Descriptive Review of Safety, Reactogenicity and Immunogenicity of Dengue Vaccine Clinical Trials, 2003 –2013
- Author:
Jelitha Ramachanderam
;
Nirmalatiban Parthiban
;
Nyanamalar Sivapalan
;
Cabriz
- Publication Type:Journal Article
- Keywords:
Dengue;
Dengue vaccine;
safety;
Immunogenicity;
live attenuated tetravalent dengue vaccine;
Malaysia;
Review
- MeSH:
Dengue Vaccines;
Dengue
- From:
The Medical Journal of Malaysia
2015;70(2):67-75
- CountryMalaysia
- Language:English
-
Abstract:
Dengue vaccine development has been one of the strategies
to reduce dengue incidence in the world alongside with
other horizontal interventions such as vector control and the
transgenic mosquito programmes. The objective of this
paper is to evaluate the safety, reactogenicity and
immunogenicity of dengue vaccine clinical trials for the last
ten years systematically through a descriptive review. This
paper discusses safety issues like adverse events, systemic
adverse reactions, injection site reactions, viraemia,
morbidity and mortality as well as immunogenicity which
measures effectiveness through mean geometric titre and
seropositive rates. Adverse events were seen to range from
0% to 28.3%. Immunogenicity was noted to increase post 1st
and 2nd dose and decrease post 3rd dose. The
seropositivity at baseline ranged between 53.1% and 97.8%
at post 3rd dose, and it was 88.5% for at least four serotypes.
The dengue vaccine studies that were reviewed were shown
to be relatively safe with low reactogenicity, however the
immunogenicity was unequal and waning. The
immunogenicity waned post 3rd dose showing a decrease in
all serotypes of varying degrees although the seropositivity,
on average, at post 3rd dose was 97.8%. It can be concluded
that dengue vaccine development would require further
studies on its unequal and waning immunogenicity, which
could result in a more severe form of dengue following wild
infection, during re-immunisation, especially if there is
variation in the circulating virus.
- Full text:P020150724523963037591.pdf
