Influenza
Conditions
Keywords
Seasonal
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.
Interventions
BIOLOGICALLicensed seasonal influenza vaccine
20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Sponsors
Optimal Health Research
Altimmune, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women 18 to 50 years of age, inclusive 2. Good general health status, as determined by the Investigator 3. Adequate venous access for repeated phlebotomies 4. 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) 5. Negative drug and alcohol screen at Screening and pre-dose on Day I 6. For women of child bearing potential, negative pregnancy test 7. 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
1. Pregnant, possibly pregnant, or lactating women 2. Body mass index\> 35.0 kg/m2 3. Positive results for HIV, hepatitis B vims, or hepatitis C virus at Screening 4. 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 5. History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range) 6. History of coronary artery disease, arrhythmia, or congestive heart failure 7. Clinically significant ECG abnormality 8. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg) at Screening or pre-dose on Day I 9. History of anaphylaxis or angioedema 10. Known allergy to any of the ingredients in the vaccine formulation including egg allergy 11. History of chronic rhinitis, nasal septal defect,cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration 12. Previous nasal surgery or nasal cauterization 13. Any symptoms of upper respiratory infection or temperature\> 38°C within 3 days before Day I 14. Significant nasal congestion or rhinorrhea as assessed by the investigator. 15. 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 16. 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 17. Use of statin medication within 30 days before Day I (including atorvastatin, fluvastatin,lovastatin, pravastatin, rosuvastatin, simvastatin, pitavastatin) 18. Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1 19. Receipt of any IP within 30 days before Day 1 20. Receipt of any vaccine within 30 days before Day I 21. Receipt of intranasal vaccine within 90 days before Day I 22. Receipt of any influenza vaccine within 6 months before Day I 23. Any change in medication for a chronic medical condition within 30 days before Day I 24. Past regular use or current use of intranasal illicit drugs or any regular use of illicit drugs by any other route. 25. Use of tobacco products or electronic cigarettes within 30 days before Day l. Any other smoking products including marijuana will be excluded. 26. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain | Day 29 after vaccine | 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
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to Divergent Influenza Strains | Day 29 after vaccine | l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine |
| Cellular Immune Response | Day 8 after vaccine | To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine |
| Mucosal Influenza Antibody Response | Day 29 after vaccine | To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Licensed seasonal influenza vaccine, intramuscular
Licensed seasonal influenza vaccine: 20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 34.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: Day 29 after vaccine
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluZone | HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain | 293.4 Geometric Mean Titer |
Secondary
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
Time frame: Day 29 after vaccine
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluZone | Antibody Response to Divergent Influenza Strains | A/Brisbane/59/2007 (H1 strain) | 12.3 GMT |
| FluZone | Antibody Response to Divergent Influenza Strains | A/New Jersey/76 (H1 strain) | 37.3 GMT |
| FluZone | Antibody Response to Divergent Influenza Strains | A/Saint-Petersburg/61/2015 (H1 strain) | 40.7 GMT |
| FluZone | Antibody Response to Divergent Influenza Strains | A/Vietnam/1203/2004XPR8 (H5 strain) | 9.3 GMT |
Secondary
Cellular Immune Response
To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine
Time frame: Day 8 after vaccine
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluZone | Cellular Immune Response | 37.1 GMT |
Secondary
Mucosal Influenza Antibody Response
To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine
Time frame: Day 29 after vaccine
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FluZone | Mucosal Influenza Antibody Response | 1.8 GMT |