IMNN-101 Vaccine for COVID-19

No longer recruiting at 1 trial location

Overseen By Ai-Ris Y Collier, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Imunon

Must not be taking: Immunotherapy, Immunosuppressants

Disqualifiers: SARS-CoV-2 infection, Severe allergies, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 vaccine called IMNN-101. Researchers aim to understand the vaccine's effectiveness and safety when administered as a single shot in the arm. Eligible participants must have received at least one COVID-19 vaccine, with the last dose over four months ago, and have no recent COVID-19 infections or treatments. Participants should be in good general health and willing to follow study procedures for a year. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects on people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving immunotherapy or immunosuppressants, you may need to stop as these are not allowed within certain timeframes before and during the study.

Is there any evidence suggesting that the IMNN-101 vaccine is likely to be safe for humans?

Research has shown that the IMNN-101 vaccine is well-tolerated. Participants who received the vaccine experienced no serious side effects. Reports indicate that the vaccine is safe and caused no major health issues. This reassures those considering joining the trial, as the safety data supports confidence in the vaccine's tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard COVID-19 vaccines, which primarily use mRNA or viral vector technology, IMNN-101 is unique because it introduces a novel mechanism of action through its delivery method as a single intramuscular dose. Researchers are excited about this treatment because it could simplify the vaccination process with just one shot, potentially improving compliance and accessibility. Additionally, the focus on a new delivery method might offer insights into more efficient immune responses, setting it apart from existing options.

What evidence suggests that the IMNN-101 vaccine could be an effective treatment for COVID-19?

Research shows that the IMNN-101 vaccine, which trial participants will receive, has yielded promising results in early studies. In a group of 24 healthy volunteers, the vaccine provided strong protection against the SARS-CoV-2 Omicron XBB1.5 variant for six months after just one dose. This finding is significant because it suggests the vaccine could offer long-lasting immunity. The vaccine employs a DNA-based method, which has lasted longer than traditional mRNA vaccines. These early findings support the potential of IMNN-101 to provide lasting protection against COVID-19. ^{1 5 6 7 8}

Who Is on the Research Team?

Douglas Faller, MD

Principal Investigator

Imunon

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who have previously been vaccinated against COVID-19. Participants must be in good health, with a BMI of 18-35 kg/m2, and agree to not receive other vaccines or join another study during the trial period. They should understand the study procedures and commit to follow-up visits.

Inclusion Criteria

For a volunteer capable of becoming pregnant: Agree to use an acceptable method of contraception

Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination

Agrees not to enroll in another study of an investigational agent during participation in the trial

Exclusion Criteria

I have been diagnosed with an immune deficiency or an autoimmune disease.

History of severe allergic reactions or allergy to any pertinent components of IMNN-101

History of alcohol or drug abuse within 3 years before first vaccination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity through 12 months post-vaccination

12 months

Multiple visits at 0.5, 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• IMNN-101

Trial Overview The safety and immune response generated by IMNN-101 are being tested in this phase 1/2 trial. Volunteers will get one intramuscular shot of the vaccine candidate and will be monitored for a year to see how well it works.

How Is the Trial Designed?

Group I: IMNN-101 Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle. IMNN-101 is for intramuscular injection only.

Who Is Running the Clinical Trial?

Imunon

Lead Sponsor

Trials

16

Recruited

1,600+

Published Research Related to This Trial

The SA-GM-CSF modified tumor cell vaccine enhances dendritic cell activation and increases tumor-specific CD8+ T-cells, but these T-cells often express PD-1, which contributes to immune resistance.

Combining PD-1/PD-L1 blockade with the GM-CSF vaccine significantly boosts the population of active T-cells and enhances the immune response, leading to effective tumor rejection in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-1/PD-L1 blockade enhances the efficacy of SA-GM-CSF surface-modified tumor vaccine in prostate cancer. Shi, X., Zhang, X., Li, J., et al.[2018]

The phase IIb KEYNOTE-942 trial suggests that the investigational mRNA-4157/V940 vaccine combined with pembrolizumab may significantly reduce the risk of disease recurrence in high-risk melanoma patients after surgery.

