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MalariaPhase 2NCT03503058

Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria

A Phase 2 study testing PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis and Normal Saline in people with Malaria, run by Sanaria Inc. at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
345 participants
Where
2 sitesIndonesia
Study dates
7 May 2022to 27 Feb 2024
Phase
Phase 2
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A male aged 18-55 years at the time of screening.
  • Assigned to the battalion of study and programmed to accompany it to eastern Indonesia for the duration of the deployment.
  • Freely provides written informed consent to participate in the study.
  • Agrees to adhere to Indonesian military medical guidance regarding screening and treatment of malaria.
  • Physical examination and laboratory results without clinically significant findings that would jeopardize the safety of the participant or the integrity of the study, and a body mass index (BMI) ≤35 kg/m^2.

Who cannot join

  • Previous vaccination with an investigational malaria vaccine.
  • Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination.
  • Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months before the first vaccination. This includes any dose level of oral steroids, but not inhaled steroids or topical steroids.
  • Administration or planned administration of 1 live or 3 or more other type vaccines in the period beginning 28 days before the first study vaccination and ending 28 days after the last vaccination.
  • Confirmed or suspected immunosuppressive or immunodeficient condition.
  • Confirmed or suspected autoimmune disease.
Show all 25Show fewer
  • History of allergic reactions or anaphylaxis to CQ or other 4-aminoquinolone derivatives.
  • History of serious allergic reactions to a drug (anaphylaxis, or requiring hospitalization).
  • History of allergy to phosphate buffered saline or human serum albumin.
  • Use or planned use of any drug with anti-malarial activity during the course of the study except for antimalarial medication administered by study clinicians.
  • History of splenectomy.
  • Laboratory evidence of liver disease (the final decision will be made by the PI and clinical officers, but in general a volunteer will be excluded if any of the screening liver function tests (ALT, bilirubin, gamma GTP) are > double the upper limit of normal measured twice without an explanation for the abnormal values).
  • Laboratory evidence of renal disease (serum creatinine > 1.5 mg/dL. measured twice).
  • Laboratory evidence of hematologic disease (platelet count or hemoglobin <80% of the lower limit of normal for Indonesia measured twice).
  • Abnormal screening ECG showing prolonged QTc interval (>450 msec) or any signs of arrythmia/irregularity, ischemia, cardiac enlargement considered considered indicative of acute or chronic cardiovascular disease.
  • Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that may increase the risk of participating in the study as determined by the principal investigator or her designee.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the first study vaccination or planned administration during the study period.
  • Simultaneous participation in any other interventional clinical trial.
  • Other conditions that in the opinion of the principal investigator or her designee would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol or might compromise the integrity of the data.
  • Any evidence of active malaria, whether symptomatic or asymptomatic, confirmed by RDT, microscopy or PCR before first injection of PfSPZ Vaccine or PfSPZ-CVac, unless treated by the clinical team.
  • History of non-febrile seizures or atypical febrile seizures.
  • Under treatment for tuberculosis.
  • Laboratory evidence of active infection with hepatitis B, or hepatitis C.
  • Subjects with > 10% 5-year cardiovascular risk (fatal and non-fatal) based on the Gaziano scoring system; subjects in the 18-34 year old age group will be assessed as though they are in the 35-44 age group.
  • History of psychiatric disorders (such as personality disorders, anxiety disorders, or schizophrenia) or behavioral tendencies (including active alcohol or drug abuse) discovered during the screening process that in the opinion of the investigator would make compliance with the protocol difficult.

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Department of Internal Medicine, Universitas Indonesia

    Jakarta, 10430

  • Eijkman-Oxford Clinical Research Unit, Eijkman Institute of Molecular Biology

    Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria in Eastern Indonesia of Two Plasmodium Falciparum Sporozoite Vaccines, Sanaria® PfSPZ Vaccine and Sanaria® PfSPZ-CVac: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial in Healthy Indonesian Adults

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.

Read the detailed description

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.

Conditions
Malaria
Being tested
PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis, Normal Saline, Chloroquine chemoprophylaxis alone
Keywords
Plasmodium falciparum, Sporozoites, PfSPZ
Medical subject headings
Malaria, Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PfSPZ VaccineBiological

    Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)

  • PfSPZ Challenge under chloroquine (CQ) chemoprophylaxisBiological

    Also called PfSPZ-CVac

    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.

  • Normal SalineOther

    Also called NS

    0.9% Sodium chloride

  • Chloroquine chemoprophylaxis aloneDrug

    Also called 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 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.

Study groups in NCT03503058
Study groupRoleWhat they receive
Group 1ExperimentalN=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.
Receives: Biological: PfSPZ Vaccine
Group 2Placebo comparatorN=62 will receive normal saline; three doses of NS administered by DVI given on day 1, 8 and 29.
Receives: Other: Normal Saline
Group 3ExperimentalN=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.
Receives: Biological: PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis
Group 4Placebo comparatorN=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.
Receives: Other: Normal Saline; Drug: Chloroquine chemoprophylaxis alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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).

    Measured: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).

Secondary outcomes (1)

  1. 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).

    Measured: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2018
  2. Study start7 May 2022
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 2024

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503058
Sponsor's protocol ID
IDSPZV1
Status last verified
Mar 2026
First submitted
11 Apr 2018
Last updated
4 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis and Normal Saline in people with Malaria, run by Sanaria Inc. at 2 sites in Indonesia.

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 5 inclusion and 25 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 May 2026). 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?

Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) 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).). The study lists 2 primary outcomes in all. 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 NCT03503058.

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 4 May 2026.

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