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Blood-Stage Plasmodium Vivax Cell Bank
Phase 1 trial testing HMPBS02-Pv in Malaria in 2 participants. Completed in 15 September 2022.
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 2 |
| Start date | 15 February 2022 |
| Primary completion | 24 June 2022 |
| Estimated completion | 15 September 2022 |
| Sites | 1 location across United States |
National Institute of Allergy and Infectious Diseases (NIAID)
Adults 18 to 50, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Collection of blood for the production of a P. vivax blood-stage parasite bank from study participants following experimental infection with P. vivax isolate HMPBS02-Pv.
| Group | Value | 95% CI |
|---|---|---|
| Healthy Malaria-naive US Adults Between 18 and 50 Years of Age | 2 |
Time frame: Time of enrollment until initiation of antimalarial treatment (10-11 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Healthy Malaria-naive US A… |
|---|---|---|
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Fatigue | General disorders | — |
| Headache | Nervous system disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Malaise | General disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Platelet count decreased | Investigations | — |
| Chest discomfort | General disorders | — |
| Chills | General disorders | — |
| Haemoglobin decreased | Investigations | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Neutrophil count decreased | Investigations | — |
| Proteinuria | Renal and urinary disorders | — |
| Pyrexia | General disorders | — |
| Tachycardia | Cardiac disorders | — |
| White blood cell count decreased | Investigations | — |
Data from ClinicalTrials.gov NCT05095272 adverse events section.
Background: Malaria is caused by a parasite (a type of germ called P. vivax) that is carried by mosquitoes. The disease is transmitted to people when they are bitten by infected mosquitoes. To make drugs and vaccines for malaria, researchers need malaria-infected blood. Plasmodium vivax cell cultures are currently not cultured in vivo, and thus establishing a blood bank from P. vivax infections will be vital for future research. Objective: The goal of this study is to infect people with early-stage malaria, then collect infected blood samples to store in a cell bank for future use. Eligibility: Healthy adults ages 18-50 who will not be living alone during the study period. Design: Participants will be screened with a physical exam, heart health test, and medical history. They will have blood and urine tests. They will take a mental health survey. They must pass an exam to prove they understand the study. Participants will have red blood cells infected with P. vivax injected into an arm vein. They will be observed for side effects. They will get a thermometer to measure their temperature at home. For the next 3 days, they will be monitored via phone call or text. Starting on day 4 after the infection, they will have daily study visits to give blood samples. They will likely develop symptoms of malaria, such as fever, chills, headache, and muscle pain. Participants will be admitted to the hospital for 2-3 days when either they develop symptoms or the daily blood tests detect a certain amount of parasites. Once malaria is confirmed, a sample of their blood will be collected for the cell bank. Then they will be treated for malaria with oral medication that will cure the infection. Those who do not develop malaria will begin treatment after 15 days. Participants will have follow-up visits 28 and 90 days after infection. Participation will last for 3-5 months.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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