Immunogenicity and safety of a second heterologous booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Interim analysis report of a phase 3 open-label trial.

BACKGROUND: The phase 3, single-arm, open-label TAK-019-3001 study assessed two heterologous booster doses of NVX-CoV2373 administered 5 months apart in healthy Japanese adults who had completed a primary series of a COVID-19 mRNA vaccine 6-12 months previously. In the main part of this study, a first booster induced rapid and robust anti-SARS-CoV-2 immune responses, addressing waning immunity in participants. METHODS: This interim analysis evaluated the immunogenicity and safety of a second booster in the extension part of this study including comparisons with the first booster. Immunogenicity was assessed on extension day (ED) 1 (before vaccination) and ED15. Solicited and unsolicited adverse events occurring in the 7 and 28 days, respectively, after vaccination were assessed. RESULTS: Of the 150 participants who received a first NVX-CoV2373 booster, 129 were administered a second booster on ED1. Participant characteristics were consistent between the main and extension parts of the study. Titres of anti-SARS-CoV-2 rS serum immunoglobulin G and serum neutralizing antibodies against the SARS-CoV-2 ancestral strain at ED15 were 4.0- and 3.0-fold higher, respectively, than those observed 5 months after the first booster on ED1, and 3.0- and 1.4-fold higher, respectively, than those observed 14 days after the first booster on day 15. The proportions of participants who experienced solicited local and systemic adverse events (AEs) in the 7 days after the second booster were 73.6 % and 51.2 %, respectively: most were of grade 2 severity or lower. Seven percent of participants experienced unsolicited AEs in the 28 days after the second booster: all were unrelated to the treatment. There were no deaths or AEs leading to study discontinuation. DISCUSSION: A second heterologous NVX-CoV2373 booster in healthy Japanese adults induced more robust anti-SARS-CoV-2 immune responses than the first booster. The second booster was well tolerated. No new safety concerns were identified.

One-year follow-up of the immunogenicity and safety of a primary series of the NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Final report of a phase I/II randomized controlled trial.

BACKGROUND: In the interim report of this phase I/II randomized, placebo-controlled trial in Japanese adults, a two-dose primary series of NVX-CoV2373 (5 µg SARS-CoV-2 recombinant nanoparticle spike protein [rS]; 50 µg Matrix-M) administered 21 days apart induced robust anti-SARS-CoV-2 immune responses up to day 50 and had an acceptable safety profile. METHODS: Following the double-blind phase of this study (day 1-50), participants were informed about their assignment to NVX-CoV2373 or placebo, and their reconsent was required for continuation in the open-label phase (day 51-387). This final report evaluated immunogenicity on days 202 and 387, and safety findings from the 1-year follow-up. RESULTS: In total, 131/150 participants in the NVX-CoV2373 arm and 4/50 in the placebo arm completed the study. The most common reason for discontinuation was because the participant requested a publicly available COVID-19 vaccine. At 6 months and 1 year after the second vaccine dose, both the geometric mean titres of anti-SARS-CoV-2 rS serum immunoglobulin G and serum neutralizing antibodies against the SARS-CoV-2 ancestral strain were numerically higher than before the second dose. There were no deaths, adverse events (AEs) leading to participant withdrawal, or AEs of special interest throughout the trial. During follow-up, 2.0 % (1/50) of participants in the placebo arm reported COVID-19 approximately 1 month after the second vaccine dose (serious AE requiring hospitalisation, already presented in the interim report) and 2.7 % (4/150) in the NVX-CoV2373 arm after approximately 10 months (mild [2/4] or moderate [2/4] in severity). DISCUSSION: A primary series of NVX-CoV2373 induced persistent immune responses up to 1 year after the second dose. The vaccine was well tolerated and had an acceptable safety profile. We believe our findings offer important insights for determining dosing intervals between primary and booster vaccinations.

Asociación entre niveles ANTI-PGL-I IgM y parámetros clínicos y demográficos en la lepra / No disponible

Objetivo: Determinar los factores de riesgo y significado clínico de la seropositividad anti-PGL-I. Diseño: Se llevó a cabo un gran estudio sero-epidemiológico (COLEP) en el noroeste de Bangladesh. Se obtuvo sangre en papel de filtro de 1025 nuevos pacientes antes del tratamiento y se analizaron mediante un ELISA anti-PGL_I; la relación entre los factores determinantes del paciente y la seropositividad se calculó mediante regresión logística. Resultados: La edad media era de 30 años y la proporción varón-hembra era 1.9. En total, 342 pacientes (33-4%) eran seropositivos. Las siguientes variables revelaron una correlación significativa con la seropositividad (P<0,05) en un análisis multivariable: sexo, edad, grado de discapacidad, índice bacteriológica y clasificación de acuerdo con el sistema de la Organización Mundial de la Salud. La cantidad y extensión de los signos clínico se correlacionaron con la seropositividad, excepto la presencia de lesiones satélite. Las personas con o sin cicatriz de vacunación BCG presentaron riesgos similares en cuanto a seropositividad. Conclusión: La serología es un marcador de una carga bacteriana sistémica y puede identificar fuentes de infección con los pacientes con pocos síntomas clínicos. El tamaño de la lesión se correlaciona positivamente con la seropositividad. No hallamos distintos niveles de seropositividad en pacientes con o sin lesiones satélite (AU)

Objetive: To determinate the risk factors and clinical significance of anti-PGL-I seropositivity. Design A large-scale sero-epidemiological study (COLEP) was carried out in northwest Bangladesh. Blood on filter paper from 1025 newly diagnosed patients was collected before treatment was started and tested with an anti-PGL-I-ELISA, the relation between patient determinants and seropositivity was calculated using logistic regression. Results. The median age was 30 years and the male: female ratio 1.9. Overall 342 patients (33.4%) were seropositive. The following determinants showed a significant correlation with seropositivity (P<0,05) in multivariate analysis: sex, age, disability grade, bacterial index and classification according to the World Health Organization (WHO) system. The number and extent of clinical signs correlated with seropositivity, except for the presence of satellite lesions. People with or without a BCG vaccination scar had a similar to be seropositive. Conclusion Serology is a marker for a higher systemic bacterial load and may identify potential infectious sources among patients with few clinical signs. The size of skin lesions was positively correlated with seropositive. We did not find different level of seropositivity among patients with one or two skin lesions, neither did we find different levels among patients with or without satellite lesions (AU)