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Clostridium Difficile InfectionPhase 1NCT01296386

An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84

A Phase 1 study testing IC84 in people with Clostridium Difficile Infection, run by Valneva Austria GmbH at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Clostridium Difficile Infection
What is being tested?
IC84
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
3 sitesin 2 countries
Study dates
Dec 2010to Apr 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Healthy adults ≥18 years of age.
  • 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.
  • 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.
  • Weight: ≥ 45.5 kg and <= 150 kg at Visit 0 (Screening Visit).
  • White blood cells ≥2,500/mm3 and <11,000/mm3 at Visit 0.
  • Platelets within normal limits at Visit 0.
  • Written informed consent obtained from the subject prior to any study related procedures.

Who cannot join

  • 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.
  • Active or passive vaccination four weeks before first vaccination at Visit 1 and during the entire study period.
  • Immunodeficiency including status post-organ-transplantation or immuno-suppressive therapy, and a family history of congenital or hereditary immunodeficiency.
  • 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).
  • History of severe hypersensitivity reactions and anaphylaxis.
  • History of allergic bronchial asthma and severe allergic rhinoconjunctivitis.
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  • Known hypersensitivity or allergic reactions to one of the components of the vaccine.
  • History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
  • 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.
  • 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.
  • Systemic antibiotic use within four weeks prior to first vaccination and during treatment period (until Day 28).
  • Clinically significant diseases as judged by the investigator.
  • 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.).
  • 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).
  • Intake of NSAID within three days prior to and within three days after all three vaccinations (Day 0, 7 and 21).
  • 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).
  • Body temperature > 37°C (oral) immediately prior to each vaccination.
  • 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.
  • 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.
  • Pregnancy (positive pregnancy test during screening), lactation or unreliable contraception in female subjects with child-bearing potential ( and unreliable contraception in male subjects.
  • Not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
  • Blood donation within 4 weeks prior to first vaccination.
  • Clinically significant mental disorder not adequately controlled by medical treatment.
  • History of Guillain-Barré-Syndrome (GBS).
  • 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.
  • Inability or unwillingness to provide informed consent.
  • Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Austria2 sites

  • Privatklinik Leech

    Graz

  • Medizinische Universität Wien

    Vienna

Other trials in Austria

Hungary1 site

  • St. Imre Teaching Hospital

    Budapest

Other trials in Hungary

About this study

Official title: An Open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, a New Vaccine Against Clostridium Difficile, in Healthy Subjects

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

Read the detailed 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.

Being tested
IC84
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IC84Biological

    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.

Study groups in NCT01296386
Study groupRoleWhat they receive
IC84, 75 µg w/ AlumExperimental75 µg w/ Alum (microgram with Alum)
Receives: Biological: IC84
IC84, 75 µg w/o AlumExperimental75 µg w/o Alum (microgram without Alum)
Receives: Biological: IC84
IC84, 200 µg w/ AlumExperimental200 µg w/ Alum (microgram with Alum)
Receives: Biological: IC84
IC84, 200 µg w/o AlumExperimental200 µg w/o Alum (microgram without Alum)
Receives: Biological: IC84

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of subjects with any SAE (Serious Adverse Event) possibly, probably or certainly related to the study vaccine at any time during the study

    Measured: day 201

  2. 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

    Measured: day 201

  3. 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)

    Measured: day 201

  4. 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.

    Measured: 6 days after vaccination

  5. 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.

    Measured: 6 days after vaccination

  6. 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.

    Measured: day 201

  7. 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.

    Measured: day 28

Secondary outcomes (3)

  1. 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)

    Measured: day 201

  2. 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)

    Measured: day 201

  3. 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)

    Measured: day 201

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01296386
Sponsor's protocol ID
IC84-101
Status last verified
Sep 2014
First submitted
21 Jan 2011
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Bezay N, Ayad A, Dubischar K, Firbas C, Hochreiter R, Kiermayr S, Kiss I, Pinl F, Jilma B, Westritschnig K. Safety, immunogenicity and dose response of VLA84, a new vaccine candidate against Clostridium difficile, in healthy volunteers. Vaccine. 2016 May 17;34(23):2585-92. doi: 10.1016/j.vaccine.2016.03.098. Epub 2016 Apr 11.

    PubMed 27079932

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IC84 in people with Clostridium Difficile Infection, run by Valneva Austria GmbH at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of subjects with any SAE (Serious Adverse Event) possibly, probably or certainly related to the study vaccine at any time during the study (time frame: day 201). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01296386, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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