Malaria, FalciparumPhase 4PMC-VACNCT07322068
Perennial Malaria Chemoprevention in the Malaria Vaccine Era
A Phase 4 study testing Sulfadoxine pyrimethamine + Amodiaquine and Dihydroartemisinin Piperaquine in people with Malaria, Falciparum, run by Stanford University at 1 site in Uganda.
Trial summary
Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary… Read more about this study
- Who is it for?
- Ages 1 day to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Sulfadoxine pyrimethamine + Amodiaquine and Dihydroartemisinin Piperaquine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,290 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2026to Jun 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 1 day to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Residency in Busia District, Uganda
- Provision of informed consent by the parent/guardian for her child
- Agreement to come to the study clinic for any febrile episode or other illness and avoid, where possible, medications given outside the study protocol
Who cannot join
- Intention of permanently moving outside Busia district during the study period
- Active medical problem requiring inpatient evaluation or chronic medical condition requiring frequent medical attention at the time of screening
- Evidence of sickle cell disease (Hemoglobin SS genotype)
- Biological mother known to be HIV positive
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary vaccination series, or ~9 months of age. The goal of this study is to see whether combining R21 vaccination with two novel perennial malaria chemoprevention regimens can enhance protection against malaria compared with R21 alone. This study will take place at Masafu General Hospital (MGH) in Busia District, a rural area in Southeastern Uganda bordering Lake Victoria.
- Conditions
- Malaria, Falciparum
- Being tested
- Sulfadoxine pyrimethamine + Amodiaquine, Dihydroartemisinin Piperaquine, Dihydroartemisinin Piperaquine Placebo, Sulfadoxine pyrimethamine + Amodiaquine placebo
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine pyrimethamine + AmodiaquineDrug
Also called SPAQ
Each round of study drugs will consist of once daily oral dosing x 3 days. The first daily dose will be directly observed in the study clinic, and day 2 and day 3 doses will be provided for administration at home. Daily dosing of SPAQ will be based on manufacturer's recommendations: infants <12 months of age will receive one dose of 12.5/250 mg SP and 3 daily doses of 76.5 mg AQ, children >=12 months of age will receive one does of 25/5000 mg SP and 3 daily doses of 153 mg AQ.
Dihydroartemisinin PiperaquineDrug
Also called DP
Each round of study drugs will consist of once daily oral dosing x 3 days. The first daily dose will be directly observed in the study clinic, and day 2 and day 3 doses will be provided for administration at home. Daily dosing of DP will consist of half-strength tablets given once a day for 3 consecutive days and will depend on bodyweight, targeting 4 mg/kg of dihydroartemisinin and 24 mg/kg of piperaquine phosphate.
Dihydroartemisinin Piperaquine PlaceboDrug
Also called DP Placebo
Participants receive oral placebos with an identical appearance to DP active drug.
Sulfadoxine pyrimethamine + Amodiaquine placeboDrug
Also called SPAQ Placebo
Participants receive oral placebos with an identical appearance to SPAQ active drug.
| Study group | Role | What they receive |
|---|---|---|
| PMC-Placebo | Placebo comparator | Placebo given at Expanded Program of Immunization (EPI) visits (8 doses of placebo at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will receive DP placebo plus SPAQ placebo. Placebos with an identical appearance to either DP or SPAQ active drugs will be provided by their manufacturers. Receives: Drug: Dihydroartemisinin Piperaquine Placebo; Drug: Sulfadoxine pyrimethamine + Amodiaquine placebo |
| PMC-SPAQ | Experimental | Perennial malaria chemoprevention with sulfadoxine-pyrimethamine + amodiaquine (SPAQ) given at Expanded Program of Immunization (EPI) visits (8 doses of SPAQ at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will also receive DP placebo along with active SPAQ. Placebo with an identical appearance to DP active drug will be provided by its manufacturer. Receives: Drug: Sulfadoxine pyrimethamine + Amodiaquine; Drug: Dihydroartemisinin Piperaquine Placebo |
| PMC-DP | Experimental | Perennial malaria chemoprevention with dihydroartemisinin-piperaquine (DP) given at Expanded Program of Immunization (EPI) visits (8 doses of DP at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will also receive SPAQ placebo along with active DP. Placebo with an identical appearance to SPAQ active drug will be provided by its manufacturer. Receives: Drug: Dihydroartemisinin Piperaquine; Drug: Sulfadoxine pyrimethamine + Amodiaquine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic malaria
The incidence of symptomatic malaria is defined as the number of incident episodes of malaria requiring treatment per time at risk. Treatments within 14 days of a prior episode are not considered incident events.
