Transmission-Blocking Vaccine Pvs230D1-EPA/Matrix-M in Healthy Malaria-Naive Adults Using a Plasmodium Vivax Controlled Human Malaria Infection and Transmission Model
NCT07930585, Phase 1, Phase 2, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Transmission-Blocking Vaccine Pvs230D1-EPA/Matrix-M in Healthy Malaria-Naive Adults Using a Plasmodium Vivax Controlled Human Malaria Infection and Transmission Model | ClinicalTrials.gov |
| NCT number | NCT07930585 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 220 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ClinicalTrials.gov |
| Conditions | Healthy Volunteers, Malaria, Plasmodium Vivax | ClinicalTrials.gov |
| Interventions | Plasmodium vivax Challenge Agent Derived from PvHMB-CCE001, Pvs230D1-EPA/Matrix-M | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To assess efficacy of Pvs230D1-EPA/MM vaccine using the CHMI-T model. | Day 11 after the administration of the Pv challenge agent. | Transmission of P. vivax to Anopheles spp. using direct skin feeding (DSF) assay as determined by the detection and quantification of oocysts following midgut dissection. | ClinicalTrials.gov |
| Primary | To assess the safety and reactogenicity of Pvs230D1-EPA/MM primary vaccine series in healthy malaria-naive adults. | From inoculation (day 0) to end of study visit (day 224) | Incidence of immediate AEs within 30 minutes following each vaccine dose.Incidence and severity of local and systemic AEs within 14 days following each vaccine dose. Incidence of SAEs for the entire study duration. | ClinicalTrials.gov |
| Secondary | To determine the antibody response to Pvs230D1-EPA/MM primary series and booster vaccine. | From inoculation (day 0) to end of study visit (day 224) | Anti-Pvs230D1 antibody levels and durability of immune response, as measured by enzyme-linked immunosorbent assay (ELISA), at various time points. | ClinicalTrials.gov |
| Secondary | To assess functional activity of Pvs230D1-EPA/MM primary vaccine series and booster vaccine using the CHMI-T model. | From inoculation (day 0) to end of study visit (day 224). | Transmission of P. vivax to Anopheles spp. using membrane feeding assays (MFA) as determined by the detection and quantification of oocysts following midgut dissection and/or other methods. | ClinicalTrials.gov |
| Secondary | To assess the safety of CHMI-T. | From day of Pv challenge agent administration (C0) until 34 days post inoculation. | Incidence and severity of CHMI-T-related local and systemic AEs or SAEs from challenge administration and through mosquito procedures, until 34 days post-challenge agent inoculation. | ClinicalTrials.gov |
| Secondary | To assess the safety and reactogenicity of Pvs230D1-EPA/MM booster vaccine in healthy malaria-naive adults. | From inoculation (day 0) to end of study visit (day 224). | Incidence of immediate adverse events (AEs) within 30 minutes following booster vaccine. Incidence and severity of local and systemic AEs within 14 days following booster vaccine. Incidence of SAEs following booster vaccine for the entire study duration. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.