Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 107

Inclusion Criteria

Aged 18-32 years, or 60 years and older
No history of Novel H1N1 virus or vaccine
Female not able to bear children or not pregnant and agrees to practice effective birth control
Female negative pregnancy test
Good Health
Ability to understand and comply with protocol
Provided Informed Consent

Exclusion Criteria

Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
Previous history of vaccination with A/New Jersey/76 vaccine (for subjects 60 & older
History of egg allergy or is allergic to other components of the vaccine
Women who are pregnant or breastfeeding or intends to get pregnant during the study period between enrollment & 30 days following vaccination
Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy/radiation therapy in the preceding 36 months
Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. "Active" is defined as treatment within the past 5 years.
Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal & topical steroids allowed)
Received immunoglobulin or other blood product within 3 months prior to enrollment in this study
Subject has received an inactivated vaccine within 2 weeks or a live vaccine within 4 weeks prior to enrollment or plans to receive another vaccine within the next 28 days
Subject has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. Those conditions include chronic conditions recognized as risk factors for influenza complications or as contraindicated for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment
Subject has an acute illness or an oral temperature greater then 99.9 F(37.7 C)within 3 days of enrollment or vaccination. Subject who has acute illness that was treated, symptoms resolved are eligible to enroll as long as treatment is complete & symptoms resolved > 3 days prior to enrollment.
Subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month of enrollment in this study, or intends to donate blood during this period.
Subject has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
Subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or are receiving psychiatric drugs. Subjects who are receiving a single anti-depressant drug & are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study.
Subject has a history of alcohol or drug abuse in the 5 years of enrollment.
Subject has known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
Subject has a previous history of Guillain-Barre syndrome within 6 weeks of receipt of influenza vaccine
Subject has any condition that the principal investigator (PI) believes may interfere with the successful completion of the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inactivated H1N1 Vaccine	Inactivated H1N1 vaccine	Subject will recieve 0.5 mL IM injection of Inactivated H1N1 vaccine

Primary Outcome Measures

Name	Time	Method
Determination of Immune Response to Vaccination.	28 days	Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination

Secondary Outcome Measures

Name	Time	Method
Assessment of the Reactogenicity Events Post Vaccination.	7 days	Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination