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RECRUITING
NCT07221162
PHASE1

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-12-05

Completion Date

2026-11-24

Last Updated

2026-04-03

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Aluminum Hydroxide Suspension

Aluminum hydroxide adjuvant.

BIOLOGICAL

Boost-2867

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.

BIOLOGICAL

CpG 7909

CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant.

OTHER

Sodium Chloride, 0.9%

0.9% Sodium Chloride Injection

Locations (8)

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

Center for Immunization Research, Johns Hopkins Bloomberg School Public Health

Baltimore, Maryland, United States

Saint Louis University Center for Vaccine Development

St Louis, Missouri, United States

University of Rochester Medical Center - Vaccine Research Unit

Rochester, New York, United States

Duke Vaccine and Trials Unit

Durham, North Carolina, United States

University of Pittsburgh - Medicine - Infectious Diseases

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States