VZV vaccine.
- Receipt of blood transfusion or blood products within the previous 6 months.
- Participation in another interventional clinical trial currently or within the previous 3 months.
- History of severe or very severe local or systemic reactogenicity events after vaccination, history of severe or very severe allergic reactions, or history of anaphylactic/anaphylactoid reaction to neomycin.
- History of toxic shock syndrome.
- Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous clearance leading to natural immunity, indicated by antibodies to core + antigens, is not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection.
- Immunosuppressive medications 30 days before or during the study period.
- Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder, suicidal attempt or ideation in the previous 3 years.
- Contra-indication for undergoing a biopsy due to bleeding diathesis, haemorrhoids, mucosal infection at the biopsy site, medication that interfere with clotting (e.g. warfarin or heparin) - both clinical and laboratory.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Characterize the Immune Response Induced by a Commercial Varicella Zoster Virus Vaccine in Healthy Adult Females in Nairobi, Kenya.
The re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when used as a vaccine vector in conjunction with HIV to generate durable immunity systemically and at the mucosa. This study aims to characterize mucosal immunity before and after vaccination with a commercial live-attenuated varicella-zoster virus vaccine with respect to immune activation state, mucosal homing properties and VZV-specific effector immune responses in healthy women at low risk for HIV acquisition.
Read the detailed description
An ideal HIV vaccine should be able to induce an effector specific immune response at the mucosal site which serves as the portal of HIV entry. The use of a persistent replicating viral vector such as Varicella-Zoster Virus (VZV) has great potential to assemble this specific response. Live-attenuated varicella-zoster virus has been used as a vaccine worldwide for over 25 years and has a well-described safety profile. However, its immunogenicity data in the African population are lacking.
The general objective of this study will be to measure the magnitude and kinetics of the effector immune response and immune activation induced by live-attenuated varicella-zoster virus vaccine in a population of Kenyan women. Specifically, the study will measure immune activation in both cervical and rectal mucosae in the context of VZV-effector responses after vaccination and compare the observed immune activation in mucosal tissues and in blood.
A total of 44 healthy women in Nairobi, aged 18-50 years will be recruited into the study, after obtaining their written informed consent. Eligibility to participate in the study will depend on results of laboratory tests, review of medical history, physical examination and answers to questions about HIV risk behaviours.
The study will assess immune responses to both immediate and delayed administration of live-attenuated virus varicella-zoster vaccine in VZV-seropositive individuals. Participants will be randomly divided into 2 groups. Group 1 will receive a single dose of the vaccine at day 0 and Group 2 at day 84. The participants will be followed for a period of 9-12 months after receiving the vaccine.
- Conditions
- Healthy
- Being tested
- Live-attenuated varicella-zoster virus vaccine
- Keywords
- Varicella-Zoster Virus, Immune Activation, HIV Vaccine, Mucosal Immunity
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live-attenuated varicella-zoster virus vaccineBiological
Also called shingles vaccine, chickenpox vaccine, zoster vaccine, Zostavax® (Merck)
Commercial vaccine used to prevent shingles
| Study group | Role | What they receive |
|---|---|---|
| Immediate Group | Other | Live-attenuated varicella-zoster virus vaccine (≥ 19,400 Plaque-forming unit - PFU) administered as a single-dose at day 0 Receives: Biological: Live-attenuated varicella-zoster virus vaccine |
| Delayed Group | Other | Live-attenuated varicella-zoster virus vaccine (≥ 19,400 PFU) administered as a single-dose at day 84 (+/- 3 days) Receives: Biological: Live-attenuated varicella-zoster virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the median frequency of cervical CD38+HLA-DR+CD4+T cells after VZV-vaccination as a measure of immune activation
Comparison of the change in the median (Interquartile range - IQR) frequency of cervical CD38+HLA-DR+CD4+T cells between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups).
