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VRC 309: A Multi-Center, Open-Label, Randomized Phase I Study of an Investigational Influenza DNA Vaccine Followed by 2009/2010 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to Two Injections of TIV in Adults 45-70 Years

NCT00995982 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-02

No results posted yet for this study

Summary

Background:

* Vaccines are substances used to try to create resistance or immunity to a disease and to prevent an infection. Investigators are looking into improved ways to give and test the results of different kinds of vaccines.
* Researchers are interested in comparing the results of an experimental DNA vaccine for the prevention of seasonal influenza against a standard FDA-approved vaccine for the prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by the FDA for preventing the flu.

Objectives:

\- To test the safety and immune response of an experimental DNA vaccine for seasonal influenza, compared to the standard vaccine for seasonal influenza.

Eligibility:

\- Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza vaccine.

Design:

* Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two telephone follow-up contacts (within 2 days after each injection) during this study.
* Participants will be divided into two groups: one group will receive two standard (TIV) flu vaccine injections given using a needle and syringe, while the other will receive the DNA flu vaccine using a needleless injection system followed by the TIV vaccine.
* The vaccine injections for both groups will be given approximately 3 weeks apart,
* Clinic staff will observe participants for at least 30 minutes after each vaccination. One to two days after each injection, participants must telephone the clinic staff, and for 7 days after the vaccination participants will keep a diary card to report on possible side effects.
* During study visits, blood samples will be collected for research purposes to test for responses to vaccine.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

VRC-FLUDNA056-00VP

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-08
Primary Completion
2010-09-03
Completion
2010-09-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995982 on ClinicalTrials.gov