Influenza Clinical Trial
Official title:
Type 1 Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | October 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection. - Has a history of alcohol or drug abuse in the last 5 years. - Has a history of Guillain-Barre syndrome. - Has received the 2006-2007 formulation influenza vaccine by injection or by nose drops (fall of 2006 or since). - Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Primary | 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. | No |
Secondary | Local and/or Systemic Solicited Symptoms After Intranasal Immunization. | Number of participants (frequency) reporting solicited (systematically collected on a Memory Aid) reactogenicity events of any severity and number reporting severe occurrences. | 0-7 days following immunization | Yes |
Secondary | Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) 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 14 days after immunization, relative to pre-immunization levels. | 14 days after immunization. | No |
Secondary | Unsolicited Adverse Events After Intranasal Immunization | Number of subjects (frequency) with spontaneous reports of Adverse Events of any severity and severe or higher severity, during the 28 days after vaccination regardless of relatedness. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term. | Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination. | Yes |
Secondary | Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) 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 28 days after immunization, relative to pre-immunization levels. | 28 days after immunization | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |