Safety and Efficacy of wSp Vaccine in Young Children
ConditionAcute Otitis Media (AOM)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-7
SponsorSerum Life Science Europe GmbH
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female who is 6 months (- 30 to +75 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 PCV15 or PCV20.
Written informed consent obtained from the subject's parent/legal guardian.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
wSp vaccine
Biological/VaccinewSp 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.
Saline (0.9% NaCl)
Biological/VaccineSaline 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.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: 2x 1 mg wSp vaccineExperimental treatment 1 intervention
Group B: 2x 0.5 mL salinePlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
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 episodesSecondary outcomes
1
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
Time frame
between 14 days after the second dose of vaccine and 24 months of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Serum Life Science Europe GmbH
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Rochester General Hospital
Collaborator
Serum Institute of India Pvt. Ltd.
Collaborator
Alira Health
Collaborator
Source ClinicalTrials.gov