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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1 SPWCV+Alum 100 mcg

each individual receiving 3 vaccinations of same dose 28 days apart

Group Type EXPERIMENTAL

SPWCV+Alum 100 mcg

Intervention Type BIOLOGICAL

3 injections 28 days apart

Cohort 2 SPWCV+Alum 300 mcg

each individual receiving 3 vaccinations of same dose 28 days apart

Group Type EXPERIMENTAL

SPWCV+Alum 300 mcg

Intervention Type BIOLOGICAL

3 injections 28 days apart

Cohort 3 SPWCV+Alum 600 mcg

each individual receiving 3 vaccinations of same dose 28 days apart

Group Type EXPERIMENTAL

SPWCV+Alum 600 mcg

Intervention Type BIOLOGICAL

3 injections 28 days apart

Normal Saline Injection

placebo group within each cohort receive 3 injections of normal saline 28 days apart

normal saline injection: 3 cohorts of normal saline injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

3 cohorts of normal saline injection

Interventions

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Placebo

3 cohorts of normal saline injection

Intervention Type OTHER

SPWCV+Alum 100 mcg

3 injections 28 days apart

Intervention Type BIOLOGICAL

SPWCV+Alum 600 mcg

3 injections 28 days apart

Intervention Type BIOLOGICAL

SPWCV+Alum 300 mcg

3 injections 28 days apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes