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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Immunization
• Intervention / Treatment: Biological: Pneumococcal Conjugate Vaccine; Biological: Prevnar 13®

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Metairie, Louisiana, United States, 70427
      • Investigational Site Number: 0002
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Investigational Site Number: 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I; Participants will receive 1 intramuscular injection of PCV formulation SP0202-I	Biological: Pneumococcal Conjugate Vaccine; Suspension for Intramuscular injection
Experimental: Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II; Participants will receive 1 intramuscular injection of PCV formulation SP0202-II	Biological: Pneumococcal Conjugate Vaccine; Suspension for Intramuscular injection
Experimental: Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III; Participants will receive 1 intramuscular injection of PCV formulation SP0202-III	Biological: Pneumococcal Conjugate Vaccine; Suspension for Intramuscular injection
Experimental: Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV; Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV	Biological: Pneumococcal Conjugate Vaccine; Suspension for Intramuscular injection
Active Comparator: Group 5: Prevnar 13®	Biological: Prevnar 13®; Suspension for Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of unsolicited systemic AEs reported in the 30 minutes after injection	Occurrence of any unsolicited (spontaneously reported) systemic Adverse Events (AEs) reported in the 30 minutes after injection of a SP0202 formulation or Prevnar 13.	Up to 30 minutes post-vaccination
Occurrence of solicited injection site and systemic reactions	Number of participants reporting solicited injection site reactions (pain, redness, swelling) and solicited systemic reactions (pyrexia, headache, malaise, myalgia, arthralgia, chills)	Up to 7 days post-vaccination
Occurrence of unsolicited (spontaneously reported) AEs up to 30 days after injection	Occurrence of unsolicited (spontaneously reported) Adverse Events (AEs) up to 30 days after injection of a SP0202 formulation or Prevnar 13.	Up to 30 days after vaccination
Serotype-specific immunoglobulin type G (IgG) concentrations	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	Up to 30 days after vaccination
Serotype-specific opsonophagocytic activity (OPA) titers	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)	Up to 30 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype-specific IgG concentrations ratio (post/pre-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	Up to 30 days after vaccination
≥ 4-fold serotype-specific IgG concentrations increase	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	Up to 30 days after vaccination
Serotype-specific OPA titers ratio (post/pre-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	Up to 30 days after vaccination
≥ 4-fold serotype-specific OPA titers increase	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	Up to 30 days after vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PSK00007 (Other Identifier: Sanofi); U1111-1210-0812 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No