MalariaPhase 1NCT05095272
Blood-Stage Plasmodium Vivax Cell Bank
A Phase 1 study testing HMPBS02-Pv in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- HMPBS02-Pv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 15 Sep 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All of the following criteria must be fulfilled for a participant to participate in this trial:
- Age >=18 and <=50 years.
- In good general health and without clinically significant medical history.
- Does not live alone from study Day 0 until the end of the antimalarial drug treatment.
- Malaria comprehension exam completed, passed (a score of >=80% or per investigator s discretion) and reviewed prior to enrollment.
- Reliable access to the NIH CC and availability to participate for duration of study.
- Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to study Day 0 to 28 days following IBSM.
- Sign written informed consent prior to undertaking any study-related procedure.
Who cannot join
- A participant will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Currently breastfeeding (if female).
- Pregnant as determined by a positive urine or serum human choriogonadotropin (Beta-hCG) test (if female).
- Planned travel to a malaria-endemic area during the study period and up to 2 weeks following the EOS visit.
- History of recent travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks during the past 5 years.
- Planned travel to a malaria-endemic region during the course of the study (for endemic regions, see www.cdc.gov/malaria/travelers/country_table).
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- Any history of confirmed malaria diagnosis on peripheral blood smear or by clinical history
- Participation in a previous malaria challenge study.
- Screening laboratory parameters outside of local lab normal range, to include serum-corrected calcium, creatinine, hepatic transaminase enzymes (ALT, AST), total bilirubin (unless the participant has documented Gilbert syndrome), and hemoglobin. Participants may be included at the investigator s discretion for not clinically significant values outside of normal range.
- Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Participant can be included if investigator determine the abnormality is not clinically significant.
- Duffy blood group negative (male or female).
- ABO blood type other than O (male or female).
- Rh blood group negative (females of childbearing potential).
- Anticipated use during the study period, or use within the following periods prior to enrollment of any of the following: Investigational malaria vaccine within the last 2 years; Malaria chemoprophylaxis within the past 6 months; Chronic systemic immunosuppressive medications (>14 days) within 6 months; Blood products or immunoglobulins within the previous 6 months; Systemic antibiotics or medications with potential antimalarial effects within the past 6 weeks; Investigational or non-registered product or vaccine within 30 days; Receipt of any vaccination within 28 days prior to P. vivax IBSM; Medications known to interact with artemether/lumefantrine; Anticoagulants within the past 28 days.
- History of:
- Sickle cell disease, sickle cell trait, or other hemoglobinopathies.
- Splenectomy or functional asplenia.
- Systemic anaphylaxis.
- Any allergic reactions to artemether/lumefantrine, chloroquine (or any 4-aminoquinolines), artemether or other artemisinin derivatives, or their excipients.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
- Blood transfusion.
- Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the investigator.
- Vital signs taken after 5 minutes of resting in seated or supine position that fall outside the following ranges:
- Systolic blood pressure <=90 mm Hg or >=140 mm Hg.
- Diastolic blood pressure <=50 mm Hg or >=90 mm Hg.
- Heart rate <=40 bpm or >=100 bpm.
- Body mass index less than 17.0 or greater than 35.0 kg/m2 at the time of screening.
- History of, or known active cardiac disease including: (1) prior myocardial infarction (heart attack); (2) angina pectoris; (3) congestive heart failure; (4) valvular heart disease; (5) cardiomyopathy; (6) pericarditis; (7) stroke or transient ischemic attack; (8) exertional chest pain or shortness of breath; (9) symptomatic cardiac arrhythmias; (10) clinically relevant bradycardia; or (11) other heart conditions under the care of a doctor.
- Clinically significant electrocardiogram (ECG) findings as determined by the expert study cardiologist, or QTcF >=450 ms, or presence of second- or third-degree atrioventricular block or abnormal T wave morphology.
- Moderate or high risk for coronary heart disease based on National Health and Nutrition Examination Survey (NHANES) I cardiovascular risk assessment (Appendix A).
- Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
- History of electrolyte disturbances, particularly hypokalemia, hypocalcemia, or hypomagnesemia.
- Acute infectious disease or fever (e.g., temperature >=38.5 degrees C) within the 5 days prior to inoculation with malaria parasites.
- Evidence of acute illness within the 4 weeks prior to screening that the investigator deems may compromise participant safety.
- Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibodies, and anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- Positive urine drug test for any drug unless there is an explanation acceptable to the investigator.
- Elevated serum ethanol level.
- Psychiatric condition that precludes compliance with the protocol.
