What side effects are associated with this type of intervention?

Common side effects of treatments for Cytomegalovirus (CMV), particularly those involving vaccines like the CMV recombinant protein subunit (CMVsu) vaccine, often include local reactions at the injection site such as pain, redness, and swelling. Systemic side effects may include fever, fatigue, headache, and muscle aches. These side effects are generally mild to moderate in severity and resolve on their own. In rare cases, more serious adverse reactions can occur, and it is important for patients to discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of Cytomegalovirus (CMV) infections, particularly in immunocompromised patients. These include ganciclovir, valganciclovir, foscarnet, and cidofovir, which primarily inhibit viral DNA replication. While these treatments are effective in managing CMV infections, they do not function by stimulating the immune system in the same way as the CMV recombinant protein subunit (CMVsu) vaccine, which presents glycoproteins B and pentamer antigens to elicit an immune response. Currently, there are no FDA-approved vaccines specifically designed to prevent CMV by targeting these antigens, making the CMVsu vaccine a novel approach in CMV prevention.

What other types of research exist?

Promising novel alternatives to the CMV recombinant protein subunit (CMVsu) vaccine for Cytomegalovirus patients include mRNA-based vaccines and viral vector vaccines. These platforms have shown potential in other viral infections and are being explored for CMV. Additionally, novel antiviral therapies, such as those targeting viral replication mechanisms, are under investigation and may offer new treatment options in the near future.

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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]

Summary

This trial is testing a new CMV vaccine in healthy adults aged 18 to 50. The vaccine uses parts of the CMV virus to help the immune system recognize and fight it. The study will check if the vaccine is safe and effective. Live CMV vaccines in healthy adults have been shown to be safe and to induce immune responses similar to those that occur with natural CMV infection.

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.

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.

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 weeks3 visits

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]

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The CMV recombinant protein subunit (CMVsu) vaccine stimulates the immune system by presenting glycoproteins B (gB) and pentamer antigens, which are key components of the CMV virus. This helps the body recognize and mount a defense against CMV infections. Other common treatments for CMV include antiviral medications like ganciclovir and valganciclovir, which inhibit viral DNA replication, thereby reducing the viral load and preventing the virus from spreading. These treatments are crucial for CMV patients, especially those who are immunocompromised, as they help control the infection and prevent severe complications.