Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01296386
Other study ID # IC84-101
Secondary ID
Status Completed
Phase Phase 1
First received January 21, 2011
Last updated September 24, 2014
Start date December 2010
Est. completion date April 2013

Study information

Verified date September 2014
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyHungary: Ministry of Health, Social and Family Affairs
Study type Interventional

Clinical Trial Summary

An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects


Description:

This is an open-label, partially randomized, dose escalation Phase 1 study which will consist of a part A in healthy adults aged between ≥18 and <65 years and a part B in healthy elderly ≥65 years, the latter age group being the most vulnerable population to suffer from C. difficile infections.

Part A consists of 3 vaccinations on Day0, Day7 and Day21 with the following groups:

Group A: IC84 20 mcg (microgram)with Alum Group B: IC84 75 mcg (microgram)with Alum Group C: IC84 75 mcg (microgram)without Alum Group D: IC84 200 mcg(microgram)with Alum Group E: IC84 200 mcg(microgram)without Alum

Part A was already finished and part B is now ongoing. All information which could be find under the other sections are referring to the information on Part B.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

1. Healthy adults =18 years of age.

2. No clinically relevant pathological findings in any of the investigations at the Screening Visit including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, cardiovascular disease or non insulin-dependent diabetes mellitus. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance.

3. In female subjects, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception.

4. Weight: = 45.5 kg and <= 150 kg at Visit 0 (Screening Visit).

5. White blood cells =2,500/mm3 and <11,000/mm3 at Visit 0.

6. Platelets within normal limits at Visit 0.

7. Written informed consent obtained from the subject prior to any study related procedures.

Exclusion Criteria:

1. Use of any other investigational or non-registered medicinal product within 30 days prior to IC84 vaccination at Visit 1 (Day 0) and throughout the entire study period.

2. Active or passive vaccination four weeks before first vaccination at Visit 1 and during the entire study period.

3. Immunodeficiency including status post-organ-transplantation or immuno-suppressive therapy, and a family history of congenital or hereditary immunodeficiency.

4. Infection with the human immunodeficiency virus (HIV, a negative test result within 30 days before screening is acceptable), Hepatitis B virus (HBV, Hepatitis B surface antigen [HBsAg]) or Hepatitis C virus (HCV).

5. History of severe hypersensitivity reactions and anaphylaxis.

6. History of allergic bronchial asthma and severe allergic rhinoconjunctivitis.

7. Known hypersensitivity or allergic reactions to one of the components of the vaccine.

8. History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.

9. Any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled.

10. Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders, which are not adequately controlled by medical treatment within the last 12 weeks before IC84 vaccination at Visit 1 (Day 0) as judged by the site's Principal Investigator.

11. Systemic antibiotic use within four weeks prior to first vaccination and during treatment period (until Day 28).

12. Clinically significant diseases as judged by the investigator.

13. Administration of chronic (defined as longer than 14 days) immunosuppressants or other immune-modifying drugs within 30 days prior to IC84 vaccination at Visit 1 (Day 0) and during the study until Visit 5 (Day 28). (For corticosteroids this means prednisone or equivalent >= 0.05 mg/kg/day; topical and inhaled steroids are allowed.).

14. Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to first IC84 vaccination at Visit 1 (Day 0) and until Visit 5 (Day 28).

15. Intake of NSAID within three days prior to and within three days after all three vaccinations (Day 0, 7 and 21).

16. Acute febrile infections or exacerbation of chronic infection within four weeks prior to first vaccination at Visit 1 and during treatment period (until Day 21).

17. Body temperature > 37°C (oral) immediately prior to each vaccination.

18. Drug addiction within 6 months prior to Visit 0 [including alcohol dependence, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day] indicated by an elevated MCV above normal value at the Screening Visit.

19. Inability or unwillingness to avoid more than the usual intake of alcohol [i.e., not more then 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day] during the 48 hours after vaccination.

