Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Status: | Completed |
---|---|
Conditions: | Pneumonia, Vaccines |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/21/2012 |
Start Date: | February 2012 |
End Date: | January 2013 |
Contact: | Megan Copeland |
Email: | mcopeland@comprehensivecd.com |
Phone: | 253.682.4380 |
A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
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.
Inclusion Criteria, Healthy adults:
- If female, not breastfeeding, not pregnant, not planning pregnancy during study
period), and willing to consistently use an adequate method of contraception and have
repeated pregnancy tests.
- In good health with normal laboratory results
- Willing to comply with study restrictions, study schedule, and can be reliably
contacted
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
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