Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza Virus Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1

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

Group Type ACTIVE_COMPARATOR

Trivalent Inactivated Influenza vaccine

Intervention Type BIOLOGICAL

0.5 ml IM once only

Cohort 2

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

Group Type ACTIVE_COMPARATOR

Trivalent Inactivated Influenza vaccine

Intervention Type BIOLOGICAL

0.5 ml IM once only

Interventions

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Trivalent Inactivated Influenza vaccine

0.5 ml IM once only

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes