Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)

Phase 1

Completed

• Conditions: Pneumococcal Immunization
• Interventions: Biological: Pneumococcal Conjugate Vaccine; Biological: Prevnar 13®

• Registration Number: NCT06698198
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-03
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2024-08
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday)
• Informed Consent Form (ICF) has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures
• Body mass index within the range of 18.5 and 29.9 kg/m2

Exclusion Criteria

• Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccine injection until at least 4 weeks after injection. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial injection, except for influenza vaccination, which may be received at least 2 weeks before SP0202 or Prevnar 13 injection.
• Previous vaccination against S. pneumoniae with either a pneumococcal conjugate vaccine (PCV) or a Pneumococcal polysaccharide vaccines (PPSV).
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV	Pneumococcal Conjugate Vaccine	Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV
Group 5: Prevnar 13®	Prevnar 13®	-
Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I	Pneumococcal Conjugate Vaccine	Participants will receive 1 intramuscular injection of PCV formulation SP0202-I
Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II	Pneumococcal Conjugate Vaccine	Participants will receive 1 intramuscular injection of PCV formulation SP0202-II
Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III	Pneumococcal Conjugate Vaccine	Participants will receive 1 intramuscular injection of PCV formulation SP0202-III

Primary Outcome Measures

Name	Time	Method
Occurrence of solicited injection site and systemic reactions	Up to 7 days post-vaccination	Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection	Up to 30 minutes post-vaccination	Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.
Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection	Up to 30 days after vaccination	Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.
Serotype-specific immunoglobulin type G (IgG) concentrations	Up to 30 days after vaccination	Geometric Mean (GM) of serotype-specific IgG concentrations for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by electro-chemiluminescence (ECL) assay
Serotype-specific opsonophagocytic activity (OPA) titers	Up to 30 days after vaccination	GM of serotype-specific OPA titers for all pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by multiplex opsonophagocytic assay (MOPA)

Secondary Outcome Measures

Name	Time	Method
Serotype-specific IgG concentrations ratio (post/pre-vaccination)	Up to 30 days after vaccination	GM of serotype-specific IgG concentrations ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL assay
≥ 4-fold serotype-specific IgG concentrations increase	Up to 30 days after vaccination	Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to 1 month post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as measured by ECL
Serotype-specific OPA titers ratio (post/pre-vaccination)	Up to 30 days after vaccination	GM of serotype-specific OPA titers ratio (post-/pre-vaccination) for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA
≥ 4-fold serotype-specific OPA titers increase	Up to 30 days after vaccination	Percentage of participants with ≥ 4-fold serotype-specific IgG concentrations increase from baseline to post-vaccination for each pneumococcal serotypes included in the Pneumococcal Conjugate Vaccine (PCV) formulations, as determined by MOPA

Trial Locations

Locations (2)

Investigational Site Number: 0002; 🇺🇸 Metairie, Louisiana, United States

Investigational Site Number: 0001; 🇺🇸 Newark, New Jersey, United States