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CMV Vaccine for Cytomegalovirus
Study Summary
This trial will study the safety and effectiveness of a new CMV vaccine in adults aged 18-50. The vaccine will be administered in four doses, with safety being evaluated after each dose.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I can get my next vaccine dose if I've had COVID-19 but now have no fever and only mild symptoms.I am a healthy adult aged 18-50, can follow study rules, and meet all COVID-19 and reproductive health criteria.If you have an infection during the initial screening, you may be able to participate in the study later if you no longer have symptoms of the infection.
- Group 1: Pentamer (med)/gB(med)/Adjuvant Group
- Group 2: Pentamer (med)/gB(low)/Adjuvant Group
- Group 3: Pentamer (high)/gB(med)/Adjuvant Group
- Group 4: Pentamer(low)/gB(low)/Adjuvant Group
- Group 5: Placebo Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In how many locales is this clinical experimentation being conducted?
"14 medical sites are actively enrolling participants for this clinical trial, located in Long Beach, Dearborn and Lexington, among other cities. To reduce the burden of travel requirements, it is best to choose a site close by."
Is this research initiative currently signing up participants?
"Affirmative. Clinicaltrials.gov has verified that enrollment for this trial is open, with the original post dated October 14th 2021 and last updated on September 8th 2022. 320 patients are needed to be recruited from 14 different sites across the country."
Do I meet the qualifications to partake in this clinical research?
"This clinical trial is searching for 320 individuals, ranging from 18 to 50 years of age, with cytomegalovirus infections. Additionally, they must have provided written consent and proven that they are generally healthy adults through medical history and physical examination prior to enrolment. Females of childbearing potential need to demonstrate a negative pregnancy test on the day of intervention administration as well as consistent contraception use over 30 days before study participation and throughout the entire treatment period (plus 3 months). Lastly, participants will be expected take appropriate precautions against further exposure SARS-CoV2 during the duration of the research; though those who initially fail screening due COVID"
How many participants is the research team accepting for this experiment?
"Affirmative, clinicaltrials.gov shows that this medical trial is currently seeking participants. It was first published on October 14th 2021 and the most recent update came out September 8th 2022. The study needs 320 patients to be recruited from 14 different locations."
How perilous is the Pentamer (med)/gB(med)/Adjuvant vaccine to humans?
"Pentamer (med)/gB(med)/Adjuvant vaccine currently has low safety ratings due to its Phase 1 status, indicating limited evidence of efficacy and protection."
What is the ultimate goal of this medical experiment?
"GlaxoSmithKline, the study sponsor, has reported that primary outcome will be evaluated over a 188 day time span with an emphasis on abnormalities in hematological and biochemical labs. As for secondary outcomes, this trial will assess unsolicited adverse effects logged by participants via diary entries, CD4+ T-cells frequency per million PBMCs to measure vaccine induced cellular immune response, as well as potential immunemediated diseases of interest which could have autoimmune origins."
Does this investigation accept geriatric individuals?
"According to the stipulations of this study, prospective participants must range between 18 and 50 years old."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- GSK Investigational Site: < 48 hours
Typically responds via
Average response time
- < 2 Days
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