InfectionPhase 2NCT00513526

Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

A Phase 2 study testing Gardasil in people with Infection and Precancerous Condition, run by AIDS Malignancy Consortium at 8 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells. PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Infection, Precancerous Condition
What is being tested?: Gardasil
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 8 sitesUnited States
Study dates: Nov 2007to Oct 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
If receiving antiretroviral therapy:
Receipt of antiretroviral therapy for at least 6 months prior to entry
No change in antiretroviral therapy within 30 days prior to entry

Show all 20Show fewer

CD4 cell count > 200 cells/mm³ within 90 days prior to study entry
HIV-1 RNA < 200 copies/mL within 90 days prior to entry
If not receiving antiretroviral therapy:
CD4 cell count ≥ 350 cells/mm³ within 90 days prior to study entry
No plans to start antiretroviral therapy prior to week 28
Normal anal cytological result, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry
Karnofsky performance status 70-100%
Absolute neutrophil count > 750 cells/mm³
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm³
Creatinine clearance ≥ 60 mL/min
AST and ALT ≤ 3 times ULN
Total or conjugated (direct) bilirubin ≤ 2.5 times ULN
See Disease Characteristics

Who cannot join

Current or history of anal or perianal carcinoma
Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results
Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN
Current or history of anal or peri-anal condyloma is allowed
PATIENT CHARACTERISTICS:
Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements

Show all 16Show fewer

Serious illness requiring systemic treatment and/or hospitalization within the past 45 days
Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Hemophilia
PRIOR CONCURRENT THERAPY:
Prior splenectomy
Currently receiving anticoagulation therapy other than acetylsalicylic acid
Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Boston University Cancer Research Center
Boston, Massachusetts, 02118
Denver Health Medical Center
Denver, Colorado, 80204-4507
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90095-1793
Laser Surgery Care
New York, New York, 10010
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, 98101
Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.

PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

Read the detailed description

OBJECTIVES:

Primary

To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.
To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.

Secondary

To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.
To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.
To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.
To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

To evaluate prevalent and incident HPV infections in the anal canal.
To evaluate cytological and histological abnormalities in the anal canal.
To evaluate prevalent and incident HPV infections in the oral cavity.
To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Conditions: Infection, Precancerous Condition
Being tested: Gardasil
Keywords: infection, low-grade squamous intraepithelial lesion, atypical squamous cells of undetermined significance
Medical subject headings: Infections, Precancerous Conditions, Squamous Intraepithelial Lesions, Atypical Squamous Cells of the Cervix

What participants receive

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

GardasilBiological
Also called quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
week 0, 8, 24, 128

Study groups in NCT00513526
Study group	Role	What they receive
Gardasil	Experimental	Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128. Receives: Biological: Gardasil

What is being measured

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

Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine
Measured: All study visits
Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline
Measured: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline
Measured: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline
Measured: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline
Measured: Week 28

Secondary outcomes (7)

Longitudinal Changes in CD4+ Cell Count From Baseline
CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
Measured: Week 0, 4, 12, 28
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
Measured: Week 0, 4, 12, 28
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 6 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Measured: weeks 0, 28, and 76
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 11 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Measured: weeks 0, 28, and 76
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 16 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Measured: weeks 0, 28, and 76
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
HPV antibody titers to type 18 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Measured: weeks 0, 28, and 76
Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series
Measured: Weeks 0, 28 and 76

Timeline

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

Nov 2007Oct 2011

First posted8 Aug 2007 (estimated)
Study startNov 2007
Primary completionMay 2010
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00513526
Sponsor's protocol ID: AMC-052
Other IDs: CDR0000559149, U01CA121947
Status last verified: Oct 2023
First submitted: 6 Aug 2007
Last updated: 14 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kang M, Umbleja T, Ellsworth G, Aberg J, Wilkin T. Effects of Sex, Existing Antibodies, and HIV-1-Related and Other Baseline Factors on Antibody Responses to Quadrivalent HPV Vaccine in Persons With HIV. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):414-422. doi: 10.1097/QAI.0000000000002891.
PubMed 34907980
Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010 Oct 15;202(8):1246-53. doi: 10.1086/656320.
PubMed 20812850

