Staphylococcal InfectionsPhase 1NCT01364571
Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
A Phase 1 study testing SA4Ag vaccine low dose, Blood draw and Colonization swab sample in people with Staphylococcal Infections, run by Pfizer at 16 sites in United States.
Trial summary
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- SA4Ag vaccine low dose, Blood draw and Colonization swab sample
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2011to Jan 2013
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
- Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).
- Ability to be contacted by telephone during study participation.
- All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.
Who cannot join
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization within 3 months before receipt of study vaccine.
- Serious chronic medical disorders and any other disorder that in the investigator's opinion precludes the subject from participating in the study
- Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection), or donation of plasma within 3 months prior to enrollment.
- Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through 1 month post-vaccination.
- Any contraindication to vaccination or vaccine components.
- Immunocompromised persons and subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy, including chemotherapy agents or long term systemic corticosteroids.
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- Previous administration of S. aureus vaccination.
- Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination.
- Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 12 months before enrollment through conclusion of the study.
- Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation.
- Subjects who are investigational site staff members or subjects who are immediate family members (1st degree relatives) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
- Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
- For Phase 1 subjects only, any abnormality in screening hematology, coagulation and/or blood chemistry laboratory values.
- Women who are pregnant (as determined by urine pregnancy test) or breastfeeding.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Benchmark Research
Austin, Texas, 78705
Roberta Braun, M.D.
Austin, Texas, 78705
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Buffalo Clinical Research Center, LLC
Buffalo, New York, 14202
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Broward Research Group
Hollywood, Florida, 33024
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Volunteer Research Group
Knoxville, Tennessee, 37920
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Vince and Associates Clinical Research
Overland Park, Kansas, 66212
Prism Research
Saint Paul, Minnesota, 55114
Miami Research Associates
South Miami, Florida, 33143
About this study
Official title: A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to <65 years.
- Conditions
- Staphylococcal Infections
- Being tested
- SA4Ag vaccine low dose, Blood draw, Colonization swab sample, SA4Ag vaccine mid dose, Blood sample
- Keywords
- Staphylococcus aureus, vaccine, staphylococcal infection
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA4Ag vaccine low doseBiological
Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
Blood drawProcedure or surgery
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various time points throughout the study.
SA4Ag vaccine mid doseBiological
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Blood sampleProcedure or surgery
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various time points throughout the study.
SA4Ag vaccine high doseBiological
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Blood drawProcedure or surgery
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various time points throughout the study.
PlaceboBiological
Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
Blood drawProcedure or surgery
Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
Colonization swab sampleProcedure or surgery
Colonization swabs will be collected from all subjects at various time points throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SA4Ag vaccine low dose Receives: Biological: SA4Ag vaccine low dose; Procedure: Blood draw; Procedure: Colonization swab sample |
| 2 | Experimental | SA4Ag vaccine mid dose Receives: Biological: SA4Ag vaccine mid dose; Procedure: Blood sample; Procedure: Colonization swab sample |
| 3 | Experimental | SA4Ag vaccine high dose Receives: Biological: SA4Ag vaccine high dose; Procedure: Blood draw; Procedure: Colonization swab sample |
| 4 | Placebo comparator | Placebo Receives: Biological: Placebo; Procedure: Blood draw; Procedure: Colonization swab sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of subjects reporting local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries)
Measured: 14 days
Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries
Measured: 14 days
Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: 1 month (AEs), 6 months (SAEs)
Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments; number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments.
Measured: 14 days
Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine based on immunoglobulin-binding and/or opsonophagocytic activity assays.
Measured: 1 month
Secondary outcomes (5)
Immunoglobulin concentrations for each antigen at each applicable blood sampling time point,
Measured: various, up to 12 months
Opsonophagocytic activity (OPA) titers at each applicable blood sampling time point,
Measured: 1 month
Immunoglobulin geometric mean fold rise (GMFR) for each antigen
Measured: 1 month
Geometric mean fold rise on opsonophagocytic activity assay titers
Measured: 1 month
Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine at at each applicable visit
Measured: various, 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 posted2 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364571
- Sponsor's protocol ID
- B3451001
- Other IDs
- 6123K1-1005
- Status last verified
- Feb 2019
- First submitted
- 31 May 2011
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Creech CB, Frenck RW, Fiquet A, Feldman R, Kankam MK, Pathirana S, Baber J, Radley D, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). Open Forum Infect Dis. 2019 Dec 24;7(1):ofz532. doi: 10.1093/ofid/ofz532. eCollection 2020 Jan.
