A Phase 2 interventional study of PfSPZ Vaccine and PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis in Malaria, sponsored by Sanaria Inc.. Completed at 2 sites in Indonesia. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Sanaria Inc. · Phase 2, Interventional, and Prevention
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in healthy Indonesian soldiers deployed to eastern Indonesia.
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in 372 healthy Indonesian soldiers aged 18-55 years who will be deployed in malarious eastern Indonesia.
PfSPZ Vaccine and PfSPZ-CVac:
Participants will be randomized to immunization with three doses of PfSPZ Vaccine (Group 1), normal saline (NS) placebo (Group 2) and PfSPZ-CVac (PfSPZ Challenge + CQ) (Group 3) or NS placebo + CQ (Group 4); randomization to four groups will be 1 : 0.5 : 1 : 0.5.
The study has three phases: immunization and follow-up at the home base; deployment to eastern Indonesia for 6 to 9 months (surveillance period #1); redeployment to the home base for 6 months (surveillance period #2); study participation will be up to 20 months per participant, and the entire clinical trial will last approximately 28 months if deployment lasts 9 months. A research monitor (RM) (= medical monitor = safety monitor) and a safety monitoring committee (SMC) will provide safety oversight. External study monitoring will be the responsibility of Sanaria or Sanaria's designated and authorized representative in Indonesia. Screening will be done within 56 days of enrollment and immunizations will be completed prior to deployment. Screening evaluation includes an electrocardiogram (ECG) performed at screening. Subjects with clinically significant abnormal cardiovascular symptoms or findings will be excluded and referred to a cardiologist for further evaluation; individuals with a history of non-febrile seizures will also be excluded. Solicited adverse events will be monitored for 7 days after each PfSPZ Vaccine/placebo administration and for 14 days after each PfSPZ-CVac/placebo administration; unsolicited adverse events will be followed during the immunization period and up to 2 weeks after the last immunization if the deployment schedule allows; serious adverse events (SAEs) will be monitored throughout the study. Follow-up of AEs occurs until resolution or stability. Case report forms (CRFs) will serve as the repository of source documents and other relevant data for each study subject. Only information that cannot be collected initially into the CRF (namely, laboratory test results, ECGs and adverse event (AE) medical records, etc.) will first be collected onto separate source documents before transcription into the CRF. The information in the CRF will then be manually entered directly into the internet data system by independent data entry technicians.
Study Arms:
Group 1 (n=124): Three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine. Group 2 (n=62): Three doses of NS. Group 3 (n=124): Three doses of 2x10\^5 PfSPZ of PfSPZ Challenge and weekly CQ. Group 4 (n=62): Three doses of NS and weekly CQ.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 345 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Sanaria Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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 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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
N=124 will receive PfSPZ Vaccine; three doses of 9x10\^5 PfSPZ of PfSPZ Vaccine administered by direct venous inoculation (DVI) given on day 1, 8 and 29.
Biological: PfSPZ Vaccine
N=62 will receive normal saline; three doses of NS administered by DVI given on day 1, 8 and 29.
Other: Normal Saline
N=124 will receive PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis; three doses of 2x10\^5 PfSPZ of PfSPZ Challenge administered by DVI on day 1, 29 and 57, with weekly CQ. Loading Dose: 10 mg/kg of CQ base (will be orally administered as a single loading dose to the participant by the study staff via directly observed therapy on PfSPZ-CVac Day -2. Weekly Dose: Subsequent doses of maintenance dose CQ (5 mg/kg CQ base) will be given weekly as a single dose, with the last dose 5 days after the last dose of PfSPZ Challenge.
Biological: PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis
N=62 will receive normal; three doses of NS administered by DVI given on day 1, 29 and 57, with weekly CQ. Loading Dose: 10 mg/kg of CQ base (will be orally administered as a single loading dose to the participant by the study staff via directly observed therapy on PfSPZ-CVac Day -2. Weekly Dose: Subsequent doses of maintenance dose CQ (5 mg/kg CQ base) will be given weekly as a single dose, with the last dose 5 days after the last dose of PfSPZ Challenge.
Other: Normal Saline · Drug: Chloroquine chemoprophylaxis alone
Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)
Infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Challenge) administered under CQ chemoprophylaxis Loading Dose: 10 mg/kg of CQ base (will be orally administered as a single loading dose to the participant by the study staff via directly observed therapy on PfSPZ-CVac Day -2. Weekly Dose: Subsequent doses of maintenance dose CQ (5 mg/kg CQ base) will be given weekly as a single dose, with the last dose 5 days after the last dose of PfSPZ Challenge.
