CHAPTER II

THEORITICAL, CONCEPTUAL AND

OPERATIONAL BASIC OF THE STUDIES

This chapter represent the recap of the chosen literature if the study. It represents

the synthesis, gap and the conceptual framework of the studies.

Related Literature

This literature you must be read is related to dengvaxia, to able concept beneficial

and also its big avail in present, to preparation these studies.

According to the anonymous report, the (DOH) Department of Health finally gave

green light the first ever anti-dengue vaccine to be sold to the public. Named dengvaxia,

the breakthrough anti-dengue measure was developed by Sanofi Pasteur, a multinational

pharmaceutical company. According to anonymous reports, the big pharma player took

more than 20 years to develop and thoroughly test the vaccine and it finally got the nod

of the World Health Organization (WHO) to be distributed. Dengvaxiais a godsend to the

Philippines a country that deals with more than 200,000 cases of dengue fever on

average. It may spell good news not just to Filipinos but also other nationalities suffering

from dengue virus.

Based on Jillianne E. Castillo (2017).The Department of Health (DOH) has put the

Philippines dengue immunization program on hold until a proper evaluation is conducted,

says newly appointed Health Secretary Francisco Duque in press in 1st day of December

that analysed about released of dengvaxia . Dengvaxia, the first licensed dengue vaccine,

is meant to protect from all four strains of the life threatening mosquito-borne disease. It

is given to individuals 9 years old and above in three doses. As of November 2017 more

than 733,000 children in public school in the National Capital Region (NCR), Region 3

and Region 4A, which are areas that have the highest incidence of dengue, have been

given the dengue vaccine in accordance with the immunization program. The Department

of Health (DOH) is still collecting data on exactly how many of the students have or do

not have a history of illness prior to receiving its vaccine. At the press conference, Sec.

Doque said there have been no reported cases of severe dengue disease in those

vaccinated since the implementation of the program.

Based on the anonymous reporter and Mrs. Jilliane E. Castillo research the

dengvaxia have been release in public school that have estimate, 733,000 children in

National Capital Region (NCR) children age 9 years old and above are allow to be

vaccinated. And based on their research, the parents and guardian of the children that

are vaccinated are very thankful in this kind of medicine, because it is very helpful to

protect their children in this severe disease.

This statement are according to Maria Rosario Capeding et al. (2014) an estimated

100 million people have symptomatic dengue infection every year. This is the first report

of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. There aimed to assess

the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed

dengue in children. They did an observer-marked, randomised controlled, multicentre,

phase III trial in five countries in the Asia-Pacific region. Between June 3, and December
1,2011 ,healthy children aged 2-14 years old were randomly assigned (2:1), by computer-

generated permuted blocks of six with an interactive voice or web response system, to

receive three injections of a recombinant, live, attenuated, tetravalent dengue

vaccine(CYD-TDV), or placebo, at months 0,6,and 12. Randomisation was stratified by

age and site. Participants were followed up until month 25.Trial staff responsible for the

preparation and administration of injections were, unmarked to group allocation, but were

not included in the follow-up of the participants; allocation was concealed from the study

sponsor, investigators, and parents and guardians. Their primary objective was to assess

protective efficacy against symptomatic, virologically confirmed dengue, irrespective of

disease severity or serotype,that took place more than 28 days after the third injection.

The primary endpoint was for the lower bound of the 95% of vaccine efficacy to be greater

than 25%. Analysis was by intention to treat and per protocol.

According to Coudeville L et al. (2016) a tetravalent dengue vaccine demonstrated

its protective efficacy in two phase III efficacy studies. Results from these studies were

used to derivevaccination impact in the five Asian (Indonesia, Malaysia, Philippines,

Thailand, Vietnam) and the five Latin American countries (Brazil, Colombia, Honduras,

Mexico and Puerto Rico) participating in these trials. Vaccination impact was investigated

with an age structured, host-vector, serotype-specific compartmental model. Parameters

related to vaccine efficacy and levels of dengue transmission were estimated using data

collected during the phase III efficacy studies. Several vaccination programs, including

routine vaccination at different ages with and without large catch-up campaigns their

investigated. All vaccination programs explored translated into significant reductions in

dengue cases at the population level over the first 10 years following vaccine introduction
and beyond. The most efficient age for vaccination varied according to transmission

intensity and 9 years was close to the most efficient age across all setting. The

combination of routine vaccination and large catch-up campaigns was found to enable a

rapid reduction of dengue burden after vaccine introduction. Their analysis suggests that

dengue vaccination can significantly reduce the public health impact of dengue in

countries where the disease is endemic.

