Immune Response Following Seasonal Influenza Vaccination
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Licensed seasonal influenza vaccine
Sponsored by
About this trial
This is an interventional diagnostic trial for Influenza focused on measuring Seasonal
Eligibility Criteria
Inclusion Criteria:
- Men and women 18 to 50 years of age, inclusive
- Good general health status, as determined by the Investigator
- Adequate venous access for repeated phlebotomies
- Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Bilirubin may be Grade 2 if associated with no1mal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant (e.g. vigorous exercise or Gilbert's syndrome)
- Negative drug and alcohol screen at Screening and pre-dose on Day I
- For women of child bearing potential, negative pregnancy test
- Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex,monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the Fluzone Intramuscular Quadrivalent vaccine dose.
Exclusion Criteria:
- Pregnant, possibly pregnant, or lactating women
- Body mass index> 35.0 kg/m2
- Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening
Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
- Daily symptoms
- Daily use of short acting beta 2 agonists
- Use of inhaled steroids or theophylline
- Use of pulse systemic steroids
- Emergency care or hospitalization related to asthma or other chronic lung disease
- Systemic steroids for asthma exacerbation
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
- History of coronary artery disease, arrhythmia, or congestive heart failure
- Clinically significant ECG abnormality
- Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or pre-dose on Day I
- History of anaphylaxis or angioedema
- Known allergy to any of the ingredients in the vaccine formulation including egg allergy
- History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
- Previous nasal surgery or nasal cauterization
- Any symptoms of upper respiratory infection or temperature> 38°C within 3 days before Day I
- Significant nasal congestion or rhinorrhea as assessed by the investigator.
- Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
- Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
- Use of statin medication within 30 days before Day I (including atorvastatin, fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)
- Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
- Receipt of any IP within 30 days before Day 1
- Receipt of any vaccine within 30 days before Day I
- Receipt of intranasal vaccine within 90 days before Day I
- Receipt of any influenza vaccine within 6 months before Day I
- Any change in medication for a chronic medical condition within 30 days before Day I
- Past regular use or current use of intranasal illicit drugs or any regular use of illicit drugs by any other route.
- Use of tobacco products or electronic cigarettes within 30 days before Day l. Any other smoking products including marijuana will be excluded.
- Any medical, psychiatric, or social condition or any occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including immunogenicity), or a subject's ability to give informed consent
Sites / Locations
- Optimal Health Research
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open label
Arm Description
Licensed seasonal influenza vaccine, intramuscular
Outcomes
Primary Outcome Measures
HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain
To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.
Secondary Outcome Measures
Antibody Response to Divergent Influenza Strains
l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine
Cellular Immune Response
To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine
Mucosal Influenza Antibody Response
To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine
Full Information
NCT ID
NCT03163342
First Posted
May 19, 2017
Last Updated
April 4, 2019
Sponsor
Altimmune, Inc.
Collaborators
Optimal Health Research
1. Study Identification
Unique Protocol Identification Number
NCT03163342
Brief Title
Immune Response Following Seasonal Influenza Vaccination
Official Title
Extent and Durability of Immune Response Following Seasonal Influenza Vaccination in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altimmune, Inc.
Collaborators
Optimal Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
Detailed Description
Subjects will be screened within 28 days prior to enrollment into the study. After qualifying for the study subjects will visit the clinical unit on Day l and will have pre-dose blood samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs) immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then be given the vaccine.
Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and 181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and alcohol testing), vital signs, 12-lead electrocardiogram and physical examination.
Adverse events (AEs) will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Seasonal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label
Arm Type
Other
Arm Description
Licensed seasonal influenza vaccine, intramuscular
Intervention Type
Biological
Intervention Name(s)
Licensed seasonal influenza vaccine
Intervention Description
20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Primary Outcome Measure Information:
Title
HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain
Description
To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.
Time Frame
Day 29 after vaccine
Secondary Outcome Measure Information:
Title
Antibody Response to Divergent Influenza Strains
Description
l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine
Time Frame
Day 29 after vaccine
Title
Cellular Immune Response
Description
To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine
Time Frame
Day 8 after vaccine
Title
Mucosal Influenza Antibody Response
Description
To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine
Time Frame
Day 29 after vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women 18 to 50 years of age, inclusive
Good general health status, as determined by the Investigator
Adequate venous access for repeated phlebotomies
Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Bilirubin may be Grade 2 if associated with no1mal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant (e.g. vigorous exercise or Gilbert's syndrome)
Negative drug and alcohol screen at Screening and pre-dose on Day I
For women of child bearing potential, negative pregnancy test
Willingness to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex,monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the Fluzone Intramuscular Quadrivalent vaccine dose.
Exclusion Criteria:
Pregnant, possibly pregnant, or lactating women
Body mass index> 35.0 kg/m2
Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening
Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
Daily symptoms
Daily use of short acting beta 2 agonists
Use of inhaled steroids or theophylline
Use of pulse systemic steroids
Emergency care or hospitalization related to asthma or other chronic lung disease
Systemic steroids for asthma exacerbation
History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
History of coronary artery disease, arrhythmia, or congestive heart failure
Clinically significant ECG abnormality
Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or pre-dose on Day I
History of anaphylaxis or angioedema
Known allergy to any of the ingredients in the vaccine formulation including egg allergy
History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
Previous nasal surgery or nasal cauterization
Any symptoms of upper respiratory infection or temperature> 38°C within 3 days before Day I
Significant nasal congestion or rhinorrhea as assessed by the investigator.
Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
Use of statin medication within 30 days before Day I (including atorvastatin, fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin)
Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
Receipt of any IP within 30 days before Day 1
Receipt of any vaccine within 30 days before Day I
Receipt of intranasal vaccine within 90 days before Day I
Receipt of any influenza vaccine within 6 months before Day I
Any change in medication for a chronic medical condition within 30 days before Day I
Past regular use or current use of intranasal illicit drugs or any regular use of illicit drugs by any other route.
Use of tobacco products or electronic cigarettes within 30 days before Day l. Any other smoking products including marijuana will be excluded.
Any medical, psychiatric, or social condition or any occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including immunogenicity), or a subject's ability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Bart, MD
Organizational Affiliation
Optimal Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optimal Health Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Immune Response Following Seasonal Influenza Vaccination
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