Status:
COMPLETED
H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Background:\<TAB\> \- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections....
Detailed Description
VRC 315 STUDY: A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or with Monov...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A subject must meet all of the following criteria:
- 18 to 60 years old.
- Available for clinic visits for up to 28 weeks after enrollment.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Willing to donate blood for sample storage to be used for future research.
- In good general health without clinically significant medical history.
- Received a current seasonal influenza vaccine at least 2 weeks before enrollment.
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment.
- Laboratory Criteria within 56 days prior to enrollment:
- Hemoglobin within institutional normal limits
- White blood cells (WBC) and differential either within institutional normal range or accompanied by site physician approval
- Total lymphocyte count greater than or equal to 800 cells/mm3
- Platelets = 125,000 500,000/mm3
- Alanine aminotransferase (ALT) less than or equal to 1.25 x upper limit of normal (ULN)
- Serum creatinine less than or equal to .1 x ULN based on the institutional normal range
- Criteria applicable to women of childbearing potential:
- Negative human chorionic gonadotropin ( \<=-HCG) pregnancy test (urine or serum) on day of enrollment
- Agree to use an effective means of birth control from 21 days prior to enrollment through 4 weeks after the second study vaccination
- EXCLUSION CRITERIA:
- A subject will be excluded if one or more of the following conditions apply. Women Specific:
- Breast-feeding or planning to become pregnant while participating in the study
- Subject has received any of the following substances:
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to initial study vaccine administration
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2 weeks of initial study vaccine administration unless approved by the study Principal Investigator (PI)
- Allergy treatment with antigen injections, unless on maintenance schedule
- Current anti-TB prophylaxis or therapy
- Previous H7 avian influenza investigational vaccine
- Subject has a history of any of the following clinically significant conditions:
- Contraindication to receiving an FDA-approved current seasonal influenza vaccination including hypersensitivity to eggs
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
- Hereditary angioedema, acquired angioedema, or idiopathic forms of Angioedema
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Hypertension that is not well controlled
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study
- Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- Type 1 hypersensitivity reaction to aminoglycoside antibiotics
- Guillain-Barr(SqrRoot)(Copyright) Syndrome
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent
Exclusion
Key Trial Info
Start Date :
July 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02206464
Start Date
July 29 2014
End Date
January 7 2016
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892