A Phase 2 interventional study of Albendazole and Albendazole in Trichuriasis and Hookworm Infections, sponsored by Jennifer Keiser. Completed at 1 site in Côte D'Ivoire. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Jennifer Keiser · Phase 2, Interventional, and Treatment
This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This study aims at providing evidence on the dose-response of increasing oral albendazole dosages against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years).
The primary objective is to determine cure rates (primary end point, i.e. conversion from being egg positive pre-treatment to egg negative post-treatment). Secondary objectives involve the determination of egg reduction rates (the reduction in the number of excreted eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic parameters will be determined from blood samples collected with a micro-sampling device (secondary end point).
This study is a single-blind randomized clinical trial conducted in Côte d'Ivoire. This study aims at providing evidence on the efficacy and safety of ascending oral albendazole dosages in children and adults infected with T. trichiura and hookworm. In preschool-aged children (2-5 years) (i) 200 mg, (ii) 400 mg and (iii) 600 mg; in schoolchildren (6-12 years) and adults (≥ 21 years) (i) 200 mg (only for hookworm infections), (ii) 400 mg, (iii) 600 mg and (iv) 800 mg will be administered and efficacy, safety and pharmacokinetic parameters will be assessed.
The primary objective is to determine the dose-response based on cure rates of albendazole in preschool-aged children (2-5 years), school-aged children (6-12 years) and adults (≥ 21 years) infected with T. trichiura and hookworm.
The secondary objectives of the trial are to determine the efficacy based on egg reduction rates of albendazole in preschool-aged children, school-aged children and adults, to determine an exposure (including length of time that the drug concentration is above the MIC, Cmax, AUC)-response correlation of albendazole in preschool-aged children, school-aged children and adults, to evaluate the safety and tolerability of albendazole in preschool-aged children, school-aged children and adults, and to determine the efficacy against concomitant soil-transmitted helminthiasis (Ascaris lumbricoides).
After obtaining informed consent from individual/parents and/or caregiver, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination and venipuncture to examine biochemical parameters in the blood carried out by the study physician before treatment. Enrollment will be based on two stool samples that will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days.
All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians. Randomization of participants into the treatment arms will be stratified according to intensity of infection. All participants will be interviewed before treatment, 3 and 24 hours and 3 weeks after treatment about the occurrence of adverse events. Children and adults will be sampled using finger pricking for micro-blood sampling at 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis and an intention-to-treat analysis will be conducted. CRs will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment. Differences among CRs will be analysed by using crude logistic regressions and adjusted logistic regressions (adjustment for age, sex, and height).
Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 2,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs. Noncompartmental and nonlinear mixed-effects (NLME) modeling will be used to determine PK parameters.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 700 is above the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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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.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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Investigational drug or device
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against T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults
Drug: Albendazole
against T. trichiura in preschool-aged children, school-aged children and adults or against hookworm infections in preschool-aged children, school-aged children and adults
Drug: Albendazole
against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults
Drug: Albendazole
against T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults
Drug: Albendazole
against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults
Drug: Placebo
Single dose of albendazole (200mg, dependent on treatment cohort)
Also known as: Zentel®
Single dose of albendazole (400mg, dependent on treatment cohort)
Also known as: Zentel®
Single dose of albendazole (600mg, dependent on treatment cohort)
Also known as: Zentel®
Single dose of albendazole (800mg, dependent on treatment cohort)
Also known as: Zentel®
Matching placebo tablets will be obtained from Fagron, Germany.
