Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.
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|ClinicalTrials.gov Identifier: NCT00192309|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: CAIV-T Biological: TIV Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Placebo-Controlled Trial to Investigate the Kinetics of the Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Adults Aged 18 to <65 Years.|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||December 2001|
Experimental: Cold-adapted influenza vaccine (CAIVT)
A single intranasal dose of 10^7 fluorescent focus units.
Liquid CAIV-T vaccine for this study consisted of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Yamanashi/166/98 influenza virus strains. The reassortant vaccine strains were grown in specific pathogen-free (SPF) eggs and the allantoic fluid, which contained virus, was harvested, concentrated and purified. Each dose of CAIV-T used in this study was formulated to contain approximately 107 FFU of each of the 6:2 influenza reassortant vaccine strains.
Other Name: FluMist
Active Comparator: Trivalent inactivated vaccine (TIV)
A single dose of commercially available Flushield was administered intramuscularly.
TIV in this study consisted of Flushield™, manufactured by Wyeth Vaccines, Marietta, PA, USA. Each 0.5 mL dose contained no less than 15 ug of the hemagglutinin antigens from each of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 strains, making TIV in this study antigenically matched to the influenza strains contained in CAIV-T.
Other Name: Flushield
Placebo Comparator: Placebo
The 0.2 mL administered intranasally.
Placebo in this study consisted of physiological saline. The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
- Kinetics of the hemagglutination inhibition antibody response to each vaccine strain [ Time Frame: Day 0-28 ]The geometric mean titers for each strain between Day 0 and 28 were examined.
- Expression of IgA in nasal wash and saliva swab samples [ Time Frame: Days 0-28 ]Nasal wash and saliva swab IgA antibody titers were expressed as the ratio of specific to total IgA.
- Expression of B-cells in peripheral blood [ Time Frame: Days 0-28 ]The B-cell ELISPOT assays are designed to detect B-cells in the peripheral blood that are actively secreting influenza strain-specific IgG or IgA antibody.
- Number of CD3+ peripheral blood mononuclear cells secreting interferon gamma [ Time Frame: Days 0-28 ]The number of CD3+ peripheral blood mononuclear cells (PBMCs), i.e., T-cells, secreting IFN-γ prior to and after vaccination following in vitro stimulation of these cells using the IFN-γ ELISPOT assay.
- Number of subjects with local reactions [ Time Frame: Days 0-7 ]Local injection site reactions were collected from subjects in the TIV treatment group only.
- Number of subjects with systemic reactions [ Time Frame: Days 0-7 ]Each study subject collected prompted reactogenicity events on a diary card worksheet for 7 days (study days 0 - 6) following vaccination.
- Number of subjects with adverse events [ Time Frame: Days 0-7 ]An Adverse Event (or Adverse Experience, AE) was any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations occurring (in a human being) in a temporal relationship to the use of a WLV product, regardless of causal relationship.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192309
|United States, Connecticut|
|David M. Radin, MD|
|Stamford, Connecticut, United States, 06905|
|Principal Investigator:||Robert Walker, MD||MedImmune LLC|