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A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
NCT07221162 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07221162 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Maryland, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07221162?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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