Safety of the Herpes Zoster Subunit Vaccine in Lupus

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures. 2. Female or male ≥18 years of age at the time of signing the informed consent. 3. Meet the 2019 EULAR/ACR Classification Criteria for SLE. 4. Female subjects must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is surgically sterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year postmenopausal, or practices sustained abstinence consistent with the subject's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (FSH) level greater than the threshold laboratory value of post-menopausal women at screening.

Exclusion Criteria:

1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax) 2. Clinical HZ infection within 12 months prior to screening or during screening. 3. Hybrid SLEDAI >12 at screening visit. 4. Presence of a mild, moderate, or severe flare per the rSFI at time of screenin. 5. Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit. 6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment. 7. Receipt of rituximab or cyclophosphamide within nine months of enrollment. 8. Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment. 9. Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment. 10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study. 11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05559671
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amit Saxena, MD
Principal Investigator Affiliation NYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Arms & Interventions

Arms

Experimental: HZ/su Vaccine, then Placebo

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.

Experimental: Placebo, then HZ/su Vaccine

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.

Interventions

Biological: - Herpes Zoster Subunit (HZ/su) Vaccine

Manufactured by GSK Biologicals SA. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.

Biological: - Placebo

Saline injection. Administered as two-time injection of 0.5 mL each at either weeks 0 and 8 or weeks 24 and 32.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma

Status

Recruiting

Address

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104

Site Contact

Cristina Arriens

[email protected]

405-271-7303