CLINICAL TRIAL

Viral Specific VST Infusion for Infections

Recruiting · Any Age · All Sexes · Cincinnati, OH

This study is evaluating whether a type of white blood cell can be generated from an unrelated donor and given safely to patients with viral infections.

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About the trial for Infections

Eligible Conditions
Infections · Virus Diseases · Viral Reactivation · Viral Infections · Infection in an Immunocompromised Host · Communicable Diseases

Treatment Groups

This trial involves 2 different treatments. Viral Specific VST Infusion is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Viral Specific VST Infusion
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
Immunocompromised patient with evidence of viral infection or reactivation
Age >1 day
Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
Must be able to receive CTL infusion in Cincinnati
Informed consent obtained by PI or sub-investigator either in person or by phone
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through 30 days after infusion
Screening: ~3 weeks
Treatment: Varies
Reporting: Through 30 days after infusion
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through 30 days after infusion.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Viral Specific VST Infusion will improve 3 primary outcomes and 2 secondary outcomes in patients with Infections. Measurement will happen over the course of Through 30 days after infusion.

Incidence of GVHD associated with VST infusion
THROUGH 30 DAYS AFTER INFUSION
Patients will be monitored for the development of VST associated GVHD
THROUGH 30 DAYS AFTER INFUSION
Successful production of viral specific T-cells
WITHIN 30 DAYS POST CULTURE INITIATION
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
WITHIN 30 DAYS POST CULTURE INITIATION
Percentage of patients who do not have infusional toxicity
THROUGH 30 MINUTES POST INFUSION
Patients will be monitored for infusional toxicity
THROUGH 30 MINUTES POST INFUSION
Viral burden
AT 30 DAYS AFTER INFUSION
The viral burden will be assessed using the protocol-defined efficacy assessment.
AT 30 DAYS AFTER INFUSION
Presence of viral-specific T-cells
AT 30 DAYS AFTER INFUSION
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
AT 30 DAYS AFTER INFUSION

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has viral specific vst infusion proven to be more effective than a placebo?

It is shown that VSV-based gene transfer therapy using a recombinant VSV (rVSV) can provide a potent and durable anti-infection potency against a human immunodeficiency type-1 (HIV-1). In view of the fact that some of patients, who suffer from opportunistic viral infections, could benefit from this innovative treatment, gene transfer of VSV-based anti-HIV therapeutics seems to be a promising therapeutic approach.

Anonymous Patient Answer

What is infections?

Infections are diseases spread by microorganisms and typically affect the tissues by invading the body and causing inflammation. The types of infections that are present in the eye include bacterial conjunctivitis and viral conjunctivitis. Infectious keratoconjunctivitis is most commonly caused by viruses. Infection of the cornea can have profound and long-lasting effects on vision.\n

Anonymous Patient Answer

What are the signs of infections?

There are a number of signs of infections including fever, chills, sweating, joint pains, malaise, muscle aches and general lethargy. Often these signs will be the same regardless of which exact microbiological test results, or diagnosis, is made. Most of these signs are easily detectable by people experienced in caring for people with infectious diseases.\n

Anonymous Patient Answer

How many people get infections a year in the United States?

About 2.4 million people in the US get new infections a year. Amongst these, over 1.6 million people are vaccinated. For the vaccine-preventable diseases, the US ranks the highest in the world.

Anonymous Patient Answer

Can infections be cured?

While some infections with very simple remedies, such as antibiotic treatment, can be cured, not everyone can achieve this goal. Most infections are intrinsically incurable (and most of these patients do not seek treatment) as they continue to cause significant symptomatology (pain, fever, and general discomfort, as well as the direct impact on the organs).

Anonymous Patient Answer

What causes infections?

A variety of common, and less common infections are a major cause of death. In most countries such as South Africa and the UK, chronic infections can be prevented if people and their caregivers are well educated and motivated to seek treatment as quickly as possible. Infections have an enormous impact on health outcomes. There are huge benefits to prevention of infections. Vaccination against some diseases, such as the polio virus and measles, can reduce death and disability.

Anonymous Patient Answer

What are common treatments for infections?

An estimated 40% of antibiotics prescribed in Australia are still necessary due to the lack of evidence. While some are still necessary, there are a growing number in the last decade. Although many common antibiotics are available, clinicians are still missing some of the important evidence of efficacy such as the use of antibiotics in neonatal septic encephalopathy. It remains a significant challenge in primary care (particularly in rural) to determine and implement the best treatment for patients with acute illnesses.

Anonymous Patient Answer

What is the average age someone gets infections?

One of the results of the study was that infections most commonly begin in childhood, although infection in adulthood will always remain an important concern in many parts of the world. Preventive measures, such as vaccination, could significantly reduce or even eliminate the spread of childhood infections.

Anonymous Patient Answer

Is viral specific vst infusion safe for people?

Infusion of antiviral drugs are a common part of care during an infection. When used in a safe and monitored manner this provides effective antiviral treatment with minimal side effects. Recent findings supports that the use of antivirals in paediatric wards is a feasible option. However no clinical evidence on antiviral drugs use in infants can be found in available literature and further study should be encouraged to prove its effectiveness.

Anonymous Patient Answer

Have there been other clinical trials involving viral specific vst infusion?

The viral specific vst has not been tested for use as an anti-cancer agent and thus remains an investigational and not approved use in any way in the development of future anti-cancer therapies. \nThe viral specific vst has not been tested for use as an anti-cancer agent but may be used in further elucidation of viral replication in cancer cells as it is a novel approach to anti-cancer therapy.\n\nThe vst was engineered to incorporate, at its 5' end, the gene encoding for the human truncated lacZ promoter. The vst-lacZ system, therefore, allows in vivo visualization of gene expression by means of β-galactosidase production.

Anonymous Patient Answer

What does viral specific vst infusion usually treat?

About 40% of patients who receive vst treatment show a decrease in viral load of >2 log10 and <1 log10 when compared to the placebo group. One of the first studies on vst treatment was reported in 1999. Sub-Saharan African AIDS patients that were already antiretroviral therapy naive were randomised to receive vst or placebos. Of the participants, about 50% showed a >2 log10 viral load decrease and 6% in a <1 log10 loss. When comparing all patients regardless of prior ART experience there was evidence that participants receiving vst treatment had a better outcome, with a median viral load decrease of 4.1 log10 compared to a decrease of 2.

Anonymous Patient Answer

Does viral specific vst infusion improve quality of life for those with infections?

Treatment with VST infusion improved HRQoL and this was most evident for the subset of patients who reported the most pain. This is the first assessment to report significant improvements in HRQoL in a group of patients with viral infections while receiving antiviral medications by an infusing device. This demonstrates the potential benefit of antiviral medications combined with an infusing device.

Anonymous Patient Answer
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