224 Participants Needed

Shingles Vaccine for Lupus

Recruiting at 1 trial location
TH
JS
TC
Overseen ByThomas Chalothron
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking rituximab or cyclophosphamide, you must not have received them within nine months of enrollment.

What data supports the effectiveness of the treatment Shingrix for preventing shingles in lupus patients?

Shingrix, a herpes zoster subunit vaccine, has shown excellent efficacy of about 90% in preventing shingles in adults aged 50 and older, with its effectiveness persisting for over three years. It is also considered safe and effective in immunocompromised patients, making it a promising option for lupus patients who are at increased risk of shingles.12345

Is the Shingrix vaccine safe for humans?

The Shingrix vaccine, also known as the herpes zoster subunit vaccine (HZ/su), has been shown to be generally safe in humans. Common side effects include mild to moderate pain, swelling, or redness at the injection site, as well as muscle pain and fatigue, which are usually temporary. It is not contraindicated for people with weakened immune systems and is preferred over live vaccines for these individuals.12356

How is the Shingrix vaccine different from other shingles treatments?

Shingrix is unique because it is a subunit vaccine, meaning it uses only a piece of the virus (glycoprotein E) combined with an adjuvant (a substance that enhances the body's immune response) to prevent shingles, unlike the older live attenuated vaccine which uses a weakened form of the virus. This makes Shingrix suitable for people with weakened immune systems, such as those with lupus, who cannot receive live vaccines.14678

What is the purpose of this trial?

This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.

Research Team

AS

Amit Saxena, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with Systemic Lupus Erythematosus (SLE) who meet specific criteria. Participants must not have had the shingles vaccine before, no recent shingles infection or severe SLE flares, and can't be on certain medications or have received other vaccines recently. Women in the study need to prevent pregnancy effectively.

Inclusion Criteria

Provision of informed consent prior to any study specific procedures
Meet the 2019 EULAR/ACR Classification Criteria for SLE
I am using birth control or do not need it due to surgery, menopause, or not having sex.

Exclusion Criteria

I have a known immune system problem or am taking medication for cancer.
Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment
Hybrid SLEDAI >12 at screening visit
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either HZ/su vaccine or placebo injection at week 0 and week 8

24 weeks
2 visits (in-person)

Treatment Period 2

Participants crossover to receive the alternate treatment (placebo or HZ/su vaccine) at week 24 and week 32

24 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Herpes Zoster Subunit (HZ/su) Vaccine
  • Placebo
Trial Overview The trial tests the safety and immune response of a Herpes Zoster Subunit (HZ/su) Vaccine compared to a placebo in people with lupus. It's designed to see if getting vaccinated causes any significant lupus flare-ups within six months after vaccination.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Placebo, then HZ/su VaccineExperimental Treatment2 Interventions
During the initial 24-week period (Period 1), participants will receive placebo saline injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive HZ/su injection at week 24 and week 32.
Group II: HZ/su Vaccine, then PlaceboExperimental Treatment2 Interventions
During the initial 24-week period (Period 1), participants will receive HZ/su injection at week 0 and week 8. During the second 24-week period (Period 2), participants will receive placebo saline injection at week 24 and week 32.

Herpes Zoster Subunit (HZ/su) Vaccine is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Shingrix for:
  • Prevention of herpes zoster (shingles) in individuals 50 years and older
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Approved in European Union as Shingrix for:
  • Prevention of herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults 50 years and older
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Approved in Canada as Shingrix for:
  • Prevention of herpes zoster (shingles) in individuals 50 years and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

The herpes zoster subunit vaccine (HZ/su) is highly effective, reducing the risk of developing shingles by over 90% compared to a placebo, making it a strong preventive measure for adults aged 50 and older.
The vaccine has a comparable safety profile to other vaccines, with common side effects including injection site pain and mild systemic reactions like fatigue and headache, supporting its routine use as recommended by the Advisory Committee on Immunization Practices (ACIP).
Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine.James, SF., Chahine, EB., Sucher, AJ., et al.[2019]
The new herpes zoster (HZ) subunit vaccine (HZ/su) demonstrated about 90% efficacy in preventing HZ in adults aged 50 and older, with protection lasting over 3 years, regardless of age.
While approximately 9.5% of participants experienced temporary injection site pain, the vaccine was generally well-tolerated, and compliance with the two-dose regimen was high at 95%.
Vaccine profile of herpes zoster (HZ/su) subunit vaccine.Cunningham, AL., Heineman, T.[2018]
The pilot study involving 10 patients with systemic lupus erythematosus (SLE) showed that the herpes zoster vaccine (Zostavax) was safe, with no cases of herpes zoster, serious adverse events, or SLE flares reported after vaccination.
While the vaccine elicited a measurable immune response in patients with mild SLE, the antibody titers increased significantly only in the control group, suggesting that while the vaccine is safe for SLE patients, its immunogenicity may be lower compared to healthy individuals.
Herpes zoster vaccination in SLE: a pilot study of immunogenicity.Guthridge, JM., Cogman, A., Merrill, JT., et al.[2021]

References

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. [2019]
Vaccine profile of herpes zoster (HZ/su) subunit vaccine. [2018]
Herpes zoster vaccination in SLE: a pilot study of immunogenicity. [2021]
Tale of two vaccines: differences in response to herpes zoster vaccines. [2019]
Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. [2022]
A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. [2021]
Non-clinical safety assessment of single and repeated administration of gE/AS01 zoster vaccine in rabbits. [2018]
[Zoster disease after Shingrix vaccination]. [2021]
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