mRNA Vaccine for RSV

Not currently recruiting at 5 trial locations

Overseen By Brittany Stine

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Immorna Biotherapeutics, Inc.

Must not be taking: Immunosuppressants, Antivirals, Corticosteroids, others

Disqualifiers: RSV, Myocarditis, Immunosuppression, others

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA-based vaccine, JCXH-108, to determine its safety and effectiveness in preventing Respiratory Syncytial Virus (RSV) infections. Participants will receive either the vaccine or a placebo (a shot with no active ingredient) for comparison. The trial seeks healthy individuals who haven't been vaccinated for RSV and don't have a recent respiratory illness. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants will be among the first to receive this new vaccine.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications. However, you cannot take immunomodulators, immune-suppressive medication, systemic corticosteroids (unless it's a stable dose of prednisone ≤10 mg/day), or systemic antiviral therapy within 28 days before the trial starts. You also cannot receive any non-live vaccine within 14 days before the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take certain vaccines or immune-suppressive medications close to the trial start. If you're on stable low-dose steroids for chronic conditions, you may continue them.

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

Research shows that JCXH-108, a new mRNA-based vaccine for RSV (Respiratory Syncytial Virus), has just begun human testing. This trial marks the first step in evaluating the vaccine's effectiveness in people. Due to the early stage of the process, limited information exists on human tolerance.

Earlier studies demonstrated that very small doses of the vaccine generated a strong immune response in animals, specifically cotton rats, against RSV strains. However, this does not directly ensure safety for humans. The trial will closely monitor participants for any side effects or reactions to ensure safety. As the trial progresses, more detailed safety information will emerge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike current treatments for RSV, which often rely on supportive care and preventive measures like monoclonal antibodies, JCXH-108 is an mRNA vaccine specifically targeting the virus. Researchers are excited about this innovative approach because mRNA vaccines can prompt the body to produce proteins that trigger an immune response, potentially offering more robust and long-lasting protection. This method has already shown success with COVID-19 vaccines, suggesting a promising new avenue for preventing RSV infections. By directly teaching the body's cells to fend off the virus, JCXH-108 could revolutionize how we protect vulnerable populations from RSV.

What evidence suggests that this treatment might be an effective treatment for RSV?

Research shows that the mRNA vaccine JCXH-108, which participants in this trial may receive, looks promising for preventing RSV (Respiratory Syncytial Virus) infections. Earlier studies found that the vaccine increased protective antibodies in both young and older adults. These antibodies play a crucial role in fighting off RSV. Additionally, even very low doses of JCXH-108 produced high levels of protective antibodies against two main types of RSV in animal studies. This suggests that the vaccine could offer strong protection against RSV infections. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are at risk of RSV infection. Specific eligibility criteria aren't provided, but typically participants must be healthy or have stable health conditions and meet certain age requirements.

Inclusion Criteria

I agree not to get any RNA-based vaccines from 30 days before to 30 days after D1.

Status: Healthy subjects

Subjects must agree to not be vaccinated with any RSV vaccine while participating in this study

Exclusion Criteria

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

I am currently diagnosed with an RSV infection.

I am currently on antiviral medication.

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 JCXH-108 or placebo administered intramuscularly on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, reactogenicity, and immunogenicity, including adverse events and antibody levels

6 months

Multiple visits (in-person and virtual) over 6 months

What Are the Treatments Tested in This Trial?

Interventions

• JCXH-108

Trial Overview The study is testing JCXH-108, an mRNA-based vaccine aimed at preventing RSV. Participants will randomly receive either the vaccine or a placebo to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: Investigational product Experimental Treatment 1 Intervention

Subjects randomized to this arm will be given the investigational product (JCXH-108).

Group II: Placebo Placebo Group 1 Intervention

Subjects randomized to this arm will be given a placebo.

Who Is Running the Clinical Trial?

Immorna Biotherapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

920+

Tigermed Consulting Co., Ltd

Industry Sponsor

Trials

34

Recruited

58,000+

Published Research Related to This Trial

Cardiac complications, particularly myopericarditis, were the most frequently reported severe adverse events associated with mRNA COVID-19 vaccines, with systemic reactions being more common after the second dose.

