Vaccine, Pneumococcal Disease
Conditions
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.
Interventions
BIOLOGICALPneumococcal Vaccine
PCV
Sponsors
University of Alabama at Birmingham
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult
Exclusion criteria
* No prior history of pneumococcal vaccination * No immunosuppressing medications or chronic diseases that affect immune function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serogroup 33 antibodies | 4 weeks post-vaccination | Serum antipneumococcal antibody concentrations (micrograms/mL) against members of serogroup 33, measured using WHO-ELISA |
| Antibody-mediated killing | 4 weeks post-vaccination | Opsonic activity of vaccine-induced antibodies (reported as opsonic index, or OI); measured using an opsonophagocytic killing (OPK) assay. |
Countries
United States
Contacts
CONTACTDavid LaFon, MD
Outcome results
None listed