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Evaluation of Long-term Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster and Postherpetic Neuralgia and Impact on Healthcare Utilization and Cost

Award Number: R01AI192603
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/10/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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Evaluation of Long-term Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster and Postherpetic Neuralgia and Impact on Healthcare Utilization and Cost - Abstract Varicella-zoster virus causes chickenpox; while it can remain dormant throughout one’s lifetime, there is a risk for the virus to reactivate as herpes zoster (HZ), a painful skin eruption or rash also known as shingles that affects about 1 million people in the United States (US) annually. The lifetime risk of HZ among unvaccinated persons ranges from 20–30%. Approximately 5–30% of persons with HZ also develop postherpetic neuralgia (PHN), a sequela characterized by long-lasting neuropathic pain at the skin eruption site with symptoms persisting for months or even years after resolution of the initial HZ episode. In addition to causing substantial pain to patients, HZ and its associated complications are estimated to cost the US healthcare system $1.1–5 billion annually. In 2017, the recombinant zoster vaccine (RZV) against HZ was licensed by the US Food and Drug Administration and recommended by the Advisory Committee on Immunization Practices (ACIP) for use in immunocompetent persons aged ≥50, recommendations that were updated in 2021 to include immunocompromised persons aged ≥19. In clinical trials, 2 doses of RZV were >90% effective against HZ in immunocompetent adults. In real-world observational studies, we and others showed that 2 doses of RZV were 70–86% effective against HZ. Two clinical trial studies reported that RZV effectiveness decreased from 97% one year after vaccination to 73% 10 years after vaccination among participants; however, clinical trials participants are often not representative of the general population. No observational long-term study of RZV effectiveness against HZ and PHN has been conducted, especially among immunocompromised persons. We propose to evaluate the long-term effectiveness of RZV against HZ and PHN over time overall and in subgroups defined by age and immunocompromising conditions. We also propose to examine RZV’s impact on healthcare utilization and costs. We will use the rich, comprehensive electronic health record (EHR) data of Kaiser Permanente Northern California (KPNC), a large integrated healthcare delivery system of more than 4.5 million members, including more than 2 million eligible for RZV. We will use a cohort study design with a series of multivariable Cox regression models to estimate adjusted hazard ratio of HZ and PHN comparing vaccinated with unvaccinated persons, overall and by time since vaccination. RZV effectiveness against HZ and PHN will be calculated as one minus the adjusted hazard ratio. To study immunocompromised persons aged 19–49, we will use a match design to carefully adjust for potential confounders. To evaluate healthcare utilization, we will compare healthcare service utilization rates between vaccinated and unvaccinated HZ and PHN cases and estimate reduction in costs among HZ and PHN cases who are vaccinated. Evaluation of long-term, real-world RZV effectiveness is vital given growing aging and immunocompromised populations, at high risk for HZ and PHN. With access to KPNC’s longitudinal EHR data, we are uniquely positioned to evaluate RZV effectiveness and healthcare costs of HZ and PHN. Study findings may inform the need for future RZV booster doses.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $825,617 )
2026	2026	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	1	8/10/2026	NEW	$825,617
														Subtotal = $825,617

Grand Total All Awards = $825,617

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Evaluation of Long-term Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster and Postherpetic Neuralgia and Impact on Healthcare Utilization and Cost

Award Number: R01AI192603

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/10/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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