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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI172733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Rochester General Hospital | OTHER |
| Serum Institute of India Pvt. Ltd. | INDUSTRY |
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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 PCV15 or 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 approximately 7 and 9 months of age.
Have blood samples taken at 6 and/or 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2x 1 mg wSp vaccine | Experimental | Intramuscular (IM) injections of 0.5 mL containing 1 mg of total protein |
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| 2x 0.5 mL saline | Placebo Comparator | Intramuscular (IM) injections of 0.5 mL saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 preferably in the left thigh at approximately 7 months of age, and dose 2 will be given preferably in the right thigh at approximately 9 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of new serotype of Streptococcus pneumoniae in the nasopharynx during viral upper respiratory infection at onset of acute otitis media | Occurrence of a culture-confirmed new serotype of S. pneumoniae in the nasopharynx during viral URI at onset of AOM (as defined by isolation of S. pneumonia of differing serotypes from NP samples) between 14 days after the second dose of vaccine and 24 months of age |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
Temporary exclusion criteria
For day of vaccination:
Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcus May, MD | Contact | +49 511 16 99 08 0 | may@sls-eu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pittsford Pediatrics | Recruiting | Pittsford | New York | 14534 | United States |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Alira Health |
| OTHER |
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Only the person administering the investigational product will be unmasked. This person does not perform any other participant-related tasks in the clinical trial.
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| Saline (0.9% NaCl) | Biological | Saline will be administered as intramuscular (IM) injections of 0.5 mL. Dose 1 will be given preferably in the left thigh at approximately 7 months of age and dose 2 will be given preferably in the right thigh at approximately 9 months of age. |
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| between 14 days after the second dose of vaccine and 24 months of age |
| Western New York Geneva Pediatrics | Active, not recruiting | Rochester | New York | 14456 | United States |
| Bay Creek Pediatrics | Active, not recruiting | Rochester | New York | 14580 | United States |
| Long Pond Pediatrics | Recruiting | Rochester | New York | 14606 | United States |
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| Rochester Medical Group General Pediatric Associates | Active, not recruiting | Rochester | New York | 14621 | United States |
| Westside Pediatric Group | Recruiting | Rochester | New York | 14624 | United States |
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| Panorama Pediatrics | Recruiting | Rochester | New York | 14625 | United States |
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| D017670 |
| Sodium Compounds |