A Phase 1/2 interventional study of Plasmodium vivax Challenge Agent Derived from PvHMB-CCE001 and Pvs230D1-EPA/Matrix-M in Healthy Volunteers, Malaria and Plasmodium Vivax, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Prevention
Among 112 studies in Malaria by National Institute of Allergy and Infectious Diseases (NIAID) — 9 open to participants now, 10 under way, none of them phase 3. Malaria · National Institute of Allergy and Infectious Diseases (NIAID).
Among the 112 studies in Malaria by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 21st largest by planned enrollment of the 63 interventional ones that give a count, is one of 4 that started in 2026, is one of 3 in phase 1/2, and was the 112th registered.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
Browse Malaria studies →9 of the 112 studies in Malaria by National Institute of Allergy and Infectious Diseases (NIAID) are open now, in 2 countries. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–54 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in Mali
Ages 15–49 · Women only · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–70 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–50 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in Mali
Ages 15–25 · Women only · Healthy volunteers
By country, each count listing its studies:
Of the 51 Malaria studies recruiting now, 15 (29%) set no upper age limit and 33 (65%) stop at 75 or younger; 37 take children under 18; 31 take healthy volunteers.
This study: 18 Years to 54 Years · all sexes · no healthy volunteers.
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112 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 13 · Phase 3 3 · Phase 4 2
First in 1998; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 220 is below the median of 252 across 937 interventional studies indexed under Malaria.
Median enrollment 90 across the 63 interventional studies, 508 across the 48 observational. Of the 97 that completed or were terminated, 20 (21%) have results posted.
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National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
1 of the studies in Malaria by National Institute of Allergy and Infectious Diseases (NIAID) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06607003National Institute of Allergy and Infectious Diseases (NIAID)Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays | 2027-11-26 |
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Among the 112 studies in Malaria by National Institute of Allergy and Infectious Diseases (NIAID), from their registry updates:
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Background:
Malaria is a disease caused by parasites spread by mosquito bites. Researchers want to test a vaccine that could stop mosquitoes from picking up these parasites when they bite infected people. This could stop malaria from spreading.
Objective:
To test a study vaccine (Pvs230D1-EPA/MM) to stop malaria transmission in healthy adults.
Eligibility:
Healthy people aged 18 to 54 years. People who already received the vaccine during a different study are also needed.
Design:
Participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function (a simple electrocardiogram or EKG).
The vaccine is given as an injectionin the upper arm. Participants who have never gotten the study vaccine will get 3 vaccines; each injection will be about 1 month apart. Participants who were vaccinated before will receive only 1 vaccine for this study. All participants will have multiple phone and in-person follow-up visits after each vaccination.
Two to 12 weeks after their last vaccine, all participants will be injected with live malaria parasites. Then they will be seenin the clinic for about 3 days. They will be monitored daily until they develop symptoms of malaria, usually in about 10 days then will be admitted to the NIH hospital.
While in the NIH hospital, participants will have 3 mosquito feedings: Two cups containing mosquitoes will be placed on an arm or leg. The mosquitoes will feed for about 15 minutes. Participants will receive medicines to relieve discomfort from the bites.
Participants will then be treated for malaria. They will have follow-up visits and calls until they fully recover.
Study Description:
This is a single-site, phase 1/2 study of Pvs230D1-EPA/MM and bloodstage controlled human malaria infection and transmission (CHMI-T) model in healthy malaria-naive adults at the NIH Clinical Center (NIHCC), to assess the safety, reactogenicity, and efficacy of Pvs230D1-EPA/Matrix- M (MM). Three doses of the primary vaccine series will be administered at 1-month intervals (study days 0, 28, and 56) to those who are vaccine naive. Concurrently, a fourth (booster) dose will be given to participants who previously received the primary vaccine series while enrolled in NIH protocol 001501, Phase 1 dose escalation study of the Plasmodium vivax transmission-blocking vaccine Pvs230D1-EPA/Matrix-M to assess safety, immunogenicity, and transmission-blocking activity in healthy malaria-naive adults. Two to twelve weeks after the final vaccination, challenge agent derived from a cell bank of cryopreserved blood-stage P. vivax (PvHMB-CCE001) will be administered intravenously (IV). Participants will be monitored and admitted to the NIHCC to undergo safety monitoring, transmission assays, and receive antimalarial treatment. Participants enrolled on NIH protocol 001970, Induced blood-stage malaria in healthy malaria-naive adults to assess the safety and infectivity of Plasmodium vivax challenge agent and evaluate transmission in mosquito feeding assays , will serve as open-label controls. This group includes 10 nonconcurrent controls and 10 controls who will undergo challenge concurrently to vaccinees.
Objectives:
Primary Objectives:
Secondary Objectives:
Exploratory Objectives:
Endpoints:
Primary Endpoints:
Secondary Endpoints:
Exploratory Endpoints:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Participants
In order to participate in this study, an individual must meet all of the following criteria:
Acceptable methods of contraception include the following:
Participants who otherwise are not at risk of becoming pregnant, at the judgement of the investigator will not be required to use contraception. Such participants may include those:
Having an exclusive male partner who has undergone vasectomy at least 4 months prior.
