2009 H1N1 Influenza Virus Clinical Trial
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
| Verified date | October 2010 |
| Source | University of Rochester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
Unlike most influenza viruses, the 2009 H1N1 virus has affected people between 5 and 40 years old more often than people 60 years old or older. It may be that older people have had greater exposure to previous strains of H1N1 influenza, and this previous exposure protects them from infection. This study will examine how older people respond to a version of the H1N1 virus vaccine that includes a live, noninfectious version of the virus.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - No prior history of infection with novel H1N1 virus or immunization with novel H1N1 vaccine documented by a laboratory - Female participants must not be capable of becoming pregnant or take steps to prevent pregnancy from 30 days before enrollment to 30 days after receiving the study vaccine - In good health, as determined by medical history and targeted physical examination - Able to understand and comply with the planned study procedures, including being available for all study visits Exclusion Criteria: - Pregnancy - Previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection - Immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months - Active neoplastic disease (excluding nonmelanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years. - Long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (greater than 800 mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to study enrollment (nasal and topical steroids are allowed) - Received immunoglobulin or another blood product within the 3 months prior to enrollment in this study - 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 - 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. - Has had an acute illness or an oral temperature greater than 99.9°F (37.7°C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated with symptoms resolved are eligible to enroll as long as treatment is completed and symptoms are resolved more than 3 days prior to enrollment. - Currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication), has received an experimental agent within 1 month prior to enrollment in this study, expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period - History of alcohol or drug abuse in the 5 years prior to enrollment - Has a known human immunodeficiency virus (HIV) or hepatitis B or C infection - Has a previous history of Guillain-Barré syndrome - Allergic to eggs or egg proteins, gentamicin, gelatin, or arginine or has experienced life-threatening reactions to previous influenza vaccination - Has any other condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Rochester Medical Center, Vaccine Research Unit | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University of Rochester | National Institutes of Health (NIH) |
United States,
Cutler J, Schleihauf E, Hatchette TF, Billard B, Watson-Creed G, Davidson R, Li Y, Bastien N, Sarwal S; Nova Scotia Human Swine Influenza Investigation Team. Investigation of the first cases of human-to-human infection with the new swine-origin influenza A (H1N1) virus in Canada. CMAJ. 2009 Aug 4;181(3-4):159-63. doi: 10.1503/cmaj.090859. Epub 2009 Jul 20. — View Citation
Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vaccine virus replication, defined as recovery of vaccine virus in cell culture on 1 or more days | Measured on Days 2, 5, and 7 | No | |
| Secondary | 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 | Measured at baseline and Day 28 | No | |
| Secondary | AUC of vaccine virus copy number assessed by quantitative polymerase chain reaction (PCR) | Measured at baseline and on Day 28 | No | |
| Secondary | Frequency and magnitude of serum hemagglutination inhibition (HAI), enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody response to vaccine | Measured at baseline and Day 28 | No | |
| Secondary | Frequency and magnitude of hemagglutinin-specific mucosal immunoglobulin A (IgA) response, assessed by ELISA on nasal secretions | Measured at baseline and Day 28 | No | |
| Secondary | Frequency of specific local and systemic symptoms occurring after vaccine | Measured until Day 180 | Yes | |
| Secondary | Development of antigen-specific T and B cells following vaccination as assessed by enzyme-linked immunosorbent spot (ELISPOT) assay | Measured at baseline and on Days 7 and 28 | No |