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 | Completed Phase 1

• 2 other identifiers: 10000410-I-0004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Influenza; Healthy; Immunity; Preventive; Flu; HV; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety (local and systemic reactogenicity, lab tests, AEs)

Secondary Outcomes (1)

• Immunogenicity (cellular and humoral immune function assays)

Interventions

VRC-FLUDNA056-00VP BIOLOGICAL

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A SUBJECT MUST MEET ALL OF THE FOLLOWING CRITERIA:
• to 70 years old.
• Available for clinical follow-up through Week 27.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to complete the informed consent process.
• Willing to donate blood for sample storage to be used for future research.
• No evidence of previously undiagnosed clinically significant chronic diseases.
• Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \< 42 within the 56 days prior to enrollment.
• LABORATORY CRITERIA WITHIN 56 DAYS PRIOR TO ENROLLMENT:
• Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
• White blood cells (WBC) equal to 3,300-12,000 cells/mm(3)
• Differential either within institutional normal range or accompanied by site physician approval as a differential that is consistent with healthy volunteer status
• Total lymphocyte count greater than or equal to 800 cells/mm(3)
• Platelets equal to 125,000 - 500,000/mm(3)

You may not qualify if:

• A subject will be excluded if one or more of the following conditions apply:
• Women Specific:
• Breast-feeding or planning to become pregnant during the 27 weeks after enrollment in the study.
• Subject has received any of the following substances:
• Seasonal influenza TIV within the 12 weeks prior to enrollment.
• Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. \[With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not exclude study participation.\]
• Blood products within 112 days (16 weeks) prior to HIV screening
• Immunoglobulin within 56 days (8 weeks) prior to HIV screening
• Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration
• Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration
• Medically indicated subunit or killed vaccines (e.g., pneumococcal, or allergy treatment with antigen injections) within 14 days (2 weeks) of initial study vaccine administration
• Current anti-TB prophylaxis or therapy
• Subject has a history of any of the following clinically significant conditions:
• Contraindication to receiving an FDA approved current seasonal influenza vaccination (e.g., egg allergy).
• Serious reactions to vaccines that preclude receipt of study vaccinations as determined by investigator.

Sponsors & Collaborators

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

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Clinical Alliance for Research and Education

Annandale, Virginia, United States

Location

Related Publications (4)

• Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. doi: 10.1016/j.immuni.2005.12.005.

  PMID: 16413916 BACKGROUND

• Luke CJ, Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis. 2006 Jan;12(1):66-72. doi: 10.3201/eid1201.051147.

  PMID: 16494720 BACKGROUND

• Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009 Jul 31;58(RR-8):1-52.

  PMID: 19644442 BACKGROUND

• Ledgerwood JE, Hu Z, Costner P, Yamshchikov G, Enama ME, Plummer S, Hendel CS, Holman L, Larkin B, Gordon I, Bailer RT, Poretz DM, Sarwar U, Kabadi A, Koup R, Mascola JR, Graham BS; VRC 307 and VRC 309 Study Teams. Phase I clinical evaluation of seasonal influenza hemagglutinin (HA) DNA vaccine prime followed by trivalent influenza inactivated vaccine (IIV3) boost. Contemp Clin Trials. 2015 Sep;44:112-118. doi: 10.1016/j.cct.2015.08.006. Epub 2015 Aug 12.

  PMID: 26275339 DERIVED

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 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: October 8, 2009
• Primary Completion: September 3, 2010
• Study Completion: September 3, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-09-03

Locations

US (2)