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

NCT06698198 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: PSK00007U1111-1210-0812
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumococcal Immunization

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Serotype-specific IgG concentrations ratio (post/pre-vaccination)

  Up to 30 days after vaccination

• ≥ 4-fold serotype-specific IgG concentrations increase

  Up to 30 days after vaccination

• Serotype-specific OPA titers ratio (post/pre-vaccination)

  Up to 30 days after vaccination

• ≥ 4-fold serotype-specific OPA titers increase

  Up to 30 days after vaccination

Study Arms (5)

Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I

EXPERIMENTAL

Participants will receive 1 intramuscular injection of PCV formulation SP0202-I

Biological: Pneumococcal Conjugate Vaccine

Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II

EXPERIMENTAL

Participants will receive 1 intramuscular injection of PCV formulation SP0202-II

Biological: Pneumococcal Conjugate Vaccine

Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III

EXPERIMENTAL

Participants will receive 1 intramuscular injection of PCV formulation SP0202-III

Biological: Pneumococcal Conjugate Vaccine

Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV

EXPERIMENTAL

Participants will receive 1 intramuscular injection of PCV formulation SP0202-IV

Biological: Pneumococcal Conjugate Vaccine

Group 5: Prevnar 13®

ACTIVE COMPARATOR

Biological: Prevnar 13®

Interventions

Pneumococcal Conjugate Vaccine BIOLOGICAL

Suspension for Intramuscular injection

Group 1: Pneumococcal Conjugate Vaccine (PCV) SP0202-I; Group 2: Pneumococcal Conjugate Vaccine (PCV) SP0202-II; Group 3: Pneumococcal Conjugate Vaccine (PCV) SP0202-III; Group 4: Pneumococcal Conjugate Vaccine (PCV) SP0202-IV

Prevnar 13® BIOLOGICAL

Suspension for Intramuscular injection

Group 5: Prevnar 13®

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Investigational Site Number: 0002

Metairie, Louisiana, 70427, United States

Location

Investigational Site Number: 0001

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Interventions

Pneumococcal Vaccines; 13-valent pneumococcal vaccine

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: December 3, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)