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

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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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