Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.
The primary objective of this study was to perform a variety of assays on blood, serum, nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A & B, live, cold-adapted (liquid formulation CAIV-T; Wyeth, Marietta, PA).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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.|
- Kinetics of the hemagglutination inhibition antibody response to each vaccine strain [ Time Frame: Day 0-28 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2001|
|Study Completion Date:||December 2001|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
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).
This was a randomized, open-label, placebo-controlled, outpatient study carried out in healthy adults 18 to < 65 years of age. The study was designed to evaluate the kinetics of the immune responses generated by each of the study products in order to determine the best sampling time for future studies. Subjects were randomized in a 1:1:1 ratio to receive a single dose of either CAIV-T, inactivated influenza virus vaccine (TIV), or placebo.
|United States, Connecticut|
|David M. Radin, MD|
|Stamford, Connecticut, United States, 06905|
|Principal Investigator:||Robert Walker, MD||MedImmune LLC|