Phase 1
N=42
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Pneumococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT01537185 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Jun 2014
Primary outcome: Primary: Unsolicited Adverse Event Reports — 7; 6; 5; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Other); SPWCV+Alum 100 mcg (Biological); SPWCV+Alum 600 mcg (Biological); SPWCV+Alum 300 mcg (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- PATH Vaccine Solutions
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unsolicited Adverse Event Reports |
7; 6; 5; 6 | — |
| SECONDARY Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG |
0; 0; 0; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01537185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.