Also known as: PfSPZ-CVac
0.9% Sodium chloride
Also known as: NS
Loading Dose: 10 mg/kg of CQ base (will be orally administered as a single loading dose to the participant by the study staff via directly observed therapy on NS Day -2. Weekly Dose: Subsequent doses of maintenance dose CQ (5 mg/kg CQ base) will be given weekly as a single dose, with the last dose 5 days after the last dose of NS.
Also known as: CQ
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
1. The proportion of participants experiencing solicited AEs occurring within 7 days (PfSPZ Vaccine) or 14 days (PfSPZ-CVac) of each administration of investigational product (IP). 2. The proportion of participants experiencing serious adverse events (SAEs) deemed related to IP during active participation in the trial. 3. The proportion of participants experiencing unsolicited AEs occurring within 14 days of each administration of IP deemed related to vaccination or placebo administration.
Time frame: PfSPZ Vaccine: 7 days after each vaccination (2 days for local solicited AEs); PfSPZ-CVac: 14 days after each administration; SAEs for both products: from day of immunization until end of study (20 months-immunizations started ~2 months after FSFV).
Primary Efficacy Endpoint - Number of Participants With First Clinical Pf Malaria Cases
The deployment surveillance period was from 10 days after arriving in Papua to 2 days before departure (which was the last day that the clinical team had access to the study population). Primary endpoint: number of first clinical malaria cases caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Clinical malaria caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test) plus * measured axillary temperature ≥ 37.5 degrees Celsius or history of fever in the last 24 hours; or * at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; or * meeting criteria for severe malaria (this third option was not used).
Time frame: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).
Secondary Efficacy Endpoint - Number of Confirmed First Infections Caused by Pf
The deployment surveillance period extended from 10 days after arriving in Papua to two days before departure (which was the last day that the clinical team had access to the study population). Secondary endpoint: number of first infections caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Malaria infection caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test).
Time frame: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).
The study lasted about 22 months (May 2022 to Feb 2024).
| Milestone | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) |
|---|---|---|---|---|
| Started | 115 | 57 | 116 | 57 |
| Completed | 110 | 55 | 113 | 56 |
| Not completed | 5 | 2 | 3 | 1 |
1. The proportion of participants experiencing solicited AEs occurring within 7 days (PfSPZ Vaccine) or 14 days (PfSPZ-CVac) of each administration of investigational product (IP). 2. The proportion of participants experiencing serious adverse events (SAEs) deemed related to IP during active participation in the trial. 3. The proportion of participants experiencing unsolicited AEs occurring within 14 days of each administration of IP deemed related to vaccination or placebo administration.
| participants | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) |
|---|---|---|---|---|
| No. of subjects with local solicited AEs in 2 days (Vaccine) or 14 days (CVac) of each dose. | 6 | 5 | 8 | 3 |
| No. of subjects with systemic solicited AEs in 7 days (Vaccine) or 14 days (CVac) of each dose. | 77 | 36 | 115 | 55 |
| No. of subjects with SAEs deemed related to IP during active participation in the trial. | 0 | 0 | 0 | 0 |
| No. of subjects with unsolicited AEs in14 days of each dose of IP deemed related (IP/placebo). | 23 | 13 | 69 | 30 |
The deployment surveillance period was from 10 days after arriving in Papua to 2 days before departure (which was the last day that the clinical team had access to the study population). Primary endpoint: number of first clinical malaria cases caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Clinical malaria caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test) plus * measured axillary temperature ≥ 37.5 degrees Celsius or history of fever in the last 24 hours; or * at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; or * meeting criteria for severe malaria (this third option was not used).
| participants | Group 1 (PfSPZ Vaccine) | Group 3 (PfSPZ Challenge + CQ) | Placebo Combined (Group 2-NS + Group 4-NS+CQ) |
|---|---|---|---|
| First clinical malaria cases caused by Pf (first 24 weeks of deployment). | 24 | 27 | 47 |
| First clinical malaria cases caused by Pf (entire deployment). | 39 | 44 | 59 |
The deployment surveillance period extended from 10 days after arriving in Papua to two days before departure (which was the last day that the clinical team had access to the study population). Secondary endpoint: number of first infections caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Malaria infection caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test).