Cure Rate Against T. Trichiura and Hookworm Infections
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Time frame: 14-21 days after treatment
Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively
Percent change in geometric mean eggs per gram of stool from before to after treatment
Time frame: 14-21 days after treatment
Maximum Concentration (Cmax) of Albendazole Sulphoxide
To determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Time to Reach Cmax (Tmax) of Albendazole Sulphoxide
To determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Area Under the Curve (AUC) of Albendazole Sulphoxide
To determine the area under the curve (AUC) of albendazole sulphoxide in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
| Milestone | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 27 | 27 | 30 | 27 | 46 | 45 | 46 | 43 | 10 | 11 | 9 | 12 | 0 | 13 | 13 | 12 | 24 | 27 | 27 | 29 | 26 | 40 | 41 | 38 | 40 | 37 |
| Completed | 24 | 21 | 23 | 18 | 46 | 43 | 43 | 41 | 7 | 9 | 8 | 11 | 0 | 13 | 13 | 12 | 23 | 27 | 27 | 28 | 25 | 35 | 35 | 30 | 39 | 34 |
| Not completed | 3 | 6 | 7 | 9 | 0 | 2 | 3 | 2 | 3 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 5 | 6 | 8 | 1 | 3 |
| Withdrew: Lost to follow-up | 3 | 6 | 7 | 9 | 0 | 2 | 3 | 2 | 3 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 5 | 6 | 8 | 1 | 3 |
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
| Participants | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cured | 4 | 2 | 4 | 5 | 3 | 7 | 11 | 7 | 1 | 5 | 4 | 3 | — | 9 | 8 | 10 | 10 | 17 | 20 | 18 | 19 | 5 | 16 | 16 | 22 | 32 |
| Not cured | 20 | 19 | 19 | 13 | 43 | 36 | 32 | 34 | 6 | 4 | 4 | 8 | — | 4 | 5 | 2 | 13 | 10 | 7 | 10 | 6 | 30 | 19 | 14 | 17 | 2 |
Percent change in geometric mean eggs per gram of stool from before to after treatment
| percent change | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively | 79.1 (53.5 to 91.2) | 63.8 (33.1 to 83.1) | 87.1 (67.3 to 95.3) | 88.5 (70.4 to 95.7) | 55.9 (26.1 to 75.2) | 82.0 (67.8 to 90.5) | 88.4 (74.8 to 94.8) | 78.7 (60.5 to 89.1) | 85.2 (65.9 to 95.3) | 97.7 (86.7 to 99.8) | 94.7 (61.0 to 99.6) | 92.6 (71.9 to 98.5) | — | 99.0 (94.7 to 99.9) | 96.2 (83.5 to 99.4) | 99.6 (98.5 to 100.0) | 90.6 (72.3 to 97.3) | 97.7 (93.5 to 99.3) | 99.0 (97.4 to 99.7) | 98.3 (95.4 to 99.5) | 98.4 (95.9 to 99.6) | 33.0 (-27.1 to 67.3) | 93.8 (87.0 to 97.3) | 95.8 (90.2 to 98.3) | 97.0 (92.5 to 98.9) | 99.8 (99.5 to 100.0) |
To determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
| mikromol/L | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Maximum Concentration (Cmax) of Albendazole Sulphoxide | 3.41 ± 2.58 | 6.61 ± 4.56 | 9.98 ± 7.16 | 3.67 ± 2.54 | 5.51 ± 3.778 | 7.14 ± 4.82 | 2.03 ± 1.44 | 2.95 ± 1.89 | 4.03 ± 2.62 | 1.70 ± 1.28 | 3.27 ± 2.28 | 4.98 ± 3.61 | 1.02 ± 0.74 | 2.11 ± 1.56 | 3.16 ± 2.41 | 4.12 ± 3.21 | 0.61 ± 0.44 | 1.22 ± 0.91 | 1.78 ± 1.20 | 2.43 ± 1.71 |
To determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
| hours | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time to Reach Cmax (Tmax) of Albendazole Sulphoxide | 6.8 ± 4.4 | 6.8 ± 3.8 | 6.8 ± 4.1 | 7.1 ± 4.6 | 7.0 ± 4.4 | 7.1 ± 4.3 | 7.3 ± 4.3 | 7.2 ± 4.3 | 7.4 ± 4.5 | 4.2 ± 2.7 | 4.2 ± 2.4 | 4.2 ± 2.6 | 4.5 ± 2.8 | 4.7 ± 3.1 | 4.7 ± 3.0 | 4.8 ± 3.0 | 5.3 ± 3.2 | 5.3 ± 3.2 | 5.4 ± 3.3 | 5.4 ± 3.4 |
To determine the area under the curve (AUC) of albendazole sulphoxide in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml.
