Safety and Efficacy of wSp Vaccine in Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2029-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Otitis Media (AOM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Only the person administering the investigational product will be unmasked. This person does not perform any other participant-related tasks in the clinical trial.

Study Groups

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2x 1 mg wSp vaccine

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

Group Type EXPERIMENTAL

wSp vaccine

Intervention Type 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.

2x 0.5 mL saline

Intramuscular (IM) injections of 0.5 mL saline

Group Type PLACEBO_COMPARATOR

Saline (0.9% NaCl)

Intervention Type 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.

Interventions

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wSp vaccine

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.

Intervention Type BIOLOGICAL

Saline (0.9% NaCl)

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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SPWCV PATH-wSP

Eligibility Criteria

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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.

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.

Minimum Eligible Age

5 Months

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes