Prevention of Zika InfectionPhase 1NCT02996461

VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, inHealthy Adults

A Phase 1 study testing VRC-ZKADNA090-00-VP in people with Prevention of Zika Infection and Zika-Specific Immune Response, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background: People get Zika virus from infected mosquitos. They usually don t get very sick. But birth defects were reported in babies born to mothers who had Zika infection. In rare cases, people with Zika infection had a nervous system disease that causes severe muscle weakness and can be life threatening. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Prevention of Zika Infection, Zika-Specific Immune Response
What is being tested?: VRC-ZKADNA090-00-VP
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 12 Dec 2016to 3 Sep 2019
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A subject must meet all of the following criteria:
18 to 50 years old
Available for clinic visits for 24 months after enrollment
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
Able and willing to complete the informed consent process
Willing to donate blood for sample storage to be used for future research

Show all 20Show fewer

In good general health without clinically significant medical history
Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment
Agrees not to receive licensed or investigational flavivirus vaccines through 4 weeks after last product administration
Laboratory Criteria within 56 days prior to enrollment:
Hemoglobin within institutional normal limits or accompanied by the site Principal Investigator (PI) or designee approval
WBC and differential either within institutional normal range or accompanied by site PI or designee approval
Total lymphocyte count greater than or equal to 800 cells/mm^3
Platelets = 125,000 - 500,000/mm^3
Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN)
Serum creatinine less than or equal to 1.1 x institutional ULN
Negative for HIV infection by an FDA approved method of detection
Criteria applicable to women of childbearing potential:
Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment
Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after the last study vaccination

Who cannot join

A subject will be excluded if one or more of the following conditions apply:
Female-specific: Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination
Subject has received any of the following:
More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
Blood products within 16 weeks prior to enrollment
Inactivated vaccines within 2 weeks prior to enrollment

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Live attenuated vaccines within 4 weeks prior to enrollment
Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
Current allergen immunotherapy with antigen injections, unless on maintenance schedule
Current anti-TB prophylaxis or therapy
Subject has a history of any of the following clinically significant conditions:
Laboratory confirmed ZIKV infection by self-report at the time of enrollment
Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the site investigator
Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
Asthma that is not well controlled
Diabetes mellitus (type I or II), with the exception of gestational diabetes
Evidence of autoimmune disease or immunodeficiency
Idiopathic urticaria within the past year
Hypertension that is not well controlled
Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
Malignancy that is active or history of malignancy that is likely to recur during the period of the study
Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
Guillain-Barre Syndrome, Bell's palsy or similar neurological conditions
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to enrollment, a history of suicide plan or attempt
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, in Healthy Adults

Background:

People get Zika virus from infected mosquitos. They usually don t get very sick. But birth defects were reported in babies born to mothers who had Zika infection. In rare cases, people with Zika infection had a nervous system disease that causes severe muscle weakness and can be life threatening. A new vaccine made from DNA in the code for a Zika virus protein could help the body build an immune response against the virus.

Objectives:

To see if a new vaccine against Zika virus disease is safe and causes any side effects. To study specific immune responses to the vaccine.

Eligibility:

Healthy people ages 18-50

Design:

Participants will be screened with:

Medical history

Physical exam

Urine tests

Participants will have 18 visits over 2 years.

Participants will be randomly assigned to 1 of 3 groups. All will get 3 vaccines at 3 separate monthly visits. They will receive the vaccine in the upper arm muscle. Some will get it by needle and syringe, others by a device that uses high pressure to push the vaccine through the skin.

Vaccine visits last 4-6 hours. Participants will get a thermometer to measure their temperature and a ruler to measure any skin changes at the injection site. They will record this data for 7 days after each injection.

Other visits last 1-2 hours. These include:

Evaluation of any health changes or problems

Blood tests: Some samples may be used for future research.

Participants with side effects may have extra visits.

...

Read the detailed description

STUDY DESIGN:

This is a Phase I, randomized clinical study to evaluate the safety, tolerability, and immunogenicity of a 3 dose vaccination regimen with the Zika virus (ZIKVwt) DNA vaccine, VRC-ZKADNA090-00-VP. Subjects will be randomized to one of three groups to receive a full 4 mg dose: 1) full dose by one intramuscular (IM) injection with needle and syringe; 2) split dose given as two 0.5 mL IM injections with needle and syringe; 3) split dose given as two 0.5 mL IM injections with PharmaJet, a needle-free injection device. The primary hypothesis is that the investigational ZIKVwt DNA vaccine will be safe and well tolerated in healthy adults. A secondary hypothesis is that the vaccine will elicit a ZIKV-specific immune response. The primary objectives are to evaluate the safety and tolerability of the vaccine in healthy adults. Secondary objectives are related to the immunogenicity of the vaccine and vaccination regimens.

