Valencerina, Djan Kurvie R.

BSN IV-D4

Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue

Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded
Phase 1 Clinical Trial

Dengue (DENV) is the worlds most common human arboviral infection. It is estimated that
390 million people are infected annually; 96 million have clinically apparent infections, with
fever, headache, body aches, nausea, and rash, and 22 000 die from infection [1]. The 4
serotypes of DENV (DENV-14) are transmitted by Aedes mosquitoes. Development of a safe
vaccine that provides durable protection from dengue disease is a global health priority. A
recombinant live attenuated tetravalent dengue vaccine (TDV) candidate was developed by
genetic engineering on the basis of the attenuated DENV-2 PDK-53 strain.
The study enrolled 72 flavivirus-naive healthy adults in a phase 1 double-blinded,
randomized, placebocontrolled dose-escalation trial (low and high dose) of a live attenuated
recombinant tetravalent dengue vaccine candidate (TDV) given in 2 doses 90 days apart.
Volunteers were followed for safety, vaccine component viremia, and development of
neutralizing antibodies to the 4 DENV serotypes. Results showed the majority of adverse events
were mild, with no vaccine-related serious adverse events. Vaccinees reported injection site pain
(52% vs 17%) and erythema (73% vs 25%) more frequently than placebo recipients. Low levels
of TDV-serotype 2 (TDV-2), TDV-3, and TDV-4 viremia were observed after the first but not second
administration of vaccine. Overall seroconversion rates and geometric mean neutralization titers
after 2 doses were 84.2% and 54.1, respectively, for DENV serotype 1 (DENV-1); 92.1% and
292.8, respectively, for DENV-2; 86.8% and 32.3, respectively, for DENV-3; and 71.1% and 15.0,
respectively, for DENV-4. More than 90.0% of high-dose recipients had trivalent or broader
responses. They concluded that TDV was generally well tolerated, induced trivalent or broader
neutralizing antibodies to DENV in most flavivirus-naive vaccinees, and is undergoing further
development.
Implication to Nursing Practice: We as nurses should advocate such immunizations so that
the people could be protected from acquiring DENV. Implication to Nursing Education: This topic
could be discussed in pharmacology to know what are the specific actions of this drug and how it
can help defend against DENV Implication to Nursing Research: The study could be done here in
the Philippines if how well do the patients who receive this drug tolerate the vaccine.

Reference:
George, S. L., Wong, M. A., Dube, T. T., Boroughs, K. L., Stovall, J. L., Luy, B. E., & ...
Stinchcomb, D. T. (2015). Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue
Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical
Trial. Journal Of Infectious Diseases, 212(7), 1032-1041. doi:10.1093/infdis/jiv179