Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines

Not Applicable

Not yet recruiting

• Conditions: Vaccine; Pneumococcal Disease
• Interventions: Biological: Pneumococcal Vaccine

• Registration Number: NCT07135453
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The goal of this study is to learn whether different types of vaccines to prevent bacterial infections are able to effectively create antibodies that defend against certain types of bacteria.

We will give two different types of vaccine and evaluate the effectiveness of antibodies produced by each vaccine in killing bacteria.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Submitted: 2025-11-05
• Last Update Posted: 2025-11-10
• Study Start: 2025-12-01
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Healthy adult

Exclusion Criteria

• No prior history of pneumococcal vaccination
• No immunosuppressing medications or chronic diseases that affect immune function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCV20	Pneumococcal Vaccine	Will receive PCV20
PCV21	Pneumococcal Vaccine	Will receive PCV21

Primary Outcome Measures

Name	Time	Method
Serogroup 33 antibodies	4 weeks post-vaccination	Serum antipneumococcal antibody concentrations (micrograms/mL) against members of serogroup 33, measured using WHO-ELISA
Antibody-mediated killing	4 weeks post-vaccination	Opsonic activity of vaccine-induced antibodies (reported as opsonic index, or OI); measured using an opsonophagocytic killing (OPK) assay.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States