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

2018 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 / colonization / non-vaccine serotypes / pneumococcal vaccines / bacterial load / children / Nepal

Outline of Annual Research Achievements

We have received the approval to conduct the research in Siddhi Memorial Hospital and use its laboratory to store clinical specimens. We have revised the research design and applied to the Nepal Health Research Council, Kathmandu Nepal for ethical approval. It is in final stage, which also approves the transfer of the 3,000 DNA and 3,000 RNA samples to Nagasaki from Nepal.

We have developed the data collection system in Open Data Kit in collaboration with London School of Hygiene and Tropical Medicine (LSHTM), London. We have prepared the barcode system to provide identity to the data collection forms, enrollment log, specimen storage log, and labeling to the specimens. Research assistants have been trained and necessary equipment and materials have been purchased.

Current Status of Research Progress

3: Progress in research has been slightly delayed.

Reason

It took time to get agreement with local co-investigators, and co-investigators in Nagasaki to finalize the research methodology. As this research is prospective study of young infants and involves of transfer of 3,000 DNA and 3,000 RNA samples, Nepalese research council asked clarification and additional documentations. It took time. The ethical application has been revised twice, now in final stage of approval. For ethical approval in TMGH; we are informed that expedite application may take one month to get approval.

We have received the permission to conduct research in the hospital and to use lab. We have purchased the necessary equipment and materials. Data collection system, barcode printing system, and laboratory are prepared and ready to use. Research assistants have been trained.

Strategy for Future Research Activity

We expect to receive the ethical approvals from both institutions (NHRC and TMGH) by 15th of June and we will start enrolling the children from 15th of July. We have already purchased the necessary equipment and materials to conduct the research that includes a barcode printer, barcode thermal labels, tablets for data entry, nasopharyngeal swabs, DNA extraction kits etc. The followings are the tentative schedule:
15th May 2019: Ethical approval from NHRC; 15th Jun 2019: Ethical approval from TMGH; 15th Jul 2019 - 14th Jan 2020: Enrolling babies; 15th Oct - 14th Feb 2020: DNA and RNA extraction; 15th Feb - 14th March 2020: Transfer of DNA and RNA samples to Nagasaki; 15th Mar - 14th May 2020: Testing of the DNA and RNA samples; 15th May 2020 -14th Sep 2020: Data analysis, report preparation