| micogram/ml/h-1 | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Area Under the Curve (AUC) of Albendazole Sulphoxide | 45.3 ± 31.4 | 90.3 ± 58.7 | 135.4 ± 89.6 | 47.3 ± 27.7 | 73.1 ± 44.2 | 96.9 ± 58.3 | 26.99 ± 15.9 | 40.2 ± 23.4 | 53.4 ± 29.9 | 16.6 ± 10.1 | 33.1 ± 18.8 | 49.5 ± 28.5 | 11.4 ± 6.7 | 22.3 ± 13.4 | 34.5 ± 22.1 | 45.2 ± 29.0 | 7.4 ± 4.0 | 14.9 ± 8.0 | 22.3 ± 12.1 | 29.8 ± 15.7 |
Collected over Adverse events were collected at 3 hours and 24 hours after treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Against T. Trichiura in PSAC | 0/27 (0%) | 0/27 (0%) | 3/27 (11.1%) |
| ALB 200 mg Against T. Trichiura in PSAC | 0/27 (0%) | 1/27 (3.7%) | 2/27 (7.4%) |
| ALB 400 mg Against T. Trichiura in PSAC | 0/30 (0%) | 0/30 (0%) | 3/30 (10%) |
| ALB 600 mg Against T. Trichiura in PSAC | 0/27 (0%) | 0/27 (0%) | 2/27 (7.4%) |
| Placebo Against T. Trichiura in SAC | 0/46 (0%) | 0/46 (0%) | 4/46 (8.7%) |
| ALB 400 mg Against T. Trichiura in SAC | 0/45 (0%) | 0/45 (0%) | 9/45 (20%) |
| ALB 600 mg Against T. Trichiura in SAC | 0/46 (0%) | 0/46 (0%) | 8/46 (17.4%) |
| ALB 800 mg Against T. Trichiura in SAC | 0/43 (0%) | 0/43 (0%) | 8/43 (18.6%) |
| Placebo Against T. Trichiura in Adults | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| ALB 400 mg Against T. Trichiura in Adults | 0/11 (0%) | 0/11 (0%) | 3/11 (27.3%) |
| ALB 600 mg Against T. Trichiura in Adults | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| ALB 800 mg Against T. Trichiura in Adults | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Placebo Against Hookworm in PSAC | — | — | — |
| ALB 200 mg Against Hookworm in PSAC | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| ALB 400 mg Against Hookworm in PSAC | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| ALB 600 mg Against Hookworm in PSAC | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Placebo Against Hookworm in SAC | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) |
| ALB 200 mg Against Hookworm in SAC | 0/27 (0%) | 0/27 (0%) | 3/27 (11.1%) |
| ALB 400 mg Against Hookworm in SAC | 0/27 (0%) | 0/27 (0%) | 2/27 (7.4%) |
| ALB 600 mg Against Hookworm in SAC | 0/29 (0%) | 0/29 (0%) | 1/29 (3.4%) |
| ALB 800 mg Against Hookworm in SAC | 0/26 (0%) | 0/26 (0%) | 3/26 (11.5%) |
| Placebo Against Hookworm in Adults | 0/40 (0%) | 0/40 (0%) | 2/40 (5%) |
| ALB 200 mg Against Hookworm in Adults | 0/41 (0%) | 0/41 (0%) | 4/41 (9.8%) |
| ALB 400 mg Against Hookworm in Adults | 0/38 (0%) | 0/38 (0%) | 5/38 (13.2%) |
| ALB 600 mg Against Hookworm in Adults | 0/40 (0%) | 0/40 (0%) | 3/40 (7.5%) |
| ALB 800 mg Against Hookworm in Adults | 0/37 (0%) | 0/37 (0%) | 4/37 (10.8%) |
| Event | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inpatient hospitalization due to clinical malariaInfections and infestations | 0/27 | 1/27 | 0/30 | 0/27 | 0/46 | 0/45 | 0/46 | 0/43 | 0/10 | 0/11 | 0/9 | 0/12 | — | 0/13 | 0/13 | 0/12 | 0/24 | 0/27 | 0/27 | 0/29 | 0/26 | 0/40 | 0/41 | 0/38 | 0/40 | 0/37 |