| participants | Group 1 (PfSPZ Vaccine) | Group 3 (PfSPZ Challenge + CQ) | Placebo Combined (Group 2-NS + Group 4-NS+CQ) |
|---|---|---|---|
| First infections caused by Pf (first 24 weeks of deployment). | 25 | 27 | 47 |
| First infections caused by Pf (entire deployment). | 39 | 44 | 60 |
Collected over The time frame for data collection is: - PfSPZ Vaccine: 7 days after each vaccination (2 days after each vaccination for local solicited AEs) - PfSPZ-CVac: 14 days after each administration - SAEs for both products: from day of immunization until end of study (24 months). The total period of data collection is approximately between 14 months to 18 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (PfSPZ Vaccine) | 0/115 (0%) | 9/115 (7.8%) | 85/115 (73.9%) |
| Group 2 (NS Placebo) | 0/57 (0%) | 6/57 (10.5%) | 43/57 (75.4%) |
| Group 3 (PfSPZ Challenge + CQ) | 0/116 (0%) | 7/116 (6%) | 115/116 (99.1%) |
| Group 4 (NS Placebo + CQ) | 0/57 (0%) | 4/57 (7%) | 55/57 (96.5%) |
| Event | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) |
|---|---|---|---|---|
| Chemical poisoningInjury, poisoning and procedural complications | 0/115 | 2/57 | 0/116 | 0/57 |
| Appendicitis non-infectiveGastrointestinal disorders | 1/115 | 0/57 | 0/116 | 1/57 |
| FuruncleInfections and infestations | 0/115 | 1/57 | 0/116 | 0/57 |
| MalariaInfections and infestations | 0/115 | 1/57 | 0/116 | 0/57 |
| OrchitisInfections and infestations | 0/115 | 0/57 | 0/116 | 1/57 |
| Plasmodium falciparum infectionInfections and infestations | 0/115 | 1/57 | 0/116 | 1/57 |
| PneumoniaInfections and infestations | 1/115 | 1/57 | 0/116 | 0/57 |
| TuberculosisInfections and infestations | 0/115 | 0/57 | 0/116 | 1/57 |
| Typhoid feverInfections and infestations | 0/115 | 0/57 | 0/116 | 1/57 |
| Systemic viral infectionInfections and infestations | 0/115 | 0/57 | 0/116 | 1/57 |
| Event | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) |
|---|---|---|---|---|
| PyrexiaGeneral disorders | 46/115 | 12/57 | 91/116 | 28/57 |
| HeadacheNervous system disorders | 49/115 | 20/57 | 91/116 | 38/57 |
| FatigueGeneral disorders | 30/115 | 12/57 | 89/116 | 34/57 |
| NasopharyngitisInfections and infestations | 16/115 | 6/57 | 83/116 | 37/57 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/115 | 0/57 | 81/116 | 37/57 |
| ChillsGeneral disorders | 38/115 | 13/57 | 80/116 | 27/57 |
| MalaiseGeneral disorders | 24/115 | 9/57 | 75/116 | 21/57 |
| MyalgiaMusculoskeletal and connective tissue disorders | 38/115 | 14/57 | 73/116 | 22/57 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 25/115 | 9/57 | 64/116 | 17/57 |
| DizzinessNervous system disorders | 1/115 | 0/57 | 56/116 | 26/57 |
| Age, Categorical(Participants) | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 115 | 57 | 116 | 57 | 345 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(Years) | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) | Total |
|---|---|---|---|---|---|
| Median | 23 (19 to 41) | 24 (18 to 34) | 23 (19 to 42) | 23 (19 to 41) | 23 (18 to 42) |
| Sex: Female, Male(Participants) | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 115 | 57 | 116 | 57 | 345 |
| Race (NIH/OMB)(Participants) | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 115 | 57 | 116 | 57 | 345 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group 1 (PfSPZ Vaccine) | Group 2 (NS Placebo) | Group 3 (PfSPZ Challenge + CQ) | Group 4 (NS Placebo + CQ) | Total |
|---|---|---|---|---|---|
| Indonesia | 115 | 57 | 116 | 57 | 345 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2022 to primary completion in Feb 2024, 21 months.
Results were first posted in May 2026, 2 years 2 months after primary completion.
Of 39 phase 2 interventional studies under Malaria, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 27. This study's 21 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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