Effectiveness of Latest Dengue Vaccine by utilizing in vivo models By Team 01: Arham, ThuThu, Jenny, Charmaine, Jayden INTRODUCTION Dengue virus (DENV) is a significant global health concern - necessitating the development of effective vaccines. After finding success in in vivo drug testing, we desire to share our findings in order to proceed with human clinical trials. DISCOVERY PHASE & PRECLINICAL Preclinical testing: Involves experiments to gather data on vaccines safety and efficacy Only once the pre clinical is done the vaccine can be approved for human clinical trials Biological effects in mouse to predict the treatment outcome in humans. Identified intellectual properties (IPs) to register for the vaccine: Patent for vaccine recipe Trademark the name of the vaccine Keep the vaccine formula as a trade secret OBJECTIVE Our study aims to present our breakthrough in vaccine synthesis based on an innovative approach. We investigated the impact of the new vaccine on viral concentrations in mice, comparing it with a placebo group and a traditional control group. HYPOTHESIS Null hypothesis: The vaccine will not be effective in curing dengue fever in the mice. Alternative hypothesis: The vaccine will be effective in curing dengue fever in mice. The significance level (α) set was at 0.05 or 5%. This is because we need to balance between the type 1 and type 2 errors. Significance level of 0.05 balances the controlling and risk of making a type 1 error and risk of making type 2 error MAIN FINDINGS METHODOLOGY During subject recruitement, we ensured that the mice are healthy and is not affected by the virus before the clinical trials. However, we are unsure about other variables which the mice may possess that may affect the efficacy of the vaccine. Pre-screening We used single-blinded randomization when assigning mice to the 3 different groups. We do this as it is important for the researchers to know which mice is under Placebo, Experimental and Control groups as most mice are identical. Experiment group Mouse in the experiment group was exposed to the virus and then injected with vaccines of 4 different concentrations: 5ug-ml, 7.5ug-ml, 9ug-ml, and 11.5ug-ml. 4 different concentrations were used to test the toxicity and optimal dosage of the vaccine. Placebo group The placebo group is exposed to the virus and dummy inert vaccine. This is done to assess the minimize expectation bias and to ensure an accurate assessment of vaccine efficacy. If the state of the mouse under the placebo effect is different from the mouse that took the vaccine, it will show that the vaccine has an effect on the virus. We injected water in the mouse with a placebo effect. Control group The control group is not exposed to any vaccine or virus. This is to show that the increase in virus concentration is only caused due to the virus. Once we place the different concentrations of viruses in the placebo and the experimental groups, we record the concentration of virus in the mouse from each group every 6 hours for 48 hours. At the end of 52 hours, we assess if the mouse is dead or alive. INDEPENDENT T-TEST IS USED Because we are comparing datas that are unrelated. Mice in the vaccinated group are not paired with mice that are non-vaccinated. They are a seperate and independent sets of data. RESULTS & DISCUSSION CONCLUSION Efficacy: The most effective vaccine is when the concentration is at 9ug-ml as the efficacy is the highest at 50% Toxicity: 11.5ugml of vaccine Dosage: 9ug-ml of vaccine According to the charts, we can see the amount of 9ugml is the most effective since it kept most alive while 11.5ugml is the most toxic where it killed a higher amount, after 52 hours. Use data sampling for more effective results Use a larger rodent sample size to increase accuracy Test on one rodent and one non-rodent for better understanding of the vaccine’s efficacy and toxicity Obtain approval with proceeding with human clinical trials Proceed with human clinical trials to validate the vaccine’s safety and efficacy in humans Average viral concentration in mouse in placebo group under 9ug-ml of vaccine is lower than average viral concentration in mouse in placebo group under 11.5ug-ml of vaccine. Graph of average viral concentration in mouse in placebo group under 9ug-ml of vaccine increases gradually, while the graph of average viral concentration in mouse in experiment group under 11.5ug-ml of vaccine increases then decreases. Moreover, from graph 9, we can conclude that the efficacy of vaccince at 9ug-ml concentration is highest at 50%, hence the vaccine is most effective at 9ug-ml P-value is the result that we get from the t-test. It tells us how likely the difference between the 2 different groups could have happened by accident. The p-value that we observed is 0.08 Overall, when we observe the P value is higher than 0.05—the significance level, this means we can't reject the null hypothesis because we don't have enough evidence. Since p-value > α, we fail to reject the null hypothesis as there is insufficient evidence to support the alternative hypothesis. The reason why we chose unequal varience is beacause we are unsure about how all the different mice responds differently to the virus and want to avoid the risk of making a Type I error. 2 mice died from the control group of the 11.5ug-ml FURTHER STUDIES Survivability rate of mice after 52 hours under 9 ug-ml of vaccine is higher than the survivability rate of mice after 52 hours under 11.5ug-ml of vaccine Moreover, the vaccine is effective in preventing the virus concentration from increasing drastically. From graph 1 & 2, the final average concentration for the placebo is 935.06 Uml but for the experimental group is 111.33 U/ml. Hence, we can conclude that the virus is effective in preventing the viral concentration from increasing drastically. Vaccine is MOST effective when the concentration of the vaccine is 9 ug-ml REFERENCES From the viral concentration of control group graph, we can evaluate that there’s no change which means the only factor affecting the viral concentration is the amount of injected vaccine. Sagar Aryal. (August 3 2023). Methodology. Research Methodology. https://microbenotes.com/category/researchmethodology/#:~:text=The%20research%20methodology%20consists% 20of,are%20essential%20while%20conducting%20research. Anupama Sapkota. (August 3 2023). P Value. P Value- Definition, Formula,Table, Finding P-value, Significance. i https://microbenotes.com/p-value/ DATA - For whom are we creating value?