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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
31
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.
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.
David M. Radin, MD
Stamford, Connecticut, United States
Kinetics of the hemagglutination inhibition antibody response to each vaccine strain
The geometric mean titers for each strain between Day 0 and 28 were examined.
Time frame: Day 0-28
Expression of IgA in nasal wash and saliva swab samples
Nasal wash and saliva swab IgA antibody titers were expressed as the ratio of specific to total IgA.
Time frame: Days 0-28
Expression of B-cells in peripheral blood
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.
Time frame: Days 0-28
Number of CD3+ peripheral blood mononuclear cells secreting interferon gamma
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.
Time frame: Days 0-28
Number of subjects with local reactions
Local injection site reactions were collected from subjects in the TIV treatment group only.
Time frame: Days 0-7
Number of subjects with systemic reactions
Each study subject collected prompted reactogenicity events on a diary card worksheet for 7 days (study days 0 - 6) following vaccination.
Time frame: Days 0-7
Number of subjects with adverse events
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: Days 0-7