20. Pregnancy (positive pregnancy test during screening), lactation or unreliable contraception in female subjects with child-bearing potential ( and unreliable contraception in male subjects.

21. Not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

22. Blood donation within 4 weeks prior to first vaccination.

23. Clinically significant mental disorder not adequately controlled by medical treatment.

24. History of Guillain-Barré-Syndrome (GBS).

25. Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator.

26. Inability or unwillingness to provide informed consent.

27. Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
IC84
IC84, a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B, which will be administered at two different doses: 75 and 200 µg without or with Al(OH)3, respectively, intramuscular (i.m.) injection, four vaccinations on Day 0, 7, 28 and 56.

Locations

Country Name City State
Austria Privatklinik Leech Graz
Austria Medizinische Universität Wien Vienna
Hungary St. Imre Teaching Hospital Budapest

Sponsors (1)

Lead Sponsor Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Austria,  Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of subjects with any SAE (Serious Adverse Event) possibly, probably or certainly related to the study vaccine at any time during the study day 201 Yes
Primary Rate of subjects with any unsolicited or solicited Grade 3 or higher adverse event possibly, probably or certainly related to the study vaccine at any time during the study day 201 Yes
Primary Rate of subjects with any unsolicited or solicited Grade 3 or higher adverse event possibly, probably or certainly related to the study vaccine during treatment phase (i.e. until Day 28) day 201 Yes
Primary Rate of subjects with solicited local AEs (Adverse Events) (injection site pain, tenderness, redness, swelling, induration, itching) within 1 week (Day 0-6) after each vaccination: Severity and duration. 6 days after vaccination Yes
Primary Rate of subjects with solicited systemic AEs (headache, muscle pain, fever, flu-like symptoms, nausea, vomiting, rash, excessive fatigue) within 1 week (Day 0 6) after each vaccination: Severity and duration. 6 days after vaccination Yes
Primary Rate of subjects with unsolicited non-serious AEs (including safety laboratory parameters (hematology, serum chemistry, urinalysis)) within 6 months after last vaccination: Severity and causality. day 201 Yes
Primary Rate of subjects with unsolicited non-serious AEs (including safety laboratory parameters (hematology, serum chemistry, urinalysis) during treatment phase (i.e., until Day 28): Severity and causality. day 28 Yes
Secondary Determination of vaccine (IC84) specific IgG levels on Day 0, 7, 14, 21, 28, 113 and 201 after the first vaccination using an Enzyme-Linked Immunosorbent Assay (ELISA) day 201 No
Secondary Determination of C. difficile Toxin A- and Toxin B-specific IgG levels on Day 0, 7, 14, 21, 28, 113 and 201 after the first vaccination using an Enzyme-Linked Immunosorbent Assay (ELISA) day 201 No
Secondary Determination of vaccine-induced C. difficile Toxin A- and Toxin B-neutralizing antibody levels on Day 0, 7, 14, 21, 28, 113 and 201 after the first vaccination using a Toxin Neutralization Assay (TNA) day 201 No
See also
  Status Clinical Trial Phase
Completed NCT02214771 - Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients N/A
Withdrawn NCT01552668 - Fidaxomicin to Prevent Clostridium Difficile Colonization Phase 4
Recruiting NCT03325855 - Fecal Microbiota Transplant National Registry
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Suspended NCT03350711 - A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
Withdrawn NCT03643887 - Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients Phase 2
Terminated NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
Completed NCT03710694 - Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI) N/A
Completed NCT02865616 - MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI) Phase 1
Recruiting NCT04940468 - High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology N/A
Completed NCT02589847 - Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT02086916 - Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection N/A
Completed NCT01230957 - Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults Phase 2
Completed NCT01241552 - A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) Phase 3
Not yet recruiting NCT04567134 - Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Completed NCT04075422 - Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Recruiting NCT03712722 - Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Recruiting NCT05192148 - Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile N/A