- Suspected or known current alcohol or drug abuse as defined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, at the discretion of the investigator.
- Smoking more than 5 cigarettes or equivalent per day and unable to stop smoking for the duration of admission. Participants may smoke up to 5 cigarettes or equivalent per day for the rest of the study.
- History or presence of alcohol abuse (alcohol consumption of more than 4 standard drinks per day), drug habituation, or any prior intravenous usage of an illicit substance.
- Excessive consumption of beverages or food containing xanthine bases (such as Red Bull, chocolate, etc.), or more than 400 mg of caffeine per day (equivalent to more than 4 cups of coffee per day).
- Ingestion of any poppy seeds within the 24 hours prior to the screening blood test (participants will be advised by phone not to consume any poppy seeds in this time period).
- Use of prescription drugs or non-prescription drugs and herbal supplements (such as St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to the inoculation administration. (Note: diazepam interferes with the analysis of blood levels of chloroquine and thus should not have been used for at least 8 weeks prior to administration of the study drug). If needed (i.e., an incidental and limited need), ibuprofen up to 1.2 g/day or acetaminophen up to 4 g/day is acceptable. The participant must inform the investigator of any ibuprofen or acetaminophen use at the next convenient time. Limited use of other non-prescription medications or dietary supplements not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor in consultation with the investigator. Participants are requested to refrain from taking non-approved concomitant medications from recruitment until the conclusion of the study.
- Clinical trial staff with direct involvement in the conduct of the trial are excluded from participation.
- Participating in other clinical trials involving investigational interventions or off-label medication use during the study period or within the 12 weeks preceding study day 0. Participation in other trials such as observational or imaging studies will be discussed with the investigators.
- Blood donation of any volume within 4 weeks prior to study day 0, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to Red Cross (or other) blood bank within 8 weeks prior to study day 0.
- Unwillingness to defer blood donations for at least 3 years.
- Unwillingness to abstain from consumption of quinine-containing foods/beverages, such as tonic water or lemon bitter, from inoculation (study day 0) to the end of antimalarial treatment.
- Unwillingness to abstain from consumption of grapefruit or Seville oranges from inoculation (study day 0) to the end of antimalarial treatment.
- Any participant without a good peripheral venous access.
- Participant who, in the judgment of the investigator, is likely to be noncompliant during the study, or is unable to cooperate because of a language or mental deficit.
- Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant s ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Induced Blood-Stage Plasmodium Vivax Infection With HMPBS02-Pv Challenge Agent in Healthy Malaria-Naive Adults to Produce a Plasmodium Vivax Parasite Cell Bank for Future Studies
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.
Read more
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.
Read the detailed description
This is a single-center, open-label study using induced blood-stage malaria (IBSM) to produce a human malaria parasite (HMP) bank for use in future studies. This study will be conducted in up to two participants. Participants will be inoculated intravenously (IV) with human malaria parasite blood stage P. vivax (HMPBS02-Pv) parasite-infected erythrocytes (day 0) and then monitored closely via outpatient clinic visits, phone visits, and while inpatient at the NIH Clinical Center (CC) for symptoms and signs of malaria to characterize the safety, tolerability, and infectivity in healthy malaria-naive participants inoculated with P. vivax. Blood sampling will be done periodically to measure parasitemia via quantitative polymerase chain reaction (qPCR) targeting the P. vivax 18S rRNA gene.
The threshold for the commencement of collection of blood for production of the HMP bank and subsequent antimalarial rescue treatment with artemether/lumefantrine will occur when the Malaria Clinical Score is >6 (admission within 24 hours of notification), or parasitemia is >20,000 parasites/mL, or at the investigator s discretion. When this threshold is reached, the participant will be admitted to the NIH CC for further safety assessments before undergoing the blood collection procedure.
After blood collection, the first dose of artemether/lumefantrine will be administered and the participant will remain inpatient for 48-72 hours to monitor for safety and tolerability of rescue therapy, and to ensure adequate clinical and parasitological response to treatment. In the unlikely and unprecedented event that artemether/lumefantrine fails to clear parasitemia, participants will be treated with chloroquine. If oral administration of either artemether/lumefantrine or chloroquine is not possible (e.g., the participant is vomiting), the participant will receive IV treatment with artesunate. After discharge, participants will be followed on an outpatient basis for monitoring of safety and parasite clearance. Follow-up for safety assessments will be performed on day 28 plus or minus 3, day 56 plus or minus 7 (phone call only), and day 90 plus or minus 7 (End of Study).
Participants may also be evaluated for the presence of sexual parasite stages (gametocytes) and other parasite lifecycle stages in the blood during the study using quantitative reverse transcriptase PCR (qRT-PCR).
