A Phase 1/2 interventional study of TB31F and Normal saline in Malaria,Falciparum, sponsored by Radboud University Medical Center. Completed at 1 site in Mali. Open to participants aged 10 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Radboud University Medical Center · Phase 1/2, Interventional, and Other
Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat this disease. The monoclonal antibody TB31F shows promise in reducing the transmission of malaria. This clinical trial will evaluate the safety and efficacy of the monoclonal antibody TB31F.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 167 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
SAFETY COHORT (STUDY ARM 1-5)
Inclusion Criteria:
Exclusion Criteria:
EFFICACY COHORT (STUDY ARM 6)
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.2 mL normal saline
Other: Normal saline
0.2 mL (10 mg) TB31F
Drug: TB31F
2 mL normal saline
Other: Normal saline
2 mL (100 mg) TB31F
Drug: TB31F
4 mL normal saline
Other: Normal saline
4 mL (200 mg) TB31F
Drug: TB31F
0.2 mL normal saline
Other: Normal saline
0.2 mL (10 mg) TB31F
Drug: TB31F
2.0 mL normal saline
Other: Normal saline
2.0 mL (100 mg) TB31F
Drug: TB31F
0.6 or 2.0 mL normal saline
Other: Normal saline
0.6 mL (30 mg) TB31F
Drug: TB31F
2.0 mL (100 mg) TB31F
Drug: TB31F
transmission-blocking monoclonal antibody TB31F
normal saline as control (placebo)
Occurrence of at least possibly related solicited local and systemic adverse events
Time frame: within 7 days of monoclonal antibody TB31F administration
Occurrence of at least possibly related unsolicited adverse events
Time frame: within 28 days of monoclonal antibody TB31F administration
Occurrence of at least possibly related serious adverse events
Time frame: from enrollment to the end of follow-up at 28 or 84 days
Terminal serum half-life (t½) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Maximum observed serum concentration (Cmax) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Time to reach maximum serum concentration (tmax) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Accumulation index (Racc) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Area under the serum concentration-time curve (AUC0-τ, AUC0-t and AUC) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Within-group percent reduction in the proportion of mosquitoes infected at day 5 post-treatment compared to baseline (day 0), assessed through direct membrane feeding assays and measured as oocyst prevalence
Time frame: day 0 [baseline] & 5
Within-group percent reduction in the proportion of mosquitoes infected in direct skin feeding assay (DSF), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Within-group percent reduction in the proportion of mosquitoes infected in direct membrane feeding assays (DMFA), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Mosquito infection prevalence, assessed by direct skin feed and measured as the proportion dissected mosquitoes with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Mosquito infection prevalence, assessed by DMFA and measured as the proportion dissected with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Mosquito infection intensity, assessed by direct skin feed and measured as the number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Mosquito infection intensity, assessed by DMFA and measured as the average number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Participant infection prevalence, assessed by DSF as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Participant infection prevalence, assessed by DMFA as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Transmission-reducing activity in school-age children and adults, measured as the percent reduction in mean oocyst intensity compared to experimental controls, compared within groups and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
Total serum immunoglobulin G level
Quantification of the effect of nutritional and protein metabolism status
Time frame: day 0 [baseline]
Serum leptin level
Quantification of the effect of nutritional and protein metabolism status
Time frame: day 0 [baseline]
Total protein level
Quantification of the effect of nutritional and protein metabolism status
Time frame: day 0 [baseline]
Albumin level
Quantification of the effect of nutritional and protein metabolism status
Time frame: day 0 [baseline]
Pre-albumin level
Quantification of the effect of nutritional and protein metabolism status
Time frame: day 0 [baseline]
Human genotype analysis at baseline (G6PD, CYP2D6, HBB)
To assess human genomic variation in the study population
Time frame: day 0 [baseline]
Plasma biomarkers (i.e. antibodies) at baseline and at post-administration timepoints
To assess the presence of plasma biomarkers in the study population
Time frame: day 0 [baseline]
Transmission-blocking activity measured as the percent reduction in mosquito infection prevalence compared to experimental controls, compared within and between groups at all feeding timepoints.
To assess the transmission-blocking activity of participant serum after TB31F administration as assessed in the Standard Membrane Feeding Assay (SMFA) at each dose level in adults and school-age children
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
The concentration of TB31F in serum that provides >80% reduction in the average proportion of infected mosquitoes as measured in direct skin feeding assay after TB31F administration.
Time frame: day 0 [baseline], 1, and 5.
The concentration of TB31F in serum that provides >80% reduction in the average proportion of infected mosquitoes as measured in direct membrane feeding assays after TB31F administration.
Time frame: day 0 [baseline], 1, 5, and 14.
The concentration of TB31F in serum that provides >80% transmission blocking activity relative to experimental controls as measured in standard membrane feeding assay after TB31F administration.
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
Measure the concentration of TB31F in serum that provides >80% reduction in the average mosquito infection intensity (oocyst number) as measured in direct skin feeding assay after TB31F administration.
Time frame: day 0 [baseline], 1, and 5.
The concentration of TB31F in serum that provides >80% reduction in the average mosquito infection intensity (oocyst number) as measured in direct membrane feeding assays after TB31F administration.
Time frame: day 0 [baseline], 1, 5, and 14.
The concentration of TB31F in serum that provides >80% transmission reducing activity relative to experimental controls as measured in standard membrane feeding assay after TB31F administration.
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
The correlation between naturally acquired anti-gametocyte immune responses and naturally acquired functional TRA on mosquito infection prevalence, assessed by SMFA and measured as the proportion dissected mosquitoes with any number of oocysts.
To assess the impact of naturally acquired TRA, present prior to TB31F administration, on transmission endpoints and TB31F efficacy estimates
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
The correlation between naturally acquired anti-gametocyte immune responses and naturally acquired functional transmission-reducing activity on mosquito infection intensity, assessed by SMFA and measured as the number of oocysts in dissected mosquitoes.
To assess the impact of naturally acquired TRA, present prior to TB31F administration, on transmission endpoints and TB31F efficacy estimates
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
The correlation between naturally acquired anti-gametocyte immune responses and naturally acquired functional TRA on participant infectivity, assessed by SMFA as the proportion of individuals infectious to any number of mosquitoes.
To assess the impact of naturally acquired TRA, present prior to TB31F administration, on transmission endpoints and TB31F efficacy estimates
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
Parasite genotype analysis (amplicon and whole genome sequencing)
To assess human and parasite genomic variation and association with parasite measures
Time frame: day 0 [baseline]
Antibodies and parasite protein in plasma at baseline and at post-administration timepoints
To assess the impact of plasma biomarkers on malaria transmission efficiency
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Statistical analysis plan, Informed consent form
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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