The literatures that are mentioned are all about dengvaxia. Based on our

observation the author Capeding, Coudeville et al. are discussed more about the phase

III vaccine efficacy trial candidate of the dengue vaccine and the levels of dengue

transmission their estimated using the data collection during the phase III efficacy studies.

According to Scott B. Halstead (2017) they said that during a large scale clinical

efficacy trial of the Sanofi Pasteur live attenuated tetravalent dengue vaccine

(Dengvaxia), features of hospitalizes disease accompanying dengue infections in placebo

recipients were closely similar to those in vaccinated children.

However, the age specific hospitalization curves for these two populations differed.

The curve for children vaccinated at ages 2-16 years closely resembled that 1981 age

specific hospitalization rate curve, for Cuban children infected with DENV 2 who were

sensitized by a prior DENV 1 infection. The corresponding age specific hospitalization

curve for placebos, experiencing heterotypic secondary dengue infections peaked at age,

9- features support the conclusion that antibody dependent enhanced (ADF) dengue

disease occurred in seronegatives who were sensitized by vaccine. As hospitalizations

continue to occur in all age groups dengvaxia consumers should be warned that
sensitized vaccinated seronegatives will experience enhanced dengue disease into the

foreseeable future.

According to our research allergic patient should not use dengue vaccine or

dengvaxia, it because there are active substances or any of the other ingredients of this

dengvaxia that are listed in description that has developed an allergic reaction after prior

Administration of dengvaxia. There are some signs of allergic reaction, including itchy

rash, shortness of breath and swelling of the face and tongue, suffering from mild to high

fever or acute disease. Pregnant or breastfeeding women must not give this medicine

even those woman that think they are pregnant or planning to have a baby, they should

ask the physician, pharmacist or nurses for advice before using or receiving Dengvaxia.

Based on Scott B. Halstead there are some children that are not allow to use this

vaccine, like the seronegative or the person who had not affected by dengue. And based

on our research in a 2nd paragraph in this page, allergic patient should not use dengue

vaccine although pregnant women, who are planning to have a baby, should ask first for

physician, pharmacist or nurses.

Related Studies

The following studies will be contributed to improve the concepts writing about the

Dengvaxia to be prepared and aware for this.

World Health Organization severe dengue is a mosquito-burne viral disease that

has rapidly spread in all regions.

 According to Shepard Ds et al. (2016),”The global economic burden of dengue a

systematic analysis.” They used the latest dengue incidence estimate from the Institute

for Health Metrics and Evaluation Global Burden of Disease study 2013 almost 58.40

million symptomatic dengue virus infection and it rich out 24 million- 122 million including

13,586 fatal cases. Our country are one of 141 countries: that suffered in this current

issues the severed problem that should give our attention.

This statement are from Fact sheet (2017) according to them dengue virus is

transmitted by female mosquitoes. Severe dengue also known as Dengue Haemorrhagic

Fever. In year 1950’s dengue recognized during the dengue mostly effect Asian and Latin

American countries and has become a leading cause of hospitalization and death among

the children in these regions.

Based on Scott B. Halstead there are some children that are not allow to use this

vaccine, like the seronegative or the person who had not affected by dengue. And based

on our research in a 2nd paragraph in this page, allergic patient should not use dengue

vaccine although pregnant women, who are planning to have a baby, should ask first for

physician, pharmacist or nurses. Based on Capeding M.R, Tran N.H et al. (2014)

“Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in

Asia- a phrase 3 randomised, observes-masked, placebo controlled trial’. According to

them an estimated 100 million people have symptomatic dengue infection every year.

This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine.

We aimed to assess the efficacy of the CYD dengue vaccine againt symptomatic

virologically comfirmed dengue in children in age 2 to 14 years old.

 According to Coudeville L, Baurin N, et al. (2016) “Potential impact of dengue

vaccination insights from two large scale phase III trials with a tetravalent dengue

vaccine”.A tetravalent dengue vaccine demonstrated its protective efficacy in two phase

III efficacy studies. Results from these studies, were used to derive vaccination impact in

the five asian .

The two studies that are mentioned has a significant related in current studies. Its

the same they focus the phrase III efficacy trial. The different of the first study is more on

Clinical efficacy and the safety of a novel tetravalent dengue vaccine in healthy of the

children, while the current studies are based on the Potential impact of dengue

vaccination from Dengvaxia.

