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NCT07221162 · ClinicalTrials.gov registry record · Phase 1
A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
A Phase 1 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 6
- Study locations
NCT07221162 is a Phase 1 study of COVID-19 that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 140 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT07221162, a Phase 1 study of COVID-19, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of Boost-2867, given intramuscular (IM) with or without adjuvant or intranasal (IN) without adjuvant, as a booster dose to previously vaccinated healthy adults. Each of the study sites will be assigned to enroll either only participants who will receive IM administration (up to 5 sites) or only participants who will receive IN administration (up to 5 sites); no site will administer both IM and IN study product administrations. Within the IM and IN Arms the cohorts will be sequentially enrolled. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating one dose level of Boost-2867 without adjuvant administered IM, three dose levels of Boost-2867 with adjuvant administered IM, and three dose levels of Boost-2867 without adjuvant administered IN. A sample size of 140 participants (20 participants per dose cohort) is anticipated. To evaluate for early safety signals for this first-in-human trial, study product administration of participants enrolled for IM administration and those enrolled for IN administration will proceed in a staged fashion. For Cohorts 1 (IM administration without adjuvant) and 5 (IN administration), which may be enrolled and dosed concurrently, 3 sentinel participants under 50 years of age will be enrolled in each Cohort over at least 2 days. For each of those Cohorts independently, a safety review of halting rules and clinical safety data through at least Day 8 will be conducted by the Protocol Safety Review Team (PSRT) prior to enrollment of the remainder of the cohort. Enrollment, dosing, and safety oversight for IM Cohorts 2, 3, and 4 will proceed in the same fashion as Cohort 1, except that sentinel enrollment need not be spaced over at least 2 days. Similarly, for IN Cohorts 6 and 7, enrollment and safety oversight will proceed in the same fashion as Cohort 5, except that sentinel enrollment need not be spaced over a
Conditions Studied
Interventions
- DRUG Aluminum Hydroxide Suspension
- BIOLOGICAL Boost-2867
- BIOLOGICAL CpG 7909
- OTHER Sodium Chloride, 0.9%
Study Locations (6)
California
- University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine - San Francisco
Maryland
- Center for Immunization Research, Johns Hopkins Bloomberg School Public Health - Baltimore
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
Pennsylvania
- University of Pittsburgh - Medicine - Infectious Diseases - Pittsburgh
Tennessee
- Vanderbilt University Medical Center - Nashville
Washington
- Kaiser Permanente Washington Health Research Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-12-05 |
| Est. Completion | 2026-11-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07221162
The ClinicalTrials.gov registry entry for NCT07221162 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 4 interventions - of which Aluminum Hydroxide Suspension is the first listed.
NCT07221162 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Maryland, Missouri.
Frequently Asked Questions
What is clinical trial NCT07221162 about?
NCT07221162 is a clinical study titled "A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes". This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of Boost-2867, given intramuscular (IM) with or without adjuvant or intranasal (IN) without adjuvant, as a booster dose to previously vaccinated healthy adults. Each of the study sites will be assigned to enroll...
What is the current status of trial NCT07221162?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2025-12-05. Estimated completion is 2026-11-24.
What conditions does trial NCT07221162 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT07221162?
The interventions under investigation include: Aluminum Hydroxide Suspension (DRUG), Boost-2867 (BIOLOGICAL), CpG 7909 (BIOLOGICAL), Sodium Chloride, 0.9% (OTHER).
Who is sponsoring clinical trial NCT07221162?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07221162 being conducted?
This trial has 6 study locations across California, Maryland, Missouri, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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