Induction of Cross-protective Antibodies for Serogroup 33... | NCT07135453

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

NCT07135453

Sponsor

University of Alabama at Birmingham

Status

Recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

70Estimated

Phase

Phase 4

Conditions

Vaccine
Pneumococcal Disease

Interventions

Pneumococcal Vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MISP102547	Other Grant/Funding Number	Merck Corporation

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Aug 14, 2025

First Submission Date that Met QC Criteria

Aug 20, 2025

First Posted Date

Aug 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 9, 2026Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCV20	Experimental	Will receive PCV20	Biological: Pneumococcal Vaccine
PCV21	Experimental	Will receive PCV21	Biological: Pneumococcal Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal Vaccine	Biological	PCV	PCV20 PCV21

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David LaFon, MD	Contact	2059343411		dlafon@uabmc.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham	Recruiting	Birmingham	Alabama	35294	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011008	Pneumococcal Infections

Ancestor Terms

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D022242	Pneumococcal Vaccines

Ancestor Terms

ID	Term
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products

Browse Leaves

Not provided

Browse Branches

Not provided