Objectives: Primary Objective: The collection of blood from healthy participants experimentally infected with P. vivax isolate HMPBS02-Pv for the production of a P. vivax blood-stage parasite bank for use in future studies.
Secondary Objective: To assess the safety and tolerability of the P.vivax IBSM model following inoculation of healthy malaria-naive participants with P. vivax.
Exploratory Objective: To further characterize blood- and sexual stage parasite growth profiles following inoculation with P. vivax isolate and treatment with artemether/lumefantrine.
Endpoints: Primary Endpoint: 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.
Secondary Endpoint: Occurrence of solicited and unsolicited adverse events (AEs) following P. vivax inoculation prior to the initiation of antimalarial treatment.
Exploratory Endpoint: The rate of growth of blood- and sexual-stage P. vivax isolate following inoculation and treatment with artemether/lumefantrine as determined by blood smear and/or qPCR.
- Conditions
- Malaria
- Being tested
- HMPBS02-Pv
- Keywords
- Malaria, Parasitemia, IBSM, inoculation, Challenge
- Medical subject headings
- Malaria, Parasitemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPBS02-PvBiological
The blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine.
| Study group | Role | What they receive |
|---|---|---|
| Healthy malaria-naive US adults | Experimental | A single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV Receives: Biological: HMPBS02-Pv |
What is being measured
The primary outcome is the main question the study is designed to answer.
P. Vivax Blood Collection
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.
Measured: Time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start15 Feb 2022
- Primary completion24 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patrick E Duffy, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095272
- Sponsor's protocol ID
- 10000212
- Other IDs
- 000212-I
- Status last verified
- Aug 2022
- First submitted
- 26 Oct 2021
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffin P, Pasay C, Elliott S, Sekuloski S, Sikulu M, Hugo L, Khoury D, Cromer D, Davenport M, Sattabongkot J, Ivinson K, Ockenhouse C, McCarthy J. Safety and Reproducibility of a Clinical Trial System Using Induced Blood Stage Plasmodium vivax Infection and Its Potential as a Model to Evaluate Malaria Transmission. PLoS Negl Trop Dis. 2016 Dec 8;10(12):e0005139. doi: 10.1371/journal.pntd.0005139. eCollection 2016 Dec.
PubMed 27930652McCarthy JS, Griffin PM, Sekuloski S, Bright AT, Rockett R, Looke D, Elliott S, Whiley D, Sloots T, Winzeler EA, Trenholme KR. Experimentally induced blood-stage Plasmodium vivax infection in healthy volunteers. J Infect Dis. 2013 Nov 15;208(10):1688-94. doi: 10.1093/infdis/jit394. Epub 2013 Aug 1.
PubMed 23908484Collins KA, Wang CY, Adams M, Mitchell H, Robinson GJ, Rampton M, Elliott S, Odedra A, Khoury D, Ballard E, Shelper TB, Lucantoni L, Avery VM, Chalon S, Moehrle JJ, McCarthy JS. A Plasmodium vivax experimental human infection model for evaluating efficacy of interventions. J Clin Invest. 2020 Jun 1;130(6):2920-2927. doi: 10.1172/JCI134923.
PubMed 32045385
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Blood-Stage Plasmodium Vivax Infection With HMPBS02-Pv Challenge Agent in Healthy Malaria-Naive Adults to Produce a Plasmodium Vivax Parasite Cell Bank for Future Studies
- ClinicalTrials.gov ID
- NCT05095272
- Acronym / sponsor ID
- 10000212
- Conditions
- Malaria
- Keywords
- Malaria, Parasitemia, IBSM, inoculation, Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, open-label study using induced blood-stage malaria (IBSM) to produce a human malaria parasite (HMP) bank for use in future studies. This study will be conducted in up to two participants. Participants will be inoculated intravenously (IV) with human malaria parasite blood stage P. vivax (HMPBS02-Pv) parasite-infected erythrocytes (day 0) and then monitored closely via outpatient clinic visits, phone visits, and while inpatient at the NIH Clinical Center (CC) for symptoms and signs of malaria to characterize the safety, tolerability, and infectivity in healthy malaria-naive participants inoculated with P. vivax. Blood sampling will be done periodically to measure parasitemia via quantitative polymerase chain reaction (qPCR) targeting the P. vivax 18S rRNA gene.
