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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a shingles vaccine to determine its safety and effectiveness for people with lupus, a condition where the immune system attacks healthy tissue. Participants will receive either the shingles vaccine (Herpes Zoster Subunit (HZ/su) Vaccine) or a placebo (a harmless substance) in two stages. Researchers aim to discover if the vaccine causes lupus symptoms to flare up and if it helps the body build protection against shingles. This trial might suit someone diagnosed with lupus who hasn't received the shingles vaccine before. As a Phase 4 trial, the vaccine is already FDA-approved and proven effective, and this research helps understand its benefits for more patients.

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 is the safety track record for the Herpes Zoster Subunit (HZ/su) Vaccine?

Research has shown that the herpes zoster subunit (HZ/su) vaccine is generally safe for people with lupus. Studies have found that it helps protect against shingles and is well-tolerated by those with systemic lupus erythematosus (SLE). Other research indicates that the vaccine is effective and safe for the general population, although specific data for lupus patients is still being collected. In SLE patients, the vaccine's ability to prevent shingles ranges from 54% to 70%. Importantly, it carries a low risk of causing severe lupus flare-ups. Overall, these findings suggest that the HZ/su vaccine is safe for people with lupus. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Herpes Zoster Subunit (HZ/su) Vaccine for lupus patients because it targets shingles prevention without using live virus components, making it safer for individuals with compromised immune systems. Unlike traditional shingles vaccines, which are often live attenuated and not recommended for lupus patients, this subunit vaccine uses specific proteins from the virus to trigger an immune response. This approach reduces the risk of infection while still effectively boosting the body’s defenses against shingles.

What evidence suggests that the Herpes Zoster Subunit (HZ/su) Vaccine might be an effective treatment for lupus?

Studies have shown that the Herpes Zoster Subunit (HZ/su) vaccine is highly effective. In large studies, it prevented shingles (herpes zoster) in over 90% of participants. For individuals with systemic lupus erythematosus (SLE), research indicates the vaccine is also effective, with success rates of about 70% and 54% in different groups. In this trial, participants will receive either the HZ/su vaccine followed by a placebo or a placebo followed by the HZ/su vaccine. The vaccine boosts the immune system to fight shingles and is safe for people with SLE. Overall, these findings suggest the HZ/su vaccine can effectively prevent shingles, even in those with lupus. ^{1 2 3 5 6}

Who Is on the Research Team?

Amit Saxena, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6363132/

Herpes zoster vaccination in systemic lupus erythematosus Pooled data of the ZOE-50 and ZOE-70 studies reported a vaccine efficacy of 91.3% against HZ and 88.8% against post-herpetic neuralgia. A long-term study showed ...

2. rmdopen.bmj.com rmdopen.bmj.com/content/11/3/e005839

Effectiveness and safety of the recombinant zoster vaccine ... Using administrative claims data, we showed a RZV 2-dose vaccine effectiveness of 70% and 54% in two separate, representative SLE patient ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38710192/

Immunogenicity, reactogenicity, and safety of two-dose ... The herpes zoster subunit vaccine induces humoral and cellular immunity against herpes zoster with a good safety profile in patients with SLE.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05559671

Safety of the Herpes Zoster Subunit Vaccine in Lupus 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 ...

5. academic.oup.com academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaf395/8230148

The Journal of Infectious Diseases | Oxford Academic Data on RZV's effectiveness against herpes zoster in patients with autoimmune diseases (AIDs) is limited. Vaccine effectiveness ranged from ...

6. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(24)00084-5/abstract

Immunogenicity, reactogenicity, and safety of two-dose ... The adjuvanted herpes zoster subunit vaccine has shown good efficacy and safety in the general population. However, its effectiveness has not ...