What side effects are associated with this type of intervention?

Common side effects of treatments that stimulate the immune system, such as vaccines, include local reactions at the injection site (pain, redness, swelling) and systemic reactions like fever, fatigue, and headache. Less commonly, individuals may experience allergic reactions, with severe cases like anaphylaxis being rare. These side effects are generally mild and temporary, reflecting the body's immune response to the treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for infectious diseases that stimulate the immune system to produce humoral and cellular responses. Notable examples include monoclonal antibody therapies such as raxibacumab and obiltoxaximab for inhalation anthrax, which have shown efficacy in pre- and postlicensure studies. Additionally, vaccines for Ebola virus, such as the recombinant vesicular stomatitis virus (VSV) vaccine, have been developed to elicit strong immune responses. These treatments and vaccines are designed to enhance the body's immune defenses, similar to the goals of the JCXH-221 vaccine currently under study.

What other types of research exist?

Promising novel alternatives to the JCXH-221 vaccine for infectious diseases patients in 2024 include: 1) mRNA-based vaccines, which have shown significant efficacy and safety in recent trials; 2) Outer Membrane Vesicle (OMV)-based vaccines, which are being developed for their ability to induce strong immune responses; and 3) Immunotherapy approaches such as CAR T-cell therapy and monoclonal antibodies targeting specific pathogens. These alternatives are in various stages of clinical trials and have demonstrated potential in stimulating both humoral and cellular immune responses.

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Virus Therapy

JCXH-221 Vaccine for COVID-19

Phase 1

Waitlist Available

Research Sponsored by Immorna Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18 years of age or older, at screening.

Status: Healthy subjects.

Must not have

Subjects who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 within 4 months before Day 1.

Subjects with history of myocarditis or pericarditis, or with AEs after mRNA vaccination that are in nature and severity beyond the common AEs expected and necessitating medical intervention.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1- day 365 (12 months)

Summary

This trial is testing a new vaccine called JCXH-221 in healthy adults aged 18 and older. The vaccine aims to train the immune system to recognize and fight off infections. Researchers are looking to find a safe and effective dose while monitoring the immune response.

Who is the study for?

Healthy adults over 18 who've completed their initial COVID-19 vaccination series at least 4 months prior can join. They shouldn't have had recent exposure to COVID-19, current infections, or past SARS-CoV-2 infection confirmed within the last 4 months. People on COVID-19 treatment meds or with immune system issues are excluded.

What is being tested?

The trial is testing JCXH-221, a new mRNA-based vaccine for broad protection against COVID-19. Phase 1 compares it to a placebo in healthy volunteers, while Phase 2 uses an FDA-approved vaccine as the active comparator to find the best dose and measure immune responses.

What are the potential side effects?

While specific side effects aren't listed here, common reactions to vaccines like soreness at injection site, fatigue, headache, muscle pain may occur. Severe allergic reactions are rare but possible; monitoring for myocarditis or pericarditis will likely be part of safety assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am currently healthy without any ongoing medical conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't received COVID-19 convalescent serum or antibodies in the last 4 months.

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I have had severe reactions to mRNA vaccines or have a history of heart inflammation.

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I do not have a fever or signs of an infection at the time of enrollment and vaccination.

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I have an immune system condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1- day 365 (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1- day 365 (12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1- day 365 (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AE frequency

Injection site reaction

Medical AE frequency

+3 more

Secondary study objectives

SARS-CoV-2 anti-receptor antibody levels

SARS-CoV-2 antibody levels

Other study objectives

T-cell responses

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational productExperimental Treatment1 Intervention

Patients randomized to this arm will be given the investigational product (JCXH-221).

Group II: PlaceboPlacebo Group1 Intervention

Patients randomized to this arm will be given a placebo vaccine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JCXH-221

2023

Completed Phase 1

~80

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for infectious diseases often work by either directly targeting the pathogens or by stimulating the immune system to enhance its response. Vaccines like JCXH-221 are designed to stimulate both humoral and cellular immune responses, which involve the production of antibodies and activation of T-cells, respectively. This dual approach helps the body to recognize and eliminate pathogens more effectively. Antiviral drugs, such as those used for COVID-19, may inhibit viral replication, while antibiotics target bacterial cell walls or protein synthesis. Immunomodulatory treatments, like monoclonal antibodies, can enhance the immune system's ability to fight infections. These mechanisms are crucial for infectious disease patients as they provide targeted and efficient ways to control and eliminate infections, reducing morbidity and mortality.

South American Hemorrhagic Fevers: A summary for clinicians.Splenic CD8α⁺ dendritic cells undergo rapid programming by cytosolic bacteria and inflammation to induce protective CD8⁺ T-cell memory.