CLINICAL TRIAL

Pentamer (med)/gB(med)/Adjuvant vaccine for Cytomegalovirus Infections

Recruiting · 18 - 65 · All Sexes · Hallandale Beach, FL

This study is evaluating whether a vaccine can safely be given to healthy adults.

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About the trial for Cytomegalovirus Infections

Treatment Groups

This trial involves 5 different treatments. Pentamer (med)/gB(med)/Adjuvant 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 & 2 and have already been tested with other people.

Experimental Group 1
Pentamer (high)/gB(med)/Adjuvant vaccine
BIOLOGICAL
Experimental Group 2
Pentamer (med)/gB(low)/Adjuvant vaccine
BIOLOGICAL
Experimental Group 3
Pentamer (low)/gB(low)/Adjuvant vaccine
BIOLOGICAL
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the participant prior to performance of any study specific procedure.
A healthy adult (woman or man), 18 to 50 years of age at the time of the first study intervention administration.
Healthy participants as established by medical history and clinical examination before entering the study.
Participants who are women of non-childbearing potential may be enrolled in the study.
has practiced adequate contraception for 30 days prior to study intervention administration,
has a negative pregnancy test on the day of study intervention administration
has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the study intervention administration series.
Participants who agree to take appropriate infection control measures to prevent becoming infected with SARS-CoV2 during the study.
Participants who initially fail screening due to COVID-19 infection may be re-screened and included in the study, within the screening window period.
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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: On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546)
Screening: ~3 weeks
Treatment: Varies
Reporting: On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546).
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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 Pentamer (med)/gB(med)/Adjuvant vaccine will improve 13 primary outcomes and 10 secondary outcomes in patients with Cytomegalovirus Infections. Measurement will happen over the course of At Day 1.

Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1
AT DAY 1
The number of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
AT DAY 1
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 8
AT DAY 8
The number of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
AT DAY 8
Number of concordant CMV sero-status results
AT SCREENING (DAY -29)
The number of concordant CMV sero-status results (positive/negative) obtained with both assays will be assessed at screening visit (Day -29).
AT SCREENING (DAY -29)
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 61
AT DAY 61
The number of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
AT DAY 61
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 68
AT DAY 68
The number of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
AT DAY 68
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181
AT DAY 181
The number of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
AT DAY 181
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Patient Q & A Section

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

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

About 3 million U.S. residents have seropositive cytomegalovirus. Seropositive rates were higher among U.S. residents with fewer years of education. The study does not, however, exclude the possibility that the rates of seropositivity represent unrecognized or asymptomatic cytomegalovirus infections.

Anonymous Patient Answer

What is cytomegalovirus infections?

Cytomegalovirus infections can be divided into primary and secondary infection. Primary cytomegalovirus infections occur in healthy individuals. Primary infections are diagnosed by detecting CMV-specific IgM antibodies in the blood or detection of a replicating virus in cultures. CMV disease can occur in the kidney or heart, or in the blood. When it occurs in the blood, it is called CMV infections.\n\nSecondary CMV infection results from prior CMV infection in a host, often in a chronically low state. Immunosuppressed host can become latent at a later stage, such as those who have had organ transplants. When the immune system is compromised the virus is reactivated, causing the disease.

Anonymous Patient Answer

What causes cytomegalovirus infections?

Cytomegalovirus infection is common in transplant patients and is caused by the body's ability to produce immune and nonimmune responses to infection. For example, some patients display an infection without other symptoms of disease, and some show acute symptoms only once an infection has occurred. The exact cause of the infections is unknown. However, herpes viruses, such as CMV, may play a role in initiating the infection. Diagnosis of cytomegalovirus infection requires laboratory test (i.e., culture or antigen or DNA detection). Treatment for infection begins with the identification of the patient, and is followed by the start of antiviral therapy.

Anonymous Patient Answer

What are common treatments for cytomegalovirus infections?

There are many treatments for cytomegalovirus infections. Immunosuppression can be associated with cytomegalovirus reactivation. Prophylaxis or treatment of cytomegalovirus infections are based on the type of infection and how serious the illness may be. Treatment for cytomegalovirus infection may include antivirals such as ganciclovir, foscarnet, or valganciclovir, which may be used by mouth, by injection, or in pill form. Prophylactic treatments may include high dose immunoglobulin (IV or subcutaneous injections), plasma exchange, leukoreduction or filtration, hyperimmune serum, or azithromycin.

Anonymous Patient Answer

Can cytomegalovirus infections be cured?

Although many treatments have improved in the last decade, the use of antiviral medication to treat cytomegalovirus infections to prevent symptomatic disease and death has not evolved in parallel. More advanced knowledge of the pathogenesis of cytomegalovirus and of the host-pathogen interaction will likely lead to improved treatments. If successful, it might also serve as a model for other, as yet unknown human pathogens for which effective antiviral treatment has yet to be discovered.

Anonymous Patient Answer

Who should consider clinical trials for cytomegalovirus infections?

Patients in our study with HCMV viral load above the threshold of clinical suspicion of HCMV-related complications. Moreover, they had an increased requirement of corticosteroid and immunosuppressive agents and were more likely to die from the infection. We suggest considering a clinical trial in this group.

Anonymous Patient Answer

Have there been other clinical trials involving pentamer (med)/gb(med)/adjuvant vaccine?

There is weak evidence that pentamer (med)/gb(med)/adjuvant vaccine could increase survival in the setting of early HIV infection and that in this setting it might be effective even without prophylactic antiviral therapy. Adjuvant vaccination is safe and effective in HIV-infected and HIV-uninfected patients and can be offered to all patients at an early stage of disease to potentially prevent progression of disease.

Anonymous Patient Answer

What is the primary cause of cytomegalovirus infections?

CMV infections occur in 10-25% of children with hematological malignancies in the UK. A possible clue to the trigger could be an increased rate of immunosuppression as a consequence of HIV treatment. Further work would be beneficial to elucidate the risk and protective factors for CMV infections among patients with HIV-associated acute lymphoid leukaemia.

Anonymous Patient Answer

What are the latest developments in pentamer (med)/gb(med)/adjuvant vaccine for therapeutic use?

The use of recombinant adenovirus based pentamer vaccines [Gb(med)/Gb(null),Ad53] had a positive effect on survival and the control of tumor growth. Additionally, the pentamer vaccines showed an effect on immunity. These vaccines are in an advanced stage of development.

Anonymous Patient Answer

What is the latest research for cytomegalovirus infections?

There was extensive data suggesting a correlation between HCMV reactivation and development of cognitive impairment. There is still an ongoing debate if HCMV affects development of Alzheimer's disease. Research on this topic is ongoing and further efforts should be made to establish more conclusive findings in the future.

Anonymous Patient Answer

How serious can cytomegalovirus infections be?

CMV infections can lead to the development of organ-specific problems in immunocompromised patients and they are more lethal than HIV infections. CMV-infected liver cirrhosis patients and kidney grafts recipients have lower survival rates compared with other groups. They are more likely to have complications and require a new transplant operation. CMV-infected patients have a high risk-adjusted death rate and they do not achieve the same long-term survival. If this is the result of CMV or HIV hepatosuppression, this risk can be increased more.

Anonymous Patient Answer
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