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Also known as Salmonella typhi vaccine (Typhim Vi)
Salmonella typhi vaccine · 1 trial · 1 indication
Participants score on a scale ranging from 0 (not at all) to 4 (extremely) any of 30 statements related to their mood / energy level by circling the appropriate number.
Participants rate the way they feel on a 10 mm line separating statements along the extremes of different dimensions (eg, alert - drowsy).
Participants endorse any of 14 statements in 4 categories (Strongly Agree, Agree, Disagree, Strongly Disagree) by ticking the appropriate answer.
The MADRS is used by trained blinded site staff to rate the severity of depression. It consists of 10 items. The minimal rating is 0 (absent) and the maximal rating is 6 (most serious).
| Arm | Type | Description |
|---|---|---|
| Group 1 | OTHER | Treatment AB: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered \[Period 2\] |
| Group 2 | OTHER | Treatment BA: Treatment B (typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\] |
| Group 3 | OTHER | Treatment AC: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment C (TSST+Placebo vaccination) administered \[Period 2\] |
| Group 4 | OTHER | Treatment CA: Treatment C (TSST+Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\] |
| Group 5 | OTHER | Treatment AD:Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment D (TSST+typhoid vaccination) administered \[Period 2\] |
| Group 6 | OTHER | Treatment DA:Treatment D (TSST+typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\] |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2. |
| Salmonella typhi vaccine (Typhim Vi) | BIOLOGICAL | Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2. |
Inclusion criteria: * Has body mass index (BMI) \[weight in kilograms / (height in meters x height in meters)\] between 18 and 30 kg/m2 * For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: ≥ 65 years of age \& with baseline C-reactive protein (CRP) ...
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The Salmonella typhi vaccine is being studied in Major Depressive Disorder as an exploratory immunomodulatory approach. A completed early Phase 1 trial in Belgium enrolled 40 female participants, including healthy volunteers and MDD patients, to examine mood and cytokine levels. It is not an approved treatment for depression.
Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with the Salmonella typhi vaccine program in Major Depressive Disorder. The work is at the exploratory research stage, with one completed early Phase 1 study conducted in Belgium.
The Salmonella typhi vaccine is in Phase 1 development for Major Depressive Disorder. The single recorded trial, NCT01533285, is classified as Early Phase 1 and has been completed. No active trials are currently listed, so the program remains investigational and is not approved for psychiatric use.
Trial NCT01533285, titled an Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients, evaluated the Salmonella typhi vaccine. The completed early Phase 1 study enrolled 40 female participants aged 25 years and older in Belgium and used a controlled, randomized design without blinding.
Yes, the Salmonella typhi vaccine is also known as Typhim Vi. Typhim Vi is the branded name for the Salmonella typhi vaccine, and searches for either name refer to the same product. In this program it is being explored in Major Depressive Disorder rather than for typhoid prevention.