Shingles Vaccine for Lupus

Recruiting at 1 trial location

Overseen By Thomas Chalothron

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must not be taking: Rituximab, Cyclophosphamide, Antibiotics, others

Disqualifiers: Prior HZ vaccine, Recent HZ infection, High SLEDAI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

224 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 4 6 7 8}

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

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

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

Group I: Placebo, then HZ/su Vaccine Experimental Treatment 2 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 Placebo Experimental Treatment 2 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:

Approved in United States as Shingrix for:

• Prevention of herpes zoster (shingles) in individuals 50 years and older

Approved in European Union as Shingrix for:

• Prevention of herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults 50 years and older

Approved in Canada as Shingrix for:

• Prevention of herpes zoster (shingles) in individuals 50 years and older

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).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herpes zoster vaccination in SLE: a pilot study of immunogenicity. Guthridge, JM., Cogman, A., Merrill, JT., et al.[2021]

A study comparing two herpes zoster vaccines, the live attenuated zoster vaccine (ZV) and the newer adjuvanted subunit vaccine (HZ/su), found that HZ/su induces a stronger immunologic response in both vaccine-naive individuals and those previously vaccinated.

The superior clinical protection offered by the HZ/su vaccine over the ZV vaccine helps explain its effectiveness and may also shed light on the underlying reasons for susceptibility to herpes zoster in certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tale of two vaccines: differences in response to herpes zoster vaccines. Gershon, AA.[2019]

Shingrix® is a highly effective recombinant zoster vaccine that significantly reduces the risk of herpes zoster (HZ) and postherpetic neuralgia (PHN) in adults aged 50 and older, with efficacy remaining strong even after 4 years.

While Shingrix® is associated with more side effects than a placebo, such as injection-site reactions and fatigue, these reactions are generally mild to moderate and transient, making it a well-tolerated option for preventing HZ and PHN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. Syed, YY.[2022]

HZ/Su, also known as 'Shingrix', is a new subunit vaccine designed to prevent shingles, particularly important for aging populations who are at higher risk.

Unlike the older live attenuated shingles vaccine, HZ/Su is suitable for a broader range of individuals, addressing safety concerns and potential long-term effectiveness issues associated with the previous vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. Bharucha, T., Ming, D., Breuer, J.[2021]

The investigational HZ/su vaccine, designed to prevent shingles, was well-tolerated in rabbits with only minor local inflammatory reactions observed at injection sites after both single and repeated doses.

Systemic effects were minimal, with only transient increases in certain blood markers, and all rabbits fully recovered one month after the last injection, supporting the vaccine's safety for further clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-clinical safety assessment of single and repeated administration of gE/AS01 zoster vaccine in rabbits. Giordano, G., Segal, L., Prinsen, M., et al.[2018]

Shingrix is an approved vaccine in Germany for preventing shingles (zoster) and its complications, specifically for adults aged 60 and older.

If patients experience bullous skin lesions after receiving Shingrix, it is important to consider the possibility of zoster disease and report any unexpected side effects to the appropriate medical authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. Kohn, D., Wetzig, T.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Shingrix: The New Adjuvanted Recombinant Herpes Zoster Vaccine. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Vaccine profile of herpes zoster (HZ/su) subunit vaccine. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Herpes zoster vaccination in SLE: a pilot study of immunogenicity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Tale of two vaccines: differences in response to herpes zoster vaccines. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Recombinant Zoster Vaccine (Shingrix®): A Review in Herpes Zoster. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A critical appraisal of 'Shingrix', a novel herpes zoster subunit vaccine (HZ/Su or GSK1437173A) for varicella zoster virus. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Non-clinical safety assessment of single and repeated administration of gE/AS01 zoster vaccine in rabbits. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

[Zoster disease after Shingrix vaccination]. [2021]