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Salmonella typhi vaccine

Phase 1

Major Depressive Disorder | Monoclonal antibody | Psychiatry |Johnson & Johnson|Last Updated: Mar 28, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Salmonella typhi vaccine · 1 trial · 1 indication

Early Phase 1 1
NCT01533285Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder PatientsMajor Depressive Disorder
COMPLETED40 Analytics
EARLY_PHASE1COMPLETED
Exploratory Study on the Mood and Cytokine Levels in Female Healthy Participants and Major Depressive Disorder Patients
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Profile of Mood States (POMS) scores from Baseline to Day 1 of Period 1 and Period 2.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.

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.

Change in Visual Analogue Scale (VAS) scores from Baseline to Day 1 of Period 1 and Period 2.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.

Participants rate the way they feel on a 10 mm line separating statements along the extremes of different dimensions (eg, alert - drowsy).

Change in Snaith-Hamilton Pleasure Scale (SHAPS) scores from Baseline to Day 1 of Period 1 and Period 2.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.

Participants endorse any of 14 statements in 4 categories (Strongly Agree, Agree, Disagree, Strongly Disagree) by ticking the appropriate answer.

Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from Baseline to Day 1 of Period 1 and Period 2.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.

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).

Secondary Endpoints

Change in Cognitive Test Battery performance from Baseline to Day 1 of Period 1 and Period 2.
Baseline (≤ Day -1 [1 day before starting study drug]), Day 1 of Period 1 and Period 2.
Changes in levels of hormones and cytokines from Baseline to Day 1 of Period 1 and Period 2.
Baseline (pretreatment), Day 1 of Period 1 and Period 2.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1OTHERTreatment AB: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment B (typhoid vaccination) administered \[Period 2\]
Group 2OTHERTreatment BA: Treatment B (typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\]
Group 3OTHERTreatment AC: Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment C (TSST+Placebo vaccination) administered \[Period 2\]
Group 4OTHERTreatment CA: Treatment C (TSST+Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\]
Group 5OTHERTreatment AD:Treatment A (Placebo vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment D (TSST+typhoid vaccination) administered \[Period 2\]
Group 6OTHERTreatment DA:Treatment D (TSST+typhoid vaccination) administered \[Period 1\], after the washout period (7-14 days) Treatment A (Placebo vaccination) administered \[Period 2\]

Interventions

NameTypeDescription
PlaceboBIOLOGICALPlacebo 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)BIOLOGICALSalmonella 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.
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Eligibility Criteria

Age Range25 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites2

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) ...

Countries:Belgium
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Frequently asked questions about Salmonella typhi vaccine

What is Salmonella typhi vaccine used for in Major Depressive Disorder?

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.

Who is developing Salmonella typhi vaccine?

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.

What phase is Salmonella typhi vaccine in?

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.

What clinical trials is Salmonella typhi vaccine in?

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.

Is Salmonella typhi vaccine a monoclonal antibody?

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.