Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Influenza Virus Vaccine

Treatments: Biological: Trivalent Inactivated Influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01522248

CIR 281

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Cohort 1

Active Comparator group

Description:

receives vaccine in morning. Blood drawn at 3, 7, 24, and 48 hours and 14 days after vaccination.

Treatment:

Biological: Trivalent Inactivated Influenza vaccine

Cohort 2

Active Comparator group

Description:

receives vaccine in evening, Blood drawn 16, 40 hours and 14 days after vaccination.

Treatment:

Biological: Trivalent Inactivated Influenza vaccine