Safety and immunogenicity of locally produced trivalent inactivated influenza vaccine (Tri Fluvac) in healthy Thai adults aged 18-64 years in Nakhon Phanom: A Phase III double blinded, three-arm, randomized, controlled trial.

BACKGROUND: Domestic influenza vaccine production facilitates a sustainable supply for mitigating seasonal influenza and improves national health security by providing infrastructure and experience for pandemic vaccine production, if needed. METHODS: A Phase III, double blind, randomized controlled trial was conducted from Sep 2019-Oct 2020 in healthy adults 18-64 years in Nakhon Phanom, Thailand. Randomization (3:3:1) compared study vaccine (Tri Fluvac), saline placebo, and an active comparator (licensed vaccine). Primary outcomes were superior efficacy compared to placebo based on RT-PCR-confirmed influenza virus infection within 12 months and non-inferiority compared to active comparator based on immunogenicity (HAI assay) at 28 days. Safety was also assessed. RESULTS: The trial enrolled 4,284 participants (Tri Fluvac = 1,836; placebo = 1,836; active comparator = 612). There were 29 RT-PCR positive influenza infections (10 Tri Fluvac, 5.5/1,000 PY; 19 placebo, 10.4/1,000PY; 0 comparator) for an absolute protective efficacy of 46.4 (95 % CI = -22.0-76.5) compared with placebo, but the power was 43.7 %. Seroconversion difference rates between Tri Fluvac and comparator at Day 28 were 1.74 (95 % CI: -2.77, 6.25), 2.22 (-2.40, 6.84), and -0.57 (-5.41, 4.27) for A(H1N1), A(H3N2), and B strains, respectively. Adverse and severe adverse events occurred in 175 (9.5 %) Tri Fluvac, 177 (10.8 %) placebo, and 66 (10.8 %) comparator arms (p-value = 0.437, Tri Fluvac vs. comparator) CONCLUSIONS: Tri Fluvac was well tolerated, and immunogenicity was non-inferior to the active comparator, meeting U.S. Food and Drug Administration (FDA) criteria for adult vaccine licensure. Few acute respiratory infections were reported during intense COVID-19 pandemic restrictions, resulting in insufficient power to evaluate clinical efficacy.

Effect of acute respiratory illness on short-term frailty status of older adults in Nakhon Phanom, Thailand-June 2015 to June 2016: A prospective matched cohort study.

BACKGROUND: Frailty is associated with increased risk of mortality and decline in functional status among older adults. Older adults are at increased risk of severe disease from acute respiratory illness (ARIs), but ARI effects on frailty status among older adults are not well understood. We evaluated how ARIs affect short-term frailty status among community-dwelling adults aged ≥65 years in Nakhon Phanom, Thailand. METHODS: During May 2015 to May 2017, older adults were contacted weekly to identify ARIs as part of a community-based longitudinal cohort study. Each participant's frailty status was assessed at baseline and every 6 months using the Vulnerable Elders Survey-13 (VES-13). We selected cohort participants with an ARI and compared them with a sample of participants without an ARI matched on age, sex, influenza vaccination status, and most recent VES-13 score. For these matched cohort members, an additional VES-13 was recorded at 3-4 weeks after the ARI episode date. RESULTS: Of 3220 cohort study participants, 114 participants with an ARI and 111 comparison participants without an ARI were selected for the matched cohort; three comparison participants were matched to two ARI cases. We found no statistically significant difference between ARI and non-ARI participants in modified VES-13 score 3-4 weeks post-episode (cases = 0.90, controls = 0.63, P = 0.07). Only two ARI episodes required hospitalization. CONCLUSIONS: Primarily mild ARIs did not affect short-term frailty status among community-dwelling older adults in Thailand. As few cases of severe ARI were detected, the contribution of severe ARI to changes in frailty requires further investigation.

Streptococcus suis infection in hospitalized patients, Nakhon Phanom Province, Thailand.

In Nakhon Phanom, Thailand, we identified 38 hospitalized patients with Streptococcus suis infection during 2006-2012. Deafness developed in 12 patients; none died. Thirty-five reported recent exposure to pigs/pork. Annual incidence was 0.1-2.2 cases/100,000 population (0.2-3.2 in persons ≥20 years of age). Clinicians should consider S. suis infection in areas where pig exposure is common.