JYNNEOS Vaccine for Viral Diseases

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

20 Participants Needed

Trial Summary

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.

How does the JYNNEOS vaccine differ from other treatments for viral diseases?

The JYNNEOS vaccine is unique because it is specifically designed to prevent smallpox and monkeypox, using a live, non-replicating virus, which makes it safer for people with weakened immune systems compared to traditional vaccines that use live, replicating viruses. ^{1 2 3 4 5}

What is the purpose of this trial?

This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.

Research Team

Philip Mudd, MD, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. [2006]

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

Therapeutic uterine-cervix cancer vaccines in humans. [2006]

5. United States 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. [2021]