Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly

NCT ID: NCT01331161

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-10-31

Brief Summary

Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.

In this trial, the investigators will study the immunologic differences of the FDA approved licensed shingles vaccine between a younger and an older group. Thirty three healthy volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of 60-79 will be enrolled in the study. Each participant in the study will be given one shingles shot. Blood work will be obtained one month before vaccination, on the day of vaccination, one day, three days, seven days, fourteen days, one month, three months and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

Detailed Description

RATIONALE: Zoster vaccine is known to induce diminished antigen-specific T cell responses and lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in innate responses to the live attenuated virus, which translates into sub-optimal functional adaptive immune responses. Therefore, early innate signatures of vaccination should correlate with, and predict the immunogenicity of Zoster vaccine in the young and elderly.

STUDY DESIGN: Double center, open label study in which adult healthy volunteers will be vaccinated with Zoster vaccine. Blood samples will be collected on day D-30 (pre- vaccination) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 (post vaccination) to study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe, volunteers are asked to report and record any local or systemic AEs for 7 days post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days post vaccination. AEs developing the day of the blood draw will also be reported

Conditions

Shingles

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Older group

Participants between the ages of 60-79

Group Type: EXPERIMENTAL

ZOSTAVAX

Intervention Type: BIOLOGICAL

shingles vaccine, one dose

Younger group

Participants between the ages of 25-40

Group Type: EXPERIMENTAL

ZOSTAVAX

Intervention Type: BIOLOGICAL

shingles vaccine, one dose

Interventions

ZOSTAVAX

shingles vaccine, one dose

Intervention Type: BIOLOGICAL

Other Intervention Names

shingles vaccine

Eligibility Criteria

Inclusion Criteria

• Able to understand and give informed consent.
• Immunocompetent subjects aged 25-40 years, or community dwelling subjects between the ages of 60-79.

Exclusion Criteria

• Young adults aged 25-40 years who are Varicella-Zoster virus seronegative or equivocal results (mean value OD for Varicella-Zoster virus IgG lower than 1.1 by commercial enzyme-linked immunosorbent assay (ELISA) (Hope Clinic: IgG VZV ELISAII-Wampole Laboratories®, NJ, USA- Vaccine Research Trials Center:: Liaison VZV IgG Assay, DiaSorin, Italy)
• Receipt of immune products:

• Receipt of blood products within 6 months prior to vaccination with Zoster vaccine or expected receipt through 6 months after vaccination with Zoster vaccine*
• Receipt of any vaccine within 4 weeks prior to vaccination with Zoster vaccine or expected receipt within 4 weeks after vaccination with Zoster vaccine*
• Receipt of Zoster vaccine 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 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 heart, lung, liver, or kidney diseases; auto immune diseases; severe gastrointestinal diseases; and uncontrolled hypertension.
• Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
• 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 and topical steroids are allowed)],antitumor necrosis factor agents, or any other immunosuppressive therapy, anatomic or functional asplenia, congenital immunodeficiency.
• Pregnant or breast-feeding women, or women expecting to conceive 30 days before and 90 days after vaccination**.
• Conditions that could affect the safety of the volunteers such as:

• Severe reactions to prior vaccinations.
• History of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine.
• History of bleeding disorders
• Any acute illness, including any fever (> 100.4 F [> 38.0C], regardless of the route) within 3 days prior to study entry *.
• Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.

Note:

Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.

**Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 90 days after zoster vaccination.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nadine Rouphael

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine Rouphael, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

University of Colorado

Aurora, Colorado, United States

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

U19AI090023

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HIPCVAX005

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00050285

Identifier Type: -

Identifier Source: org_study_id