Influenza Virus Vaccine
Conditions
Keywords
influenza vaccine, cytokines, chemokines, symptoms
Brief summary
Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. This pilot study will help us to determine at what time points we should look.
Interventions
BIOLOGICALTrivalent Inactivated Influenza vaccine
0.5 ml IM once only
Sponsors
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 18-50 years. 2. Good general health as a result of review of medical history and medications. 3. Willingness to participate in the study as evidenced by signing informed consent document. 4. Available for the duration of the trial.
Exclusion criteria
1. Known to be pregnant. 2. Medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol. 3. Severe allergy to eggs or any component of the influenza vaccine 4. Previous receipt of the 2011-2012 season influenza vaccine 5. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol. 6. History of receiving any investigational product within the past 30 days. 7. Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. 8. History of a severe allergic reaction or anaphylaxis. 9. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia. 10. Known immunodeficiency syndrome. 11. Use of chronic (≥14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone \>10 mg/ day) or immunosuppressive drugs within 30 days of starting this study. 12. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study. 13. History of a surgical splenectomy. 14. Receipt of blood products within the past 6 months. 15. Refusal to allow storage of samples for future research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | 0 hours, 16 hours, 24 hours, 14 days | This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days. |
| Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | 0 hours, 16 hours, 24 hours, 14 days | This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days. |
| Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | 0 hours, 16 hours, 24 hours, 14 days | This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Received vaccine in morning. Blood drawn at 3, 7, 24 and 48 hours and 14 days after vaccination. Trivalent Inactivated Influenza vaccine 0.5ml IM once only | 10 |
| Cohort 2 Received vaccine in evening. Blood drawn 16 and 40 hours and 14 days after vaccination. Trivalent Inactivated Influenza vaccine 0.5 ml IM once only | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 38.1 years STANDARD_DEVIATION 9.4 | 35.8 years STANDARD_DEVIATION 10.1 | 36.9 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 8 / 10 | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Time frame: 0 hours, 16 hours, 24 hours, 14 days
Population: Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | IFN gamma | 1.3 pg/mL | Standard Deviation 1.7 |
| Cohort 1 | Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | IFN-gamma | 6.9 pg/mL | Standard Deviation 3 |
| Cohort 2 | Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | IFN gamma | 1.4 pg/mL | Standard Deviation 2.2 |
| Cohort 2 | Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | IFN-gamma | 5.1 pg/mL | Standard Deviation 5 |
| Cohort 1 & 2 | Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | IFN gamma | 1.3 pg/mL | Standard Deviation 1.9 |
| Cohort 1 & 2 | Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine | IFN-gamma | 1.2 pg/mL | Standard Deviation 0.8 |
Primary
Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Time frame: 0 hours, 16 hours, 24 hours, 14 days
Population: Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | IP-10 | 115 pg/mL | Standard Deviation 74 |
| Cohort 1 | Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | IP- 10 | 488 pg/mL | Standard Deviation 365 |
| Cohort 2 | Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | IP-10 | 149 pg/mL | Standard Deviation 194 |
| Cohort 2 | Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | IP- 10 | 292 pg/mL | Standard Deviation 309 |
| Cohort 1 & 2 | Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | IP- 10 | 127 pg/mL | Standard Deviation 71 |
| Cohort 1 & 2 | Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine | IP-10 | 123 pg/mL | Standard Deviation 146 |
Primary
Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
Time frame: 0 hours, 16 hours, 24 hours, 14 days
Population: Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | IL- 8 | 14.7 pg/mL | Standard Deviation 7.7 |
| Cohort 1 | Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | IL-8 | 10.4 pg/mL | Standard Deviation 6.1 |
| Cohort 2 | Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | IL- 8 | 11.7 pg/mL | Standard Deviation 5.5 |
| Cohort 2 | Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | IL-8 | 11.9 pg/mL | Standard Deviation 4.6 |
| Cohort 1 & 2 | Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | IL- 8 | 13.4 pg/mL | Standard Deviation 6.9 |
| Cohort 1 & 2 | Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine | IL-8 | 10.2 pg/mL | Standard Deviation 4.1 |