mRNA Vaccine for RSV

Recruiting in Saint Louis (>99 mi)

+4 other 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

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Syncytial Virus (RSV) infection and diseases. Participants will be randomized to receive either JCXH-108 or placebo.

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.

What safety data exists for the mRNA vaccine for RSV?

The provided research primarily discusses the safety of mRNA COVID-19 vaccines, not specifically the mRNA vaccine for RSV or JCXH-108. However, it highlights that mRNA vaccines, in general, have been well-tolerated and safe, with some rare adverse effects like myocarditis. Comparative studies show mRNA COVID-19 vaccines have a higher risk of certain cardiovascular issues compared to influenza vaccines but a lower risk of neurological complications. These findings suggest that while mRNA vaccines are generally safe, monitoring for specific adverse events is important. ^{1 2 3 4 5}

Is the mRNA vaccine for RSV generally safe in humans?

mRNA vaccines, like those used for COVID-19, are generally safe but can have some side effects. Common reactions include fatigue, muscle pain, and headaches, which usually go away in a few days. Rarely, more serious issues like heart inflammation have been reported. ^{1 2 3 4 5}

Is the mRNA vaccine JCXH-108 a promising treatment for RSV?

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 the body fight off the virus. The vaccine was generally well tolerated, meaning most people didn't have serious side effects. ^{6 7 8 9 10}

How is the mRNA vaccine for RSV different from other treatments?

The mRNA vaccine for RSV, JCXH-108, is unique because it uses a stabilized pre-fusion F protein to trigger a strong immune response, which is different from traditional treatments that are mainly supportive. This vaccine is designed to increase neutralizing antibodies and T-cell responses, offering a novel approach to preventing RSV infections, especially in older adults. ^{6 7 8 9 10}

What data supports the idea that mRNA Vaccine for RSV (also known as: JCXH-108) is an effective treatment?

The available research shows that the mRNA-based RSV vaccine, mRNA-1345, is being studied for its effectiveness in older adults. While specific results from this study are not detailed in the provided information, the focus on older adults suggests that the vaccine is being considered for its potential to reduce the impact of RSV in this vulnerable group. Compared to other treatments, such as the mucosal gene expression vaccine (MGXV) which showed a significant reduction in viral levels in mice, the mRNA vaccine is part of ongoing research to find effective solutions for RSV. This indicates that the mRNA vaccine is a promising option being explored for its potential benefits. ^{6 8 11 12 13}

What data supports the effectiveness of the mRNA vaccine treatment JCXH-108 for RSV?

The mRNA-based RSV vaccine, mRNA-1345, which is similar to JCXH-108, is under clinical investigation and has shown potential in older adults by encoding the stabilized RSV prefusion F glycoprotein, which is crucial for inducing an immune response. ^{6 8 11 12 13}

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.

I am either a man or a woman who may or may not be able to have children.

Status: Healthy subjects

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

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]

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]

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 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 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]

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]

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]

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]

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 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]

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 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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. [2012]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. [2023]

5. Netherlands 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. [2018]

6. Switzerland 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. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. [2023]

11. United States 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. [2022]

12. Netherlands 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. [2023]

13. United States 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. [2021]