A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
A Phase 1, Open-Label, Safety and Immunogenicity Trial of Boost-2867, an IgG-Fc-RBD Fusion Protein Next Generation SARS-CoV-2 Booster Vaccine, Via Intranasal and Intramuscular Routes in Previously Vaccinated Adults
1 other identifier
interventional
140
1 country
8
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Dec 2025
Typical duration for phase_1 covid19
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 27, 2025
CompletedStudy Start
First participant enrolled
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 24, 2026
May 1, 2026
March 9, 2026
12 months
October 23, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Occurrence of abnormal clinical safety laboratory adverse events.
Through day 8
Occurrence of adverse events of special interest (AESIs).
Through 6 months
Occurrence of medically attended adverse events (MAAEs).
Through 6 months
Occurrence of new onset chronic medical conditions (NOCMCs).
Through 6 months
Occurrence of potentially immune-mediated diseases (pIMDs)
Through 6 months
Occurrence of Serious adverse events (SAEs).
Through 6 months
Occurrence of solicited local adverse events (AEs).
Through 7 days
Occurrence of solicited systemic adverse events (AEs).
Through 7 days
Occurrence of unsolicited adverse events (AEs).
Through 28 days
Secondary Outcomes (11)
Geometric mean (GM) of nasal mucosal anti-S binding Immunoglobulin A (IgA) antibodies.
Day 1 through 181
Geometric mean (GM) of nasal mucosal anti-S binding Immunoglobulin G (IgG) antibodies.
Day 1 through 181
Geometric mean (GM) of serum anti-spike binding Immunoglobulin A antibodies (IgA).
Days 1 through 181
Geometric mean (GM) of serum anti-spike binding Immunoglobulin G antibodies (IgG).
Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of anti-spike serum neutralizing antibodies to spike variants
Days 1 through 181
- +6 more secondary outcomes
Study Arms (7)
Cohort 1
EXPERIMENTALParticipants will be administered 50 micrograms of Boost-2867 without adjuvant, intramuscularly (IM), to previously vaccinated healthy adults. 3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Cohort 2
EXPERIMENTALParticipants will be administered 5 micrograms of Boost-2867 with Alhydrogel (R) and CpG 7909 adjuvants, intramuscularly (IM), to previously vaccinated healthy adults. 3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Cohort 3
EXPERIMENTALParticipants will be administered 15 micrograms of Boost-2867 with Alhydrogel(R) and CpG 7909 adjuvants, intramuscularly (IM), to previously vaccinated healthy adults. 3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Cohort 4
EXPERIMENTALParticipants will be administered 50 micrograms of Boost-2867 with Alhydrogel (R) and CpG 7909 adjuvants intramuscularly (IM) to previously vaccinated healthy adults. 3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Cohort 5
EXPERIMENTALParticipants will be administered 20 micrograms of Boost-2867 without adjuvant, intranasally (IN) to previously vaccinated healthy adults.3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Cohort 6
EXPERIMENTALParticipants will be administered 50 micrograms of Boost-2867 without adjuvant intranasally (IN) to previously vaccinated healthy adults. 3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Cohort 7
EXPERIMENTALParticipants will be administered 125 micrograms of Boost-2867 without adjuvant intranasally, to previously vaccinated healthy adults. 3 sentinel participants, less than 50 years old, will be enrolled for safety review before enrolling the remainder. N = 20.
Interventions
Boost-2867 is a recombinant \~50 kDa SARS-CoV-2 RBD (KP.2 variant) S1 subunit joined to a human IgG1 Fc, forming a \~100 kDa homodimer.
CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant.
0.9% Sodium Chloride Injection
Eligibility Criteria
You may qualify if:
- Provides written informed consent before initiation of any study procedures.
- Able to understand and agree to comply with planned study procedures and be available for all study visits.
- Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
- Participants of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception\*\*\*.
- These criteria apply to females who are in a heterosexual relationship who are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy).
- True abstinence is 100% of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods.
- Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, intrauterine devices, birth control pills, and injectable/implantable/insertable/transdermal hormonal birth control products. Must have used at least one acceptable primary form of contraception for at least 30 days before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.
- Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.
- In general good health\*.
- Receipt of a complete primary authorized or approved COVID-19 vaccine series and at least one booster\*.
- \* Booster may be either homologous or heterologous to the primary vaccine series. It must be an FDA-authorized/licensed vaccine, though doses may have been received during a clinical trial.
- Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per the investigator's discretion\*.
- Must agree to have samples stored for secondary research.
You may not qualify if:
- Positive SARS-CoV-2 PCR at screening.
- Abnormal vital signs (Grade 1 or higher):
- \*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) \>/= 141 mmHg or \</= 89 mmHg Diastolic blood pressure (DBP) \>/= 91 mmHg Heart rate (HR) is \>/= 101 beats per minute or \</= 54 beats per minute Oral temperature \>/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)
- Self-reported or medically documented SARS-CoV-2 infection (regardless of whether symptomatic or asymptomatic) within 16 weeks prior to study product administration.
- Participant who is 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.
- Any self-reported or documented significant medical or psychiatric diseases\* or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
- \*Significant medical or psychiatric conditions include but are not limited to drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, ongoing malignancy, or recent diagnosis of malignancy in the last five years, excluding treated basal and squamous cell carcinoma of the skin and cervical carcinoma in situ, which are allowed.
- Neurological conditions\*. \*Including history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease.
- History of significant respiratory disease currently requiring daily medications, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years.
- History of cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis, pericarditis, or uncontrolled cardiac arrhythmia.
- Any autoimmune disease, including hypothyroidism, without a defined non-autoimmune cause.
- Has an acute illness determined by the site PI or appropriate sub-investigator within 72 hours before study product administration\*.
- \*An acute illness that is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine
San Francisco, California, 94110, United States
Center for Immunization Research, Johns Hopkins Bloomberg School Public Health
Baltimore, Maryland, 21205, United States
Saint Louis University Center for Vaccine Development
St Louis, Missouri, 63104-1015, United States
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, 14642-0001, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2025
First Posted
October 27, 2025
Study Start
December 5, 2025
Primary Completion (Estimated)
November 24, 2026
Study Completion (Estimated)
November 24, 2026
Last Updated
May 1, 2026
Record last verified: 2026-03-09