The threshold for the commencement of collection of blood for production of the HMP bank and subsequent antimalarial rescue treatment with artemether/lumefantrine will occur when the Malaria Clinical Score is >6 (admission within 24 hours of notification), or parasitemia is >20,000 parasites/mL, or at the investigator s discretion. When this threshold is reached, the participant will be admitted to the NIH CC for further safety assessments before undergoing the blood collection procedure.
After blood collection, the first dose of artemether/lumefantrine will be administered and the participant will remain inpatient for 48-72 hours to monitor for safety and tolerability of rescue therapy, and to ensure adequate clinical and parasitological response to treatment. In the unlikely and unprecedented event that artemether/lumefantrine fails to clear parasitemia, participants will be treated with chloroquine. If oral administration of either artemether/lumefantrine or chloroquine is not possible (e.g., the participant is vomiting), the participant will receive IV treatment with artesunate. After discharge, participants will be followed on an outpatient basis for monitoring of safety and parasite clearance. Follow-up for safety assessments will be performed on day 28 plus or minus 3, day 56 plus or minus 7 (phone call only), and day 90 plus or minus 7 (End of Study).
Participants may also be evaluated for the presence of sexual parasite stages (gametocytes) and other parasite lifecycle stages in the blood during the study using quantitative reverse transcriptase PCR (qRT-PCR).
Objectives: Primary Objective: The collection of blood from healthy participants experimentally infected with P. vivax isolate HMPBS02-Pv for the production of a P. vivax blood-stage parasite bank for use in future studies.
Secondary Objective: To assess the safety and tolerability of the P.vivax IBSM model following inoculation of healthy malaria-naive participants with P. vivax.
Exploratory Objective: To further characterize blood- and sexual stage parasite growth profiles following inoculation with P. vivax isolate and treatment with artemether/lumefantrine.
Endpoints: Primary Endpoint: 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.
Secondary Endpoint: Occurrence of solicited and unsolicited adverse events (AEs) following P. vivax inoculation prior to the initiation of antimalarial treatment.
Exploratory Endpoint: The rate of growth of blood- and sexual-stage P. vivax isolate following inoculation and treatment with artemether/lumefantrine as determined by blood smear and/or qPCR.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy malaria-naive US adults | Experimental | Biological: HMPBS02-PvA single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- All of the following criteria must be fulfilled for a participant to participate in this trial:
- Age >=18 and <=50 years.
- In good general health and without clinically significant medical history.
- Does not live alone from study Day 0 until the end of the antimalarial drug treatment.
- Malaria comprehension exam completed, passed (a score of >=80% or per investigator s discretion) and reviewed prior to enrollment.
Key exclusion criteria (53 listed)
- A participant will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Currently breastfeeding (if female).
- Pregnant as determined by a positive urine or serum human choriogonadotropin (Beta-hCG) test (if female).
- Planned travel to a malaria-endemic area during the study period and up to 2 weeks following the EOS visit.
- History of recent travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks during the past 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPBS02-PvThe blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine. | Biological | Healthy malaria-naive US adults |
Primary outcome
P. Vivax Blood Collection
Time frame: Time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27930652Griffin P, Pasay C, Elliott S, Sekuloski S, Sikulu M, Hugo L, Khoury D, Cromer D, Davenport M, Sattabongkot J, Ivinson K, Ockenhouse C, McCarthy J. Safety and Reproducibility of a Clinical Trial System Using Induced Blood Stage Plasmodium vivax Infection and Its Potential as a Model to Evaluate Malaria Transmission. PLoS Negl Trop Dis. 2016 Dec 8;10(12):e0005139. doi: 10.1371/journal.pntd.0005139. eCollection 2016 Dec.
- Background: PubMed 23908484McCarthy JS, Griffin PM, Sekuloski S, Bright AT, Rockett R, Looke D, Elliott S, Whiley D, Sloots T, Winzeler EA, Trenholme KR. Experimentally induced blood-stage Plasmodium vivax infection in healthy volunteers. J Infect Dis. 2013 Nov 15;208(10):1688-94. doi: 10.1093/infdis/jit394. Epub 2013 Aug 1.
- Background: PubMed 32045385Collins KA, Wang CY, Adams M, Mitchell H, Robinson GJ, Rampton M, Elliott S, Odedra A, Khoury D, Ballard E, Shelper TB, Lucantoni L, Avery VM, Chalon S, Moehrle JJ, McCarthy JS. A Plasmodium vivax experimental human infection model for evaluating efficacy of interventions. J Clin Invest. 2020 Jun 1;130(6):2920-2927. doi: 10.1172/JCI134923.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick E Duffy, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPBS02-Pv in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P. Vivax Blood Collection (time frame: Time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095272, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.