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

PATH Vaccine Solutions

Status and phase: Completed; Phase 1

Conditions: Pneumococcal Vaccines

Treatments: Biological: SPWCV+Alum 300 mcg; Other: Placebo; Biological: SPWCV+Alum 100 mcg; Biological: SPWCV+Alum 600 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT01537185

VAC 002

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 4 patient groups, including a placebo group

Cohort 1 SPWCV+Alum 100 mcg

Experimental group

Description:

each individual receiving 3 vaccinations of same dose 28 days apart

Treatment:

Biological: SPWCV+Alum 100 mcg

Cohort 2 SPWCV+Alum 300 mcg

Experimental group

Description:

each individual receiving 3 vaccinations of same dose 28 days apart

Treatment:

Biological: SPWCV+Alum 300 mcg

Cohort 3 SPWCV+Alum 600 mcg

Experimental group

Description:

each individual receiving 3 vaccinations of same dose 28 days apart

Treatment:

Biological: SPWCV+Alum 600 mcg

Normal Saline Injection

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo