CMV Vaccine for Cytomegalovirus

Overseen By EU GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Viral hepatitis, Autoimmune disease, Immunodeficiency, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 549

Duration: 6 months

339 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or immune-modifying drugs, you may need to stop them 3 months before the vaccine dose. Inhaled and topical steroids are allowed.

What data supports the effectiveness of the CMV Vaccine for Cytomegalovirus treatment?

Research shows that a vaccine using the pentameric complex can induce strong neutralizing antibodies, which are important for preventing CMV infections. Additionally, a vaccine with glycoprotein B (gB) and an adjuvant reduced CMV infection rates by 50%, suggesting that similar components in the Pentamer/gB/Adjuvant Vaccine could be effective. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am a healthy adult aged 18-50, can follow study rules, and meet all COVID-19 and reproductive health criteria.

For participants in EPOCH 2: Participants who completed Epoch 1, can comply with the protocol, have written informed consent, and can be rescheduled if they have active infections

Exclusion Criteria

For participants in EPOCH 1: Various medical conditions, prior/concomitant therapy restrictions, prior/concurrent clinical study experience, and other exclusions like pregnancy, high CMV exposure risk, and substance abuse

For participants in EPOCH 2: Immunodeficient conditions, specific medical histories, therapy restrictions, and concurrent clinical study participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the candidate CMVsu vaccine at 0, 2, and 6 months in a step-wise dose escalation manner

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment until the end of the study

12 months

Multiple visits (in-person and virtual) until Day 546

Treatment Details

Interventions

• Pentamer/gB/Adjuvant Vaccine

Trial Overview 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.

Participant Groups

Group I: Pentamer(low)/gB(low)/Adjuvant Group Experimental Treatment 1 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 study (Day 546).

Group II: Pentamer (med)/gB(med)/Adjuvant Group Experimental Treatment 1 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 study (Day 546).

Group III: Pentamer (med)/gB(low)/Adjuvant Group Experimental Treatment 1 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 study (Day 546).

Group IV: Pentamer (high)/gB(med)/Adjuvant Group Experimental Treatment 1 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 study (Day 546).

Group V: Placebo Group Placebo Group 1 Intervention

Participants receive placebo (saline) at 0,2 and 6 months and are followed up until end of study (Day 546).

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

The V160 CMV vaccine was found to be generally well-tolerated in both CMV-seronegative and seropositive adults, with no serious adverse events reported and only mild-to-moderate injection-site and systemic reactions observed.

The vaccine successfully elicited robust neutralizing antibody responses and T-cell activation, maintaining these levels for up to 12 months, indicating strong immunogenicity similar to that seen after natural CMV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 Clinical Trial of a Conditionally Replication-Defective Human Cytomegalovirus (CMV) Vaccine in CMV-Seronegative Subjects. Adler, SP., Lewis, N., Conlon, A., et al.[2020]

The CMV vaccine using the envelope glycoprotein gB combined with the MF59 adjuvant was found to be more immunogenic than the same vaccine with alum, indicating a stronger immune response.

The trial, which involved a phase I study design with no serious adverse events reported, showed that the vaccine was safe, with only mild local and systemic reactions, suggesting it could be a promising candidate for further development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A subunit cytomegalovirus vaccine based on recombinant envelope glycoprotein B and a new adjuvant. Pass, RF., Duliegè, AM., Boppana, S., et al.[2008]

Cytomegalovirus (CMV) poses significant health risks to infants and immunocompromised patients, highlighting the need for effective vaccines to prevent CMV-related diseases.

Current research is advancing the development of CMV vaccines, but understanding the specific immune responses needed for effective protection remains crucial before these vaccines can be widely implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in cytomegalovirus vaccine development. Schleiss, M.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase 1 Clinical Trial of a Conditionally Replication-Defective Human Cytomegalovirus (CMV) Vaccine in CMV-Seronegative Subjects. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Cytomegalovirus vaccines. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Analysis of relationships between polymorphisms in the genes encoding the pentameric complex and neutralization of clinical cytomegalovirus isolates. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A subunit cytomegalovirus vaccine based on recombinant envelope glycoprotein B and a new adjuvant. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Progress in cytomegalovirus vaccine development. [2006]