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Comparison · NCT03952650-2d64605f

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)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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). Trial comparisons, record NCT03952650-2d64605f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03952650-2d64605f

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.49wilson
Risk in group 2000.49wilson
Risk difference, group 1 minus group 20-0.490.49newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 11a - Pilot/Safety: Dosing Interval on Days: 1Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 0 post PfSPZ04OG000
Group 22a - Pilot/Safety: Dosing Interval on Days: 1Participants received 1 dose of 4x10\^5 PfSPZ via direct venus inoculation (DVI) with 75 mg PYR day 2 \& 3 post PfSPZ04OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Positive Sensitive Blood Smear (sBS)
Description
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.
Time frame
7 -12 days post-inoculation
Population

Source ClinicalTrials.gov

Trial

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
Phases
PHASE1, PHASE2
Conditions
Malaria
Interventions
Chloroquine Phosphate, PfSPZ Challenge, Pyrimethamine, Coartem, ibuprofen
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Results first posted
2022-07-12

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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