| Event | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 1/27 | 2/27 | 3/30 | 0/27 | 3/46 | 1/45 | 3/46 | 5/43 | 1/10 | 3/11 | 2/9 | 2/12 | — | 1/13 | 0/13 | 1/12 | 1/24 | 1/27 | 0/27 | 0/29 | 0/26 | 2/40 | 3/41 | 4/38 | 2/40 | 1/37 |
| Abdominal painGastrointestinal disorders | 1/27 | 0/27 | 1/30 | 2/27 | 4/46 | 4/45 | 3/46 | 7/43 | 2/10 | 3/11 | 1/9 | 0/12 | — | 0/13 | 0/13 | 0/12 | 1/24 | 2/27 | 2/27 | 1/29 | 3/26 | 0/40 | 1/41 | 1/38 | 2/40 | 3/37 |
| NauseaGastrointestinal disorders | 0/27 | 0/27 | 0/30 | 0/27 | 0/46 | 0/45 | 0/46 | 0/43 | 0/10 | 1/11 | 0/9 | 0/12 | — | 0/13 | 0/13 | 0/12 | 0/24 | 0/27 | 0/27 | 0/29 | 0/26 | 0/40 | 0/41 | 0/38 | 0/40 | 1/37 |
| ItchingSkin and subcutaneous tissue disorders | 0/27 | 0/27 | 0/30 | 0/27 | 0/46 | 1/45 | 1/46 | 0/43 | 0/10 | 0/11 | 0/9 | 1/12 | — | 0/13 | 0/13 | 0/12 | 0/24 | 0/27 | 0/27 | 0/29 | 0/26 | 0/40 | 0/41 | 0/38 | 0/40 | 0/37 |
| DiarrheaInfections and infestations | 1/27 | 0/27 | 2/30 | 1/27 | 2/46 | 3/45 | 1/46 | 0/43 | 0/10 | 0/11 | 0/9 | 0/12 | — | 0/13 | 0/13 | 0/12 | 0/24 | 0/27 | 0/27 | 0/29 | 0/26 | 0/40 | 0/41 | 0/38 | 0/40 | 0/37 |
| VomitingGastrointestinal disorders | 0/27 | 0/27 | 0/30 | 0/27 | 1/46 | 0/45 | 0/46 | 0/43 | 0/10 | 0/11 | 0/9 | 0/12 | — | 0/13 | 0/13 | 0/12 | 0/24 | 0/27 | 0/27 | 0/29 | 0/26 | 0/40 | 0/41 | 0/38 | 0/40 | 0/37 |
The Placebo against hookworm in PSAC arm was removed from the trial after discussion with with principal investigators.
| Age, Continuous(years) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age | 4.1 ± 0.9 | 4.0 ± 0.9 | 3.8 ± 1.1 | 4.0 ± 0.9 | 8.9 ± 1.9 | 8.9 ± 1.9 | 8.7 ± 2.0 | 8.8 ± 1.8 | 44.3 ± 12.3 | 40.5 ± 11.9 | 36.6 ± 12.2 | 44.8 ± 15.9 | — | 3.8 ± 1.2 | 3.8 ± 1.3 | 3.8 ± 1.1 | 9.1 ± 2.2 | 9.1 ± 1.9 | 9.8 ± 1.9 | 9.2 ± 2.2 | 9.4 ± 2.3 | 35.4 ± 10.3 | 39.8 ± 12.2 | 36.3 ± 12.2 | 39.2 ± 11.5 | 35.7 ± 12.0 | 17.7 ± 16.3 |
| Sex: Female, Male(Participants) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 16 | 18 | 16 | 18 | 25 | 15 | 19 | 17 | 6 | 9 | 7 | 8 | — | 5 | 9 | 8 | 8 | 12 | 8 | 5 | 7 | 7 | 16 | 7 | 7 | 9 | 282 |
| Male | 11 | 9 | 14 | 9 | 21 | 30 | 27 | 26 | 4 | 2 | 2 | 4 | — | 8 | 4 | 4 | 16 | 15 | 19 | 24 | 19 | 33 | 25 | 31 | 33 | 28 | 418 |
| Race and Ethnicity Not Collected(Participants) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
| T. trichuris median eggs per gram(eggs per gram of stool) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Median | 216 (120 to 438) | 264 (96 to 558) | 210 (144 to 510) | 228 (150 to 726) | 387 (222 to 1068) | 426 (192 to 1266) | 507 (186 to 1134) | 414 (162 to 1116) | 138 (114 to 270) | 168 (114 to 504) | 156 (114 to 288) | 195 (150 to 402) | — | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 294 (162 to 972) |
| T. trichuris infection intensity(Participants) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Light (1-999 epg) | 22 | 22 | 24 | 21 | 32 | 30 | 31 | 30 | 10 | 10 | 9 | 10 | — | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 260 |
| Moderate (1000-9999 epg) | 4 | 5 | 5 | 6 | 14 | 15 | 15 | 12 | 0 | 1 | 0 | 2 | — | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 79 |
