Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine

Influenza Clinical Trial

Official title:

Evaluation of the Infectivity, Replication, and Immunogenicity of Live, Attenuated A/California/07/09 (nH1N1) Influenza Vaccine in Serosusceptible Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023776
• Other study ID #: URMC 09-006
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: November 17, 2015
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.

Description:

By looking at the immune response before and after vaccine, we hope to understand the factors that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 32 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• A/California/07/09 live monovalent H1N1 vaccine
0.1mL per nares intranasally, second identical dose given 28 days after first vaccine

Locations

Country	Name	City	State
United States	Vaccine Research Unit Room 3-5000	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Shed Virus	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.	28 days post vaccine 1 and 28 days vaccine 2	No
Secondary	Mean Difference Between Cycle Time and Detection Threshold	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.	day 10 post vaccine 1	No