The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
42
3 cohorts of normal saline injection
3 injections 28 days apart
3 injections 28 days apart
Comprehensive Clinical Development
Tacoma, Washington, United States
Unsolicited Adverse Event Reports
Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
Time frame: within 1 week (0-7 days) following each vaccinations
Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.
Time frame: 28, 56 and 84 days following initial vaccination
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3 injections 28 days apart