Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly

NCT01232868 | Completed Results

• 3 other identifiers: IRB00046787NIHVAX-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 an FDA approved licensed influenza vaccine between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65 will be enrolled in the study. Each participant in the study will be given one flu shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

Conditions

Influenza

Keywords

Innate immunity; Adaptive immunity; Slu shot; Elderly

Outcome Measures

Primary Outcomes (1)

• Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures

  The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.

  Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)

Secondary Outcomes (1)

• Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures

  2 years

Study Arms (2)

Age 25-40

OTHER

Trivalent Influenza vaccine given to age 25-40

Biological: trivalent Influenza vaccine (TIV)

Age ≥65

OTHER

Trivalent Influenza vaccine given to age≥65

Biological: trivalent Influenza vaccine (TIV)

Interventions

trivalent Influenza vaccine (TIV) BIOLOGICAL

0.5 ml IM as a single dose in a prefilled syringe.

Also known as: Fluzone

Age 25-40; Age ≥65

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals aged 25-40 years, or ≥65 years old.
• Able to understand and give informed consent.
• 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, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after trivalent Influenza vaccination.

You may not qualify if:

• Receipt of immune products:
• Receipt of blood products 3 months prior to study entry or expected receipt through 6 months after study entry
• Receipt of any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry\*
• Receipt of any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry\*
• Receipt of the 2010-2011 influenza vaccine
• Documented influenza infection during the 2010-2011 influenza season. Not excluded from the study, volunteers with prior upper respiratory infections during the 2010-2011 influenza illness.
• Presence of co-morbidities or immunosuppressive states such as:
• Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, 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.
• Pregnancy or breast feeding
• Conditions that could affect the safety of the volunteers such as:
• Severe reactions to prior vaccination with TIV, including anaphylaxis.
• History of Guillain Barré syndrome
• History of bleeding disorders
• Any allergy to any component of the vaccine including egg allergy.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Long period of time required for detailed analysis of gene expressions in different participants

Results Point of Contact

• Title: Nadine Rouphael, MD
• Organization: Emory University

nroupha@emory.edu

404-712-1435

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 23, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 30, 2015
• Results First Posted: November 30, 2015

Record last verified: 2015-10

Locations

US (1)