Phase 1
Completed N=50
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Clostridium Infections
Source: ClinicalTrials.gov NCT00127803 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine. — 2; 0; 1; 2 Participants
Summary
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy adults aged 18-55 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine. |
2; 0; 1; 2; 0; 3 | — |
| PRIMARY Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine. |
8; 11; 11; 12; 2; 6 | — |
| SECONDARY Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine. |
0; 6; 5; 10; 0; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Adult males or females, 18-55 years (inclusive)
- In good general health
- Clinical lab tests within normal range
- Non-pregnant female subjects
- Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Exclusion Criteria
- Evidence of C. difficile infection
- Evidence of any previous antibiotic-associated diarrhea
- Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
- Known or suspected history of immunodeficiency;
- Active or inactive immune-mediated or inflammatory disease;
- Pregnant or lactating female subjects;
- History of drug or alcohol abuse disorders;
- Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Receipt of antibiotic therapy or an investigational drug within prior 30 days
- Blood or organ donation within prior 30 days
Data sourced from ClinicalTrials.gov (NCT00127803). 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.