Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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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Salmonella typhi vaccine is being studied for its potential effects on mood and cytokine levels in Major Depressive Disorder. It is an investigational monoclonal antibody in Phase 1 clinical development, evaluated in a controlled trial involving female participants with the condition.
Johnson & Johnson (ticker: JNJ) is the developer of Salmonella typhi vaccine. The company is conducting early-stage research on this investigational monoclonal antibody for Major Depressive Disorder, with one completed Phase 1 trial.
Salmonella typhi vaccine is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed one early-phase trial. The study was a controlled trial with 40 female participants in Belgium.
Salmonella typhi vaccine has one completed clinical trial, NCT01533285, titled "Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients." This early Phase 1 study enrolled 40 female participants aged 25 years and older in Belgium.
Yes, Salmonella typhi vaccine is a monoclonal antibody. It is being investigated as a potential treatment for Major Depressive Disorder, with research focusing on mood and cytokine levels in affected individuals.