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NCT05132907 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein
A Phase 1 study, sponsored by HDT Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT05132907: Completed Phase 1 study, sponsored by HDT Bio.
NCT05132907 is a Phase 1 study that has completed, run by HDT Bio. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05132907, a Phase 1 study, has completed, sponsored by HDT Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine. Safety and tolerability will be the primary endpoint assessed by incidence of adverse events at each dose through 12 months after completion of the vaccination regimen (either one dose, or two doses provided 56 days apart). Immunogenicity evaluations will be conducted for pre-specified timepoints as secondary and exploratory endpoints.
Primary Outcome
Frequency and grade of solicited local and systemic AEs during a 14 day follow-up period after each vaccination (i.e., the day of vaccination and 14 subsequent days).
Interventions
- BIOLOGICAL HDT-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 1 |
What the finished NCT05132907 record still lists
NCT05132907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which HDT-301 is the first listed.
NCT05132907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05132907 about?
NCT05132907 is a clinical study titled "Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein". This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine. Safety and ...
What is the current status of trial NCT05132907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-01-24. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT05132907?
The interventions under investigation include: HDT-301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05132907?
This trial is sponsored by HDT Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05132907's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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