Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Phase 1
Completed
- Conditions
- Pneumococcal Vaccines
- Registration Number
- NCT01537185
- Lead Sponsor
- PATH Vaccine Solutions
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
- Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.
- current use or likely requirement for medications with potential for liver injury or effect immune system
- History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease
- History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Unsolicited Adverse Event Reports within 1 week (0-7 days) following each vaccinations Safety and Tolerability assessed by cohort and product received measured by:
•Number of unsolicited AEs within four weeks after each vaccination
- Secondary Outcome Measures
Name Time Method Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG 28, 56 and 84 days following initial vaccination • Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.
Trial Locations
- Locations (1)
Comprehensive Clinical Development
🇺🇸Tacoma, Washington, United States
Comprehensive Clinical Development🇺🇸Tacoma, Washington, United States