Despite the higher number of reported adverse effects following the Pfizer vaccine, the review concluded that the overall benefits of mRNA vaccines in controlling the COVID-19 pandemic significantly outweigh the risks of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. SeyedAlinaghi, S., Karimi, A., Pashaei, Z., et al.[2022]

The mRNA-1345 vaccine demonstrated high efficacy, with 83.7% effectiveness in preventing RSV-associated lower respiratory tract disease with at least two symptoms, and 68.4% efficacy against RSV-associated acute respiratory disease in a study involving 35,541 older adults.

The vaccine was generally safe, with most adverse reactions being mild to moderate and transient, although there was a higher incidence of local and systemic reactions compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. Wilson, E., Goswami, J., Baqui, AH., et al.[2023]

The investigational mRNA vaccine (mRNA-1777) targeting Respiratory Syncytial Virus (RSV) was found to be safe and well-tolerated in both younger (72 participants) and older adults (107 participants), with no serious adverse events reported.

The vaccine successfully triggered a strong immune response, indicated by increased levels of RSV neutralizing antibodies and other immune markers, suggesting its potential effectiveness in protecting against RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults. Aliprantis, AO., Shaw, CA., Griffin, P., et al.[2021]

A survey of 222 resident physicians who received a third dose of the BNT162b2 mRNA vaccine found that the most common side effects were local pain (88.3%), fatigue (58.1%), and muscle/joint pain (44.1%), all of which resolved within 48-72 hours.

Compared to the second dose, systemic reactions were less common and milder, although 36.1% of participants reported that side effects interfered with their normal activities, indicating that while the booster is generally well-tolerated, some individuals may still experience significant reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Reactions after the Third Dose of the BNT162b2 mRNA COVID-19 Vaccine among Medical School Residents in a Regional Reference University Hospital in Italy. Rahmani, A., Dini, G., Montecucco, A., et al.[2022]

The Phase 1 trial of the recombinant RSV F protein nanoparticle vaccine showed it was well-tolerated by healthy adults aged 18-49, with no significant dose-related toxicity or serious adverse events reported.

Immunogenicity results indicated a significant increase in RSV A and B neutralization and anti-F IgG levels, suggesting that the vaccine could potentially reduce the risk of hospitalization due to RSV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. Glenn, GM., Smith, G., Fries, L., et al.[2012]

Vaccination with formalin-inactivated (FI) RSV in African green monkeys led to an enhanced inflammatory response and exacerbated disease upon subsequent RSV infection, highlighting the risks associated with this type of vaccine.

In contrast, a genetically engineered subunit vaccine (FG glycoprotein) did not cause increased pulmonary inflammation, suggesting it could be a safer alternative for preventing RSV-related diseases in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human respiratory syncytial virus (RSV) primate model of enhanced pulmonary pathology induced with a formalin-inactivated RSV vaccine but not a recombinant FG subunit vaccine. Kakuk, TJ., Soike, K., Brideau, RJ., et al.[2019]

In a survey of 2,849 individuals aged 18-49 who completed mRNA COVID-19 vaccinations, about 90% reported adverse events (AEs), with 3.3% after the first dose and 4.3% after the second dose experiencing severe AEs.

Factors associated with a higher incidence of AEs included receiving the mRNA-1273 vaccine, being female, having dermatologic diseases, and a history of serious allergic reactions or anticoagulant medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. Yoon, D., Jeon, HL., Noh, Y., et al.[2023]

The mRNA-based vaccine V172, designed to target the pre-fusion form of the RSV F glycoprotein, was found to be safe and well-tolerated in a Phase 1 clinical trial involving 112 older adults and 48 younger adults, with common side effects being mild and manageable.

V172 induced higher neutralizing antibody levels compared to a previous vaccine candidate (V171.2) and demonstrated protective effects in an animal model, suggesting it could be an effective option for preventing RSV infections in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults. Nussbaum, J., Cao, X., Railkar, RA., et al.[2023]

The study developed a novel subunit vaccine against respiratory syncytial virus (RSV) using a replication-deficient Sendai virus vector, which effectively expresses the RSV F protein and stimulates a strong immune response in mice.

