wSp Vaccine for Ear Infections

(wSp005 Trial)

Recruiting at 3 trial locations

Overseen By Marcus May, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Serum Life Science Europe GmbH

Must not be taking: Immunosuppressants, Corticosteroids, Immunoglobulins, others

Disqualifiers: Immunodeficiency, Asplenia, Bleeding disorder, others

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

Compensation: Varies

Number of Visits: 8

Duration: 2 months

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, wSp, to determine if it can prevent ear infections in healthy young children who have already received the regular PCV20 vaccine. Researchers aim to find out if the wSp vaccine can reduce nasal bacteria that often lead to ear infections and if it safely boosts the immune system to protect against these infections. Children in the trial will receive two injections, either of the wSp vaccine or a saline solution (acting as a placebo), and their immune responses will be monitored through blood samples and nasal swabs over time. The trial seeks children around 6 months old who are healthy and have already received three doses of the PCV20 vaccine. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on long-term immunosuppressants or immune-modifying drugs, or if you plan to take systemic corticosteroids close to the vaccination dates.

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

Research has shown that the wSp vaccine is generally safe for young children. It aims to prevent ear infections by targeting specific bacteria. In earlier studies, children who received the wSp vaccine experienced only mild side effects, similar to those from regular vaccines, such as slight discomfort at the injection site and mild fevers.

While detailed information on side effects remains limited, the trial's advanced stage suggests that early safety results were positive enough to warrant further testing with more participants. This indicates that the vaccine has already demonstrated a reasonable level of safety in initial studies, allowing researchers to focus on its effectiveness and conduct further safety assessments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment options for ear infections, which typically involve antibiotics or pain relievers, the wSp Vaccine is designed to prevent infections before they start. This vaccine works by boosting the immune system to specifically target and combat the bacteria responsible for ear infections. Researchers are excited about the wSp Vaccine because it offers a preventative approach, potentially reducing the need for antibiotics and cutting down on the frequency and severity of infections. This new method not only aims to provide longer-lasting protection but also addresses the growing concern of antibiotic resistance.

What evidence suggests that the wSp vaccine might be an effective treatment for ear infections?

Research has shown that the wSp vaccine, which participants in this trial may receive, might help prevent ear infections by stopping certain bacteria from growing in the nose. Studies have found that this vaccine can strengthen the immune system to produce antibodies, proteins that help fight infections. Similar vaccines have shown promise in reducing infections caused by these bacteria. Although limited data exists on the wSp vaccine in humans, whole-cell vaccines have been somewhat successful in animal studies. This suggests that the wSp vaccine could potentially lower the risk of ear infections in children. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy young children who have already had the PCV20 vaccine. It's not clear what specific age range or other health conditions might affect eligibility, as the exclusion criteria are not provided.

Inclusion Criteria

Healthy subject as established by medical history and clinical examination before entering into the study

Written informed consent obtained from the subject's parent/legal guardian

Parent/legal guardian able and willing to bring subject to all study visits

Exclusion Criteria

Known or suspected impairment of immunological function, based on medical history and physical examination

Has a history of congenital or acquired immunodeficiency

Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two injections of either wSp vaccine or saline placebo at 7 and 9 months of age

2 months

2 visits (in-person)

Follow-up

Participants are monitored for immune responses and pneumococcal colonization through blood samples and nasal swabs

18 months

Multiple visits (in-person) at 6, 12, 15, 18, and 24 months

Monitoring

Participants are monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections

24 months

What Are the Treatments Tested in This Trial?

Interventions

• wSp Vaccine

Trial Overview The study tests if the wSp vaccine can prevent pneumococcal bacteria in kids' noses and boost their immune system compared to a saline placebo. Kids will get two shots of either wSp or saline at 7 and 9 months old, with blood and nasal swabs taken from 6-24 months to monitor effects.

How Is the Trial Designed?

Group I: 2x 1 mg wSp vaccine Experimental Treatment 1 Intervention

Intramuscular (IM) injections of 0.5 mL containing 1 mg of total protein

Group II: 2x 0.5 mL saline Placebo Group 1 Intervention

Intramuscular (IM) injections of 0.5 mL saline

Who Is Running the Clinical Trial?

Serum Life Science Europe GmbH

Lead Sponsor

Rochester General Hospital

Collaborator

Trials

14

Recruited

2,300+

Serum Institute of India Pvt. Ltd.

Industry Sponsor

Trials

26

Recruited

40,900+

Alira Health

Collaborator

Trials

6

Recruited

4,200+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216430

Safety and Efficacy of wSp Vaccine in Young Children A Phase 2 Study Evaluating the Safety and Efficacy of Whole-Cell Pneumococcal Vaccine (wSp) in Reducing Nasopharyngeal Colonization by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10847372/

recent advances in otitis media vaccine development and ... This review provides an updated summary of current vaccines against otitis media, various animal models of otitis media, their limitations, and some future ...

3. reporter.nih.gov reporter.nih.gov/project-details/7933803

Novel vaccines for otitis media - NIH RePORTER We propose to evaluate the immune responses and protective efficacy of two novel live, attenuated pneumococcal vaccines against otitis media using newly ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X1930324X

Effect of a pneumococcal whole cell vaccine on influenza A ... A single dose of WCV did not prevent the development of pneumococcal OM, nor accelerate pneumococcal clearance compared with mice receiving adjuvant alone.

5. researchgate.net researchgate.net/publication/378068181_Otitis_media_recent_advances_in_otitis_media_vaccine_development_and_model_systems

recent advances in otitis media vaccine development and ... At present, pneumococcal and influenza vaccines are administered as a preventive measure against otitis media, nevertheless, these vaccines are ...

6. withpower.com withpower.com/trial/phase-2-otitis-media-8-2025-c69fc

wSp Vaccine for Ear Infections (wSp005 Trial) ... wSp Vaccine will have tolerable side effects & efficacy for patients with Ear Infection and Acute Otitis Media. See if you qualify today!

7. stonybrookmedicine.edu stonybrookmedicine.edu/sites/default/files/ear_infection_and_vaccines.pdf

Ear Infection and Vaccines Conjugate vaccines are effective against otitis media in children under the age of five because they have a polysaccharide component linked to a protein ...