Primary Vaccine Series with CHMI-T Participants
In order to participate in this study an individual must meet all of the following criteria:
Booster Vaccine Participants
In order to participate in this study an individual must meet all of the following criteria:
The following additional criteria must be met in order to for participants to undergo optional CHMI-T:
EXCLUSION CRITERIA:
All Participants
An individual who meets any of the following criteria will be excluded from participation in this study:
Planned travel to a malaria-endemic area (see https://www.cdc.gov/malaria/travelers/country_table/a.html) until 6-months beyond the final vaccination.
--Exceptions may be made, at the investigator s discretion, if the travel is limited to areas without appreciable levels of P. vivax transmission.
For individuals of :
Any of the following within the specified periods:
medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history including:
Screening blood test laboratory parameters outside of local lab normal range.
Primary Vaccine Series Participants
An individual who meets any of the following criteria will be excluded from participation in this study:
For individuals of childbearing potential:
--Rh blood group negative.
Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history including:
Booster Vaccine Participants
An individual who meets any of the following criteria will be excluded from participation in the optional CHMI-T component of the study:
For individuals of childbearing potential:
--Rh blood group negative.
Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history including:
Co-enrollment guidelines: Co-enrollment in other trials is restricted. Consideration for coenrollment, other than enrollment on trials evaluating the use of an investigational malaria vaccine as described above will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol.
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.
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.
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.
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A fourth (booster) dose of of Pvs230D1-EPA/MM will be given to participants who previously received the primary vaccine series while enrolled in NIH protocol 001501, at a dose identical to that which the participant received under NIH Protocol 1501 (i.e., 5microg Pvs230D1-EPA/50microg MM, 25microg Pvs230D1-EPA/50microg MM, or 50microg Pvs230D1-EPA/50microg MM).Optionally, two to twelve weeks after the final vaccination, challenge agent derived from a cell bank of cryopreserved blood-stage P. vivax (PvHMB-CCE001) will be administered intravenously (IV). Participants will be monitored and admitted to the NIHCC to undergo safety monitoring, transmission assays, and receive antimalarial treatment.
Biological: Plasmodium vivax Challenge Agent Derived from PvHMB-CCE001 · Biological: Pvs230D1-EPA/Matrix-M
Participants enrolled on NIH protocol 001970, Induced blood-stage malaria in healthy malaria-naive adults to assess the safety and infectivity of Plasmodium vivax challenge agent and evaluate transmission in mosquito feeding assays , will serve as open-label controls.
Biological: Plasmodium vivax Challenge Agent Derived from PvHMB-CCE001
Three doses of 5microg Pvs230D1-EPA/50microg MM will be administered at 1-month intervals, via intramuscular (IM) injection. Two to twelve weeks after the final vaccination, challenge agent derived from a cell bank of cryopreserved blood-stage P. vivax (PvHMB-CCE001) will be administered intravenously (IV). Participants will be monitored and admitted to the NIHCC to undergo safety monitoring, transmission assays, and receive antimalarial treatment.
Biological: Plasmodium vivax Challenge Agent Derived from PvHMB-CCE001 · Biological: Pvs230D1-EPA/Matrix-M
Challenge agent derived from cryopreserved cell bank PvHMB-CCE001 which contains the P. vivax isolate HMP013 in red blood cells derived from a healthy US adult donor.
A protein subunit conjugate vaccine Pvs230D1-EPA formulated with adjuvant Matrix-M
To assess efficacy of Pvs230D1-EPA/MM vaccine using the CHMI-T model.
Transmission of P. vivax to Anopheles spp. using direct skin feeding (DSF) assay as determined by the detection and quantification of oocysts following midgut dissection.
Time frame: Day 11 after the administration of the Pv challenge agent.
To assess the safety and reactogenicity of Pvs230D1-EPA/MM primary vaccine series in healthy malaria-naive adults.
Incidence of immediate AEs within 30 minutes following each vaccine dose.Incidence and severity of local and systemic AEs within 14 days following each vaccine dose. Incidence of SAEs for the entire study duration.
Time frame: From inoculation (day 0) to end of study visit (day 224)
To determine the antibody response to Pvs230D1-EPA/MM primary series and booster vaccine.
Anti-Pvs230D1 antibody levels and durability of immune response, as measured by enzyme-linked immunosorbent assay (ELISA), at various time points.
Time frame: From inoculation (day 0) to end of study visit (day 224)
To assess functional activity of Pvs230D1-EPA/MM primary vaccine series and booster vaccine using the CHMI-T model.
Transmission of P. vivax to Anopheles spp. using membrane feeding assays (MFA) as determined by the detection and quantification of oocysts following midgut dissection and/or other methods.
Time frame: From inoculation (day 0) to end of study visit (day 224).
To assess the safety of CHMI-T.
Incidence and severity of CHMI-T-related local and systemic AEs or SAEs from challenge administration and through mosquito procedures, until 34 days post-challenge agent inoculation.
Time frame: From day of Pv challenge agent administration (C0) until 34 days post inoculation.
To assess the safety and reactogenicity of Pvs230D1-EPA/MM booster vaccine in healthy malaria-naive adults.
Incidence of immediate adverse events (AEs) within 30 minutes following booster vaccine. Incidence and severity of local and systemic AEs within 14 days following booster vaccine. Incidence of SAEs following booster vaccine for the entire study duration.
Time frame: From inoculation (day 0) to end of study visit (day 224).
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Nov 2029, 35 months later.
Of 16 phase 1/2 interventional studies under Malaria, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID) →