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Clostridium Difficile InfectionPhase 2NCT01230957

Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults

A Phase 2 study testing Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant) and Clostridium difficile toxoids A and B (high-dose with adjuvant) in people with Clostridium Difficile Infection and Diarrhea, run by Sanofi Pasteur, a Sanofi Company at 30 sites in United States.

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

This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility. Primary Objectives: To describe the safety profile of subjects in each of the study groups. Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Clostridium Difficile Infection, Diarrhea
What is being tested?
Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant) and Clostridium difficile toxoids A and B (high-dose with adjuvant)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
30 sitesUnited States
Study dates
Oct 2010to Mar 2013
Phase
Phase 2
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 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 40 to 75 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
  • At risk for developing Clostridium difficile infection during the trial because of impending elective surgery or hospitalization within 60 days of enrollment, or current or impending residence in a long-term care facility or rehabilitation facility.

Who cannot join

  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
Show all 21Show fewer
  • Previous vaccination against Clostridium difficile with either the trial vaccine or another vaccine
  • Current or prior Clostridium difficile infection (CDI) episode
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C
  • Anticipated or current receipt of kidney dialysis treatment
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
  • Subjects who have any history of intestinal diverticular bleeding
  • Subjects who have had surgery within the past three months for gastrointestinal (GI) malignancy.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Binghamton, New York, 13901

  • Study site

    Bristol, Connecticut, 06010

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Endwell, New York, 13760

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Marshfield, Wisconsin, 54449

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Neptune City, New Jersey, 07753

  • Study site

    Newton, Kansas, 67114

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Redding, California, 96001

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Salt Lake City, Utah, 84093

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Stamford, Connecticut, 06905

  • Study site

    Tampa, Florida, 33614

  • Study site

    Troy, Michigan, 48098

  • Study site

    Uniontown, Pennsylvania, 15401

  • Study site

    Williamsburg, Virginia, 23185

Other trials in United States

About this study

Official title: Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection

This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.

Primary Objectives:

  • To describe the safety profile of subjects in each of the study groups.
  • To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups.

Observational Objective:

  • To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
Read the detailed description

Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™ vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different vaccination schedules using one of these formulations.

Participants will be followed up for safety and immunogenicity; stool samples will also be provided in case of diarrhea.

Being tested
Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant), Clostridium difficile toxoids A and B (high-dose without adjuvant), Placebo: 0.9% normal saline
Keywords
Clostridium difficile infection, Diarrhea, Pseudomembranous colitis, Clostridium Difficile Toxoid Vaccine, ACAM-CDIFF™ vaccine
Medical subject headings
Clostridium Infections, Diarrhea, Enterocolitis, Pseudomembranous

What participants receive

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

  • Clostridium difficile toxoids A and B (Low-dose with adjuvant)Biological

    Also called ACAM-CDIFF™ vaccine

    0.5 mL, Intramuscular on Days 0, 7, and 30

  • Clostridium difficile toxoids A and B (Low-dose without adjuvant)Biological

    Also called ACAM-CDIFF™ vaccine

    0.5 mL, Intramuscular on Days 0, 7, and 30

  • Clostridium difficile toxoids A and B (high-dose with adjuvant)Biological

    Also called ACAM-CDIFF™ vaccine

    0.5 mL, Intramuscular on Days 0, 7, and 30

  • Clostridium difficile toxoids A and B (high-dose without adjuvant)Biological

    Also called ACAM-CDIFF™ vaccine

    0.5 mL, Intramuscular on Days 0, 7, and 30

  • Placebo: 0.9% normal salineBiological

    Also called 0.9% normal saline

    0.5 mL, Intramuscular on Days 0, 7, and 30

  • Clostridium difficile toxoids A and B (high-dose with adjuvant)Biological

    Also called ACAM-CDIFF™ vaccine

    0.5 mL, Intramuscular on Days 0, 7, and 180

  • Clostridium difficile toxoids A and B (high-dose with adjuvant)Biological

    Also called ACAM-CDIFF™ vaccine

    0.5 mL, Intramuscular on Days 0, 30, and 180

Study groups in NCT01230957
Study groupRoleWhat they receive
Group 1ExperimentalParticipants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
Receives: Biological: Clostridium difficile toxoids A and B (Low-dose with adjuvant)
Group 2ExperimentalParticipants will receive a dose Low-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
Receives: Biological: Clostridium difficile toxoids A and B (Low-dose without adjuvant)
Group 3ExperimentalParticipants will receive a dose High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
Receives: Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
Group 4ExperimentalParticipants will receive a dose High-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
Receives: Biological: Clostridium difficile toxoids A and B (high-dose without adjuvant)
Group 5Placebo comparatorParticipants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively.
Receives: Biological: Placebo: 0.9% normal saline
Group 6ExperimentalParticipants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 180, respectively.
Receives: Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
Group 7ExperimentalParticipants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 30, and 180, respectively.
Receives: Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)

What is being measured

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

  1. Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.

    Measured: 6 days after each vaccination and up to 6 months post-vaccination 3

  2. Serum antitoxin IgG concentrations to Clostridium difficile toxins A and B in participants vaccinated with ACAM-CDIFF™.

    Measured: Up to 6 months post-vaccination 3

Timeline

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

  1. First posted29 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionNov 2012
  4. Study completionMar 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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01230957
Sponsor's protocol ID
H-030-012
Other IDs
UTN: U1111-1114-3917
Status last verified
Jul 2018
First submitted
28 Oct 2010
Last updated
18 Jul 2018
Results posted
No
Data monitoring committee
No

Publications

  • de Bruyn G, Saleh J, Workman D, Pollak R, Elinoff V, Fraser NJ, Lefebvre G, Martens M, Mills RE, Nathan R, Trevino M, van Cleeff M, Foglia G, Ozol-Godfrey A, Patel DM, Pietrobon PJ, Gesser R; H-030-012 Clinical Investigator Study Team. Defining the optimal formulation and schedule of a candidate toxoid vaccine against Clostridium difficile infection: A randomized Phase 2 clinical trial. Vaccine. 2016 Apr 27;34(19):2170-8. doi: 10.1016/j.vaccine.2016.03.028. Epub 2016 Mar 21.

    PubMed 27013431

  • Small RD, Ozol-Godfrey A, Yan L. On the use of nonparametric tests for comparing immunological Reverse Cumulative distribution curves (RCDCs). Vaccine. 2019 Oct 16;37(44):6737-6742. doi: 10.1016/j.vaccine.2019.09.007. Epub 2019 Sep 16.

    PubMed 31537446

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant) and Clostridium difficile toxoids A and B (high-dose with adjuvant) in people with Clostridium Difficile Infection and Diarrhea, run by Sanofi Pasteur, a Sanofi Company at 30 sites in United States.

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 5 inclusion and 21 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine. (time frame: 6 days after each vaccination and up to 6 months post-vaccination 3). The study lists 2 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 NCT01230957, which also lists 2 linked publications.

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 18 Jul 2018.

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