ExPEC9V Vaccine for E. coli Infections Prevention

Recruiting at 285 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Disqualifiers: End-stage renal disease, Bleeding disorders, Polyneuropathy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

19800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, ExPEC9V, to determine its ability to prevent infections from a specific type of E. coli bacteria. Researchers compare this vaccine to a placebo to assess its effectiveness. Individuals who have experienced a urinary tract infection (UTI) in the past two years and are willing to share their medical history may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the ExPEC9V vaccine trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ExPEC9V vaccine, which helps prevent E. coli infections, has been tested for safety. In a recent study, researchers found no major safety problems, meaning participants did not experience unexpected or severe side effects. Earlier studies also support this, showing that people tolerated the vaccine well without significant negative effects. This history suggests the vaccine is generally safe. Those considering joining a trial for this vaccine can find reassurance in these findings regarding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike existing treatments for E. coli infections, which often involve antibiotics, ExPEC9V is a vaccine that aims to prevent these infections from occurring in the first place. This vaccine targets extraintestinal pathogenic Escherichia coli strains, which are responsible for causing serious infections outside the gut. Researchers are excited because ExPEC9V could reduce the reliance on antibiotics, helping combat antibiotic resistance, and offer a proactive approach to safeguarding health by preventing infections rather than treating them after they occur.

What evidence suggests that the ExPEC9V vaccine might be an effective treatment for E. coli infections?

This trial will compare the 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) with a placebo. Research shows that ExPEC9V aims to prevent serious infections caused by certain types of E. coli bacteria, which can severely affect vulnerable populations. Earlier studies suggested that targeting specific parts of the bacteria might reduce disease severity. However, recent findings indicate that the vaccine has not effectively prevented these serious infections. Despite this, researchers have found no safety issues with ExPEC9V. Overall, current evidence leaves the vaccine's ability to protect against E. coli infections uncertain. ^{1 2 3 4 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Adults aged 60+ with a history of UTI in the past 2 years can join this trial. They must be postmenopausal or sterile if born female, not planning to conceive, and able to use digital devices for communication. Excluded are those with bleeding disorders, certain neuropathies, previous E. coli vaccines, or needing dialysis.

Inclusion Criteria

Participant must be willing to share relevant medical information pertaining to medical history and to share medical records relevant to the medical events identified as suspected cases of invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infections (UTI), or acute bacterial prostatitis (ABP) occurring during the study observation period

I can provide ID and stay in touch with the study team.

I had a urinary tract infection (UTI) in the last 2 years, but it was resolved more than 14 days ago.

Exclusion Criteria

I require dialysis for my end-stage kidney disease.

Participant has a contraindication to intramuscular (IM) injections and blood draws example, due to bleeding disorders or a history of difficult blood draws

I have had Guillain-Barre syndrome or a similar nerve condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 8 days

1 visit (in-person)

Vaccination

Participants receive a single intramuscular injection of either the ExPEC9V vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination

Up to 4 years

Long-term Follow-up

Participants continue to be monitored for long-term safety and efficacy outcomes

Up to 6 years 9 months

What Are the Treatments Tested in This Trial?

Interventions

• ExPEC9V
• Placebo

Trial Overview The study tests whether a vaccine called ExPEC9V prevents invasive diseases caused by certain E. coli types better than a placebo in older adults who've had UTIs before.

How Is the Trial Designed?

Group I: ExPEC9V Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a single IM injection of matching placebo on Day 1.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

The ExPEC10V vaccine was found to be well tolerated in elderly adults, with adverse event rates comparable to those of the pneumococcal vaccine, indicating a favorable safety profile.

Immunogenicity results showed a strong antibody response to ExPEC10V over one year, although there was a limited response to serotype O8, suggesting that the high-dose ExPEC10V is the optimal formulation for preventing invasive E. coli disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Reactogenicity, Immunogenicity, and Dose Selection of 10-Valent Extraintestinal Pathogenic Escherichia coli Bioconjugate Vaccine (VAC52416) in Adults Aged 60-85 Years in a Randomized, Multicenter, Interventional, First-in-Human, Phase 1/2a Study. Fierro, CA., Sarnecki, M., Doua, J., et al.[2023]

The ExPEC4V vaccine, targeting four E. coli serotypes, was well tolerated in a phase 1b trial with 93 women, showing no serious adverse events and only mild to moderate side effects.

