Dengvaxia Incident: Impact on Vaccine Hesitancy among Parents in Iloilo

Province

A Research Proposal

In partial fulfillment of the requirements for the course

NCM111
Nursing Research 1

Submitted by:
Caguimabay, Christine Claire
Escartin, Eunice
Lavente, Chelsea Nicole
Mendez, John Menvel
BSN III - D

Submitted to:
Rodenie A. Olete
Faculty / Clinical Instructor
v1.0
 I. Introduction
Background & Rationale
Statement of the Problem
Significance of the Study
Scope and Delimitation

II. Review of Related Literature

Conceptual Literature
International
Local
Research Literature
International
Local
Synthesis of Literature Review

III. Methodology
Rationale of the Study Design
Study Settings and Population
Criteria of the Study Population
Recruitment Process
Instrumentation
Plans for Data Processing and Analysis
Data Analysis
Workplan Schedule & Timelines
Ethical / Biosafety Clearance
Budgetary Requirements
 I. Introduction
Background and Rationale
Philippines is in the midst of a national epidemic of dengue fever, a tropical
disease that causes flu-like symptoms and can be life-threatening, particularly to
children. According to Khunsha, et.al (2018) Through vaccination campaigns of DOH,
Dengvaxia vaccine was launched and more than 800,000 school children were
involved. Dengvaxia were subject to controversy due to Sanofi’s analysis that the
vaccine will reduce the risk of severe dengue and hospitalization to those who have a
prior history of dengue infection and can get protective benefits of the vaccine. The
safety of the vaccine is more apparent to those who have a history of dengue infection.
Discovering that those children who have no history of dengue infection before they
acquire the vaccine has a higher risk of severe dengue and hospitalization. This incident
led to the suspension of distribution, but due to the fear of the parents because of the
incident, parents are hesitant to vaccinate their children.
In 2015, dengvaxia as anti- dengue vaccine was licensed and approved for use
by the government (Manlapaz, J. et al., 2019). Although there is a strong anti-
vaccination sentiment among minority parents, the proportion identified as vaccine-
hesitant can rise; even parents who vaccinate their child may have substantial
immunization concerns and fears (Dubé E. et al., 2015). Year 2016 dengvaxia vaccine
causing panic and fear among parents all experience has given doubt to the
government's immunization initiatives, but the lessons gained from experience have
shown that every family is resilient in the midst of the controversy (Manlapaz, J. et al.,
2019). Parents experience fear and emotional trauma due to their children’s lives. It is
an important step to evolve effective strategies to have a good understanding of both
the causes and of the contexts leading to vaccine hesitancy and refusal.
Parents who are receiving the dengue vaccine to their children claim that the
vaccine raises their children's risk of other serious diseases. Several studies have shown
that parental decisions to use or delay immunization for their children are nuanced and
multi-dimensional, including contextual determinants, vaccine services-related
determinants, and individual determinants, such as the experience, attitudes and beliefs
of parents, or sociodemographic features (Dubé E. et al., 2015). It is an important step
to establish successful strategies, the first essential step is to have a clear understanding
of both the causes and the contexts that contribute to hesitancy and rejection of
vaccines.
 This study needs to assess the impact of Dengvaxia vaccine hesitancy among
parents in Iloilo Province. Specifically, we intend to explore the different reasons why
parents are hesitant to use the vaccine and review the preventive practices to be used.
Statement of the Problem
This research aims to understand determinants of vaccine hesitancy among
parents in Iloilo Province:
● socioeconomic,
● educational background, etc.
Major Research Question:
How did the dengvaxia-related deaths in 2016 affect the rate of vaccination refusal
in Iloilo Province?
Minor Questions:
1. Why are parents hesitant to have their children vaccinated after the Dengvaxia
incident?
2. What are the dengue preventive practices that parents are using?
3. How does the Dengvaxia incident affect vaccine hesitancy among parents of
Iloilo Province?
4. What is the perception of parents to the dengvaxia incident?

