NCT07666750 EDV-01 Dysentery, Bacillary Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07666750 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07666750 is a hot trial to watch
Dysentery, Bacillary is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07666750 is notable because it evaluates EDV-01 in a Phase 1/2 design sponsored by International Vaccine Institute. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07666750 |
| Official title | Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants |
| Phase / status | Phase 1/2 / Not yet recruiting |
| Intervention | EDV-01 |
| Sponsor | International Vaccine Institute |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE) |
| Endpoint time frame | through study completion, an average of 6 months |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali. This first-in-human study is intended to obtain initial data on the safety of the adjuvanted IP-QSV vaccine and its effect on immune responses in a Shigella-endemic region.
Allocation is Randomized, masking is Quadruple, and the intervention model is Sequential Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE) (through study completion, an average of 6 months) — Occurrence of any SAE / AESI / MAAE from the first dose vaccination throughout the final study visit
- Immediate adverse events (Within 30 minutes post each dose) — Occurrence of immediate adverse events within 30 minutes after each dose vaccination
- Solicited adverse events (Within 7 days post each dose) — Occurrence of solicited injection site and solicited systemic adverse events from the time of each study vaccination through 7 days after each study vaccination
- Unsolicited adverse events (Within 28 days post each dose) — Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: EDV-01 is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: International Vaccine Institute is resolved to a normalized organization record in South Korea. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07666750 provides a focused lens on Dysentery, Bacillary development. Its value will be determined by whether EDV-01 can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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