VRC 307: A Double-Blind, Randomized Phase I Study of the Safety and Immunogenicity of a Prime-Boost Schedule of the Investigational DNA Trivalent Influenza Vaccine, VRC-FLUDNA047-00-VP, Followed by the 2008/2009 Seasonal Influenza Trivalent Inactivat...
This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC)
First received: March 7, 2009
Last updated: June 22, 2010
Last verified: June 2010
- To evaluate the safety and tolerability of a prime-boost study regimen that includes the recombinant DNA vaccine followed by licensed 2008/2009 FluLaval(Registered Trademark) in adults ages 18-50 years and adults ages 51-70 years as compared with control groups that receive the licensed vaccine only.
- To evaluate whether the study participants in each age group receiving a prime-boost schedule have a greater frequency of H1 or H3 neutralizing antibodies compared with those of the same age group who received only the 2008/2009 trivalent influenza vaccine.
- To evaluate differences in antibody or T cell responses (quantity, quality, or durability) between the two groups.
- Participants ages 18 to 70 years of age who are available for clinic follow-up through Week 24 and who have no previously undiagnosed clinically significant chronic diseases. Participants will provide blood samples for further testing to determine eligibility. Females must not be or become pregnant during the study.
- Volunteers who have been immunized with the current season FDA-approved influenza vaccine (2008-2009), or who are being treated for tuberculosis may not participate.
- The study lasts for 24 weeks.
- Week 0: The first day of Week 0 (i.e., Day 0) is defined as the day of enrollment and first injection. Specific eligibility is reviewed. Participants will receive an injection of either the DNA vaccine VRC-FLUDNA047-00-VP (at 4 mg dosage) or a placebo.
- Week 4: All study participants will receive an injection of the trivalent seasonal influenza vaccine, according to the manufacturer's package insert directions.
- Participants will be given 7-day diary cards on which to record temperature and symptoms (e.g., muscle aches, headache, chills, nausea) and injection site reactions (e.g., pain, tenderness). Participants may also enter this information via the Internet. Presence of symptoms may require additional visits to the clinic.
- Participants will return to the clinic 2 weeks after each injection for the following procedures:
- Blood draws for further tests to determine the immune system's response to the vaccine(s) Clinical evaluations: vital signs and weight, examinations of the lymph nodes, and targeted physical exam on any visit if indicated by interim complaints or laboratory findings.
Drug: Flulaval (Registered) Seasonal Influenza Vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||VRC 307: A D/B Randomized Ph. I Study of Safety/Immunogenicity of a Prime-Boost Schedule of an Investigational DNA Influenza Vaccine, Followed by the Seasonal Influenza Trivalent Inactivated Vaccine (TIV), Compared to TIV Alone in Healthy Adults|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- safety (local and systemic reactogenicity, lab tests, AEs)
Secondary Outcome Measures:
- lmmunogenlcity (cellular and humoral immune function assays)
|Study Start Date:||March 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Intervention Details:Show Detailed Description
N/ADrug: Flulaval (Registered) Seasonal Influenza Vaccine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858611
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
Sponsors and Collaborators