TB31F / Radboud University, PATH - LARVOL DELTA

Malaria infection and gametocyte carriage in children and adults during the high transmission season in Ouélessébougou, Mali (ASTMH 2025) - P1/2 | "Data from a cross-sectional survey for enrolment into TB31F trial (NCT06413108) during the high malaria transmission season from July 2024 to December 2024 were analyzed to determine the prevalence of malaria infection and gametocyte carriage in school-age children and adults aged 10 to 49 years...Malaria infection and gametocyte carriage are high among older children and adults during the peak malaria transmission season in Ouélessébougou. Interventions such as drugs, vaccines, or monoclonal antibodies are urgently needed to reduce the gametocyte carriage and subsequently malaria transmission and move towards malaria elimination in these high transmission settings."

Clinical • Late-breaking abstract • Infectious Disease • Malaria

Safety and efficacy of Plasmodium falciparum malaria transmission-blocking monoclonal antibody TB31F in adults and children in Mali: a phase 1/2 trial randomised, placebo-controlled, double-blind, dose escalation, age de-escalation clinical trial (ASTMH 2025) - "SMFA analyses are currently ongoing. These interim findings suggest that TB31F is well tolerated and can completely block transmission of naturally circulating P. falciparum isolates from humans to mosquitoes."

Clinical • P1/2 data • Infectious Disease • Malaria

Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali (clinicaltrials.gov) - P1/2 | N=165 | Recruiting | Sponsor: Radboud University Medical Center | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria

Magnitude and durability of ProC6C-AlOH/Matrix-Mtm vaccine-induced malaria transmission-blocking antibodies in Burkinabe adults from a Phase 1 randomized trial. (PubMed, Hum Vaccin Immunother) - "To identify immune biomarkers for high levels of TRA, the Pfs48/45-6C IgG concentration (calculated relative to the transmission-blocking mAb TB31F) was compared among TRA positive and negative individuals...This finding was corroborated by the observation that complement had no effect on TRA in the standard membrane feeding assay (SMFA). Collectively, these efforts confirm the transmission-blocking attributes of ProC6C and suggest that an alternative dosing regimen be evaluated in future clinical trials to improve longevity of functional transmission-reducing antibodies."

Clinical • Journal • P1 data • Infectious Disease • Malaria

Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali (clinicaltrials.gov) - P1/2 | N=165 | Active, not recruiting | Sponsor: Radboud University Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2024 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Malaria • HBB • LEP

Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali (clinicaltrials.gov) - P1/2 | N=165 | Recruiting | Sponsor: Radboud University Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria • LEP

Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali (clinicaltrials.gov) - P1/2 | N=165 | Not yet recruiting | Sponsor: Radboud University Medical Center

New P1/2 trial • Infectious Disease • Malaria • LEP

Modelling the impact of a highly potent Plasmodium falciparum transmission-blocking monoclonal antibody in areas of seasonal malaria transmission. (PubMed, J Infect Dis) - "Targeting school-aged children gave the largest reduction in terms of cases averted per dose. An annual administration of transmission-blocking monoclonal TB31F may be an effective intervention against malaria in seasonal malaria settings."

Journal • Infectious Disease • Malaria

Safety, efficacy and predicted public health impact of TB31F as potent P. falciparum transmission blocking antibody (ASTMH 2022) - No abstract available

Clinical

Safety, tolerability, and Plasmodium falciparum transmission-reducing activity of monoclonal antibody TB31F: a single-centre, open-label, first-in-human, dose-escalation, phase 1 trial in healthy malaria-naive adults. (PubMed, Lancet Infect Dis) - P1 | "TB31F is a well tolerated and highly potent monoclonal antibody capable of completely blocking transmission of P falciparum parasites from humans to mosquitoes. In areas of seasonal transmission, a single dose might cover an entire malaria season."

Journal • P1 data • Infectious Disease • Malaria

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: Radboud University; Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F (clinicaltrials.gov) - P1; N=25; Active, not recruiting; Sponsor: Radboud University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Malaria

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: Radboud University; Trial completion date: Nov 2020 ➔ Mar 2021; Trial primary completion date: Nov 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Malaria

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Radboud University; Active, not recruiting ➔ Recruiting; Trial completion date: Aug 2020 ➔ Nov 2020; Trial primary completion date: Aug 2020 ➔ Nov 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Malaria

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: Radboud University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Radboud University

Clinical • New P1 trial