Effectiveness of early introduction of ten-valent pneumococcal conjugate vaccine (PCV-10) on reducing pneumococcal bacterial load in the nasopharynx among neonates.

2017 Fiscal Year Research-status Report

• Project/Area Number: 17K16272
• Research Institution: Nagasaki University
• Principal Investigator: ドバデル ビム 長崎大学, 熱帯医学・グローバルヘルス研究科, 助教 (80761113)
• Project Period (FY): 2017-04-01 – 2020-03-31
• Keywords: Pneumococcus / PCV-10 / multiple serotypes / bacterial load / children

Outline of Annual Research Achievements

We have conducted trainings to research nurses for data collection, data entry, and management in the hospital. One lab technician has been trained for specimen storage, lab data management and DNA extraction. We have installed a deep freezer (-40°C) in the lab.

We had meetings with the local collaborators (Doctors in the hospital and members of Nepal Paediatric Society) on the research site as well as online in Polycom. We decided to modify the research plan so as to get ethical approval from the Ethical Review Board of Nepal Health Research Council. We planned for the assessment of the impact of PCV-10 vaccine on bacterial load and multiple serotypes on children at the age of 6, and 10 weeks and 9 months when they come for PCV-10 vaccination in the hospital.

Current Status of Research Progress

2: Research has progressed on the whole more than it was originally planned.

Reason

Meetings with the local collaborators, training to the research nurses and lab technician in the hospital have been finished. Preparation of the lab for the specimen storage is completed.

Now, we need to apply for the Nepal Health Research Council for the ethical clearance to start the research project, along with the ethical clearance in the School of Tropical Medicine and Global Health, Nagasaki University. It took some time as we had to modify the original research plan, which needed to have many meetings.

Strategy for Future Research Activity

The followings are the plan to carryout the research:

* May-July, 2018: Ethical clearance in TMGH and Nepal Health Research Council, along with preparation of questionnaire in Epi Info, informed consent forms, Standard Operating Procedures for nasopharyngeal sample taking and storage.
*Aug, 2018-April, 2019: Enrollment of children, data and sample collection. The research progress will be monitored every month by checking the number of enrolments of children, completion of necessary documents, follow up of SOPs by the nurses and lab technician.
*May-Sep, 2019: Sample processing (DNA extraction, and serotyping and bacterial load determination) and data cleaning.
*Oct 2019-Mar 2020: Data-analysis, manuscript preparation and publication.

Causes of Carryover

I spent the budget systematically as planned, however, a small amount was left which I will use next year. The research site is in Nepal. This money will be used to buy some reagents that will be used for the lab procedures.