CLINICAL TRIAL

RSV ΔNS2 Δ1313 I1314L Vaccine for Respiratory Syncytial Virus Infections

Recruiting · < 18 · All Sexes · Laurel, MD

This study is evaluating whether a vaccine may help prevent respiratory syncytial virus.

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About the trial for Respiratory Syncytial Virus Infections

Treatment Groups

This trial involves 8 different treatments. RSV ΔNS2 Δ1313 I1314L Vaccine is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
RSV ΔNS2 Δ1313 I1314L Vaccine
BIOLOGICAL
Experimental Group 2
RSV ΔNS2 Δ1313 I1314L Vaccine
BIOLOGICAL
Experimental Group 3
RSV ΔNS2 Δ1313 I1314L Vaccine
BIOLOGICAL
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Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
You will need to be available for the entire study. show original
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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: Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children.
View detailed reporting requirements
Trial Expert
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- 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 RSV ΔNS2 Δ1313 I1314L Vaccine will improve 2 primary outcomes in patients with Respiratory Syncytial Virus Infections. Measurement will happen over the course of Measured through follow-up period, up to 1 year after study entry.

Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination
MEASURED THROUGH FOLLOW-UP PERIOD, UP TO 1 YEAR AFTER STUDY ENTRY
Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).
Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study
MEASURED AT DAYS 0-10 FOR SEROPOSITIVE CHILDREN AND DAYS 0-28 FOR SERONEGATIVE INFANTS AND CHILDREN

Patient Q & A Section

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

Can respiratory syncytial virus infections be cured?

In carefully selected patients with severe respiratory syncytial virus infection after surgery but without respiratory distress, respiratory syncytial virus shedding is frequently and reproducibly suppressed.

Anonymous Patient Answer

What are the signs of respiratory syncytial virus infections?

Symptoms include a purulent cough in young children, persistent or worsening lower respiratory tract symptoms in older children. The most important symptom is decreased appetite. The diagnosis usually requires confirmation by an appropriate serologic test. RSV infection may also be detected serologically if the disease presents as a febrile illness with respiratory symptoms. Other signs include erythema nodosum and lymphadenopathy.

Anonymous Patient Answer

What causes respiratory syncytial virus infections?

RSV is not the only cause of bronchiolitis in infants and children. The most accurate way to demonstrate an upper respiratory infection includes the presence of RSV, rhinovirus, influenza or adenovirus in a patient's upper airway samples. RSV is a common cause of bronchiolitis in pediatric health care facilities.

Anonymous Patient Answer

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

Each year over one million children in the United States are infected with RSV. More than 80% of cases occur during the first two years of life. Nearly half of these cases occur at less than one month of age. It remains to be seen whether this will be the result of increased risk due, in part, to recent vaccination programs or decreased natural immunity of the immunocompromised newborn infant. The increased risks may result in many more cases of RSV infection, not only in children, who have few natural immunity options, but in all infants (especially infants less than two years of age). Prevention of RSV infection in infancy is critical to prevention of disease later in life.

Anonymous Patient Answer

What is respiratory syncytial virus infections?

The respiratory manifestations of the viral infection are the most common, but they may vary according to the pathogenic viral strain. The most important symptom is a prodromal prodrome (symptoms prior to clinical manifestations), followed by upper airway involvement and the final respiratory involvement. Most frequently the upper airway manifestations are absent in infants. These viral infections may be more likely to be associated with a bronchial obstruction in infants and toddlers. The respiratory symptoms of RSV infections, especially in the first week of infection or in children younger than 24 months, is probably the most important clinical manifestation. RSV is a common infectious agent, but a possible pathogenic factor is the high variability of the viral strains.

Anonymous Patient Answer

What are common treatments for respiratory syncytial virus infections?

There is currently no specific treatment for RSV infections. Current prevention options include immunization of the infant, avoiding close contact with infected persons and decreasing the chance of exposure to the virus through increased cleaning, disinfection and air purification. There is no vaccine for RSV, therefore prevention through these strategies is critical to controlling respiratory syncytial virus infections. A study shows that the number of cases of RSV is associated with increased visits to an emergency provider. It is advisable to be present in any children hospitalized with RSV-like illness, not to touch them and to report any respiratory infection to your pediatrician or hospital's infectious disease ward.

Anonymous Patient Answer

Has rsv δns2 δ1313 i1314l vaccine proven to be more effective than a placebo?

With regard to RSV pneumonia rate, rsa Δns2 Δ1313 Δi1314 Δ l vaccine is more effective than a placebo and with regard to recurrent wheezing, it is also more effective than other vaccines.

Anonymous Patient Answer

How does rsv δns2 δ1313 i1314l vaccine work?

This article shows that in mice, RSV δns2 δ1313 i1314l vaccines, like the rM2 prophylactic strategy, elicits protection against lethal RSV challenge. Therefore, the rM2 δns2 δ1313 i1314l vaccine is an effective strategy for preventing lethal RSV challenge in naïve and previously infected, as well as immunocompromised murine hosts.

Anonymous Patient Answer

What is the latest research for respiratory syncytial virus infections?

This is the most recent evidence and a review of the research on the effects of RSV infections in the lung. Researchers have made advances in understanding RSV infections and they are looking to understand how RSV is able to cause lung disease and how and why certain babies are more likely to be affected. There are potential new therapies, vaccines, and strategies for RSV-infected babies to reduce their symptoms and death. To help researchers discover more about RSV and the lung, you can search for recently published peer-reviewed papers at PUBMED. Furthermore, you can go to PubMed and search under [Respiratory Syncytial Virus] (http://www.ncbi.nlm.nih.

Anonymous Patient Answer

What does rsv δns2 δ1313 i1314l vaccine usually treat?

This rSvo δns2 δ1313 i1314l vaccine may be efficacious against RSV-mediated airway disease in children, and may be evaluated as a potential treatment for children hospitalized with RSV-mediated LRTI.

Anonymous Patient Answer

Who should consider clinical trials for respiratory syncytial virus infections?

Results from a recent clinical trial from this study provide further evidence that most patients with persistent pulmonary disease following RSV infection are being managed suboptimally. The major contributor to this discrepancy in management appears to be that many patients in this population have more severe disease or are receiving inappropriate management. Patients with persistent disease after RSV infection are at risk of persistent lung disease. These patients may be eligible for clinical trials investigating new therapies to reduce this burden.

Anonymous Patient Answer

Is rsv δns2 δ1313 i1314l vaccine typically used in combination with any other treatments?

The efficacy of the vaccine in preventing RSV disease during the first 4 years of life does not depend on the vaccine used or the concurrent administration of additional treatments. This is in good agreement with the results of previous randomized clinical trials as well as the results of our previous observational studies, since receipt of any treatment is associated both with higher risk of RSV disease and with more severe disease.

Anonymous Patient Answer
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