Patients receiving this combination therapy showed better outcomes compared to those treated with only the PD-1 inhibitor, indicating a promising new approach for adjuvant therapy in melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mRNA Vaccine Slows Melanoma Recurrence. [2023]

In a phase 1/2 study involving 30 patients with metastatic melanoma, the combination of the immune-modulatory vaccine (IO102/IO103) with nivolumab showed a high objective response rate of 80%, with 43% of patients achieving complete responses.

The safety profile of the combination therapy was comparable to nivolumab alone, and after a median follow-up of nearly 23 months, the median progression-free survival was 26 months, indicating promising efficacy and tolerability for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. Kjeldsen, JW., Lorentzen, CL., Martinenaite, E., et al.[2023]

In cohort A, which included 30 patients with metastatic melanoma, the combination of an IDO/PD-L1 vaccine and nivolumab resulted in an impressive overall response rate of 80%, with 50% achieving a complete response and a median progression-free survival of 25.5 months.

Cohort B, where the vaccine was added to patients already on anti-PD-1 therapy, showed limited efficacy with only stable disease in 2 out of 10 patients and a median progression-free survival of just 2.4 months, indicating that the combination may not be effective for those with progressive disease during anti-PD-1 treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab. Lorentzen, CL., Kjeldsen, JW., Ehrnrooth, E., et al.[2023]

In a study involving 99 breast cancer patients, the optimal biologic dose (OBD) of the E75 vaccine combined with GM-CSF was found to be 1000 microg E75 plus 250 microg GM-CSF, administered monthly for 6 months, showing similar toxicity levels compared to lower doses.

Patients receiving the optimal dose exhibited a significantly larger immune response, indicated by a greater delayed type hypersensitivity (DTH) reaction and a trend towards reduced cancer recurrence, suggesting that the E75 vaccine may enhance immunity against HER-2/neu in breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal dose and schedule of an HER-2/neu (E75) peptide vaccine to prevent breast cancer recurrence: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Holmes, JP., Gates, JD., Benavides, LC., et al.[2008]

Citations

1. investors.imunon.com investors.imunon.com/news-releases/news-release-details/imunon-announces-six-month-data-showing-durability-protection

Press Release Details - News & Investors - Imunon Results in 24 healthy volunteers demonstrated IMNN-101's durability of protection at six months after a single dose targeting the SARS-CoV-2 Omicron XBB1.5 ...

2. investors.imunon.com investors.imunon.com/news-releases/news-release-details/imunon-announces-new-immunogenicity-data-phase-1-clinical-trial

IMUNON Announces New Immunogenicity Data from Phase 1 ... Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine technology.

3. trial.medpath.com trial.medpath.com/news/bdb48610486c7f06/imunon-s-dna-vaccine-shows-superior-durability-over-mrna-vaccines-in-phase-1-covid-19-trial

IMUNON's DNA Vaccine Shows Superior Durability Over ... IMUNON's IMNN-101 DNA vaccine demonstrated better durability of protection compared to mRNA vaccines after a single dose targeting SARS-CoV-2 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMsa2514268

Updated Evidence for Covid-19, RSV, and Influenza ... One case–control study showed a vaccine effectiveness of 43% (95% CI, −6 to 70) against ICU admission, with imprecise estimates reflecting the ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835590

Estimated 2023-2024 COVID-19 Vaccine Effectiveness in ... In this study, the 2023-2024 COVID-19 vaccines were associated with fewer cases of medically attended COVID-19, with more robust outcomes for critical illness.

6. reaganudall.org reaganudall.org/clinical-trial/study-evaluate-safety-immunogenicity-imnn-101-administered-healthy-adults-previously

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Positive RT-PCR test for SARS-CoV-2 within two days of screening. 2. Known history of SARS-CoV-2 infection within 3 months of screening. 3. COVID-19 monoclonal ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/imunon-dna-plasmid-vaccine/

Imunon reports data from DNA plasmid vaccine trial IMNN-101 was given as a single-dose vaccine, which was found to be well-tolerated and safe, without any serious adverse effects. The vaccine “ ...

8. investor.celsion.com investor.celsion.com/news-releases/news-release-details/imunon-announces-site-activation-imnn-101-phase-1-vaccine-study

IMUNON Announces Site Activation for IMNN-101 Phase 1 ... For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1. 5 variant, in accordance with the FDA's Vaccines and Related ...