Aims and Objectives of the Study

This study aims to determine the factors that influence vaccine hesitancy among
parents of Iloilo Province. And to improve the understanding of vaccine hesitancy
among the parents of Iloilo Province.
Explore vaccination history that resulted in adverse effects among children.
Primary
● Factors that affects the vaccine hesitancy
● Explore demographic, psychosocial variables, and assess vaccine hesitancy-
related parental participation.
Secondary
● Perception on the Dengvaxia vaccine.
● Decision-making towards the vaccination.
● Confidence and trust

Hypothesis Formulation
How did the dengvaxia-related deaths in 2016 affect the rate of vaccination refusal in
Iloilo Province?

• Null (H0): There is no association between underlying factors influenced by

the Dengvaxia incident and level of vaccine hesitancy.

• Non-Directional (H1): There is an association between underlying factors

influenced by the Dengvaxia incident and level of vaccine hesitancy.

• Directional H2: As the perception towards Dengvaxia, decision making and

confidence and trust improves, the vaccine hesitancy lessens.

Research Framework
The primary basis of the association between the Dengvaxia incident and the attitude,
beliefs and vaccine hesitancy among the parents was adapted from the Health Belief
Model (researchgate). The Dengvaxia incident resulted in these factors psychosocial
factors such as knowledge, behavior, and feelings, their perception on the Dengvaxia
vaccine, their decision making and their confidence and trust. These factors led to the
vaccine hesitancy among parents in Iloilo Province

Definition of Terms
1. Dengvaxia- vaccine used to help protect against dengue disease.(Dengvaxia |
European Medicines Agency)
2. Vaccine- any preparation used as a preventive inoculation to confer immunity
against a specific disease, usually employing an innocuous form of the disease
 agent, as killed or weakened bacteria or viruses, to stimulate antibody
production. (dictionary.com)
3. Hesitancy- a lack of willingness or desire to do or accept something.
(Merriam Webster)
4. Efficacy- The effectiveness and its ability to do what it is supposed to.
(collinsdictionary.com)
Significance of the Study
This study should play a vital role in removing the myths and skepticism that
resulted from controversy of Dengvaxia in the past. And to the improved nursing
professional practice by promoting and maintaining public health by helping to avoid a
decrease in vaccination rates and by ensuring that potential vaccinations are
appropriate. In addition to improved awareness and understanding of key vaccine
designs and safety principles can help promote adequate use and perceptions of
vaccines, increase trust in vaccination research and help minimize vaccine hesitation.
Scope and Coverage
This study is important to educate the public not only through this research, but
also through mass outreach
● Awareness campaign, and conferences
● Removing the myths and skepticism.
● Promoting and maintaining public health
● Improve nursing professional practice.
Limitations of the Study
This research is focused on the parent’s hesitancy about the Dengvaxia incident and
improves the understanding and knowledge about the vaccine.
This study aims to assess the impact of Dengvaxia Vaccine Hesitancy among Parents
of Iloilo Province. This research shall utilize non- experimental research on impact of
vaccine hesitancy of parents in Iloilo Province through a survey and descriptive in
gathering data.
The potential confounding factors that may interfere are the following:
● Parental Obligations
● Social Desirability bias
● Limited Number of Respondents

