What is the mechanism of action of this treatment?

Common treatments for risk reduction, such as the Vivotif oral vaccine, work by stimulating the immune system to recognize and combat specific pathogens. Vivotif introduces a weakened form of the typhoid bacteria to the body, prompting an immune response that prepares the body to fight off future infections. This mechanism is essential for risk reduction as it enhances the immune system's ability to respond to actual infections, thereby decreasing the likelihood and severity of disease. Such immunological preparedness is particularly important for individuals at higher risk of exposure to enteric pathogens.

What side effects are associated with this type of intervention?

Common treatments aimed at eliciting protective immunological responses against enteric pathogens, such as the Vivotif oral typhoid vaccine, generally have a good safety profile. Reported side effects are typically mild and may include gastrointestinal symptoms like nausea, vomiting, and abdominal pain, as well as systemic reactions such as fever, headache, and fatigue. Serious adverse events are rare. It is important for patients to discuss potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several vaccines aimed at risk reduction by eliciting protective immunological responses. For example, Vivotif is an oral vaccine approved for typhoid fever prevention. Other similar vaccines include the hepatitis A and B vaccines, which protect against their respective viral infections, and the rotavirus vaccine, which reduces the risk of severe gastroenteritis in infants. These vaccines work by stimulating the immune system to recognize and combat specific pathogens, thereby reducing the risk of infection and its associated complications.

What other types of research exist?

Promising novel alternatives to Vivotif for risk reduction in 2024 include: 1) Typhoid Conjugate Vaccines (TCVs) such as Typbar-TCV, which have shown higher efficacy and longer-lasting immunity compared to older vaccines. 2) Oral cholera vaccines (OCVs) like Vaxchora, which may offer cross-protection against other enteric pathogens. 3) Advances in fecal microbiota transplantation (FMT) for preventing recurrent Clostridioides difficile infections, which may also enhance gut immunity against other enteric pathogens.

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Vaccine

Vivotif Vaccine for Typhoid Risk Reduction

Phase 4

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Be older than 18 years old

Must not have

Any of the following laboratory abnormalities detected during medical screening: WBC <0.81 x LLN or > 1.09 x ULN, Hemoglobin <0.91 x LLN or >1.18 x ULN (women) or <0.92 x LLN or >1.18 x ULN (men), Platelet count <0.8 x LLN or > 1.2 x ULN, SGOT or SGPT >1.5 times normal, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen, Positive serology for hepatitis B core antibody, Poor peripheral venous access for blood donation, Positive RPR, Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study, Positive urine pregnancy test (HCG) on day of vaccination. Prior to each blood donation -females with menstrual history consistent with pregnancy. Pregnant women will not be enrolled, because immunological changes that occur during pregnancy may interfere with laboratory assays.

History of recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial involves giving volunteers an oral vaccine called Vivotif to protect against typhoid fever. The study focuses on travelers to developing countries who are at higher risk of the disease. The vaccine helps the body learn to fight off typhoid bacteria. Researchers will collect samples from participants over time to understand how the vaccine works and if it can help with other similar diseases.

Who is the study for?

Adults over 18 in good health can join this trial. They must not have heart disease, active ulcers, intestinal conditions, recent anemia treatment, substance abuse issues, diabetes or recent cancer (except certain skin and cervical cancers). Blood tests will exclude those with abnormal blood counts or liver function, hepatitis B/C or HIV infections. Pregnant women and those on anti-malarial drugs cannot participate.

What is being tested?

The study involves the Vivotif typhoid oral vaccine already approved for travelers to certain countries. Participants will receive the vaccine and provide blood, saliva, and stool samples for up to eight years to help researchers understand how it protects against other similar diseases.

What are the potential side effects?

While specific side effects are not listed here for Vivotif typhoid oral vaccine within this trial context; generally such vaccines may cause stomach pain, nausea, fever, headache or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized more than 3 times for serious infections like pneumonia or meningitis.

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I have been treated for anemia in the past 6 months.

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I have a history of serious heart issues in the last 5 years or currently have heart disease symptoms.

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I have a history of stomach ulcers or ongoing intestinal issues.

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I have a history of diabetes.

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I am currently taking anti-malarial medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Responders

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vaccination with Oral Typhoid Vaccine (Vivotif)Experimental Treatment1 Intervention

Volunteers receive immunization with Vivotif oral typhoid vaccine. Blood, saliva, and stool specimens are collected at subsequent visits.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for risk reduction, such as the Vivotif oral vaccine, work by stimulating the immune system to recognize and combat specific pathogens. Vivotif introduces a weakened form of the typhoid bacteria to the body, prompting an immune response that prepares the body to fight off future infections. This mechanism is essential for risk reduction as it enhances the immune system's ability to respond to actual infections, thereby decreasing the likelihood and severity of disease. Such immunological preparedness is particularly important for individuals at higher risk of exposure to enteric pathogens.

Evidence that antihuman tumor necrosis factor monoclonal antibody prevents OKT3-induced acute syndrome.[Acute clinical syndrome associated with OKT3 administration. Prevention by single injection of an anti-human TNF monoclonal antibody].ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies: an infectious diseases perspective (Soluble immune effector molecules [II]: agents targeting interleukins, immunoglobulins and complement factors).