Safety and Efficacy of wSp Vaccine in Young Children

NCT07216430 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: wSp-US-2.03AOM1U01AI172733-01A1
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV20 vaccination. The main questions it aims to answer are: Does wSp vaccine reduce pneumococcal colonization in the nose? Does wSp vaccine safely stimulate the immune system to produce antibodies and protective immune responses? Researchers will compare children receiving two injections of wSp vaccine to those receiving saline placebo to see if wSp vaccine reduces colonization and boosts immunity. Participants will: Receive two injections of either wSp or saline at 7 and 9 months of age. Have blood samples taken at 6 and 12 months to measure immune responses. Have nasal swabs collected at several time points and during infections from 6-24 months. Be monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections.

Conditions

Acute Otitis Media (AOM)

Outcome Measures

Primary Outcomes (1)

• Occurrences of Streptococcus pneumoniae in the nasopharynx

  Occurrence of a culture-confirmed S. pneumoniae of differing serotypes in the nasopharynx (as defined by isolation of S. pneumoniae from NP samples) * at four healthy visits, child age 12, 15, 18 and 24 months old and/or * 14 days after second vaccine dose through 24 months of age, at AOM, LRTI, and URTI visits throughout study participation.

  3, 6, 9 and 15 months after second dosing, if healthy, and 14 days through 15 months after second dosing at the time of AOM, LRTI, and/or URTI episodes

Secondary Outcomes (1)

• Occurrence of new serotype of Streptococcus pneumoniae in the nasopharynx during viral upper respiratory infection at onset of acute otitis media

  between 14 days after the second dose of vaccine and 24 months of age

Study Arms (2)

2x 1 mg wSp vaccine

EXPERIMENTAL

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

Biological: wSp vaccine

2x 0.5 mL saline

PLACEBO COMPARATOR

Intramuscular (IM) injections of 0.5 mL saline

Biological: Saline (0.9% NaCl)

Interventions

wSp vaccine BIOLOGICAL

wSp vaccine will be administered as intramuscular (IM) injections of 0.5 mL (thus 1 mg total protein). wSp vaccine is supplied as single-dose glass vials in saline (0.9% sodium chloride) at 2 mg protein/mL, with aluminum hydroxide at 1.2 mg elemental Al/mL. Dose 1 will be given in the left thigh at 7 months of age, and dose 2 will be given in the right thigh at 9 months of age.

Also known as: SPWCV, PATH-wSP

2x 1 mg wSp vaccine

Saline (0.9% NaCl) BIOLOGICAL

Saline will be administered as intramuscular (IM) injections of 0.5 mL. Dose 1 will be given in the left thigh at 7 months of age and dose 2 will be given in the right thigh at 9 months of age.

2x 0.5 mL saline

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
• Known or suspected impairment of immunological function, based on medical history and physical examination.
• Has a history of congenital or acquired immunodeficiency.
• Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs, or during the study period.
• Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
• Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
• External auditory canal atresia/stenosis.
• Has known or history of functional or anatomic asplenia.
• Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
• 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.
• Direct descendant (child or grandchild) of study site personnel.
• For day of vaccination:
• Fever (transcutaneous temperature ≥38.0°C) or acute illness
• 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.

Sponsors & Collaborators

• Serum Life Science Europe GmbH: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Rochester General Hospital: collaborator
• Serum Institute of India Pvt. Ltd.: collaborator
• Alira Health: collaborator

Study Sites (4)

Western New York Geneva Pediatrics

Rochester, New York, 14456, United States

RECRUITING

Bay Creek Pediatrics

Rochester, New York, 14580, United States

ACTIVE NOT RECRUITING

Rochester Medical Group General Pediatric Associates

Rochester, New York, 14621, United States

ACTIVE NOT RECRUITING

Panorama Pediatrics

Rochester, New York, 14625, United States

RECRUITING

MeSH Terms

Conditions

Otitis Media

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Marcus May, MD

CONTACT

+49 511 16 99 08 0; may@sls-eu.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the person administering the investigational product will be unmasked. This person does not perform any other participant-related tasks in the clinical trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 14, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)