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NCT02304185 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers
A Phase 1 study, sponsored by Crucell Holland.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT02304185: Completed Phase 1 study, sponsored by Crucell Holland.
NCT02304185 is a Phase 1 study that has completed, run by Crucell Holland. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02304185, a Phase 1 study, has completed, sponsored by Crucell Holland.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodeficiency virus (HIV)-uninfected participants.
Primary Outcome
Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination. These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.
Interventions
- DRUG Placebo
- BIOLOGICAL gp140, 50 mcg
- BIOLOGICAL gp140, 50 mcg + Adjuvant
- BIOLOGICAL gp140, 250 mcg
- BIOLOGICAL gp140, 250 mcg + Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT02304185 record still lists
NCT02304185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02304185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02304185 about?
NCT02304185 is a clinical study titled "Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers". The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodefic...
What is the current status of trial NCT02304185?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2014-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02304185?
The interventions under investigation include: Placebo (DRUG), gp140, 50 mcg (BIOLOGICAL), gp140, 50 mcg + Adjuvant (BIOLOGICAL), gp140, 250 mcg (BIOLOGICAL), gp140, 250 mcg + Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT02304185?
This trial is sponsored by Crucell Holland, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02304185's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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