Non-inferiority study of purified Vero rabies vaccine - serum free in three-dose and two-dose pre-exposure prophylaxis regimens in comparison with licensed rabies vaccines.

Background: A next-generation, serum-free, highly purified Vero cell rabies vaccine, PVRV-NG2, is in development.

Methods: This multicenter, observer-blind, phase 3 study evaluated the immunogenicity and safety of PVRV-NG2, compared with two licensed rabies vaccines (purified Vero cell rabies vaccine [PVRV] and human diploid cell vaccine [HDCV]), as a pre-exposure prophylaxis (PrEP) regimen. Participants were randomized 3:1:1 to PVRV-NG2, PVRV, or HDCV, as a three-dose (Cohort 1; children and adults; day [D] 0, D7, and D28) or two-dose (Cohort 2; adults; D0 and D7) PrEP regimen.

Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand.

Background: A serum-free, highly purified Vero rabies vaccine-next generation (PVRV-NG2) is under development. We conducted a phase III trial to describe the safety and immunogenicity profile of PVRV-NG2 compared with those of licensed purified Vero rabies vaccine (PVRV) in a simulated rabies postexposure prophylaxis (PEP) Zagreb regimen in Thailand.

Methods: Healthy adults aged ≥18 years (n = 201) were randomized in a 2:1 ratio to receive PVRV-NG2 or PVRV in a rabies PEP Zagreb (days 0, 7, 21 [2-1-1]) regimen, with concomitant human rabies immunoglobulin (HRIG) at day 0.

Metabolic and genetic risk factors associated with pre-diabetes and type 2 diabetes in Thai healthcare employees: A long-term study from the Siriraj Health (SIH) cohort study.

Background: The study of non-communicable diseases (NCDs) in a developing country like Thailand has rarely been conducted in long-term cohorts, especially among the working-age population. We aim to assess the prevalence and incidence of risk factors and their associations underlying NCDs, especially type-2 diabetes mellitus (T2DM) among healthcare workers enrolled in the Siriraj Health (SIH) study cohort.

Methods: The SIH study was designed as a longitudinal cohort and conducted at Siriraj hospital, Thailand.

Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial.

Background: Lenacapavir, a first-in-class HIV-1 capsid inhibitor, is in development as a long-acting agent for treating and preventing HIV-1. We aimed to evaluate the efficacy and safety of lenacapavir with an optimised background regimen in adults living with multidrug-resistant HIV-1 up to 52 weeks.

Methods: This ongoing, international, phase 2/3 trial at 42 sites included adults living with multidrug-resistant HIV-1.

Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials.

Objectives: Data on switching to bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed Asian people living with HIV are limited. We performed a pooled analysis of virologically suppressed Asian participants from three international phase III trials to evaluate the efficacy and safety of switching to B/F/TAF.

Methods: Virologically suppressed people living with HIV were randomized to switch to B/F/TAF or to stay on baseline regimens.