Clinical trial NCT01522248: Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study
Official title: A Pilot Study to Examine the Early Cytokine Responses After Inactivated Influenza Vaccination in Adults 18-50.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Virus Vaccine
Keywords: influenza vaccine
cytokines
chemokines
symptoms
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine
timeFrame: 0 hours, 16 hours, 24 hours, 14 days
measure: Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine
timeFrame: 0 hours, 16 hours, 24 hours, 14 days
measure: Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine
timeFrame: 0 hours, 16 hours, 24 hours, 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Center for Immunization Research
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Kawsar Talaat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talaat KR, Halsey NA, Cox AB, Coles CL, Durbin AP, Ramakrishnan A, Bream JH. Rapid changes in serum cytokines and chemokines in response to inactivated influenza vaccination. Influenza Other Respir Viruses. 2018 Mar;12(2):202-210. doi: 10.1111/irv.12509. Epub 2018 Jan 4.