Both intranasal and intramuscular immunization routes induced significant RSV-specific immune responses, including neutralizing antibodies and cytotoxic T cells, while demonstrating safety without causing vaccine-enhanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Respiratory Syncytial Virus Vaccine Vectored by a Stable Chimeric and Replication-Deficient Sendai Virus Protects Mice without Inducing Enhanced Disease. Wiegand, MA., Gori-Savellini, G., Gandolfo, C., et al.[2022]

A comparative safety study involving 18,755 individuals vaccinated with mRNA COVID-19 vaccines and 27,895 individuals vaccinated with influenza vaccines found that mRNA vaccines had a different safety profile, with more systemic reactions like chills and fatigue compared to the influenza vaccine.

While mRNA COVID-19 vaccines showed a higher risk for some manageable cardiovascular issues, such as hypertensive crisis and supraventricular tachycardia, they had a lower risk of serious neurological complications compared to influenza vaccines, indicating a generally favorable safety profile for mRNA vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. Kim, MS., Jung, SY., Ahn, JG., et al.[2022]

The developed RSV vaccine candidate using adenovirus vectors (Ad26 and Ad35) effectively induced strong immune responses in mice, producing high levels of RSV neutralizing antibodies and T cells, indicating its potential efficacy.

In cotton rats, both single and prime-boost immunizations resulted in long-lasting protective immunity against RSV, with minimal lung damage observed post-challenge, suggesting the vaccine's safety and effectiveness for further investigation in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant low-seroprevalent adenoviral vectors Ad26 and Ad35 expressing the respiratory syncytial virus (RSV) fusion protein induce protective immunity against RSV infection in cotton rats. Widjojoatmodjo, MN., Bogaert, L., Meek, B., et al.[2018]

A case of acute myocarditis was reported in a 44-year-old man who experienced chest pain four days after receiving the second dose of the mRNA-1273 SARS-CoV-2 vaccine, highlighting a potential rare adverse effect of this vaccine.

Despite the occurrence of myocarditis, the patient fully recovered within a month with supportive treatment, indicating that while this side effect can occur, it may be manageable and does not necessarily lead to long-term cardiac issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. Tailor, PD., Feighery, AM., El-Sabawi, B., et al.[2023]

The mucosal gene expression vaccine (MGXV), delivered intranasally using chitosan-DNA nanospheres, significantly reduced viral levels in a mouse model of respiratory syncytial virus (RSV) infection after a single dose of 25 micrograms per mouse.

MGXV treatment did not cause any significant airway reactivity or pulmonary inflammation, indicating a favorable safety profile while effectively targeting RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mucosal gene expression vaccine: a novel vaccine strategy for respiratory syncytial virus. Mohapatra, SS.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06564194

A Phase 1 Study to Evaluate JCXH-108, an mRNA-based ... The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory ...

2. withpower.com withpower.com/trial/phase-1-communicable-diseases-7-2024-1294a

mRNA Vaccine for RSV · Info for Participants Yes, the mRNA vaccine JCXH-108 is a promising treatment for RSV. It has shown to increase protective antibodies in both younger and older adults, which helps ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ame2.70018

mRNA Design, clinical studies, and future challenges - Zheng This review article summarizes the design, clinical research, and future challenges of mRNA vaccines for respiratory viruses.

4. synapse.patsnap.com synapse.patsnap.com/drug/069c054f93a04ff693cc44cf6e191c00

JCXH-108 - Drug Targets, Indications, Patents Very low doses of JCXH-108 elicited high titers of neutralizing antibodies against both RSV A and RSV B strains. Immunization of cotton rats ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06564194/a-phase-1-study-to-evaluate-jcxh-108-an-mrna-based-vaccine-against-rsv?state=FL&city=Jupitor

A Phase 1 Study to Evaluate JCXH-108, an mRNA-based ... The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06564194/

Trial | NCT06564194 The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory ...

7. ctv.veeva.com ctv.veeva.com/study/a-phase-1-study-to-assess-the-safety-reactogenicity-and-immunogenicity-of-jcxh-108-an-mrna-based-v

A Phase 1 Study to Evaluate JCXH-108, an mRNA-based ... The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory ...