JYNNEOS Vaccine for Viral Diseases

Not currently recruiting at 1 trial location

Overseen By Philip Mudd, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington University School of Medicine

Disqualifiers: Immunocompromise, Active malignancy, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the JYNNEOS vaccine to evaluate its ability to boost the immune system in various parts of the body, such as the blood, lungs, skin, and bone marrow. The focus is on assessing the strength and duration of the immune response after vaccination. The trial is suitable for healthy individuals aged 18-60 who have not previously received a smallpox or monkeypox vaccine and do not have chronic health issues affecting daily life. Participants will receive the vaccine and undergo several tests, including blood draws and biopsies, over time. As an Early Phase 1 trial, this research aims to understand how the vaccine works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if your medications cause immunocompromise, you may not be eligible to participate.

Is there any evidence suggesting that the JYNNEOS vaccine is likely to be safe for humans?

Research has shown that the JYNNEOS vaccine, which protects against diseases like smallpox and monkeypox, is generally safe. Real-world data indicates that the most common side effects are mild and occur at the injection site, including redness, swelling, pain, and itching.

In studies involving over 8,000 individuals who had never received a smallpox vaccine, serious side effects were rare. The FDA approved the vaccine in 2019 for adults at high risk for smallpox, confirming its safety through careful evaluation.

Overall, the JYNNEOS vaccine is considered safe, with most people experiencing only minor side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for viral diseases work by targeting specific viral components or enhancing the body's general immune response. However, the JYNNEOS vaccine is unique because it uses a highly attenuated, non-replicating version of the MVA-BN virus to safely stimulate a robust immune response. This vaccine is designed to offer protection without causing the disease itself, making it potentially safer for individuals with compromised immune systems. Researchers are excited about JYNNEOS because it could provide broad protection against multiple viral diseases with fewer side effects compared to traditional vaccines.

What evidence suggests that the JYNNEOS Vaccine could be effective for viral diseases?

Studies have shown that the JYNNEOS vaccine, which participants in this trial will receive, effectively prevents mpox disease. Receiving two doses provides better protection than a single dose. Research indicates that even if infection occurs post-vaccination, JYNNEOS can prevent severe disease. Although some estimates of its effectiveness are limited, the vaccine has proven very effective in real-world situations. Overall, these findings suggest that JYNNEOS can significantly reduce the risk of contracting mpox and lessen its severity. ^{6 7 8 9 10}

Who Is on the Research Team?

Philip Mudd, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals who are healthy and willing to undergo procedures like bronchoscopy, skin biopsy, and bone marrow aspiration to study their immune response after receiving the JYNNEOS vaccine for smallpox and monkeypox.

Exclusion Criteria

Previous infection with monkeypox

Pregnancy

Platelet count of less than 100,000 at study enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive the MVA-BN vaccine on day 0 and day 28

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for immune response in blood, lung mucosa, skin, and bone marrow

13 months

Multiple visits for phlebotomy, bronchoscopy, skin punch biopsy, and bone marrow aspiration

What Are the Treatments Tested in This Trial?

Interventions

• JYNNEOS Vaccine

Trial Overview The trial is studying how strong and long-lasting the immune response is to the JYNNEOS vaccine by examining participants' blood, lung tissue, skin, and bone marrow after vaccination.

How Is the Trial Designed?

Group I: MVA-BN vaccinated Experimental Treatment 5 Interventions

MVA-BN vaccine administered: day 0 and day 28 Phlebotomy: within 30 days prior to first vaccine dose, day 0, day 14, day 28, day 35, day 42, day 56, day 90, day 110, day 150, day 210, day 395 Research bronchoscopy: within 30 days prior to first vaccine dose, day 42, day 210, day 395 Skin punch biopsy: within 30 days prior to first vaccine dose, day 42, day 210, day 395 Bone marrow aspiration: within 30 days prior to first vaccine dose, day 56, day 110, day 210, day 395

JYNNEOS Vaccine is already approved in United States, European Union for the following indications:

Approved in United States as JYNNEOS for:

• Prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection

Approved in European Union as Imvamune/Imvanex for:

• Prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Virus-like particle (VLP) subunit vaccines targeting human papillomaviruses (HPVs) have shown to be safe and immunogenic in phase I and II clinical trials, but their efficacy data is still pending.

Various vaccine strategies, including recombinant and peptide vaccines targeting HPV oncoproteins E6 and E7, have demonstrated immunogenicity and potential efficacy in animal models, suggesting promising avenues for both therapeutic and prophylactic applications against HPV-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. Stanley, MA.[2006]

Cervicovaginal vaccination with the TA-HPV vaccine, following an initial DNA vaccine, significantly increased the accumulation of HPV-specific CD8 T cells in the cervicovaginal tract compared to intramuscular vaccination, suggesting a more effective immune response in targeting cervical cancer.

The study demonstrated that cervicovaginal vaccination can induce strong local immune responses against HPV-16 E7, regardless of the route of the initial DNA vaccine, supporting the potential for this method in clinical applications for treating cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local HPV Recombinant Vaccinia Boost Following Priming with an HPV DNA Vaccine Enhances Local HPV-Specific CD8+ T-cell-Mediated Tumor Control in the Genital Tract. Sun, YY., Peng, S., Han, L., et al.[2021]

Virus-like particle (VLP) subunit vaccines targeting the major capsid protein L1 of human papillomaviruses (HPVs) are currently in Phase III trials, demonstrating strong immune responses and safety, with early indications of efficacy.

Vaccines designed to provoke cytotoxic T-lymphocytes against HPV oncoproteins E6 and E7 have shown immunogenicity and safety in early trials, but their efficacy remains limited, suggesting further development is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in prophylactic and therapeutic vaccines for human papillomavirus infection. Stanley, MA.[2022]

Therapeutic vaccines targeting the E6 and E7 oncoproteins of high-risk HPV types 16 and 18 are being tested in phase I clinical trials, marking a significant step towards developing vaccines for HPV-related cervical cancers.

A polytope DNA vaccination strategy, when combined with immunomodulatory cytokines, shows promise in potentially reducing the risk of cancer relapse and metastasis after standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic uterine-cervix cancer vaccines in humans. Gariglio, P., Benitez-Bribiesca, L., Berumen, J., et al.[2006]

The quadrivalent HPV vaccine was found to be safe and well-tolerated in juvenile dermatomyositis (JDM) patients, with mild adverse events reported that were similar to those in healthy controls, and no severe adverse events related to vaccination.

Immunogenicity was high, with 100% seropositivity for HPV16 and 97% for HPV18 in JDM patients one month after the third vaccine dose, indicating that the vaccine is effective in generating an immune response in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study. Grein, IHR., Pinto, NBF., Groot, N., et al.[2021]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2215201

Vaccine Effectiveness of JYNNEOS against Mpox Disease ... The findings suggest that JYNNEOS vaccine was effective in preventing mpox disease, and a two-dose series appeared to provide better protection.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11420512/

Effectiveness of a single dose of JYNNEOS vaccine in real world Vaccine effectiveness (VE), defined as the reduction in the risk of mpox infection among vaccinated individuals versus unvaccinated individuals.

3. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00180-X/fulltext

Effect of JYNNEOS vaccination on mpox clinical progression Finally, we found that post-exposure prophylaxis with JYNNEOS provided 16% effectiveness in preventing progression to disseminated lesions.

4. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7422a3.htm

Use of JYNNEOS (Smallpox and Mpox Vaccine, Live ... Infections despite vaccination could occur; however, JYNNEOS prevented or decreased the severity of many infections during the ongoing clade IIb ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24006947

Review Vaccine effectiveness of 3rd generation mpox ... Both 1 and 2 doses of MVA-BN are highly effective at preventing mpox. Effectiveness estimates, specifically of PEP are limited by immortal time bias.

6. jynneos.com jynneos.com/

JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non ... Real-world Safety data · Most commonly reported adverse reactions to VAERS have been injection site symptoms (redness, swelling, pain, itching) · The frequencies ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38839518/

Real-world safety data for MVA-BN: Increased frequency of ... Real-world data from large-scale administration of MVA-BN has confirmed the vaccine's established safety profile when administered subcutaneously.

8. fda.gov fda.gov/media/131078/download

Package Insert - JYNNEOS (Refrigerator) The integrated analyses of serious adverse events (SAEs) pooled safety data across 23 studies, which included a total of 8,222 smallpox vaccine-naïve ...

9. cdc.gov cdc.gov/vaccine-safety/vaccines/mpox.html

Monkeypox Vaccine Safety FDA approved JYNNEOS in 2019. It is approved for use in people ages 18 years and older and determined to be at high risk for smallpox or ...

10. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/imvanex

Imvanex | European Medicines Agency (EMA) The safety profile of Imvanex is considered favourable, with vaccinated people experiencing mild to moderate side effects. The Agency therefore decided that ...