Measured: 3 months after VZV-vaccination
Secondary outcomes (10)
Composite measures of immune activation observed in mucosal tissues
Comparison of the change in the median (IQR) expression of activation markers such as CD38, CD69, Ki67 and HLA-DR in mucosal T cells (CD4+ and CD8+ T cells) between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups)
Measured: 3 months after VZV-vaccination
Composite measures of mucosal homing marker and HIV co-receptors observed in mucosal tissues
Comparison of the change in the median (IQR) expression of α4β7 and CCR5 in mucosal CD4+T cells between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups)
Measured: 3 months after VZV-vaccination
Mucosal level of inflammation (including IL-1β, IL-6 and IL8)
Measured: 3 months after VZV-vaccination
Composite measures of immune activation observed in blood
Comparison of the change in the median (IQR) expression activation markers such as CD38, CD69, Ki67 and HLA-DR in systemic T cells (CD4+ and CD8+ T cells) between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups)
Measured: 3 months after VZV-vaccination
Composite measures of mucosal homing marker and HIV co-receptors observed in blood
Comparison of the change in the median (IQR) expression of α4β7 and CCR5 in systemic CD4+T cells between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups).
Measured: 3 months after VZV-vaccination
Plasma level of inflammation (including IL-1β, IL-6 and IL8)
Measured: 3 months after VZV-vaccination
Frequency and function of mucosal VZV-specific immune cells (including CD8+ and CD4+ T cell subsets)
Measured: Longidudinally througout the study (up to 12 months)
Concentration of mucosal VZV-specific antibodies (IgG and IgA)
Measured: Longidudinally througout the study (up to 12 months)
Frequency and function of systemic VZV-specific immune cells (including CD8+ and CD4+ T cell subsets)
Measured: Longidudinally througout the study (up to 12 months)
Concentration of systemic VZV-specific antibodies (IgG and IgA)
Measured: Longidudinally througout the study (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyan AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR), University of Nairobi, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr Walter Jaoko, University of Nairobi
- Investigators
- Walter Jaoko, MD, Principal investigator, KAVI-Institute of Clinical Research / University of NairobiKelly MacDonald, MD, Principal investigator, University of TorontoOmu Anzala, MD, Principal investigator, KAVI-Institute of Clinical Research / University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514018
- Sponsor's protocol ID
- KAVI-VZV-001
- Acronym
- KAVI-VZV-001
- Status last verified
- Oct 2016
- First submitted
- 29 Jun 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perciani CT, Farah B, Kaul R, Ostrowski MA, Mahmud SM, Anzala O, Jaoko W; KAVI-ICR Team; MacDonald KS. Live attenuated varicella-zoster virus vaccine does not induce HIV target cell activation. J Clin Invest. 2019 Feb 1;129(2):875-886. doi: 10.1172/JCI124473. Epub 2019 Jan 22.
PubMed 30511963Perciani CT, Sekhon M, Hundal S, Farah B, Ostrowski MA, Anzala AO, McKinnon LR, Jaoko W, MacDonald KS; Institute of Tropical and Infectious Diseases (UNITID) Group and the Kenyan AIDS Vaccine Initiative-Institute of Clinical Research (KAVI-ICR) Team. Live Attenuated Zoster Vaccine Boosts Varicella Zoster Virus (VZV)-Specific Humoral Responses Systemically and at the Cervicovaginal Mucosa of Kenyan VZV-Seropositive Women. J Infect Dis. 2018 Sep 8;218(8):1210-1218. doi: 10.1093/infdis/jiy320.
PubMed 29800309Perciani CT, Jaoko W, Walmsley S, Farah B, Mahmud SM, Ostrowski M, Anzala O, Team KI, MacDonald KS. Protocol of a randomised controlled trial characterising the immune responses induced by varicella-zoster virus (VZV) vaccination in healthy Kenyan women: setting the stage for a potential VZV-based HIV vaccine. BMJ Open. 2017 Sep 21;7(9):e017391. doi: 10.1136/bmjopen-2017-017391.
