Trial · NCT03952650
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
NCT03952650, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2022-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa... Trials, record NCT03952650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03952650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
- NCT number
- NCT03952650
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 252 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Malaria
- Interventions
- Chloroquine Phosphate, PfSPZ Challenge, Pyrimethamine, Coartem, ibuprofen
- First posted
- 2019-05-16
- Last updated
- 2022-07-12
- Results first posted
- 2022-07-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Positive Sensitive Blood Smear (sBS) | 7 -12 days post-inoculation | Count of participants with positive sensitive blood smear (sBS) occurring after PfSPZ-CVac immunization starting on day 7 post DVI. Only pilot phase arms (Arms 1a, 2a) were analyzed for this outcome measure. Arms 5a and 6a were not performed, as no patent parasitemia was observed in either Arms 1a or 2a, per the protocol. |
| Primary | Number of Participants With Local and Systemic Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs) | From day of inoculation to 14 days post-inoculation | Count of participants with local and systemic grade 3 signs or symptoms lasting more than 48 hours despite adequate management and serious adverse events (SAEs) occurring after PfSPZ-CVac DVI. Only arm 3a was analyzed for this outcome measure, per the protocol objectives. |
| Primary | Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | For the main phase: from the day of inoculation to approximately 6 months post-3rd inoculation. For the booster phase: from the time of inoculation to approximately 6 months post-booster inoculation | Count of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs) occurring after PfSPZ-CVac immunization. This outcome measure applies to main phase arms 1b, 2b, 4a, and 4b. Arms 5b and 6b were not performed as patent parasitemia with the higher dose of PfSPZ was not observed in the pilot phase (Arms 1a, 2a). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Positive Sensitive Blood Smear (sBS) | 7 -12 days post-inoculation | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Local and Systemic Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs) | From day of inoculation to 14 days post-inoculation | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | For the main phase: from the day of inoculation to approximately 6 months post-3rd inoculation. For the booster phase: from the time of inoculation to approximately 6 months post-booster inoculation | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Positive Sensitive Blood Smear (sBS) | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | Participants | ||
| Number of Participants With Positive Sensitive Blood Smear (sBS) | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | Participants | ||
| Number of Participants With Local and Systemic Grade 3 Adverse Events (AEs) and Serious Adverse Events (SAEs) | 3a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | Participants | ||
| Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 88 | Participants | ||
| Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | 2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 59 | Participants | ||
| Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | 4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 51 | Participants | ||
| Number of Participants With Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | 4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 36 | Participants |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 4 | |
| Overall Study | STARTED | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 90 | |
| Overall Study | STARTED | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 4 | |
| Overall Study | STARTED | 2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 60 | |
| Overall Study | STARTED | 3a - Pilot/Safety: Dosing Interval on Days: 1 | 4 | |
| Overall Study | STARTED | 4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 54 | |
| Overall Study | STARTED | 4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 36 | |
| Overall Study | COMPLETED | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 4 | |
| Overall Study | COMPLETED | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 83 | |
| Overall Study | COMPLETED | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events595
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 1 | 90 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | 2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 1 | 60 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | 3a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | 4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 2 | 54 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | 4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 3 | 36 | 4 |
| other | Abscess | Infections and infestations | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 | 0 |
| other | Abscess | Infections and infestations | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 1 | 90 | 1 |
| other | Abscess | Infections and infestations | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 | 0 |
1 to 10 of 595Source ClinicalTrials.gov
See all 595 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 |
| Total, all-cause mortality | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 1 | 90 |
| Total, all-cause mortality | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 |
| Total, all-cause mortality | 2b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 0 | 60 |
| Total, all-cause mortality | 3a - Pilot/Safety: Dosing Interval on Days: 1 | 0 | 4 |
| Total, all-cause mortality | 4a - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 0 | 54 |
| Total, all-cause mortality | 4b - Safety Comparator: Dosing Interval on Days: 1, 29, 57 | 0 | 36 |
| Total, other adverse events | 1a - Pilot/Safety: Dosing Interval on Days: 1 | 1 | 4 |
| Total, other adverse events | 1b - Safety/Efficacy: Dosing Interval on Days: 1, 29, 57 | 88 | 90 |
| Total, other adverse events | 2a - Pilot/Safety: Dosing Interval on Days: 1 | 1 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 1a - Pilot/Safety: Dosing Interval on Days: 1 vs 2a - Pilot/Safety: Dosing Interval on Days: 1: Number of Participants With Positive Sensitive Blood Smear (sBS) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03952650
GET https://conductscience.org/api/trials/v1/NCT03952650/flow?page=2