Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
Type 1 Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
3 other identifiers
interventional
95
1 country
1
Brief Summary
Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought that type 1 interferon (a protein that helps the immune system fight viruses) will make flu vaccines more effective. This study will determine if type 1 interferon added to a specific flu vaccine will help the immune system of healthy adults fight off infection better than vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will attend 3 study visits and have a final follow-up study visit, email, or phone call about six months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed into the nose. Study procedures including blood samples and nasal washes (the inside of the nose is washed out) will be collected to evaluate immune system responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2007
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 16, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
November 18, 2008
CompletedJune 13, 2011
October 1, 2009
1 month
February 15, 2007
October 9, 2008
June 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels
14 days after immunization.
Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization
Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 28 after immunization, relative to pre-immunization levels.
28 days after immunization.
Secondary Outcomes (4)
Local and/or Systemic Solicited Symptoms After Intranasal Immunization.
0-7 days following immunization
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.
14 days after immunization.
Unsolicited Adverse Events After Intranasal Immunization
Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination.
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.
28 days after immunization
Other Outcomes (2)
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.
14 days after immunization
Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.
28 days after immunization
Study Arms (3)
Group 1: 0.6 ml of IVV
ACTIVE COMPARATOR30 subjects to receive 0.6 ml of inactivated influenza virus vaccine (IVV).
Group 3: 0.7 ml of IVV + 10M units of IFN
EXPERIMENTAL30 subjects to receive 0.7 ml of IVV containing 10M units of interferon (IFN).
Group 2: 0.6 ml of IVV + 1M unit of IFN
EXPERIMENTAL30 subjects to receive 0.6 ml of IVV containing 1M units of interferon (IFN).
Interventions
Commercially available trivalent inactivated influenza virus vaccine without or with 1 of 2 dosages of commercially available type 1 interferon administered once by nasal instillation. Dosages: 0.6 ml of IVV or 0.7 ml of IVV.
Commercially available lyophilized IFN; dosages 1 M unit (Mu) of IFN; 10 M units (Mu) of IFN.
Eligibility Criteria
You may qualify if:
- Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (e.g., barrier method, abstinence, and licensed hormonal methods) for at least 3 months after immunization.
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
You may not qualify if:
- Has a known allergy to eggs, chicken protein or other components of the vaccine.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is lactating, or has the intention to become pregnant within 3 months of receipt of vaccine.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids or other immunosuppressive or cytotoxic drugs.
- Has used any nasal or aerosol treatments in the past 2 weeks or likely to use any in the next 2 weeks.
- Has a diagnosis of hay fever or asthma.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in the study, or expects to receive an experimental agent during the 6-month study period.
- Is planning to enroll in another clinical trial at any time during the study period.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Couch, MD
- Organization
- Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 16, 2007
Study Start
March 1, 2007
Primary Completion
April 1, 2007
Study Completion
October 1, 2007
Last Updated
June 13, 2011
Results First Posted
November 18, 2008
Record last verified: 2009-10