Effects of Age on Response to the 2009 H1N1 Virus Vaccine
2009 H1N1 Influenza Virus
Biological: 2009 H1N1 Virus Vaccine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Assessment of the Effect of Age on the Immunological and Virological Response to a Live Attenuated Influenza Vaccine for the 2009 H1N1 Virus|
- Vaccine virus replication, defined as recovery of vaccine virus in cell culture on 1 or more days [ Time Frame: Measured on Days 2, 5, and 7 ] [ Designated as safety issue: No ]
- Area under the curve (AUC) of live vaccine virus shedding, calculated by determination of 50% tissue culture infectious dose (TCID50) on Madin Darby canine kidney (MDCK) cells at 33ºC [ Time Frame: Measured at baseline and Day 28 ] [ Designated as safety issue: No ]
- AUC of vaccine virus copy number assessed by quantitative polymerase chain reaction (PCR) [ Time Frame: Measured at baseline and on Day 28 ] [ Designated as safety issue: No ]
- Frequency and magnitude of serum hemagglutination inhibition (HAI), enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody response to vaccine [ Time Frame: Measured at baseline and Day 28 ] [ Designated as safety issue: No ]
- Frequency and magnitude of hemagglutinin-specific mucosal immunoglobulin A (IgA) response, assessed by ELISA on nasal secretions [ Time Frame: Measured at baseline and Day 28 ] [ Designated as safety issue: No ]
- Frequency of specific local and systemic symptoms occurring after vaccine [ Time Frame: Measured until Day 180 ] [ Designated as safety issue: Yes ]
- Development of antigen-specific T and B cells following vaccination as assessed by enzyme-linked immunosorbent spot (ELISPOT) assay [ Time Frame: Measured at baseline and on Days 7 and 28 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: 2009 H1N1 Vaccine
Participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
Biological: 2009 H1N1 Virus Vaccine
Single 0.2 mL dose of live monovalent vaccine, delivered through nasal spray
Other Name: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Unlike most influenza viruses, the 2009 H1N1 virus affects many individuals between 5 and 40 years old, but very few 60 years old or older. It is not completely understood why, but scientists believe it may be because older people may have been exposed to other H1N1 viruses in their lives. H1N1 viruses were common until 1957, when they were eclipsed by H2N2 viruses.
In order to test susceptibility to the 2009 H1N1 virus, this study will examine how often people older than 60 get infected by the 2009 H1N1 live attenuated influenza vaccine (LAIV). The LAIV is made from a live virus that has been weakened, so the ability of the immune system to combat this weakened form is likely to mimic its ability to combat the normal form. Additionally, this study will examine how LAIVs work in older people; inactivated virus vaccines are used more often than LAIVs in older people, so little is known of LAIV's effects on this population.
Participation in this study will last 6 months. Participants will be people older than 60, divided into equal groups of people between the ages of 60 and 70 and people older than 70. Both groups will receive one dose of LAIV for 2009 H1N1 vaccine.
There will be six study visits, occurring at baseline and 2, 5, 7, 28, and 180 days after vaccination. Nasal wicks and throat swabs will be taken on Days 2, 5, and 7; a nasal wick alone will be taken at baseline and on Day 28. Blood samples will be taken at baseline and on Days 7 and 28. Participants will undergo physical exams at each visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055184
|United States, New York|
|University of Rochester Medical Center, Vaccine Research Unit|
|Rochester, New York, United States, 14642|
|Principal Investigator:||John Treanor, MD||University of Rochester|