NCT07135453

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
May 2026Aug 2027

First Submitted

Initial submission to the registry

August 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

August 14, 2025

Last Update Submit

May 4, 2026

Conditions

Pneumococcal DiseaseVaccine

Outcome Measures

Primary Outcomes (2)

  • Serogroup 33 antibodies

    Serum antipneumococcal antibody concentrations (micrograms/mL) against members of serogroup 33, measured using WHO-ELISA

    4 weeks post-vaccination

  • Antibody-mediated killing

    Opsonic activity of vaccine-induced antibodies (reported as opsonic index, or OI); measured using an opsonophagocytic killing (OPK) assay.

    4 weeks post-vaccination

Study Arms (2)

PCV20

EXPERIMENTAL

Will receive PCV20

Biological: Pneumococcal Vaccine

PCV21

EXPERIMENTAL

Will receive PCV21

Biological: Pneumococcal Vaccine

Interventions

Pneumococcal VaccineBIOLOGICAL

PCV

PCV20PCV21

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

David LaFon, MD

CONTACT

2059343411dlafon@uabmc.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 22, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

US(1)