II. Review of Related Literature

International Literature
Conceptual Literature
Therefore, vaccine-hesitant parents differ from non-parents in their understanding of
the risks of vaccination, the risk of side effects and the advantages of safety. Similarly,
a lack of motivation to vaccinate is associated with the perceived risk of vaccinations.
(Manlapaz, J. et al., 2019). These themes are as follows: drives of involvement,
emotional imbalance, controls of injury, and the aftermath phenomenon (Manlapaz, J.
et al., 2019). According to Khunsha et. al (2019) In view of the size and complexity of
this issue, both government and non-government health care authorities need to work
together to recover the confidence of parents. As a global body, the WHO should play
its role in promoting and maintaining public health by helping to avoid a decrease in
vaccination rates and by ensuring that potential vaccinations are appropriate.
Research Literature
Dengvaxia has now become a subject of controversy following Sanofi's latest
report, which shows that the vaccine can put certain people at increased risk of being
more serious. The overall risk of extreme dengue and hospitalization has been
decreased due to this disease. They detected Dengvaxia. For those who were previously
infected with dengue, however this protection was more apparent. Sanofi has recently
found that people who have never had a dengue infection before are at a significantly
higher risk than if they were sick.
Local Literature
Conceptual Literature
The acceptability of the dengue vaccine was based on the previous vaccination
experience of parents. Parents with good experience with government vaccines have
approved the vaccine. Some parents objected to the vaccine because their children had
an adverse reaction or were scared of the injection. Parents who resisted immunization
also requested more information on the safety of vaccines and the benefits, particularly
when other vaccines had previous reactions. Those who refuse tend to know about
vaccinations only among other vaccines and refuse dengue vaccines. Since it was new,
it is presumed that the vaccine has not been effective.
Research Literature
Emotionally, and physically, parents have encountered difficult times,
particularly at the height of the controversy, as they concentrate on their children's
health and well-being. The parents had to suffer the mental pain they had to face
because of the fear of their children's lives. All of the experience has raised concerns
about the government's immunization policies, but experience has shown the strength
of each family amid the controversy.
Synthesis of Literature Review
For parents who have been vaccinated with the dengvaxia vaccine, the causes
of vaccine hesitancy are causing many children to lose their lives. The authorities are
reluctant to take responsibility for further trials of a safe vaccine that could help
Filipinos minimize dengue in the Philippines.
Several studies have shown that parental decisions to use or delay immunization
for their children are nuanced and multi-dimensional, including contextual
determinants, vaccine services-related determinants, and individual determinants, such
as the experience, attitudes and beliefs of parents, or sociodemographic features.
Although there is a strong anti-vaccination sentiment among minority parents, the
proportion identified as vaccine-hesitant can rise; even parents who vaccinate their
child may have substantial immunization concerns and fears. To establish successful
strategies, a first and essential step is to have a clear understanding of both the causes
and the contexts that contribute to hesitancy and rejection of vaccines. (Dubé E. et al.,
2015)

III. Research Methodology

Research Design
The quantitative research was used in collecting data through online surveys that will
gather and analyze the hesitancy of Dengvaxia vaccine. Overall target is in the
Philippines, specifying the parents in Iloilo Province. Non-Probability sampling
doesn't have a list and more convenience to select the participants. This study needs a
larger population and convenience sampling will be an appropriate method in
conducting online surveys among parents in Iloilo Province .
This study will be using descriptive correlational design in a survey to gather all the
data towards Dengvaxia vaccine.

Population
The target population of the study are the parents of Iloilo, Province. The study
settings are Health Centers of Oton, Igbaras, Leon and Maasin. This study is a baseline
assessment of underlying factors that affect vaccine hesitancy because of that, in order
we decided to contribute 100 survey participants. Having 100 participants would not
represent the entire Iloilo Province therefore, it is part of limitations that is research
intrusion enough, this will provide baseline data.
Criteria of the Study Population
Inclusion
The qualifications to determine the sample
1. The demographic location of the parents must be in Iloilo Province
Exclusion
1. Those parents who are not living in Iloilo Province.

Recruitment Process
Using the convenience sampling method, only 100 parents will be chosen from different
municipalities in Iloilo Province .
In conducting the study the researcher will hand out the written permission to allow the
study and survey questionnaires among selected municipalities.
In distributing the survey questionnaire the health center of each municipality will help
in giving the questionnaire to the parents including the consent provided with their
mobile number and messenger that is accessible for them.
Instrumentation
The researchers will be utilizing a self-reporting method. The questionnaire there will
be open ended questions
● The questionnaire will measure:
➔ Knowledge
➔ Confidence and Trust
➔ Perception in Dengvaxia
➔ Decision making
● 20 minutes of every questionnaire each question will spend 30 seconds to
answer.
Plans for Data Processing and Analysis
Data collected by the researchers will be safely maintained by the principal investigator
in a virus and malware-free flash drive and in Google Drive for backup in case of
failure.
Data Analysis
The quantitative data gathered will be analyzed using survey questionnaires. This will
help the understanding regarding the Dengvaxia vaccine in Iloilo Province
The descriptive correlational design in a survey to gather all the data towards Dengvaxia
vaccine.
Descriptive Statistics:
1. Frequency Distribution
2. Mean/ General Average
3. Standard Deviation
4. Test of Goodness of Fit
Inferential Statistics
1. One Way ANOVA
2. Pearson Coefficient Correlation
Workplan Schedule & Timelines