PubMed 31993453Frenck RW Jr, Creech CB, Sheldon EA, Seiden DJ, Kankam MK, Baber J, Zito E, Hubler R, Eiden J, Severs JM, Sebastian S, Nanra J, Jansen KU, Gruber WC, Anderson AS, Girgenti D. Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): Results from a first-in-human randomised, placebo-controlled phase 1/2 study. Vaccine. 2017 Jan 5;35(2):375-384. doi: 10.1016/j.vaccine.2016.11.010. Epub 2016 Dec 1.
PubMed 27916408
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years
- ClinicalTrials.gov ID
- NCT01364571
- Acronym / sponsor ID
- B3451001
- Conditions
- Staphylococcal Infections
- Keywords
- Staphylococcus aureus, vaccine, staphylococcal infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Jun 2011 (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.
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to <65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to <65 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: SA4Ag vaccine low dose, Procedure: Blood draw, Procedure: Colonization swab sampleSA4Ag vaccine low dose |
| 2 | Experimental | Biological: SA4Ag vaccine mid dose, Procedure: Blood sample, Procedure: Colonization swab sampleSA4Ag vaccine mid dose |
| 3 | Experimental | Biological: SA4Ag vaccine high dose, Procedure: Blood draw, Procedure: Colonization swab sampleSA4Ag vaccine high dose |
| 4 | Placebo comparator | Biological: Placebo, Procedure: Blood draw, Procedure: Colonization swab samplePlacebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
- Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).
- Ability to be contacted by telephone during study participation.
- All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.
Key exclusion criteria (15 listed)
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization within 3 months before receipt of study vaccine.
- Serious chronic medical disorders and any other disorder that in the investigator's opinion precludes the subject from participating in the study
- Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection), or donation of plasma within 3 months prior to enrollment.
- Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through 1 month post-vaccination.
- Any contraindication to vaccination or vaccine components.
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 |
|---|---|---|
| SA4Ag vaccine low doseSubjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine. | Biological | 1 |
| Blood drawBlood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints. | Procedure or surgery | 1 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various time points throughout the study. | Procedure or surgery | 1 |
| SA4Ag vaccine mid doseSubjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine. | Biological | 2 |
| Blood sampleBlood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints. | Procedure or surgery | 2 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various time points throughout the study. | Procedure or surgery | 2 |
| SA4Ag vaccine high doseSubjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine. | Biological | 3 |
| Blood drawBlood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints. | Procedure or surgery | 3 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various time points throughout the study. | Procedure or surgery | 3 |
| PlaceboSubjects receive one intramuscular injection (0.5 mL) of commercially available normal saline. | Biological | 4 |
| Blood drawBlood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints. | Procedure or surgery | 4 |
| Colonization swab sampleColonization swabs will be collected from all subjects at various time points throughout the study. | Procedure or surgery | 4 |
Primary outcome
Number and proportion of subjects reporting local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries)
Time frame: 14 days
Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries
Time frame: 14 days
Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: 1 month (AEs), 6 months (SAEs)
Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments; number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments.
Time frame: 14 days
Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine based on immunoglobulin-binding and/or opsonophagocytic activity assays.
Time frame: 1 month
5 secondary outcomes
Immunoglobulin concentrations for each antigen at each applicable blood sampling time point,
Time frame: various, up to 12 months
Opsonophagocytic activity (OPA) titers at each applicable blood sampling time point,
Time frame: 1 month
Immunoglobulin geometric mean fold rise (GMFR) for each antigen
Time frame: 1 month
Geometric mean fold rise on opsonophagocytic activity assay titers
Time frame: 1 month
Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine at at each applicable visit
Time frame: various, up to 12 months
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 4 Mar 2019.
- Derived from this study: PubMed 31993453Creech CB, Frenck RW, Fiquet A, Feldman R, Kankam MK, Pathirana S, Baber J, Radley D, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). Open Forum Infect Dis. 2019 Dec 24;7(1):ofz532. doi: 10.1093/ofid/ofz532. eCollection 2020 Jan.
- Derived from this study: PubMed 27916408Frenck RW Jr, Creech CB, Sheldon EA, Seiden DJ, Kankam MK, Baber J, Zito E, Hubler R, Eiden J, Severs JM, Sebastian S, Nanra J, Jansen KU, Gruber WC, Anderson AS, Girgenti D. Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): Results from a first-in-human randomised, placebo-controlled phase 1/2 study. Vaccine. 2017 Jan 5;35(2):375-384. doi: 10.1016/j.vaccine.2016.11.010. Epub 2016 Dec 1.
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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.
Pfizer CT.gov Call Center study director
Pfizer
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SA4Ag vaccine low dose, Blood draw and Colonization swab sample in people with Staphylococcal Infections, run by Pfizer at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study 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?
Number and proportion of subjects reporting local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries) (time frame: 14 days). 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 NCT01364571, which also lists 2 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 4 Mar 2019.