PubMed 28939581
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Characterize the Immune Response Induced by a Commercial Varicella Zoster Virus Vaccine in Healthy Adult Females in Nairobi, Kenya.
- ClinicalTrials.gov ID
- NCT02514018
- Acronym / sponsor ID
- KAVI-VZV-001 / KAVI-VZV-001
- Conditions
- Healthy
- Keywords
- Varicella-Zoster Virus, Immune Activation, HIV Vaccine, Mucosal Immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Kenyan AIDS Vaccine Initiative - Institute of Clinical Research (KAVI-ICR), University of Nairobi, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 3 Aug 2015 (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 re-activating nature of Varicella Zoster Virus (VZV) may allow life long boosting when used as a vaccine vector in conjunction with HIV to generate durable immunity systemically and at the mucosa. This study aims to characterize mucosal immunity before and after vaccination with a commercial live-attenuated varicella-zoster virus vaccine with respect to immune activation state, mucosal homing properties and VZV-specific effector immune responses in healthy women at low risk for HIV acquisition.
Detailed description
An ideal HIV vaccine should be able to induce an effector specific immune response at the mucosal site which serves as the portal of HIV entry. The use of a persistent replicating viral vector such as Varicella-Zoster Virus (VZV) has great potential to assemble this specific response. Live-attenuated varicella-zoster virus has been used as a vaccine worldwide for over 25 years and has a well-described safety profile. However, its immunogenicity data in the African population are lacking.
The general objective of this study will be to measure the magnitude and kinetics of the effector immune response and immune activation induced by live-attenuated varicella-zoster virus vaccine in a population of Kenyan women. Specifically, the study will measure immune activation in both cervical and rectal mucosae in the context of VZV-effector responses after vaccination and compare the observed immune activation in mucosal tissues and in blood.
A total of 44 healthy women in Nairobi, aged 18-50 years will be recruited into the study, after obtaining their written informed consent. Eligibility to participate in the study will depend on results of laboratory tests, review of medical history, physical examination and answers to questions about HIV risk behaviours.
The study will assess immune responses to both immediate and delayed administration of live-attenuated virus varicella-zoster vaccine in VZV-seropositive individuals. Participants will be randomly divided into 2 groups. Group 1 will receive a single dose of the vaccine at day 0 and Group 2 at day 84. The participants will be followed for a period of 9-12 months after receiving the vaccine.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Other | Biological: Live-attenuated varicella-zoster virus vaccineLive-attenuated varicella-zoster virus vaccine (≥ 19,400 Plaque-forming unit - PFU) administered as a single-dose at day 0 |
| Delayed Group | Other | Biological: Live-attenuated varicella-zoster virus vaccineLive-attenuated varicella-zoster virus vaccine (≥ 19,400 PFU) administered as a single-dose at day 84 (+/- 3 days) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy females, as assessed by a medical history, physical examination and laboratory tests;
- Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
- VZV-seropositive, as assessed by the Vitek Immunodiagnostic Assay System (VIDAS) assay.
- Ability to comply with the study requirements and available for follow-up for the planned duration of the study.
- In the opinion of the Principal Investigator or designee, the volunteer has understood the information provided and signed the consent document.
Key exclusion criteria (23 listed)
- Any relevant abnormality on history or examination that, in the opinion of the Principal Investigator or designee, is clinically significant, and/or:
- A high risk for HIV-acquisition defined by the experience of any of the follow situations:
- Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to therapy (2 consecutive attempts by study team).
- Confirmed HIV-1 or HIV-2 infection.
- Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the Principal Investigator or designee, would make the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal, cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic, respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency status and rectal problems).
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 varicella-zoster virus vaccineAlso: shingles vaccine, chickenpox vaccine, zoster vaccine, Zostavax® (Merck)Commercial vaccine used to prevent shingles | Biological | Delayed Group, Immediate Group |
Primary outcome
Change in the median frequency of cervical CD38+HLA-DR+CD4+T cells after VZV-vaccination as a measure of immune activation
Time frame: 3 months after VZV-vaccination
Comparison of the change in the median (Interquartile range - IQR) frequency of cervical CD38+HLA-DR+CD4+T cells between 1) Baseline and 3 months after (for the delayed group), and 2) Before and after 3 months of VZV vaccination (immediate and delayed groups).
