wSp vaccine to prevent pneumococcal colonization in young children

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

This will test whether two doses of the wSp vaccine can safely reduce pneumococcal bacteria in the nose of healthy infants who have already received PCV20.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 5 Months to 7 Months
• Sex: All
• Sponsor: Serum Life Science Europe GmbH (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 4 sites (Rochester, New York and 3 other locations)
• Trial ID: NCT07216430 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives healthy infants two injections of either the wSp vaccine or a saline placebo at about 7 and 9 months of age. Blood samples are taken at 6 and 12 months to measure antibody and immune responses, and nasal swabs are collected at multiple time points and during respiratory infections through 24 months to track pneumococcal colonization. Investigators will monitor for ear infections, respiratory illnesses, and other pneumococcal-related outcomes to evaluate safety and impact on carriage. Participants were limited to infants who previously received three doses of PCV20 and who meet standard health and immunologic criteria.

Who should consider this trial

Good fit: Ideal candidates are healthy 6-month-old infants who have received three doses of PCV20 and whose parents can commit to clinic visits.

Not a fit: Children with known immunodeficiency, prior invasive pneumococcal disease, recent immunoglobulin or blood product exposure, or chronic immunosuppressant use are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the wSp vaccine could lower pneumococcal carriage in infants and reduce related ear and respiratory infections.

How similar studies have performed: Other vaccine approaches targeting pneumococcal colonization have had mixed results, and the wSp formulation is relatively novel in this age group.

Eligibility criteria

Inclusion Criteria:

1. Male or female who is 6 months (+/- 30 days) of age at time of enrollment
2. Healthy subject as established by medical history and clinical examination before entering into the study.
3. Received 3 doses of PCV-20.
4. Written informed consent obtained from the subject's parent/legal guardian.
5. Parent/legal guardian able and willing to bring subject to all study visits.

Exclusion Criteria:

1. Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
2. Known or suspected impairment of immunological function, based on medical history and physical examination.
3. Has a history of congenital or acquired immunodeficiency.
4. Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs, or during the study period.
5. Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
6. Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
7. External auditory canal atresia/stenosis.
8. Has known or history of functional or anatomic asplenia.
9. Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
10. 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.
11. Direct descendant (child or grandchild) of study site personnel.

    Temporary exclusion criteria

    For day of vaccination:
12. Fever (transcutaneous temperature ≥38.0°C) or acute illness
13. Has received systemic corticosteroids (equivalent of prednisone \> 0.5 mg/kg/day or equivalent) and not completed this course of treatment at least 30 days prior to the study vaccination. Inhaled, topical, and ophthalmic steroids are allowed.

Where this trial is running

Rochester, New York and 3 other locations

• Western New York Geneva Pediatrics — Rochester, New York, United States (Recruiting)
• Bay Creek Pediatrics — Rochester, New York, United States (Active_not_recruiting)
• Rochester Medical Group General Pediatric Associates — Rochester, New York, United States (Active_not_recruiting)
• Panorama Pediatrics — Rochester, New York, United States (Recruiting)

Study contacts

• Study coordinator: Marcus May, MD

Conditions Acute Otitis Media