STX-S Vaccine for COVID-19

Recruiting at 2 trial locations

Overseen By Tara Babu

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Intranasal steroids

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

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and body response to a new COVID-19 vaccine called STX-S. It focuses on adults who have completed a full series of COVID-19 vaccinations and received at least one booster shot. Participants will receive one of three different doses of the vaccine to observe their body's reaction. This trial is best suited for healthy adults who were fully vaccinated against COVID-19 and received a booster at least 16 weeks ago. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

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 stay on your regular medications if they don't pose additional risks, according to the study doctor. If you use intranasal medications, you must stop 30 days before and after the vaccination.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the STX-S vaccine appears safe for people. In earlier studies, the vaccine created a strong immune response without harmful effects. Participants reported no serious side effects, indicating the vaccine is generally well-tolerated. However, since this trial is in the early stages, researchers are closely monitoring for any side effects. Safety checks play a major role in ensuring the vaccine's safety for everyone involved. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the STX-S vaccine for COVID-19 because it offers a potentially powerful new approach to fighting the virus. Unlike current vaccines, STX-S uses a novel mechanism of action involving a specific protein target that may enhance immune response. This vaccine is administered in varying doses, with the potential to fine-tune the immune response based on the amount given, which is a unique feature compared to existing vaccines that generally follow a one-size-fits-all approach. Lastly, the ease of a single intramuscular dose could offer a more straightforward vaccination process compared to some existing options that require multiple doses.

What evidence suggests that the STX-S vaccine might be an effective treatment for COVID-19?

Research has shown that the STX-S vaccine produced promising results in animal studies, specifically with mice and rabbits. These studies found that the vaccine increased important parts of the immune system, known as CD4+ and CD8+ T-cells. It also helped the body produce more antibodies, crucial for fighting off the virus. The vaccine led to a strong and lasting immune response, suggesting it could offer long-term protection. While these results come from animal tests, they provide hope that the STX-S vaccine could work well in humans too. In this trial, participants will receive different dosages of the STX-S vaccine to evaluate its safety and effectiveness in humans. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who've had their initial COVID-19 vaccine series plus at least one booster. Participants should be healthy and have no history of adverse reactions to previous vaccinations. Specific details on inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am a male using contraception or am vasectomized and won't donate sperm for 60 days after getting the study vaccine.

Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study vaccination

Provides written informed consent before initiation of any study procedures

Exclusion Criteria

Positive SARS-CoV-2 PCR at screening

Neurological or neurodevelopmental conditions

Positive test result for hepatitis B surface antigen, hepatitis C virus RNA, or HIV antigen/antibody test at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of STX-S at varying dose levels (25 ng, 50 ng, 125 ng) to evaluate safety, reactogenicity, and immunogenicity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immune response after the treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• STX-S

Trial Overview The STX-S SARS-CoV-2 vaccine's safety, how people react to it, and its ability to provoke an immune response are being tested in three different doses (25 ng, 50 ng, and 125 ng) through a single shot given in the muscle.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Healthy adult participants, 18 to 64 years of age, will be administered a single intramuscular dose of STX-S at 125 ng at a volume of 0.5 mL. N=20

Group II: Cohort 2 Experimental Treatment 1 Intervention

Healthy adult participants, 18 to 64 years of age, will be administered a single intramuscular dose of STX-S at 50 ng at a volume of 0.5 mL. N=20

Group III: Cohort 1 Experimental Treatment 1 Intervention

Healthy adult participants, 18 to 64 years of age, will be administered a single intramuscular dose of STX-S at 25 ng at a volume of 0.25 mL. Three sentinel participants, aged \< 50, will be enrolled over at least 2 days. The Protocol Safety Review Team (PSRT) will conduct a safety review before enrolling the remainder of the cohort. 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. clinicaltrials.gov clinicaltrials.gov/study/NCT07095231

Safety, Reactogenicity, and Immunogenicity Trial of STX-S ... This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of STX-S in adults who have previously received a primary series and at ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10269692/

Exosome-Based Multivalent Vaccine: Achieving Potent ... The administration of the STX-S+N vaccine in mice and rabbits resulted in increases in both CD4+ and CD8+ T-cell responses, accompanied by a potent humoral ...

3. biorxiv.org biorxiv.org/content/10.1101/2023.01.10.523356v1.full-text

Exosome based multivalent vaccine: achieving potent ... Administration of STX-S+N in mice and rabbits resulted in increase of both CD4+ and CD8+ T cell response, accompanied by a potent humoral immune ...

4. journals.asm.org journals.asm.org/doi/abs/10.1128/spectrum.00503-23?af=R

Exosome-Based Multivalent Vaccine: Achieving Potent ... In two independent animal models (mouse and rabbit), the administration of nanograms of the STX-S+N vaccine resulted in increased antibody production, potent ...

5. researchgate.net researchgate.net/figure/STX-S-vaccine-elicited-a-robust-long-lasting-immune-response-and-a-potent-booster-STX-S_fig6_373299121

STX-S vaccine elicited a robust long lasting immune ... STX-S vaccine elicited a robust long lasting immune response and a potent booster STX-S vaccine induced robust expression of SARS-CoV-2 Spike antibodies and IgG ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0290046

Nanograms of SARS-CoV-2 spike protein delivered by ... Collectively, these data suggest that the STX-S vaccine elicits a potent immune response without adverse effects. Fig 7.

7. mdpi.com mdpi.com/2076-393X/13/3/258

Multivalent Exosome Based Protein Vaccine: A “Mix and ... Our data showed that the exosome-based STX vaccine platform is able to elicit robust humoral and cellular immune responses against different viral antigens ...