Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Aged 18-32 years, inclusive
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
History of egg allergy or is allergic to other components of the vaccine
A women who is pregnant or breastfeeding or intends to get pregnant during the study period between enrollment and 30 days following vaccination
Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy or 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 and topical steroids allowed)
Received immunoglobulin or another 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 in this study or plans to receive another vaccine within the next 28 days (or 56 days for the vaccine naive recipients)
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 degrees F(37.7 C)within 3 days prior to enrollment or vaccination. Subject who has acute illness that was treated, symptoms resolved are eligible to enroll as long as treatment is complete and symptoms resolved > 3 dyas 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 prior to enrollment in this study, or intends to donate blood during this period.
Subject has any condition that would, in the opinion of the site 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 history of alcohol or drug abuse in the 5 years prior to 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
live monovalent H1N1 vaccine	A/California/07/09 live monovalent H1N1 vaccine	A/California/07/09 live monovalent H1N1 vaccine 0.2 given intranasally, 2 doses given 28 days apart

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Shed Virus	28 days post vaccine 1 and 28 days vaccine 2	number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.

Secondary Outcome Measures

Name	Time	Method
Mean Difference Between Cycle Time and Detection Threshold	day 10 post vaccine 1	The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.