Task Week 1 Week 2 Week 3 Week 4

Study Plan

Alloted for
contacting the
participants

Distribution of
survey
questionnaires and
data collection

Printing of final
manuscript

Ethical / Biosafety Clearance

Informed consent to the disclosure of their information to the researchers will
be obtained prior to the distribution of survey questionnaires to the sample participants.
Researchers will clarify the purpose of the analysis, the data collection process
thoroughly to the respondents, and will be assured that information being revealed by
them and the total data collected will be treated with utmost confidentiality and will
only be used for research purposes.
Budgetary Requirements
Time, effort, collaboration, and resources will be shared in designing the questionnaire
by each member of the research team.

BUDGET PURPOSE

Php 5000.00 Load allowance for internet connectivity

Php 500.00 Printing of the final manuscript

Php 2000.00 Advisory fee for 2 semesters from thesis proposal to

manuscript

References:
● Manlapaz, J., San Pedro, M., Santos, E. R., Silva, J. A., Soriano, P. R., Sta.
Maria, A. L., Sy, Ma. C., Tan, I. A., & Umali, G. E. (2019). Dengvaxia
Phenomenon: Lived Experiences of Parents with Dengvaxia-vaccinated
Children. Annals of Tropical Medicine and Health, Vol. 22 (11B).
http://doi.org/10.36295/ASRO.2019.221149
● Khunsha, F., & Syed, N. I. (2018). Dengvaxia controversy: impact on vaccine
hesitancy. The University of Edinburgh, 8(2): 020312.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214489/
● Dubé, E., Vivion M., & MacDonald N. (2014). Vaccine hesitancy, vaccine
refusal and the anti-vaccine movement: influence, impact and implications.
Expert Review of Vaccines, 99-117.
https://www.tandfonline.com/doi/full/10.1586/14760584.2015.964212
● Dayrit, M.M., Mendoza, R.U. & Valenzuela, S.A. (2020). The importance of
effective risk communication and transparency: lessons from the dengue
 vaccine controversy in the Philippines. Journal of Public Health Policy, 252-
267 https://doi.org/10.1057/s41271-020-00232-3
● Laksanawati, I.S., Valido, E.M., & Utarini, A. (2018). Acceptability of the
dengue vaccination among parents in urban poor communities of Quezon City,
Philippines before and after vaccine suspension. BMC Research, 661 (2018).
https://doi.org/10.1186/s13104-018-3766-y
● MacDonald, N. E., Butler, R., & Dubé E. (2017). Addressing barriers to vaccine
acceptance: an overview. Expert Review of Vaccines, 218-224. DOI:
10.1080/21645515.2017.1394533
● Williams S. E. (2014). What are the factors that contribute to parental vaccine-
hesitancy and what can we do about it? Human Vaccines &
Immunotherapeutics, 2584-2596. https://doi.org/10.4161/hv.28596
● Flores-Romo, L. & Zaidi, M. B. (2020). The Growing Threat of Vaccine
Resistance: a Global Crisis. Viral Infections, 122-134.
https://doi.org/10.1007/s40506-020-00219-4
● Dayan G. H., Gailhardou S., Jezorwski J., Saville M., Skipetrova A., & Van der
Vliet D. (2016). Safety Overview of a Recombinant Live-Attenuated
Tetravalent Dengue Vaccine: Pooled Analysis of Data from 18 Clinical Trials.
Neglected Tropical Disease, 10(7): e0004821. DOI:
10.1371/journal.pntd.0004821
● Iftikhar, S., Nasar, S., & Rashid, N., (2019). Dengue proteins with their role in
pathogenesis, and strategies for developing an effective anti‐dengue treatment.
Journal of Medical Virology, 941-995. https://doi.org/10.1002/jmv.25646
● The Health Belief Model
● https://www.researchgate.net/figure/The-Health-Belief-
Model_fig2_295839499
● Dengvaxia
● (Dengvaxia | European Medicines Agency)
● Refusal
● https://www.collinsdictionary.com/dictionary/english/refusal
● Vaccine
● https://www.dictionary.com/browse/vaccine
● Hesitancy
● https://www.merriam-webster.com/dictionary/hesitant.
● Acceptability
● https://www.yourdictionary.com/acceptability