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Virus Therapy

Malaria Challenge Agent for Malaria

Phase 1

Recruiting

Led By Joel A Goldberg, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 and ≤54 years

Be between 18 and 65 years old

Must not have

Use of chronic systemic immunosuppressive medications (>14 days) within 6 months

Current or planned use of medications known to significantly prolong the QT interval or otherwise interfere with study agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of inpatient admission to the time of discharge.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of a malaria challenge agent in participants who have never had malaria before. The challenge agent will be given intravenously and participants will be closely monitored for any

Who is the study for?

This trial is for healthy adults who have never had malaria. They will be part of a study at the NIH Clinical Center to test how safe and effective two types of Plasmodium vivax (a malaria parasite) are in causing controlled malaria infection, which could help develop vaccines.

What is being tested?

The trial involves giving participants one of two P. vivax challenge agents intravenously to induce malaria. The effects will be monitored to find the right dose, understand transmission via mosquitoes, and gather data for future vaccine studies.

What are the potential side effects?

Participants may experience local or systemic adverse events ranging from mild to severe as a result of the induced malaria infection. These side effects will be closely monitored by medical professionals throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 54 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken long-term immune-weakening drugs in the last 6 months.

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I am not taking any medications that affect heart rhythm or interfere with the study treatment.

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I haven't received blood products or immunoglobulins in the last 6 months.

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I am not willing to stop donating blood for 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of inpatient admission to the time of discharge. expected to be approximately 2 days after admission.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of inpatient admission to the time of discharge. expected to be approximately 2 days after admission.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of inpatient admission to the time of discharge. expected to be approximately 2 days after admission. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the safety of the P. vivax IBSM model following inoculation of healthy subjects.

Secondary study objectives

To establish a dataset that may be used as a historical control in future interventional IBSM studies.

To establish an appropriate challenge agent dose for use in P. vivax IBSM studies.

To evaluate transmission of P. vivax to vector mosquitoes in the IBSM model by mosquito feeding assays.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: P. vivax challenge agent derived from PvHMB-CCE002 Pilot ArmExperimental Treatment1 Intervention

1-2 subjects will undergo IBSM to establish the safety and infectivity of the P. vivax challenge agent derived PvHMB-CCE002 challenge agent.

Group II: P. vivax challenge agent derived from PvHMB-CCE002 Main ArmExperimental Treatment1 Intervention

Up to 16 subjects will undergo IBSM to further develop the P. vivax challenge agent derived from PvHMB-CCE002 model including to evaluate transmission to mosquitoes using feeding assays and assess the host response to P. vivax infection.

Group III: P. vivax challenge agent derived from PvHMB-CCE001 Pilot ArmExperimental Treatment1 Intervention

1-2 subjects will undergo IBSM to establish the safety and infectivity of the P. vivax challenge agent derived from PvHMB-CCE001.

Group IV: P. vivax challenge agent derived from PvHMB-CCE001 Main ArmExperimental Treatment1 Intervention

Up to 16 subjects will undergo IBSM to further develop the P. vivax challenge agent derived PvHMB-CCE001 model including to evaluate transmission to mosquitoes using feeding assays and assess the host response to P. vivax infection.

0 / 5Eligibility criteria met