Systems Biology of Zoster Vaccine

NCT04047979 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB001058381U19AI090023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to better understand how the immune system responds to the new herpes zoster (shingles) vaccine (Shingrix®). The study will be looking at certain markers in the blood after vaccination with Shingrix®.

Conditions

Zoster; Zoster Varicella; Shingles; Chicken Pox

Keywords

Zoster; Immune responses; Vaccine; Vaccine Trials; Clinical Trials; Chicken Pox; Shingles

Outcome Measures

Primary Outcomes (1)

• Change in Innate Immune Signatures Post-vaccine Dose

  Will be assessed between D0, D1, and D7 and each dose of Zoster vaccine recombinant, adjuvanted, in both age cohorts: 50-60 years and \>70 years of age. Results will be reported using Mean Normalized Enrichment Score (NES) of the Antiviral Interferon Signature Module (NES reflects the degree to which the activity level of a set of transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the score (less activity), and a positive score reflects more activity of the module).

  Day 1 from Day 0, Day 7 from Day 0, Day 61 from day 60, Day 67 from day 60

Secondary Outcomes (1)

• Safety of Zoster Vaccine Recombinant, Adjuvanted

  Day 270 post-intervention

Study Arms (2)

Younger Group

EXPERIMENTAL

Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)

Biological: Shingrix®

Older Group

EXPERIMENTAL

Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)

Biological: Shingrix®

Interventions

Shingrix® BIOLOGICAL

A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.

Older Group; Younger Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to understand and provide informed consent.
• Adults aged 50-60 years, or community dwelling adults aged 70 years and above.

You may not qualify if:

• Inability or unwillingness of a subject to give written informed consent or comply with study protocol.
• Receipt of immune products:
• Receipt of blood products within 6 months prior of the first dose of the study Zoster vaccine or expected receipt through 6 months after vaccination with the second dose of the study Zoster vaccine.
• Receipt of any vaccine within 4 weeks prior to vaccination with any of the two doses of the study Zoster vaccine or expected receipt within 4 weeks after vaccination with any of the two doses of the study Zoster vaccine.
• Receipt of any Zoster or varicella vaccines at any time prior to study entry.
• Subject taking any non-topical antiviral therapy with activity against herpes viruses, including but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir 3 days prior to each vaccination or 14 days after.
• Prior history of shingles.
• Presence of certain co morbidities or immunosuppressive states such as:
• Chronic medical problems including (but not limited to) insulin-dependent diabetes, severe (at the discretion of the investigator or study physician) heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.
• Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C, tuberculosis, organ transplant, cancer, current and or expected receipt of chemotherapy, radiation therapy, steroids \[i.e., \> 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days); (nasal (less than 1mg/day of fluticasone equivalent inhaled corticosteroid is allowable) and topical steroids are allowed)\], antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.
• Conditions that could affect the safety of the subjects such as:
• Severe reactions to prior vaccinations.
• History of anaphylactic/anaphylactoid reaction to any component of the vaccines.
• History of bleeding disorders.
• Any acute illness, including any fever (\> 100.4 F \[\> 38.0 C\], regardless of the route) within 3 days prior to study entry.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Hope Clinic

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Herpes Zoster; Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Dr. Nadine Rouphael
• Organization: Emory University

nroupha@emory.edu

404-712-1435

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single center, open label mechanistic study in which older adult subjects will receive Zoster vaccine recombinant, adjuvanted Vaccination will occur on Day 0 and Day 60. There will be no randomization, study participant or clinical study personnel blinding, or masking.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: November 14, 2019
• Primary Completion: April 3, 2023
• Study Completion: October 30, 2023
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At the time of publication or 9 months after submission of the manuscript. It will be available indefinitely.
• Access Criteria: Data will be uploaded into www.immport.org and made available to researchers with a registered account. Type of Analysis: Any Purpose Mode of Access: Data will be shared on www.immport.org

Locations

US (1)