tetano
Editor, Senior Moderator
Trials. 2017 Feb 10;18(1):67. doi: 10.1186/s13063-017-1808-8.
[h=1]The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial.[/h] Young B[SUP]1,[/SUP][SUP]2[/SUP], Sadarangani S[SUP]3,[/SUP][SUP]4[/SUP], Yew HS[SUP]3[/SUP], Yung CF[SUP]5[/SUP], Leo YS[SUP]3,[/SUP][SUP]4,[/SUP][SUP]6[/SUP], Chen MI[SUP]3,[/SUP][SUP]6[/SUP], Wilder-Smith A[SUP]3,[/SUP][SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore.
[h=4]METHODS/DESIGN:[/h] This is a single-centre, randomised, observer-blind, active-comparator controlled, parallel-group, phase IV trial in 200 adults aged 65 years or older. Study participants will be assigned to one of two groups in a 1:1 ratio and followed for 1 year, with five scheduled visits. The control group will receive IIV3 at day 1, and an active comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive IIV3 containing the same strains at day 1 and day 180. Endpoints are immunological, and include measures of HI titres, microneutralisation titres (MN) and cell-mediated immunity from first vaccination up to day 360.
[h=4]DISCUSSION:[/h] If superiority of 6-monthly influenza vaccination is demonstrated, this study could form the basis for a larger clinical trial with influenza infection as the primary endpoint.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov, ID: NCT02655874 . Registered on 12 January 2016.
[h=4]KEYWORDS:[/h] Antibody persistence; Haemagglutination inhibition; Influenza; Older people; Tropics; Vaccine
PMID: 28183326 DOI: 10.1186/s13063-017-1808-8
[PubMed - in process]
[h=1]The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial.[/h] Young B[SUP]1,[/SUP][SUP]2[/SUP], Sadarangani S[SUP]3,[/SUP][SUP]4[/SUP], Yew HS[SUP]3[/SUP], Yung CF[SUP]5[/SUP], Leo YS[SUP]3,[/SUP][SUP]4,[/SUP][SUP]6[/SUP], Chen MI[SUP]3,[/SUP][SUP]6[/SUP], Wilder-Smith A[SUP]3,[/SUP][SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore.
[h=4]METHODS/DESIGN:[/h] This is a single-centre, randomised, observer-blind, active-comparator controlled, parallel-group, phase IV trial in 200 adults aged 65 years or older. Study participants will be assigned to one of two groups in a 1:1 ratio and followed for 1 year, with five scheduled visits. The control group will receive IIV3 at day 1, and an active comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive IIV3 containing the same strains at day 1 and day 180. Endpoints are immunological, and include measures of HI titres, microneutralisation titres (MN) and cell-mediated immunity from first vaccination up to day 360.
[h=4]DISCUSSION:[/h] If superiority of 6-monthly influenza vaccination is demonstrated, this study could form the basis for a larger clinical trial with influenza infection as the primary endpoint.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov, ID: NCT02655874 . Registered on 12 January 2016.
[h=4]KEYWORDS:[/h] Antibody persistence; Haemagglutination inhibition; Influenza; Older people; Tropics; Vaccine
PMID: 28183326 DOI: 10.1186/s13063-017-1808-8
[PubMed - in process]