A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older

Официальное название

A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIOIDES DIFFICILE VACCINE IN ADULTS 65 YEARS OF AGE AND OLDER

Обзор

The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle. This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly works or clearly doesn't. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years. During this time, participants will have 3 planned clinical visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study. Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.

Вмешательства

• Биопрепарат C.difficile vaccine
  C.difficile vaccine given as an intramuscular injection
• Другое Saline Placebo
  0.9% sodium chloride solution given as a intramuscular injection

Первичные конечные точки

• The percentage of participants reporting local reactions [Срок оценки: For 7 days after each vaccination]
• The percentage of participants reporting systemic events [Срок оценки: For 7 days after each vaccination]
• Percentage of participants reporting adverse events [Срок оценки: From each vaccination through 1 month after each vaccination]
• Percentage of participants reporting serious adverse events [Срок оценки: From Vaccination 1 (Day 1) through 12 months after Vaccination 2 (last dose) (18 months)]
• The incidence of the first episode of medically attended and clinically meaningful primary Clostridioides difficile infection (CDI) [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]
• The incidence of the first episode of medically attended primary CDI [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]
• The incidence of the first episode of clinically meaningful primary CDI [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]

Вторичные конечные точки (4)

• The incidence of antibiotic use in the treatment of a first episode of the primary CDI [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]
• The incidence of severe primary CDI as defined by Infectious Diseases Society of America (IDSA)/ Society for Healthcare Epidemiology of America (SHEA) [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]
• The incidence of a first episode of primary CDI (any severity) [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]
• The incidence of all CDI (primary and recurrent) [Срок оценки: from 14 days after Vaccination 2 to the end of the surveillance period (up to approximately 3.5 years)]

Критерии участия

Who Can Join the Study (Inclusion Criteria):

• People with recent or future planned contact with healthcare systems or who have recently received antibiotics.

Who Cannot Join the Study (Exclusion Criteria):

• Anyone who has had CDI before.
• Anyone who has had surgery to remove part of their small or large intestine.
• Anyone who often has diarrhea (meaning three or more loose stools in a day, more than once a month).
• Anyone who has already received a vaccine or special antibody treatment for C. difficile.
• Anyone who has had a serious allergic reaction to a vaccine or to any part of the study vaccines.
• Anyone who might not respond well to the vaccine because their immune system is weak (either from a disease or from treatment).
• Anyone with cancer that has spread, kidney failure, or another serious health problem.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 135 центров

• North Alabama Research Center — Athens
• Lakeview Clinical Research — Guntersville
• Medical Affiliated Research Center — Huntsville
• Epic Medical Research-Sun City — Sun City
• Applied Research Center of Arkansas — Little Rock
• Kaiser Permanente Daly City — Daly City
• Kaiser Permanente Los Angeles Medical Center — Los Angeles
• Kaiser Permanente Oncology Pharmacy #014C — Los Angeles
• … и ещё 127 центров

Великобритания · 19 центров

Список центров уточняется — проверьте первичный протокол.

Япония · 12 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 8 центров

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07282665 · C4771002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