ClinicalTrials.gg
RecruitingNCT07135453Group 33/PCVsUpdated Aug 21, 2026

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

A Phase 4 interventional study of Pneumococcal Vaccine in Vaccine and Pneumococcal Disease, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vaccine
  • Pneumococcal Disease
03

In context

Pneumococcal Infections

298 studies on the registry are indexed under Pneumococcal Infections; 26 are open to participants now.

This study's planned enrollment of 70 is below the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy adult

Exclusion criteria

Exclusion Criteria:

  • No prior history of pneumococcal vaccination
  • No medications or chronic diseases that affect immune function
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    PCV20

    Will receive PCV20

    Biological: Pneumococcal Vaccine

  • Experimental
    PCV21

    Will receive PCV21

    Biological: Pneumococcal Vaccine

Interventions

  • BiologicalPneumococcal Vaccine

    PCV

06

What researchers measure

Primary outcomes

  1. Serogroup 33 antibodies

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

    Time frame: 4 weeks post-vaccination

  2. Antibody-mediated killing

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

    Time frame: 4 weeks post-vaccination

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.

Of 21 phase 4 interventional studies under Pneumococcal Infections, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 44. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2025
First posted
Aug 22, 2025
StartActual
Jul 1, 2026
Primary completionEst.
Mar 2027
CompletionEst.
Aug 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07135453
Responsible party
David Lafon (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 22, 2025
Start date
Jul 1, 2026
Primary completion
Mar 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

David LaFon, MD
Contact
dlafon@uabmc.edu
2059343411

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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