N/A
N=20
Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study
Influenza Virus Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT01522248 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine — 1.3; 1.4; 1.3; 6.9 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trivalent Inactivated Influenza vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine |
1.3; 1.4; 1.3; 6.9; 5.1; 1.2 | — |
| PRIMARY Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine |
14.7; 11.7; 13.4; 10.4; 11.9; 10.2 | — |
| PRIMARY Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine |
115; 149; 123; 488; 292; 127 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age between 18-50 years.
- Good general health as a result of review of medical history and medications.
- Willingness to participate in the study as evidenced by signing informed consent document.
- Available for the duration of the trial.
Exclusion Criteria
- Known to be pregnant.
- 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.
- Severe allergy to eggs or any component of the influenza vaccine
- Previous receipt of the 2011-2012 season influenza vaccine
- 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.
- History of receiving any investigational product within the past 30 days.
- Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- 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.
- Known immunodeficiency syndrome.
- 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.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Refusal to allow storage of samples for future research.
Data sourced from ClinicalTrials.gov (NCT01522248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.