PRODUCT DESCRIPTION:

The investigational vaccine, VRC-ZKADNA090-00-VP, was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes the wild type (wt) precursor membrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV. ZIKVwt

SUBJECTS:

Healthy adults 18 to 50 years of age.

STUDY PLAN:

Forty-five subjects will be enrolled at the NIH Clinical Center and randomized to 3 groups to receive study product on Day 0, Week 4 and Week 8. The protocol requires about 18 scheduled clinic visits and a telephone follow-up contact after each study product administration. Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.

VRC 320 STUDY SCHEMA:

Group 1:
Administration Method = Single Dose Needle and Syringe;
Subjects = 15;
Administration Schedule = Day 0 (ZIKVwt DNA(1 (1 mL) injection)), Week 4 (ZIKVwt DNA (1 (1 mL) injection)), Week 8 (ZIKVwt DNA (1 (1 mL) injection))
Group 2:
Administration Method = Split Dose Needle and Syringe;
Subjects = 15;
Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))
Group 3:
Administration Method = Split Dose PharmaJet;
Subjects = 15;
Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))
Subjects Total = 45 (All injections total a dose of 4 mg. ** Up to 50 total enrollments are permitted if additional subjects are needed to assess safety or immunogenicity.)

STUDY DURATION:

Subjects will be evaluated for safety and immune responses throughout the study for 44 weeks following the first vaccine administration. Durability of immune responses will be evaluated at two long term follow-up visits, occurring at 18 and 24 months

Conditions: Prevention of Zika Infection, Zika-Specific Immune Response
Being tested: VRC-ZKADNA090-00-VP
Keywords: Zika Infection, Immune Response, Flavivirus, Arthropod-Borne Virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VRC-ZKADNA090-00-VPBiological
VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.

Study groups in NCT02996461
Study group	Role	What they receive
Group 1	Experimental	ZIKV DNA vaccine administered IM via needle and syringe at a single dosage of 4 mg on Day 0, week 4 and week 8. Receives: Biological: VRC-ZKADNA090-00-VP
Group 2	Experimental	ZIKV DNA vaccine administered IM via needle and syringe as a split dose of two .5 ml injections on Day 0, week 4 and week 8. Receives: Biological: VRC-ZKADNA090-00-VP
Group 3	Experimental	ZIKV DNA vaccine administered IM via needle-free injection device, PharmaJet, as a split dose of two .5 ml injections on Day 0, week 4 and week 8. Receives: Biological: VRC-ZKADNA090-00-VP

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe.
Measured: Through 44 weeks of study participation.
To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.
Measured: Through 44 weeks of study participation.

Secondary outcomes (1)

To evaluate the magnitude and the frequency of ZIKV-specific antibody response as measured by neutralization assay.
Measured: Four weeks after the first, second and third injections for each regimen.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20163 Sep 2019

First posted19 Dec 2016 (estimated)
Study start12 Dec 2016
Primary completion3 Sep 2019
Study completion3 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Prevention of Zika InfectionStudies 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: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02996461
Sponsor's protocol ID: 170024
Other IDs: 17-I-0024
Status last verified: 3 Sep 2019
First submitted: 16 Dec 2016
Last updated: 17 Dec 2019
Results posted: No
FDA-regulated drug: Yes

Publications

Dowd KA, Ko SY, Morabito KM, Yang ES, Pelc RS, DeMaso CR, Castilho LR, Abbink P, Boyd M, Nityanandam R, Gordon DN, Gallagher JR, Chen X, Todd JP, Tsybovsky Y, Harris A, Huang YS, Higgs S, Vanlandingham DL, Andersen H, Lewis MG, De La Barrera R, Eckels KH, Jarman RG, Nason MC, Barouch DH, Roederer M, Kong WP, Mascola JR, Pierson TC, Graham BS. Rapid development of a DNA vaccine for Zika virus. Science. 2016 Oct 14;354(6309):237-240. doi: 10.1126/science.aai9137. Epub 2016 Sep 22.
PubMed 27708058
Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.
PubMed 19779298
Graham BS, Ledgerwood JE, Nabel GJ. Vaccine development in the twenty-first century: changing paradigms for elusive viruses. Clin Pharmacol Ther. 2009 Sep;86(3):234-6. doi: 10.1038/clpt.2009.128.
PubMed 19707212
Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5.
PubMed 29217376

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VRC 320: A Phase I, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Zika Virus DNA Vaccine, VRC-ZKADNA090-00-VP, Administered Via Needle and Syringe or Needle-free Injector, PharmaJet, in Healthy Adults
ClinicalTrials.gov ID: NCT02996461
Acronym / sponsor ID: 170024
Conditions: Prevention of Zika Infection, Zika-Specific Immune Response
Keywords: Zika Infection, Immune Response, Flavivirus, Arthropod-Borne Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 12 Dec 2016
Primary completion: 3 Sep 2019 (actual)
Study completion: 3 Sep 2019 (actual)
First posted: 19 Dec 2016 (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.

