Boost-2867 Vaccine for Coronavirus

Recruiting at 5 trial locations

Overseen By Lisa A. Jackson

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Intranasal steroids, others

Disqualifiers: SARS-CoV-2 infection, Neurological conditions, Cardiovascular disease, Autoimmune disease, Respiratory disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 booster, Boost-2867, for safety and immune response enhancement. Participants will receive the booster either as an intramuscular shot, with or without an additional ingredient to enhance its effect, or as an intranasal spray without extra ingredients. The trial seeks healthy adults who have completed a full COVID-19 vaccine series and received at least one booster shot. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new booster.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can continue taking medications if they don't pose additional risks, as determined by the study doctor. If you use intranasal medications, you must stop 30 days before and after the study product administration.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Boost-2867, a new coronavirus vaccine, is undergoing testing to determine its safety and effectiveness. This phase 1 trial primarily aims to ensure the vaccine's safety for humans. Phase 1 trials mark the first human testing of a new treatment, so limited safety information is available.

The vaccine is administered in two ways: into the muscle (intramuscularly) and through the nose (intranasally). Some versions include an adjuvant, an extra ingredient that enhances the body's response to the vaccine.

In other studies, similar vaccines have been tested and were generally well-tolerated, with most people not experiencing serious side effects. Common side effects for vaccines like Boost-2867 include soreness at the injection site, fatigue, and mild fever. These effects are normal and usually resolve quickly.

This trial closely monitors for any safety issues, especially since Boost-2867 is being tested in humans for the first time. Participants receive careful observation, and the trial team reviews safety information to ensure the vaccine remains safe for further testing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Boost-2867 because it offers a fresh approach to enhancing coronavirus immunity. Unlike existing vaccines that often rely on intramuscular injections with adjuvants, Boost-2867 explores both intramuscular and intranasal delivery methods, with and without adjuvants like Alhydrogel® and CpG 7909. This versatility could lead to more flexible and potentially more effective vaccination strategies, appealing to different patient needs. Additionally, the intranasal option might offer easier administration and could stimulate mucosal immunity, which is the body's first line of defense against respiratory viruses.

What evidence suggests that this trial's treatments could be effective for coronavirus?

Research has shown that booster doses of vaccines, such as Boost-2867, can enhance protection against COVID-19. This trial will evaluate different dosages and administration methods of Boost-2867 across various cohorts. Studies have found that more frequent booster shots can strengthen the immune system and improve outcomes for vaccinated individuals. For vaccines similar to Boost-2867, booster doses have successfully maintained high protection levels against various virus variants. Other mRNA vaccines, like those from Pfizer and Moderna, have demonstrated high effectiveness, with some studies reporting over 95% success rates. This evidence suggests that Boost-2867 could effectively boost immunity against COVID-19 when used as a booster. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Healthy adults aged 18-64 who've had a full COVID-19 vaccine series plus one booster can join. They must be in good health, not pregnant, and agree to use effective birth control. People with unstable chronic conditions or recent medication changes for such conditions cannot participate.

Inclusion Criteria

I have signed the consent form for this study.

I agree to use birth control or practice abstinence.

I am a woman who cannot become pregnant due to menopause or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Boost-2867 via intramuscular or intranasal administration, with or without adjuvant, depending on cohort assignment

1 day

1 visit (in-person)

Safety Monitoring

Safety review of halting rules and clinical safety data through at least Day 8 by the Protocol Safety Review Team (PSRT)

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of systemic anti-Spike humoral immune responses and nasal mucosal immunoglobulin responses

181 days

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Boost-2867

Trial Overview The trial tests Boost-2867 as a nasal spray or muscle shot booster for COVID-19 immunity. It explores different doses with/without adjuvants (substances enhancing immune response). Participants are divided into groups based on the administration route and dosage level.

How Is the Trial Designed?

Group I: Cohort 7 Experimental Treatment 2 Interventions

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.

Group II: Cohort 6 Experimental Treatment 2 Interventions

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.

Group III: Cohort 5 Experimental Treatment 2 Interventions

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.

Group IV: Cohort 4 Experimental Treatment 4 Interventions

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.

Group V: Cohort 3 Experimental Treatment 4 Interventions

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.

Group VI: Cohort 2 Experimental Treatment 4 Interventions

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.

Group VII: Cohort 1 Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. nature.com nature.com/articles/s41467-024-50376-z

Long-term safety and effectiveness of mRNA-1273 vaccine ... Primary vaccination and boosting with mRNA-1273 demonstrated acceptable safety, effectiveness and immunogenicity against COVID-19, including emergent variants.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031506/

The Impact of Vaccination Frequency on COVID-19 Public ... The outcomes for the vaccinated population improve as boosting frequency increases (Figure 2D–F, Supplementary Figures S7 and S8).

3. cdc.gov cdc.gov/mmwr/volumes/70/wr/mm7044e3.htm

Effectiveness of 2-Dose Vaccination with mRNA COVID-19 ... Effectiveness of mRNA vaccination against laboratory-confirmed COVID-19–associated hospitalization was lower (77%) among immunocompromised adults than among ...

4. academic.oup.com academic.oup.com/ofid/article/11/12/ofae689/7908454

Who to Boost When: The Effect of Age and Dosing Interval on ... To help inform COVID-19 vaccination recommendations, we evaluated the impact of age and dosing interval on clinical benefit of a third dose of mRNA-1273.

5. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-phase-3-trial-data-showing

Pfizer and BioNTech Announce Phase 3 Trial Data ... First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95.6% against ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07221162

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, ... This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of Boost-2867, given intramuscular (IM) with or without adjuvant or ...

7. absolutelymaybe.plos.org absolutelymaybe.plos.org/2025/11/06/a-bumper-update-on-next-generation-covid-vaccines-no-34/

A Bumper Update on Next Generation Covid Vaccines (No 34) Tests included a one- or two-dose regimen, and as a booster after mRNA primary vaccination, and including Delta and Omicron XBB challenge tests ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24005231

A SARS-CoV-2 recombinant spike protein vaccine (S- ... We evaluated the efficacy, immunogenicity, and safety of S-268019-b, a recombinant spike protein subunit vaccine based on the ancestral strain, for preventing ...

9. vaccineadvisor.com vaccineadvisor.com/features/fda-drug-alerts-approvals-infectious-diseases/

FDA Alert: Infectious Diseases Drug News Roundup FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.

10. bmj.com bmj.com/content/382/bmj-2023-070464

Efficacy and safety of an inactivated virus-particle vaccine ... Based on the follow-up data, BIV1-CovIran was safe and effective against SARS-CoV-2 infection, preventing severe and critical cases. Considering ...