The control group will be formed of 60 overweight or obese dengue patients receiving standard of care

Two cohorts receive a 5-day course of metformin treatment. In the initial phase (cohort 1), 5 young adults and 5 children (age <16) will receive a low dose of metformin. In the second phase (cohort 2), 25 adult and 25 paediatric patients will receive a weight-based dose of metformin.

Dengue

Viral Infection

Metformin

Anti-inflammatory Agents

Obesity

Overweight

The trial will be conducted in two phases, with a dose escalation of metformin. Metformin dosing will begin at 500mg (children) and 850mg (adults) once daily for 5 days in cohort 1.
Cohort 2 will be received weight-based doses; 5 days of 1000mg (500mg twice daily) for those weighing <60kg and 5 days of 1500mg (1000mg mane, 500mg nocte) for those weighing ≥60kg

Hospital for Tropical Diseases

Metformin in Dengue With Obesity

Metformin as Adjunctive Therapy in Overweight and Obese Patients With Dengue: an Open-label Safety and Tolerability Trial

Number of severe clinical symptoms and signs, including severe diarrhoea (defined as >5 episodes watery stool/day), severe vomiting, defined as 2-5 episodes/day, severe abdominal pain and laboratory markers of severity including -Hypoglycaemia defined as glucose <3.9 mmol/l, Hyperlactatemia (lactate >3 mmol/l), ALT/AST >400 U/l

Time to temperature <37.5 for 2 consecutive days

Lowest platelet count recorded during admission

Percentage increase will be calculated from peak result to baseline (baseline is follow-up time-point)

Percentage change in parameters such as: VCAM1, ICAM1, leptin, adiponectin, LDL, AMPK levels will be calculated from peak result to baseline (follow-up time-point)

Area under the curve (AUC) of the serial measurements during days 3 - 6 (log10-transformed), time from enrollment to the first undetectable viraemia, or the first negative NS1 measurement will be compared

Phenotyping CD8/4+T cell and NK cell and T cell exhaustion markers will be assessed

Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation.

Oxford University Clinical Research Unit, Vietnam

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

This is an open-label, two-phase dose escalation trial of metformin in overweight/obese patients with dengue compared to standard of care

A total of 35 healthy adult subjects, 30-50 years old with a range of BMI from 18 to 30 kg/m2, pre-screened to be receiving long term statin therapy of ≥ 6 months and negative for diabetes (defined as HbA1c <6.5%) will be enrolled upon written informed consent. They will receive a single dose of 0.5ml of Stamaril (live attenuated yellow fever vaccine)

Another 35 healthy non-diabetic adult subjects, 30-50 years old with a range of BMI from 18 to 30 kg/m2, not receiving long-term statins will serve as controls will be enrolled upon written informed consent.
They will receive a single dose of 0.5ml of Stamaril (live attenuated yellow fever vaccine)

Yellow Fever Vaccine

Yellow Fever

They will receive a single dose of 0.5ml of Stamaril (live attenuated yellow fever vaccine)

Stamaril (live attenuated yellow fever vaccine)

SingHealth Investigational Medicine Unit

Yellow Fever Vaccine on Statin/ Non Statin Subjects

Using Systems Vaccinology to Elucidate the Effects of Anti-inflammatory Therapy on Immune Response After Vaccination With a Live Attenuated Vaccine

the difference in neutralizing antibody titer to YF17D at Day 28, as measured by plaque reduction neutralization test (PRNT)

viremia levels response in adult human volunteers on long term statins therapy compared to controls post-YF vaccination

To examine the Cd4+ and Cd8+ T cell response in adult human volunteers on long term statins therapy compared to controls post-YF vaccination

dengue/obezita

Metformin in Dengue With Obesity

Yellow Fever Vaccine on Statin/ Non Statin Subjects

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