According to Maria Aguilar et al. (2016), “The risk behind Dengvaxia

recommendation”. According to them nearly 4 billion people are at risk of dengue and

around 400 million infections are estimated to occur every year worldwide. Because four

anti-genically related but distinct serotypes cause severe and fatal outcomes, a

tetravalent vaccine is needed to protect against the huge burden of dengue disease.

Tina G. Santos on Philippine Daily Inquirer (2017) “ WHO denies recommending

use of Dengvaxia “ she discuss about the World Health Organization (WHO) denied that

it recommended to the Philippines and other countries to use Dengvaxia ,the world first

dengue vaccine for their immunization programs. In a statement, WHO said such a

recommendation was not included in its position paper released in July last year. “Who’s

position on the dengue vaccine was published in July 2016, based on recommendations

of the strategic group of experts on [immunization] which met and published preliminary

advice in mid-April 2016,” WHO said .”The WHO position paper did not include a
recommendation to countries to introduce the dengue vaccine into their national

immunization programs. Rather , WHO outlined a series of consideration national

governments should take into account in deciding whether introduce the vaccine, based

on a review of available data at the time, along with possible risks”, it said.

Their current study are different, because the first they discuss about the risk of

dengvaxia about this recommendation, serotypes cause severe and fatal cases

outcomes, and they need to protect against the huge burden of dengue diseases, while

the second she discuss about the WHO’s denied recommending to use of dengvaxia

medicine(vaccine) in the Philippines and other countries.

Synthesis of the Study

This study are related through pertaining of Dengvaxia and this recommendation.

The other study they discuss about dengue disease, and the issues of dengvaxia

vaccination.

Anonymous reporter and Castillo, research the dengvaxia have been release in

public school that have estimate, 733,000 children in National Capital Region (NCR)

children age 9 years old and above are allow to be vaccinated. And based on their

research, the parents and guardian of the children that are vaccinated are very thankful

in this kind of medicine, because it is very helpful to protect their children in this severe

disease.
 Capeding, Coudeville et al. they discussed about the phase III vaccine efficacy

trial candidate of the dengue vaccine and the levels of dengue transmission their

estimated using the data collection during the phase III efficacy studies.

Halstead, there are some children that are not allow to use this vaccine, like the

seronegative or the person who had not affected by dengue. And based on our research

in a 2nd paragraph in this page, allergic patient should not use dengue vaccine although

pregnant women, who are planning to have a baby, should ask first for physician,

pharmacist or nurses.

Fact sheet, Shepard Ds et al. the responding effect of dengue virus in the country

and they need to refine the awareness and preparedness of people about tis current

issues. They also analyse the dengue virus infection and the total fatal cases, and they

discuss the dengue virus, causes and the death among the children.

Capading, Coudeville et al. according to them they estimated 100 million people

have symptomatic dengue infection every year. And the impact of dengue vaccination

from two large scale phase III trials with a tetravalent dengue vaccine demonstrated its

protective efficacy in two phase III efficacy studies. Its results from these studies was

need to derive vaccination impact in the five Asian (Indonesia, Malaysia, Thailand,

Vietnam, Philippines and Latin America.

Aguilar, Santos they discuss about the dengvaxia risk and they denied to

recommend in the Philippines and the other country to use dengvaxia medicine. The risk

of Dengvaxia recommendation, this serotypes cause severe and fatal cases outcomes,
and they need to protect against the huge burden of dengue disease, and World Health

Organization (WHO) denied recommending to use of dengvaxia medicine (vaccine).

Gap

This study aimed to determine the preparedness of Barcelonians about the

Dengvaxia Vaccine to their children.

All studies have been made for the researchers to have an idea regarding to the

Dengvaxia, from the content of related literature and related studies. There were no

general studies conducted on the preparedness of the Barcelonian of this Dengvaxia

vaccination.

This study is conducted to how identify the preparedness of Barcelonian about the

Dengvaxia Medicine.

Conceptual Framework
 This conceptual framework of the study are based on what are the causes of

Dengvaxia to the children, why are Sanofi Pasteur recommend this vaccine. How does it

affects to the children had inject. All the feedback that is related to the program, based on

the result of the study.

1. What are the causes of

Dengvaxia to the children?

2. Why are Sanofi Pasteur

recommend this vaccine?

3. How does it affects to the

children had inject?

Figure 1. Conceptual Framework

PREPAREDNESS OF BARCELONIANS ABOUT DENGVAXIA MEDICINE

ROAN JOY E. DELLOMAS

DINAH FLORALDE

LEONILA FOMBUENA

MARCH 16, 2018