NCT00973895

VRC 308: An Open-Label Phase I Study of the Safety and Immunogenicity of an Investigational H1 DNA Influenza Vaccine, VRC-FLUDNA057-00-VP, in Healthy Adults 18-70 Years Old

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing VRC-FLUDNA057-00-VP in Influenza A Virus, H1N1 Subtype in 20 participants. Completed in 3 September 2010.

Timeline

6 August 2009

Primary endpoint
3 September 2010

3 September 2010

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	6 August 2009
Primary completion	3 September 2010
Estimated completion	3 September 2010
Sites	1 location across United States

Drugs / interventions tested

• VRC-FLUDNA057-00-VP — full drug profile →

Conditions studied

• Influenza A Virus, H1N1 Subtype — all drugs for Influenza A Virus, H1N1 Subtype →
• Novel Swine-Origin — all drugs for Novel Swine-Origin →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with Influenza A Virus, H1N1 Subtype or Novel Swine-Origin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Vaccines are substances used to try to create resistance (or immunity) to a disease and to prevent an infection. Researchers are testing a new DNA vaccine designed for a new type of influenza, often referred to as swine flu. The DNA vaccine will instruct the body to make a particular kind of influenza protein that the immune system will be able to recognize.
* Researchers are interested in determining if the vaccine is safe and effective in humans, and would like to study the immune system's response to the vaccine. The vaccine will not give participants influenza; however, it may not be effective in preventing them from getting influenza at a later date.

Objectives:

* To evaluate the safety and tolerability of the VRC-FLUDNA057-00-VP influenza vaccine as administered to healthy adults.
* To evaluate antibody responses to the new influenza vaccine.

Eligibility:

\- Healthy adults between the ages of 18 and 70.

Design:

* Participants will have seven planned clinic visits during this study (enrollment day and study weeks 1, 4, 8, 9, 12, and 32).
* All participants will receive three injections of the test vaccine, given as individual doses on day 0, day 28, and day 56 of the study. The vaccine will be given in the upper arm muscle.
* Injections will be given using a needleless system that delivers the vaccine through the skin by using the pressure of carbon dioxide to inject the vaccine through the skin and into the muscle. Participants will remain at the National Institutes of Health (NIH) Clinical Center for at least 30 minutes after the injection to be monitored for any reaction.
* Participants will be asked to keep a 7-day diary card after each injection to record their physical reactions to the vaccine.
* Participants will be asked to return to the NIH Clinical Center as requested by researchers for additional blood tests and other procedures, as required by the study.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. New Vaccine Technologies to Combat Outbreak Situations.
   Rauch S, Jasny E, Schmidt KE, Petsch B. · · 2018 · cited 380× · PMID 30283434 · DOI 10.3389/fimmu.2018.01963
2. Next-generation influenza vaccines: opportunities and challenges.
   Wei CJ, Crank MC, Shiver J, Graham BS, et al · · 2020 · cited 256× · PMID 32060419 · DOI 10.1038/s41573-019-0056-x
3. Advances in gene-based vaccine platforms to address the COVID-19 pandemic.
   Pushparajah D, Jimenez S, Wong S, Alattas H, et al · · 2021 · cited 66× · PMID 33422546 · DOI 10.1016/j.addr.2021.01.003
4. Use of Hemagglutinin Stem Probes Demonstrate Prevalence of Broadly Reactive Group 1 Influenza Antibodies in Human Sera.
   Yassine HM, McTamney PM, Boyington JC, Ruckwardt TJ, et al · · 2018 · cited 39× · PMID 29872070 · DOI 10.1038/s41598-018-26538-7
5. Phase 1 study of pandemic H1 DNA vaccine in healthy adults.
   Crank MC, Gordon IJ, Yamshchikov GV, Sitar S, et al · · 2015 · cited 18× · PMID 25884189 · DOI 10.1371/journal.pone.0123969
6. Clinical Use of DNA Vaccines
   Liu L, Morrow M, Bagarazzi M. · · 2017