| Heavy (>= 10000 epg) | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | — | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Not infected | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | — | 13 | 13 | 11 | 22 | 25 | 27 | 29 | 24 | 39 | 41 | 38 | 40 | 36 | 358 |
| hookworm median eggs per gram(eggs per gram of stool) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Median | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | — | 216 (150 to 618) | 126 (60 to 540) | 252 (111 to 423) | 183 (78 to 450) | 126 (72 to 336) | 138 (78 to 246) | 156 (84 to 528) | 153 (66 to 366) | 157 (96 to 318) | 126 (54 to 444) | 96 (54 to 264) | 189 (63 to 570) | 114 (84 to 216) | 132 (66 to 369) |
| hookworm infection intensity(Participants) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Light (1-1999 epg) | 0 | 0 | 1 | 0 | 1 | 1 | 2 | 3 | 1 | 1 | 0 | 0 | — | 12 | 12 | 11 | 22 | 26 | 27 | 27 | 24 | 38 | 40 | 38 | 40 | 36 | 363 |
| Moderate (2000-3999 epg) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | — | 1 | 1 | 1 | 2 | 1 | 0 | 2 | 0 | 2 | 1 | 0 | 0 | 1 | 12 |
| Heavy (>= 4000 epg) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
| Not infected | 27 | 27 | 29 | 27 | 45 | 44 | 44 | 40 | 9 | 10 | 9 | 12 | — | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 323 |
| A. lumbricoides infection intensity(Participants) | Placebo Against T. Trichiura in PSAC | ALB 200 mg Against T. Trichiura in PSAC | ALB 400 mg Against T. Trichiura in PSAC | ALB 600 mg Against T. Trichiura in PSAC | Placebo Against T. Trichiura in SAC | ALB 400 mg Against T. Trichiura in SAC | ALB 600 mg Against T. Trichiura in SAC | ALB 800 mg Against T. Trichiura in SAC | Placebo Against T. Trichiura in Adults | ALB 400 mg Against T. Trichiura in Adults | ALB 600 mg Against T. Trichiura in Adults | ALB 800 mg Against T. Trichiura in Adults | Placebo Against Hookworm in PSAC | ALB 200 mg Against Hookworm in PSAC | ALB 400 mg Against Hookworm in PSAC | ALB 600 mg Against Hookworm in PSAC | Placebo Against Hookworm in SAC | ALB 200 mg Against Hookworm in SAC | ALB 400 mg Against Hookworm in SAC | ALB 600 mg Against Hookworm in SAC | ALB 800 mg Against Hookworm in SAC | Placebo Against Hookworm in Adults | ALB 200 mg Against Hookworm in Adults | ALB 400 mg Against Hookworm in Adults | ALB 600 mg Against Hookworm in Adults | ALB 800 mg Against Hookworm in Adults | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Light (1-4999 epg) | 2 | 2 | 3 | 2 | 8 | 8 | 4 | 6 | 0 | 1 | 0 | 2 | — | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 44 |
| Moderate (5000-49999 epg) | 2 | 6 | 2 | 1 | 5 | 9 | 6 | 7 | 0 | 2 | 0 | 1 | — | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 41 |
| Heavy (>= 50000 epg) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Not infected | 23 | 19 | 25 | 24 | 33 | 27 | 36 | 30 | 10 | 8 | 9 | 9 | — | 12 | 13 | 11 | 23 | 26 | 27 | 28 | 26 | 40 | 41 | 38 | 39 | 37 | 614 |
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Studies of the drug tested here: Albendazole
Jennifer Keiser