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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult

Disqualifiers

No prior history of pneumococcal vaccination

No immunosuppressing medications or chronic diseases that affect immune function

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pneumococcal Vaccine

    Biological/Vaccine

    PCV

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: PCV20Experimental treatment 1 intervention
Group B: PCV21Experimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator