Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Pneumococcal Vaccines

Intervention / Treatment
-----------------
* Other: Placebo
* Biological: SPWCV+Alum 100 mcg
* Biological: SPWCV+Alum 600 mcg
* Biological: SPWCV+Alum 300 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 SPWCV+Alum 100 mcg<br>each individual receiving 3 vaccinations of same dose 28 days apart | Biological: SPWCV+Alum 100 mcg<br>* 3 injections 28 days apart<br>|
| Experimental: Cohort 2 SPWCV+Alum 300 mcg<br>each individual receiving 3 vaccinations of same dose 28 days apart | Biological: SPWCV+Alum 300 mcg<br>* 3 injections 28 days apart<br>|
| Experimental: Cohort 3 SPWCV+Alum 600 mcg<br>each individual receiving 3 vaccinations of same dose 28 days apart | Biological: SPWCV+Alum 600 mcg<br>* 3 injections 28 days apart<br>|
| Placebo Comparator: Normal Saline Injection<br>placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection | Other: Placebo<br>* 3 cohorts of normal saline injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 1 week (0-7 days) following each vaccinations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28, 56 and 84 days following initial vaccination |