The vaccine induced strong immune responses, significantly increasing antibody levels against all targeted serotypes, and resulted in fewer urinary tract infections caused by any E. coli serotype compared to the placebo group, suggesting potential efficacy in preventing UTIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial. Huttner, A., Hatz, C., van den Dobbelsteen, G., et al.[2022]

The ExPEC4V vaccine was well tolerated in a study of 848 healthy adults, with mild-to-moderate adverse events reported in 43% of vaccinated participants, compared to 35% in the placebo group, indicating a favorable safety profile.

The vaccine elicited strong immune responses, with over 80% of participants showing a significant increase in specific antibodies 15 days post-vaccination, and 66-71% maintaining this response after one year, demonstrating its potential efficacy in preventing invasive E. coli disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial. Frenck, RW., Ervin, J., Chu, L., et al.[2020]

Extraintestinal pathogenic Escherichia coli (ExPEC) is a major cause of urinary tract infections and other serious conditions, with rising multidrug resistance making treatment increasingly difficult.

A promising 4-valent O antigen conjugate vaccine is currently in clinical testing, which could provide effective protection against drug-resistant ExPEC strains, particularly for high-risk groups like the elderly and patients undergoing certain medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extraintestinal Pathogenic Escherichia coli, a Common Human Pathogen: Challenges for Vaccine Development and Progress in the Field. Poolman, JT., Wacker, M.[2018]

Nasal immunization with a genetically engineered, formalin-killed strain of extraintestinal pathogenic E. coli (ExPEC) that lacks capsule and O-antigen produced a significantly stronger immune response compared to the wild-type strain, suggesting that these components hinder optimal immune activation.

The antibodies generated from this immunization not only targeted the engineered strain but also showed effectiveness against other ExPEC strains, enhancing neutrophil activity and supporting the potential of these killed whole-cell vaccines in preventing ExPEC infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A killed, genetically engineered derivative of a wild-type extraintestinal pathogenic E. coli strain is a vaccine candidate. Russo, TA., Beanan, JM., Olson, R., et al.[2018]

In a study of 401 E. coli blood isolates from patients aged 60 and older in Japan, the O25 serotype was found to be the most prevalent (28.7%) and exhibited the highest levels of multidrug resistance, particularly to fluoroquinolones (84.3%).

The findings highlight the need for multivalent vaccines targeting prevalent and drug-resistant E. coli serotypes, especially O25B, to combat invasive extraintestinal pathogenic E. coli disease in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of extraintestinal pathogenic Escherichia coli O-serotypes and antibiotic resistance in blood isolates collected from patients in a surveillance study in Japan. Matsumoto, T., Mikamo, H., Ohge, H., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04899336

NCT04899336 | A Study of Vaccination With 9-valent ... The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11152113/

Vaccines against extraintestinal pathogenic Escherichia ... Taken together, these results show promise for targeting secreted factors to limit the pathogenic potential of ExPEC and protect against disease severity.

3. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-02-13-06-00-00-3025576

Update on extraintestinal pathogenic E. coli vaccine phase ... Sanofi and Johnson & Johnson's vaccine candidate for extraintestinal pathogenic E. coli was not sufficiently effective at preventing invasive E. coli disease ( ...

4. horizonscandb.pcori.org horizonscandb.pcori.org/report/topics/927

ExPEC9V to prevent invasive Escherichia coli disease An effective vaccine to prevent exPEC could substantially reduce rates of sickness, hospitalization, and death, as well as reduce antibiotic use ...

5. jnj.com jnj.com/media-center/press-releases/johnson-johnson-statement-on-phase-3-e-mbrace-study

Johnson & Johnson Statement on Phase 3 E.mbrace Study Independent, scheduled review finds investigational vaccine regimen lacks efficacy in preventing invasive E. coli disease (IED). No safety signals identified.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31079947/

Safety and immunogenicity of a vaccine for extra-intestinal ... Safety and immunogenicity of a vaccine for extra-intestinal pathogenic Escherichia coli (ESTELLA): a phase 2 randomised controlled trial ... Lancet Infect Dis.