Influenza, Human Clinical Trial
Official title:
A Single-centre, Randomised, Observer-blind, Active Comparator-controlled, Superiority Trial of the Immune Response to Six-monthly Versus Annual Standard Dose Inactivated Trivalent Influenza Vaccination in the Elderly
TROPICS1 is a randomized, observer-blind, active comparator-controlled, single-center, Phase
IV trial in 200 participants aged ≥65 years. The control group will receive a standard dose
licensed trivalent inactivated influenza vaccine at day 1, and an active-comparator
(Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group
will receive the same influenza vaccine at day 1 and day 180. Endpoints are immunological,
and include measures of haemagglutination-inhibition (HI) titres, micro-neutralisation titres
and cell-mediated immunity at 4 time points after the initial vaccination up to Day 360. The
primary hypothesis is that participants receiving an influenza booster at day 180 will
achieve superior influenza seroprotection (HI titre ≥1:40) at day 208, compared to controls.
The World Health Organization (WHO) estimates the global annual burden from seasonal
influenza as 1 billion infections, with 3-5 million severe cases and 300,000-500,000 deaths.
The pattern and impact of these infections varies considerably with climate. In temperate
countries, influenza epidemics characteristically occur during the cold winter months, while
in sub-tropical countries, they coincide with the rainy seasons. Closer to the equator,
influenza virus activity is more complex. In Singapore, biannual epidemics are usual, but
with continuous transmission year-round. Bi-annual epidemics, tri-annual epidemics and year
round virus activity have also been described in other tropical countries, from Indonesia and
Malaysia to Peru and Mexico.
There is no published data reporting year-round influenza vaccine effectiveness in the
elderly from countries with continuous influenza virus activity. Despite numerous studies
worldwide exploring the HI antibody response to influenza vaccination, the majority of these
do not continue follow up beyond seroconversion (21-28 days). However, of the few available,
HI antibody titres declined following influenza vaccination in the elderly, such that within
6-12 months geometric mean titres approached pre-vaccination levels. With biannual epidemics
and year-round transmission in tropical regions, year-round seroprotection may be important
to reduce influenza infections in this environment. A six-monthly vaccination cycle would
correspond with the decline in vaccine-induced seroprotection in the elderly, and the
6-monthly periodicity of outbreaks in Singapore and other tropical countries.
n/a
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