Actively Recruiting
A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-08
140
Participants Needed
8
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 at least 2 days. The primary objectives are: 1) To evaluate the safety and reactogenicity of a single IM injection of three different antigen dose levels (5, 15, and 50 microgram) of Boost-2867 with Alhydrogel (R) (alum) and CpG 7909 adjuvants, and a single injection of 50 microgram Boost-2867 without adjuvant, in previously vaccinated healthy adults. 2) To evaluate the safety and reactogenicity of a single IN administration of three different antigen dose levels (20, 50, and 125 microgram) of Boost-2867 without adjuvant in previously vaccinated healthy adults.
CONDITIONS
Official Title
A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provides written informed consent before study procedures.
- Able to comply with study procedures and attend all visits.
- Adults aged 18 through 64 years, non-pregnant.
- Females of childbearing potential must use acceptable contraception or practice true abstinence.
- Negative urine pregnancy test at screening and within 24 hours before study product administration.
- Generally in good health with stable chronic medical conditions.
- Completed a primary authorized COVID-19 vaccine series and at least one booster dose.
- Clinical laboratory tests within normal limits or grade 1 with no clinical significance.
- Agrees to have samples stored for secondary research.
You will not qualify if you...
- Positive SARS-CoV-2 PCR test at screening.
- Abnormal vital signs with Grade 1 or higher severity.
- SARS-CoV-2 infection within 16 weeks prior to study product administration.
- Pregnant or breastfeeding.
- Blood or plasma donation within 4 weeks before study product administration.
- Receipt of antibody or blood-derived products within 90 days before study product administration.
- Significant medical or psychiatric diseases or conditions that preclude participation.
- Neurological conditions including history of Bell's palsy, seizures, or major neurological diseases.
- Significant respiratory disease requiring daily medication or recent asthma treatment.
- History of cardiovascular disease including myocarditis or uncontrolled arrhythmia.
- Any autoimmune disease without a defined non-autoimmune cause.
- Acute illness within 72 hours before study product administration unless nearly resolved.
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- Immunosuppressive or immunodeficient conditions including recent immunosuppressant use.
- Receipt of investigational products within 60 days before study product administration.
- History of severe allergic reactions to vaccines or components.
- Recent receipt or planned receipt of other vaccines within specified time frames.
- Regular use of intranasal medications or sinus rinsing treatments within specified periods.
- Use of illicit intranasal drugs within 5 years.
- Current smoker or smoked within prior 3 months.
- Planned international travel between product administration and Day 29 visit.
- Significant nasal or upper airway disease including chronic sinusitis or major anatomical abnormalities.
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Trial Site Locations
Total: 8 locations
1
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine
San Francisco, California, United States, 94110
Actively Recruiting
2
Center for Immunization Research, Johns Hopkins Bloomberg School Public Health
Baltimore, Maryland, United States, 21205
Actively Recruiting
3
Saint Louis University Center for Vaccine Development
St Louis, Missouri, United States, 63104-1015
Actively Recruiting
4
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, United States, 14642-0001
Actively Recruiting
5
Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27703
Actively Recruiting
6
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 98101-1466
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
7
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