10 secondary outcomes
Composite measures of immune activation observed in mucosal tissues
Time frame: 3 months after VZV-vaccination
Composite measures of mucosal homing marker and HIV co-receptors observed in mucosal tissues
Time frame: 3 months after VZV-vaccination
Mucosal level of inflammation (including IL-1β, IL-6 and IL8)
Time frame: 3 months after VZV-vaccination
Composite measures of immune activation observed in blood
Time frame: 3 months after VZV-vaccination
Composite measures of mucosal homing marker and HIV co-receptors observed in blood
Time frame: 3 months after VZV-vaccination
Plasma level of inflammation (including IL-1β, IL-6 and IL8)
Time frame: 3 months after VZV-vaccination
Frequency and function of mucosal VZV-specific immune cells (including CD8+ and CD4+ T cell subsets)
Time frame: Longidudinally througout the study (up to 12 months)
Concentration of mucosal VZV-specific antibodies (IgG and IgA)
Time frame: Longidudinally througout the study (up to 12 months)
Frequency and function of systemic VZV-specific immune cells (including CD8+ and CD4+ T cell subsets)
Time frame: Longidudinally througout the study (up to 12 months)
Concentration of systemic VZV-specific antibodies (IgG and IgA)
Time frame: Longidudinally througout the study (up to 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Derived from this study: PubMed 30511963Perciani CT, Farah B, Kaul R, Ostrowski MA, Mahmud SM, Anzala O, Jaoko W; KAVI-ICR Team; MacDonald KS. Live attenuated varicella-zoster virus vaccine does not induce HIV target cell activation. J Clin Invest. 2019 Feb 1;129(2):875-886. doi: 10.1172/JCI124473. Epub 2019 Jan 22.
- Derived from this study: PubMed 29800309Perciani CT, Sekhon M, Hundal S, Farah B, Ostrowski MA, Anzala AO, McKinnon LR, Jaoko W, MacDonald KS; Institute of Tropical and Infectious Diseases (UNITID) Group and the Kenyan AIDS Vaccine Initiative-Institute of Clinical Research (KAVI-ICR) Team. Live Attenuated Zoster Vaccine Boosts Varicella Zoster Virus (VZV)-Specific Humoral Responses Systemically and at the Cervicovaginal Mucosa of Kenyan VZV-Seropositive Women. J Infect Dis. 2018 Sep 8;218(8):1210-1218. doi: 10.1093/infdis/jiy320.
- Derived from this study: PubMed 28939581Perciani CT, Jaoko W, Walmsley S, Farah B, Mahmud SM, Ostrowski M, Anzala O, Team KI, MacDonald KS. Protocol of a randomised controlled trial characterising the immune responses induced by varicella-zoster virus (VZV) vaccination in healthy Kenyan women: setting the stage for a potential VZV-based HIV vaccine. BMJ Open. 2017 Sep 21;7(9):e017391. doi: 10.1136/bmjopen-2017-017391.
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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.
Walter Jaoko, MD principal investigator
KAVI-Institute of Clinical Research / University of Nairobi
Kelly MacDonald, MD principal investigator
University of Toronto
Omu Anzala, MD principal investigator
KAVI-Institute of Clinical Research / University of Nairobi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live-attenuated varicella-zoster virus vaccine in people with Healthy, run by University of Toronto at 1 site in Kenya.
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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 17 Oct 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 Kenya. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Change in the median frequency of cervical CD38+HLA-DR+CD4+T cells after VZV-vaccination as a measure of immune activation (time frame: 3 months after VZV-vaccination). 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 NCT02514018, which also lists 3 linked publications.
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 17 Oct 2016.