Measured: 2.5 months to 60 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2033 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Infectious Diseases Research Collaboration, Uganda, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Prasanna Jagannathan, Stanford University
- Investigators
- Prasanna Jagannathan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322068
- Sponsor's protocol ID
- 84540
- Acronym
- PMC-VAC
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical data will be recorded on case report forms, a study database will be updated monthly, and available (blinded) data will be shared with project investigators. Monthly reports will be generated for all investigators, including data summaries, number and type of assays performed, quality control checks, etc. To facilitate interpretation of the data, study protocols, data dictionaries, and documentation related to any of the data described above will be made publicly available. The same is true for any additional metadata used in the analyses resulting in publications including data on interventions. For parasite genomic and host immunologic data deposited in public repositories (e.g. GEO, IMMPORT), project, study, sample, experimental, and file level metadata will be provided using templates provided by GEO and SRA data repositories or IMMPORT.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perennial Malaria Chemoprevention in the Malaria Vaccine Era
- ClinicalTrials.gov ID
- NCT07322068
- Acronym / sponsor ID
- PMC-VAC / 84540
- Conditions
- Malaria, Falciparum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,290 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Infectious Diseases Research Collaboration, Uganda, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary vaccination series, or ~9 months of age. The goal of this study is to see whether combining R21 vaccination with two novel perennial malaria chemoprevention regimens can enhance protection against malaria compared with R21 alone. This study will take place at Masafu General Hospital (MGH) in Busia District, a rural area in Southeastern Uganda bordering Lake Victoria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMC-Placebo | Placebo comparator | Drug: Dihydroartemisinin Piperaquine Placebo, Drug: Sulfadoxine pyrimethamine + Amodiaquine placeboPlacebo given at Expanded Program of Immunization (EPI) visits (8 doses of placebo at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age). Participants will receive DP placebo plus SPAQ placebo. Placebos with an identical appearance to either DP or SPAQ active drugs will be provided by their manufacturers. |
| PMC-SPAQ | Experimental | Drug: Sulfadoxine pyrimethamine + Amodiaquine, Drug: Dihydroartemisinin Piperaquine PlaceboPerennial malaria chemoprevention with sulfadoxine-pyrimethamine + amodiaquine (SPAQ) given at Expanded Program of Immunization (EPI) visits (8 doses of SPAQ at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age). Participants will also receive DP placebo along with active SPAQ. Placebo with an identical appearance to DP active drug will be provided by its manufacturer. |
| PMC-DP | Experimental | Drug: Dihydroartemisinin Piperaquine, Drug: Sulfadoxine pyrimethamine + Amodiaquine placeboPerennial malaria chemoprevention with dihydroartemisinin-piperaquine (DP) given at Expanded Program of Immunization (EPI) visits (8 doses of DP at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age). Participants will also receive SPAQ placebo along with active DP. Placebo with an identical appearance to SPAQ active drug will be provided by its manufacturer. |
Who may qualify
- Ages
- 1 day to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Residency in Busia District, Uganda
- Provision of informed consent by the parent/guardian for her child
- Agreement to come to the study clinic for any febrile episode or other illness and avoid, where possible, medications given outside the study protocol
Key exclusion criteria (4 listed)
- Intention of permanently moving outside Busia district during the study period
- Active medical problem requiring inpatient evaluation or chronic medical condition requiring frequent medical attention at the time of screening
- Evidence of sickle cell disease (Hemoglobin SS genotype)
- Biological mother known to be HIV positive
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 |
|---|---|---|
| Sulfadoxine pyrimethamine + AmodiaquineAlso: SPAQEach round of study drugs will consist of once daily oral dosing x 3 days. The first daily dose will be directly observed in the study clinic, and day 2 and day 3 doses will be provided for administration at home. Daily dosing of SPAQ will be based on manufacturer's recommendations: infants <12 months of age will receive one dose of 12.5/250 mg SP and 3 daily doses of 76.5 mg AQ, children >=12 months of age will receive one does of 25/5000 mg SP and 3 daily doses of 153 mg AQ. | Drug | PMC-SPAQ |
| Dihydroartemisinin PiperaquineAlso: DPEach round of study drugs will consist of once daily oral dosing x 3 days. The first daily dose will be directly observed in the study clinic, and day 2 and day 3 doses will be provided for administration at home. Daily dosing of DP will consist of half-strength tablets given once a day for 3 consecutive days and will depend on bodyweight, targeting 4 mg/kg of dihydroartemisinin and 24 mg/kg of piperaquine phosphate. | Drug | PMC-DP |
| Dihydroartemisinin Piperaquine PlaceboAlso: DP PlaceboParticipants receive oral placebos with an identical appearance to DP active drug. | Drug | PMC-Placebo, PMC-SPAQ |
| Sulfadoxine pyrimethamine + Amodiaquine placeboAlso: SPAQ PlaceboParticipants receive oral placebos with an identical appearance to SPAQ active drug. | Drug | PMC-DP, PMC-Placebo |
Primary outcome
Incidence of symptomatic malaria
Time frame: 2.5 months to 60 months of age
The incidence of symptomatic malaria is defined as the number of incident episodes of malaria requiring treatment per time at risk. Treatments within 14 days of a prior episode are not considered incident events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Yes. Clinical data will be recorded on case report forms, a study database will be updated monthly, and available (blinded) data will be shared with project investigators. Monthly reports will be generated for all investigators, including data summaries, number and type of assays performed, quality control checks, etc. To facilitate interpretation of the data, study protocols, data dictionaries, and documentation related to any of the data described above will be made publicly available. The same is true for any additional metadata used in the analyses resulting in publications including data on interventions. For parasite genomic and host immunologic data deposited in public repositories (e.g. GEO, IMMPORT), project, study, sample, experimental, and file level metadata will be provided using templates provided by GEO and SRA data repositories or IMMPORT.
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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.
Prasanna Jagannathan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfadoxine pyrimethamine + Amodiaquine and Dihydroartemisinin Piperaquine in people with Malaria, Falciparum, run by Stanford University at 1 site in Uganda.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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 Uganda. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of symptomatic malaria (time frame: 2.5 months to 60 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.