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men
ClinicalTrials.gov ID: NCT00513526
Acronym / sponsor ID: AMC-052
Conditions: Infection, Precancerous Condition
Keywords: infection, low-grade squamous intraepithelial lesion, atypical squamous cells of undetermined significance
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: AIDS Malignancy ConsortiumResearch network
Collaborators: National Cancer Institute (NCI), The Emmes Company, LLC
Study start: Nov 2007
Primary completion: May 2010 (actual)
Study completion: Oct 2011 (actual)
First posted: 8 Aug 2007 (estimated)
Results: Posted 26 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.

PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

Detailed description

OBJECTIVES:

Primary

To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.
To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.

Secondary

To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.
To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.
To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.
To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

To evaluate prevalent and incident HPV infections in the anal canal.
To evaluate cytological and histological abnormalities in the anal canal.
To evaluate prevalent and incident HPV infections in the oral cavity.
To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Gardasil	Experimental	Biological: GardasilQuadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
If receiving antiretroviral therapy:
If not receiving antiretroviral therapy:
Normal anal cytological result, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry

Key exclusion criteria (16 listed)

Current or history of anal or perianal carcinoma
Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results
Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN
Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization within the past 45 days

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
GardasilAlso: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccineweek 0, 8, 24, 128	Biological	Gardasil

Primary outcome

Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine
Time frame: All study visits
Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine
Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline
Time frame: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline
Time frame: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline
Time frame: Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline
Time frame: Week 28

7 secondary outcomes

Longitudinal Changes in CD4+ Cell Count From Baseline
Time frame: Week 0, 4, 12, 28
Longitudinal Changes in Plasma HIV-1 RNA From Baseline
Time frame: Week 0, 4, 12, 28
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Time frame: weeks 0, 28, and 76
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Time frame: weeks 0, 28, and 76
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Time frame: weeks 0, 28, and 76
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status
Time frame: weeks 0, 28, and 76
Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series
Time frame: Weeks 0, 28 and 76

Results and safety

Results posted to the registry on 26 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gardasil	109	92

Primary outcome: Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine

Time frame: All study visits. Number (95% Confidence Interval). Unit: participants

Measure	Gardasil n = 109
Value	0 (NA to 0.0275)

Population analysed: Intention to treat (i.e., received at least one dose of the vaccine)

Primary outcome: Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline

Time frame: Week 28. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Gardasil n = 60
Value	0.98 (0.92 to NA)

Population analysed: Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.

Primary outcome: Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline

Time frame: Week 28. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Gardasil n = 68
Value	0.99 (0.93 to NA)

Primary outcome: Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline

Time frame: Week 28. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Gardasil n = 62
Value	1.00 (0.95 to NA)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gardasil	5 of 109 (4.6%)	56 of 109 (51.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34907980Kang M, Umbleja T, Ellsworth G, Aberg J, Wilkin T. Effects of Sex, Existing Antibodies, and HIV-1-Related and Other Baseline Factors on Antibody Responses to Quadrivalent HPV Vaccine in Persons With HIV. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):414-422. doi: 10.1097/QAI.0000000000002891.
Derived from this study: PubMed 20812850Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010 Oct 15;202(8):1246-53. doi: 10.1086/656320.
Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.

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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.

Timothy J. Wilkin, MD, MPH study chair

Weill Medical College of Cornell University

Joel Palefsky, MD principal investigator

University of California, San Francisco

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gardasil in people with Infection and Precancerous Condition, run by AIDS Malignancy Consortium at 8 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 20 inclusion and 16 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine (time frame: All study visits). 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 NCT00513526, 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 14 Nov 2023.