Phase 1
Completed N=42
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Pneumococcal Vaccines
Source: ClinicalTrials.gov NCT01537185 ↗
Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Jun 2014
Primary outcomePrimary: Unsolicited Adverse Event Reports — 7; 6; 5; 6 participants
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.
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 | — |
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. Informational only — not medical advice.