COVID-19Phase 1NCT07221162
A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
A Phase 1 study testing Aluminum Hydroxide Suspension, Boost-2867 and CpG 7909 in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Aluminum Hydroxide Suspension, Boost-2867 and CpG 7909
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Dec 2025to 24 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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*.
- As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of the safety of participants. Chronic medical diagnoses/ conditions should be stable for the last 30 days (i.e., no hospitalizations, ER, or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis/condition 30 days before the study product administration. Any prescription change due to a change of health care provider, insurance company, etc., or done for financial reasons and in the same class of medication will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.
- 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*.
- Laboratory evaluations include White Blood Cells [WBCs] with differential, hemoglobin [Hgb], platelets [PLTs], Alanine Transaminase [ALT], Aspartate Transaminase [AST], Creatinine [Cr], Alkaline Phosphatase [ALP], and Total Bilirubin [T. Bili]). Clinical laboratory evaluations that are below the site reference range, but not graded by the toxicology table, are not exclusionary unless deemed clinically significant by an investigator.
- Must agree to have samples stored for secondary research.
Who cannot join
- 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.
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- 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.
- Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen/antibody test at screening.
- Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections, and chronic* immunosuppressant medication within the past 6 months**.
- Chronic means more than 14 continuous days.
- Ophthalmic and topical steroids are allowed.
- Has received any investigational study product within 60 days, or 5 half-lives, whichever is longer, before study product administration or is planning to receive one during the study.
- Has a history of hypersensitivity or severe allergic reaction* to any previous licensed or unlicensed study products or the candidate study product components**.
- (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction)
- See IB for study product formulation.
- Received or plans to receive licensed inactivated/subunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.
- Plan to receive a COVID-19 booster vaccine within the 180 days following study product administration.
- Regular use of intranasal medications, including steroids, and sinus rinsing treatments*.
- Participants must have had no intranasal medication use for 30 days before study product administration and do not plan to use intranasal medications for 30 days after study product administration for medications other than steroids and for 6 months after study product administration for intranasal steroids (including over-the-counter (OTC) fluticasone).Participants should not use nasal irrigation or sinus rinsing treatments (e.g., Neti pots or saline washes) for 28 days after the study product administration and 7 days before study visits for the duration of the trial.
- Use of illicit intranasal drugs in the 5 years before study product administration or plans to use during the study.
- Current smoker (including cigarettes, marijuana, and vaping) or smoking within the prior 3 months.
- Planned international travel between product administration and Day 29 visit.
- Any significant nasal or upper airway disease*. *Including, but not limited to, being prone to epistaxis, has a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head/neck radiation history, anosmia/dysosmia, and certain ear, nose and throat (ENT) conditions, including major anatomic nasopharyngeal abnormality or sinus polyp disease due to chronic sinusitis.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Center for Immunization Research, Johns Hopkins Bloomberg School Public Health
Baltimore, Maryland, 21205
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, 14642-0001
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine
San Francisco, California, 94110
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101-1466
Saint Louis University Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
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
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.
Read the detailed description
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. The secondary objectives are: 1) To evaluate the systemic anti-Spike humoral immune responses of a single IM or IN administration of Boost-2867. 2) To evaluate nasal mucosal immunoglobulin A (IgA) and immunoglobulin G (IgG) responses after IM and IN administration.
- Conditions
- COVID-19
- Being tested
- Aluminum Hydroxide Suspension, Boost-2867, CpG 7909, Sodium Chloride, 0.9%
- Keywords
- Boost-2867, coronavirus, COVID, Intramuscular, Intranasal, Next Generation Booster, Phase 1, Vaccine
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum Hydroxide SuspensionDrug
Aluminum hydroxide adjuvant.
Boost-2867Biological
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 7909Biological
CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant.
Sodium Chloride, 0.9%Other
0.9% Sodium Chloride Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants 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. Receives: Biological: Boost-2867; Other: Sodium Chloride, 0.9% |
| Cohort 2 | Experimental | Participants 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. Receives: Drug: Aluminum Hydroxide Suspension; Biological: Boost-2867; Biological: CpG 7909; Other: Sodium Chloride, 0.9% |
| Cohort 3 | Experimental | Participants 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. Receives: Drug: Aluminum Hydroxide Suspension; Biological: Boost-2867; Biological: CpG 7909; Other: Sodium Chloride, 0.9% |
| Cohort 4 | Experimental | Participants 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. Receives: Drug: Aluminum Hydroxide Suspension; Biological: Boost-2867; Biological: CpG 7909; Other: Sodium Chloride, 0.9% |
| Cohort 5 | Experimental | Participants 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. Receives: Biological: Boost-2867; Other: Sodium Chloride, 0.9% |
| Cohort 6 | Experimental | Participants 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. Receives: Biological: Boost-2867; Other: Sodium Chloride, 0.9% |
| Cohort 7 | Experimental | Participants 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. Receives: Biological: Boost-2867; Other: Sodium Chloride, 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of abnormal clinical safety laboratory adverse events.
Measured: Through day 8
Occurrence of adverse events of special interest (AESIs).
Measured: Through 6 months
Occurrence of medically attended adverse events (MAAEs).
Measured: Through 6 months
Occurrence of new onset chronic medical conditions (NOCMCs).
Measured: Through 6 months
Occurrence of potentially immune-mediated diseases (pIMDs)
Measured: Through 6 months
Occurrence of Serious adverse events (SAEs).
Measured: Through 6 months
Occurrence of solicited local adverse events (AEs).
Measured: Through 7 days
Occurrence of solicited systemic adverse events (AEs).
Measured: Through 7 days
Occurrence of unsolicited adverse events (AEs).
Measured: Through 28 days
Secondary outcomes (11)
Geometric mean (GM) of nasal mucosal anti-S binding Immunoglobulin A (IgA) antibodies.
Measured: Day 1 through 181
Geometric mean (GM) of nasal mucosal anti-S binding Immunoglobulin G (IgG) antibodies.
Measured: Day 1 through 181
Geometric mean (GM) of serum anti-spike binding Immunoglobulin A antibodies (IgA).
Measured: Days 1 through 181
Geometric mean (GM) of serum anti-spike binding Immunoglobulin G antibodies (IgG).
Measured: Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of anti-spike serum neutralizing antibodies to spike variants
Measured: Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of nasal mucosal anti-S binding Immunoglobulin A (IgA) antibodies.
Measured: Day 1 through 181
Geometric mean fold rise (GMFR) from baseline of nasal mucosal anti-S binding Immunoglobulin G (IgG) antibodies.
Measured: Day 1 through 181
Geometric mean fold rise (GMFR) from baseline of serum anti-spike Immunoglobulin A antibodies (IgA).
Measured: Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of serum anti-spike Immunoglobulin G antibodies (IgG).
Measured: Days 1 through 181
Geometric mean of anti-spike serum-neutralizing antibodies to spike variants
Measured: Days 1 through 181
Seroconversion rate
Where seroconversion is defined as at least a 4-fold increase in serum neutralizing antibody titers over baseline.
Measured: Days 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start5 Dec 2025
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221162
- Sponsor's protocol ID
- 25-1106
- Status last verified
- 9 Mar 2026
- First submitted
- 23 Oct 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07221162
- Acronym / sponsor ID
- 25-1106
- Conditions
- COVID-19
- Keywords
- Boost-2867, coronavirus, COVID, Intramuscular, Intranasal, Next Generation Booster, Phase 1, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The secondary objectives are: 1) To evaluate the systemic anti-Spike humoral immune responses of a single IM or IN administration of Boost-2867. 2) To evaluate nasal mucosal immunoglobulin A (IgA) and immunoglobulin G (IgG) responses after IM and IN administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Boost-2867, Other: Sodium Chloride, 0.9%Participants 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 | Experimental | Drug: Aluminum Hydroxide Suspension, Biological: Boost-2867, Biological: CpG 7909, Other: Sodium Chloride, 0.9%Participants 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 | Experimental | Drug: Aluminum Hydroxide Suspension, Biological: Boost-2867, Biological: CpG 7909, Other: Sodium Chloride, 0.9%Participants 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 | Experimental | Drug: Aluminum Hydroxide Suspension, Biological: Boost-2867, Biological: CpG 7909, Other: Sodium Chloride, 0.9%Participants 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 | Experimental | Biological: Boost-2867, Other: Sodium Chloride, 0.9%Participants 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 | Experimental | Biological: Boost-2867, Other: Sodium Chloride, 0.9%Participants 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 | Experimental | Biological: Boost-2867, Other: Sodium Chloride, 0.9%Participants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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*.
- Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aluminum Hydroxide SuspensionAluminum hydroxide adjuvant. | Drug | Cohort 2, Cohort 3, Cohort 4 |
| Boost-2867Boost-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 | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| CpG 7909CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant. | Biological | Cohort 2, Cohort 3, Cohort 4 |
| Sodium Chloride, 0.9%0.9% Sodium Chloride Injection | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Occurrence of abnormal clinical safety laboratory adverse events.
Time frame: Through day 8
Occurrence of adverse events of special interest (AESIs).
Time frame: Through 6 months
Occurrence of medically attended adverse events (MAAEs).
Time frame: Through 6 months
Occurrence of new onset chronic medical conditions (NOCMCs).
Time frame: Through 6 months
Occurrence of potentially immune-mediated diseases (pIMDs)
Time frame: Through 6 months
Occurrence of Serious adverse events (SAEs).
Time frame: Through 6 months
Occurrence of solicited local adverse events (AEs).
Time frame: Through 7 days
Occurrence of solicited systemic adverse events (AEs).
Time frame: Through 7 days
Occurrence of unsolicited adverse events (AEs).
Time frame: Through 28 days
11 secondary outcomes
Geometric mean (GM) of nasal mucosal anti-S binding Immunoglobulin A (IgA) antibodies.
Time frame: Day 1 through 181
Geometric mean (GM) of nasal mucosal anti-S binding Immunoglobulin G (IgG) antibodies.
Time frame: Day 1 through 181
Geometric mean (GM) of serum anti-spike binding Immunoglobulin A antibodies (IgA).
Time frame: Days 1 through 181
Geometric mean (GM) of serum anti-spike binding Immunoglobulin G antibodies (IgG).
Time frame: Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of anti-spike serum neutralizing antibodies to spike variants
Time frame: Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of nasal mucosal anti-S binding Immunoglobulin A (IgA) antibodies.
Time frame: Day 1 through 181
Geometric mean fold rise (GMFR) from baseline of nasal mucosal anti-S binding Immunoglobulin G (IgG) antibodies.
Time frame: Day 1 through 181
Geometric mean fold rise (GMFR) from baseline of serum anti-spike Immunoglobulin A antibodies (IgA).
Time frame: Days 1 through 181
Geometric mean fold rise (GMFR) from baseline of serum anti-spike Immunoglobulin G antibodies (IgG).
Time frame: Days 1 through 181
Geometric mean of anti-spike serum-neutralizing antibodies to spike variants
Time frame: Days 1 through 181
Seroconversion rate
Time frame: Days 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aluminum Hydroxide Suspension, Boost-2867 and CpG 7909 in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of abnormal clinical safety laboratory adverse events. (time frame: Through day 8). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.