Target product profile for a dengue pre-vaccination screening test.

With increasing geographic spread, frequency, and magnitude of outbreaks, dengue continues to pose a major public health threat worldwide. Dengvaxia, a dengue live-attenuated tetravalent vaccine, was licensed in 2015, but post hoc analyses of long-term data showed serostatus-dependent vaccine performance with an excess risk of hospitalized and severe dengue in seronegative vaccine recipients. The World Health Organization (WHO) recommended that only persons with evidence of past dengue infection should receive the vaccine. A test for pre-vaccination screening for dengue serostatus is needed. To develop the target product profile (TPP) for a dengue pre-vaccination screening test, face-to-face consultative meetings were organized with follow-up regional consultations. A technical working group was formed to develop consensus on a reference test against which candidate pre-vaccination screening tests could be compared. The group also reviewed current diagnostic landscape and the need to accelerate the evaluation, regulatory approval, and policy development of tests that can identify seropositive individuals and maximize public health impact of vaccination while avoiding the risk of hospitalization in dengue-naive individuals. Pre-vaccination screening strategies will benefit from rapid diagnostic tests (RDTs) that are affordable, sensitive, and specific and can be used at the point of care (POC). The TPP described the minimum and ideal characteristics of a dengue pre-vaccination screening RDT with an emphasis on high specificity. The group also made suggestions for accelerating access to these RDTs through streamlining regulatory approval and policy development. Risk and benefit based on what can be achieved with RDTs meeting minimal and optimal characteristics in the TPP across a range of seroprevalences were defined. The final choice of RDTs in each country will depend on the performance of the RDT, dengue seroprevalence in the target population, tolerance of risk, and cost-effectiveness.

Seroepidemiology of pertussis in the adult population of Singapore.

INTRODUCTION: Pertussis is a highly communicable, vaccine-preventable respiratory disease and a frequent but often underestimated cause of prolonged cough illness in adults. Protection after childhood vaccination is minimal after 10 years without boosting. The need for adult booster depends on the national epidemiology. MATERIALS AND METHODS: We did a seroepidemiological survey amongst the adult population (aged 18 to 45 years) of Singapore. None had received pertussis booster vaccine in the preceding 10 years. We measured IgG antibodies to pertussis whole cell antigen. RESULTS: Two hundred and seventy subjects with the median age of 30 years were enrolled. We found positive IgG antibody levels in 97% of the population. Seropositivity was not associated with age, gender or race. CONCLUSION: The seroprevalence in adults was much higher than the previously documented seroprevalence of around 50% in the adolescent age group in Singapore. The increase is most likely due to natural infection with B. pertussis. Pertussis booster vaccine for adolescents/young adults in Singapore would be indicated.