Background:

Objectives:

To see if a new vaccine against Zika virus disease is safe and causes any side effects. To study specific immune responses to the vaccine.

Eligibility:

Healthy people ages 18-50

Design:

Participants will be screened with:

Medical history

Physical exam

Urine tests

Participants will have 18 visits over 2 years.

Other visits last 1-2 hours. These include:

Evaluation of any health changes or problems

Blood tests: Some samples may be used for future research.

Participants with side effects may have extra visits.

...

Detailed description

STUDY DESIGN:

PRODUCT DESCRIPTION:

SUBJECTS:

Healthy adults 18 to 50 years of age.

STUDY PLAN:

VRC 320 STUDY SCHEMA:

Group 1:
Administration Method = Single Dose Needle and Syringe;
Subjects = 15;
Administration Schedule = Day 0 (ZIKVwt DNA(1 (1 mL) injection)), Week 4 (ZIKVwt DNA (1 (1 mL) injection)), Week 8 (ZIKVwt DNA (1 (1 mL) injection))
Group 2:
Administration Method = Split Dose Needle and Syringe;
Subjects = 15;
Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))
Group 3:
Administration Method = Split Dose PharmaJet;
Subjects = 15;
Administration Schedule = Day 0 (ZIKVwt DNA(2 (0.5 mL) injections)), Week 4 (ZIKVwt DNA (2 (0.5 mL) injections)), Week 8 (ZIKVwt DNA (2 (0.5 mL) injections))
Subjects Total = 45 (All injections total a dose of 4 mg. ** Up to 50 total enrollments are permitted if additional subjects are needed to assess safety or immunogenicity.)

STUDY DURATION:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: VRC-ZKADNA090-00-VPZIKV DNA vaccine administered IM via needle and syringe at a single dosage of 4 mg on Day 0, week 4 and week 8.
Group 2	Experimental	Biological: VRC-ZKADNA090-00-VPZIKV DNA vaccine administered IM via needle and syringe as a split dose of two .5 ml injections on Day 0, week 4 and week 8.
Group 3	Experimental	Biological: VRC-ZKADNA090-00-VPZIKV DNA vaccine administered IM via needle-free injection device, PharmaJet, as a split dose of two .5 ml injections on Day 0, week 4 and week 8.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (20 listed)

18 to 50 years old
Available for clinic visits for 24 months after enrollment
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
Able and willing to complete the informed consent process
Willing to donate blood for sample storage to be used for future research

Key exclusion criteria (26 listed)

Female-specific: Breast-feeding or planning to become pregnant while participating through 12 weeks after the last study vaccination
Subject has received any of the following:
Subject has a history of any of the following clinically significant conditions:

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
VRC-ZKADNA090-00-VPVRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.	Biological	Group 1, Group 2, Group 3

Primary outcome

To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe.
Time frame: Through 44 weeks of study participation.
To evaluate the safety and tolerability of ZIKV DNA vaccine administered at 4 mg IM by Pharma jet.
Time frame: Through 44 weeks of study participation.

1 secondary outcome

To evaluate the magnitude and the frequency of ZIKV-specific antibody response as measured by neutralization assay.
Time frame: Four weeks after the first, second and third injections for each regimen.

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 17 Dec 2019.
Background: PubMed 27708058Dowd KA, Ko SY, Morabito KM, Yang ES, Pelc RS, DeMaso CR, Castilho LR, Abbink P, Boyd M, Nityanandam R, Gordon DN, Gallagher JR, Chen X, Todd JP, Tsybovsky Y, Harris A, Huang YS, Higgs S, Vanlandingham DL, Andersen H, Lewis MG, De La Barrera R, Eckels KH, Jarman RG, Nason MC, Barouch DH, Roederer M, Kong WP, Mascola JR, Pierson TC, Graham BS. Rapid development of a DNA vaccine for Zika virus. Science. 2016 Oct 14;354(6309):237-240. doi: 10.1126/science.aai9137. Epub 2016 Sep 22.
Background: PubMed 19779298Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.
Background: PubMed 19707212Graham BS, Ledgerwood JE, Nabel GJ. Vaccine development in the twenty-first century: changing paradigms for elusive viruses. Clin Pharmacol Ther. 2009 Sep;86(3):234-6. doi: 10.1038/clpt.2009.128.
Derived from this study: PubMed 29217376Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5.

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.

Grace L Chen, M.D. principal investigator

National Institute of Allergy and Infectious Diseases (NIAID)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 inclusion and 26 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 17 Dec 2019. 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?

To evaluate the safety and tolerability of v ZIKV DNA vaccine administered at 4mg IM by needle and syringe. (time frame: Through 44 weeks of study participation.). The study lists 2 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 NCT02996461, which also lists 4 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 Dec 2019.