← Back to Search

Cancer Vaccine

CMV Vaccine for Cytomegalovirus

Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 6-month 7-month 12-month 18 [epoch] 1 and year 2.5, year 3.5, year 4.5, year 5.5 [epoch 2]
Awards & highlights

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.

Who is the study for?
Healthy adults aged 18-50, able to follow the study plan. Women must use contraception and have a negative pregnancy test before receiving the vaccine. Participants should not be at high risk for CMV transmission or planning to move away during the trial. They can't join if they're using certain drugs, are pregnant or breastfeeding, or have received another CMV vaccine.Check my eligibility
What is being tested?
The trial is testing different doses of a new Cytomegalovirus (CMV) vaccine in healthy adults. It will look at safety and immune response by gradually increasing doses based on previous participants' reactions.See study design
What are the potential side effects?
Possible side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain. Since it's an investigational vaccine, there might be unknown risks that will be monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 6-month 7-month 12-month 18 [epoch] 1 and year 2.5, year 3.5, year 4.5, year 5.5 [epoch 2]
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 6-month 7-month 12-month 18 [epoch] 1 and year 2.5, year 3.5, year 4.5, year 5.5 [epoch 2] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants reporting SAEs up to 30 days after each dose
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181
+10 more
Secondary outcome measures
Anti-pentamer immunoglobulin G (IgG) and anti-gB IgG concentrations
CMV specific CD8+ T-cells frequency
CMV specific cluster of differentiation (CD)4+ T-cells frequency
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Pentamer(low)/gB(low)/Adjuvant GroupExperimental Treatment1 Intervention
Participants receive the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of EPOCH 1 (Day 546). At the end of EPOCH 1, participants will have the option to enroll in the optional extension study (EPOCH 2-passive safety follow-up phase), and the participants that will agree to continue their enrollment will be followed up until Month 48 after end of EPOCH 1.
Group II: Pentamer (med)/gB(med)/Adjuvant GroupExperimental Treatment1 Intervention
Participants receive the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of EPOCH 1 (Day 546). At the end of EPOCH 1, participants will have the option to enroll in the optional extension study (EPOCH 2-passive safety follow-up phase), and the participants that will agree to continue their enrollment will be followed up until Month 48 after the end of EPOCH 1.
Group III: Pentamer (med)/gB(low)/Adjuvant GroupExperimental Treatment1 Intervention
Participants receive the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of EPOCH 1 (Day 546). At the end of EPOCH 1, participants will have the option to enroll in the optional extension study (EPOCH 2-passive safety follow-up phase), and the participants that will agree to continue their enrollment will be followed up until Month 48 after end of EPOCH 1.
Group IV: Pentamer (high)/gB(med)/Adjuvant GroupExperimental Treatment1 Intervention
Participants receive the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of EPOCH 1 (Day 546). At the end of EPOCH 1, participants will have the option to enroll in the optional extension study (EPOCH 2-passive safety follow-up phase), and the participants that will agree to continue their enrollment will be followed up until Month 48 after the end of EPOCH 1.
Group V: Placebo GroupPlacebo Group1 Intervention
Participants receive placebo (saline) at 0,2 and 6 months and are followed up until end of EPOCH 1 (Day 546). At the end of EPOCH 1, participants will have the option to enroll in the optional extension study (EPOCH 2-passive safety follow-up phase), and the participants that will agree to continue their enrollment will be followed up until Month 48 after end of EPOCH 1.

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,742 Previous Clinical Trials
8,066,032 Total Patients Enrolled

Media Library

Pentamer/gB/Adjuvant Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05089630 — Phase 1 & 2
Cytomegalovirus Research Study Groups: Pentamer (med)/gB(med)/Adjuvant Group, Pentamer (med)/gB(low)/Adjuvant Group, Pentamer (high)/gB(med)/Adjuvant Group, Pentamer(low)/gB(low)/Adjuvant Group, Placebo Group
Cytomegalovirus Clinical Trial 2023: Pentamer/gB/Adjuvant Vaccine Highlights & Side Effects. Trial Name: NCT05089630 — Phase 1 & 2
Pentamer/gB/Adjuvant Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05089630 — Phase 1 & 2
Cytomegalovirus Patient Testimony for trial: Trial Name: NCT05089630 — Phase 1 & 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Does this investigation accept geriatric individuals?

"According to the stipulations of this study, prospective participants must range between 18 and 50 years old."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Iowa
Michigan
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Healthy volunteer wanting to help others.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
~219 spots leftby Jun 2029