Th1 Response to Influenza: Aging and Vaccine Efficacy

NCT00396305 | Terminated Phase 4

• 1 other identifier: 05-0070
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being done because influenza (flu) affects many people each year throughout the world. The elderly and those with chronic health problems are at greater risk for complications from the flu. The purpose of this research study is to evaluate vaccination strategies in the elderly and others receiving the influenza vaccination in order to increase protection. All subjects will receive the flu vaccine as an injection in the muscle of the upper arm. Participants may receive a booster \[an extra dose of vaccine or placebo (inactive substance)\] shot. Study participants will include healthy adult volunteers, ages 21-40, 60-89, or 90 years and older. Subjects will be involved in study related procedures for 6 months.

Conditions

Influenza

Keywords

Influenza, vaccine, efficacy, elderly

Outcome Measures

Primary Outcomes (2)

• Immunogenicity: measured by frequency of IS-Th1 and antibody and T cell responses.

  Days 7, 28, 56, and 84 following the initial vaccination.

• Safety: including rates of serious adverse events (SAEs) and their relationship to vaccination; rates of local or systemic solicited adverse events (AEs) and their categories; and reported unsolicited AEs following vaccination.

  Safety evaluation at 4, 14, and 28 days post-vaccination.

Study Arms (4)

Group 2, Control Double Dose

EXPERIMENTAL

12 elderly and 6 young participants. This group will be vaccinated with a double dose of vaccine without booster on Day 0. These subjects will receive a double-dose of vaccine administered as 2 consecutive injections (2 injections of 0.5 mL) in the same deltoid. The control group for Group 2 is group 1, Cohort 2.

Biological: Trivalent Inactivated Influenza

Group 3-Control late booster

EXPERIMENTAL

12 elderly and 6 young participants. This group will be vaccinated with the standard dose of vaccine (0.5 mL) on Day 0 and with a booster dose of vaccine (0.5 mL) on Day 21. The control for Group 3 is Group 1, Cohort 3.

Biological: Trivalent Inactivated Influenza

Group 1, Control

ACTIVE COMPARATOR

12 elderly and 8 young participants. Group 1 will be further divided into 4 equal cohorts (each containing 3 elderly and 2 young adults). Cohorts 2, 3, and 4 will receive the standard dose of vaccine and placebo (0.5 mL saline) on Day 0, 21, or 7 respectively. Cohort 1 will be vaccinated with the standard dose of vaccine without placebo/vaccine booster.

Drug: Placebo

Group 4-Control early booster

EXPERIMENTAL

12 elderly and 6 young participants. This group will be vaccinated with the standard dose of vaccine (0.5 mL) on Day 0 and with a booster dose of vaccine (0.5 mL) on Day 7. The control for Group 4 is Group 1, Cohort 4.

Biological: Trivalent Inactivated Influenza

Interventions

Placebo DRUG

Sterile phosphate buffered saline solution.

Group 1, Control

Trivalent Inactivated Influenza BIOLOGICAL

The trivalent influenza vaccine is a sterile suspension prepared from the allantoic fluids of chicken embryos infected with a specific type of influenza virus. Each 0.5 mL dose of the vaccine contains 15 mcg hemagglutinin (HA) of 3 strains of virus (H1N1, H3N2, and B). The vaccine is a liquid preparation; as such, no diluent is required. It is essentially clear and slightly opalescent in color.

Group 2, Control Double Dose; Group 3-Control late booster; Group 4-Control early booster

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females 21 to 40 years of age or between 60 and 89, or 90 years or older at the time of enrollment.
• Subjects must provide written informed consent prior to first study intervention.
• Subject is judged to be healthy on the basis of verbal history and physical examination.
• Subject is able to cooperate with the requirements of the study (must be able to complete the diary cards and will be available for 6 months after enrollment).
• Subject is mentally capable to give consent based on investigator judgment.
• Females of childbearing potential (all women under the age of 40) must agree to use medically approved contraception and must agree to continue using this method for at least three months after enrollment. Females of childbearing potential on hormonal contraception must be stable on hormonal contraception and must agree to use this method of contraception for at least three months after enrollment. Acceptable forms of medically approved contraception include the use of: oral contraceptives, injectable contraceptives (i.e., Depo-Provera), transdermal contraceptives or double barrier method.
• All females 40 years of age and under must have a negative urine pregnancy test prior to any vaccination in this trial. Please note that even those participants that have a history of tubal ligation or hysterectomy or are post menopausal (at least one year of no menses) must still have a negative urine pregnancy test prior to any vaccination in this trial.
• Physical examination must be normal, or abnormal findings must be judged not clinically significant for this patient population by the Physician Investigator.

You may not qualify if:

• Had physician-diagnosed influenza at any time during the past two years.
• Received an influenza vaccine 6 months preceding enrollment in the study.
• Received any other vaccine within 30 days before starting this study or plan to receive any vaccine during the 30 days after enrollment.
• Received immunoglobulin therapy or transfusion with blood or blood products within the previous three months.
• Have known chemical dependency liable to compromise immune function (e.g., alcoholism or illegal drug use not including nicotine or caffeine).
• Are allergic to eggs or egg products, contact lens solution, or have ever had a severe reaction to any vaccine.
• Have a history of hypersensitivity (allergy) to thimerosal or formaldehyde.
• Have chronic respiratory illnesses (clinically significant and/or on systemic immunosuppressive medications e.g., asthma, COPD, emphysema).
• Have had symptoms of an active acute respiratory or other active infections or illnesses in the past 72 hours.
• Have a temperature greater than or equal to 100.4 degrees F (38 degrees C) at enrollment.
• Known or suspected diseases of the immune system (i.e., rheumatoid arthritis, lupus erythematosis, lymphoma, HIV, etc.).
• Have active neurologic disorders (i.e., encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy).
• Prior history of Guillain-Barré Syndrome.
• Have underlying unstable (require frequent physician office visits, have required a medication change in the past 3 months and/or require frequent medication dose changes) chronic disease such as cardiovascular disease (i.e., uncontrolled hypertension, congestive heart failure, recent heart attack (within past 6 months), cardiomyopathy; diabetes mellitus, liver disease (i.e., hepatitis, cirrhosis), functional or anatomic asplenia, cancer (excluding skin and prostate cancer) or kidney disease.
• Have a history of hematologic malignancy.

Sponsors & Collaborators

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

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: January 1, 2008
• Last Updated: August 27, 2010

Record last verified: 2010-05

Locations

US (1)