VaccinePhase 4Group 33/PCVsNCT07135453
Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines
A Phase 4 study testing Pneumococcal Vaccine in people with Vaccine and Pneumococcal Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine, Pneumococcal Disease
- What is being tested?
- Pneumococcal Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult
Who cannot join
- No prior history of pneumococcal vaccination
- No immunosuppressing medications or chronic diseases that affect immune function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
LaFon, MD, 2059343411, dlafon@uabmc.edu
David C LaFon, MD
About this study
Official title: Novel Serotype Alert: Investigate New Pneumococcal Conjugate Vaccines for Inducing Cross-protection Against Newly Discovered Serotype 33E and Putative Novel Serogroup 33 Serotypes
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.
- Conditions
- Vaccine, Pneumococcal Disease
- Being tested
- Pneumococcal Vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal VaccineBiological
PCV
| Study group | Role | What they receive |
|---|---|---|
| PCV20 | Experimental | Will receive PCV20 Receives: Biological: Pneumococcal Vaccine |
| PCV21 | Experimental | Will receive PCV21 Receives: Biological: Pneumococcal Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serogroup 33 antibodies
Serum antipneumococcal antibody concentrations (micrograms/mL) against members of serogroup 33, measured using WHO-ELISA
Measured: 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.
Measured: 4 weeks post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, David Lafon, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135453
- Sponsor's protocol ID
- IRB300008528(000544386)
- Other IDs
- MISP102547
- Acronym
- Group 33/PCVs
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided