Cytomegalovirus InfectionsPhase 1/2NCT05089630

A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults

A Phase 1/2 study testing Pentamer (low)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(low)/Adjuvant vaccine and Pentamer (med)/gB(med)/Adjuvant vaccine in people with Cytomegalovirus Infections, run by GlaxoSmithKline at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Cytomegalovirus Infections
What is being tested?: Pentamer (low)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(low)/Adjuvant vaccine and Pentamer (med)/gB(med)/Adjuvant vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 333 participants
Where: 18 sitesUnited States
Study dates: 14 Oct 2021to 2 Apr 2025
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.
Participants who are women of child-bearing potential may be enrolled in the study, if the participant:

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has practiced adequate contraception for 30 days prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration and
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.
Participants with signs/symptoms suggestive of active COVID-19 (i.e., fever, cough, etc.) should be isolated for the time period recommended by CDC since the signs/symptoms started, and symptoms have resolved.
Participants with known COVID-19 positive contacts should be quarantined for the time period since exposure recommended by CDC since the exposure and the participant remains symptom free or COVID test negative.
Participants who are diagnosed with COVID-19 may receive their subsequent CMVsu vaccination dose provided they have no fever, and their condition is considered stable by the investigator (e.g., there may be mild lingering cough, but no shortness of breath or difficulty breathing) within the original schedule.
Participants who initially fail screening due to other active infections may be re screened within the screening window period and included in the study, if they no longer have signs or symptoms of active infection in the judgment of the site investigator.
If a participant has equivocal results on CMV serodiagnostic screening test, they are permitted to be re-screened if within the 60-day screening window. Flexibility in safety blood evaluations will be permitted within the Schedule of activities time intervals.

Who cannot join

Medical conditions
Known documented medical history of or viral hepatitis B or C infection.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Any confirmed or suspected immunosuppressive or immunodeficient condition.
Family history of congenital or hereditary immunodeficiency.
History of or current autoimmune disease.

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Lymphoproliferative disorder or malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer).
Hypersensitivity to latex.
Major congenital defects
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
Recurrent history or uncontrolled neurological disorders.
Any hematological or biochemical abnormality.
Any acute or chronic, clinically significant disease or pulmonary, cardiovascular, hepatic, or renal functional abnormalities.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Participants with symptoms suggestive of active COVID-19 infection are excluded.
Participants with known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days since the exposure and the participant remains symptom free.
Any other clinical condition that, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
Any history of or planned receipt of a CMV vaccine other than the study intervention at any time point.
Use of other investigational/non-registered product during the period beginning 30 days before the first dose, or their planned use during the study period.
Planned administration of any vaccine not foreseen by the study protocol 30 days before and 30 days after each study vaccination administration any licensed influenza vaccine administered > 15 days before/ after vaccination.
In case of extraordinary emergency mass vaccination for an unforeseen public health threat the time period can be reduced if necessary, for that mass vaccination vaccine, which may be under emergency use authorization.
COVID-19 vaccines should be given at least 30 days before or after administration of a GSK study vaccine. This interval can be reduced to > 14 days, if emergency vaccination is recommended by public health authorities.
Candidate COVID-19 vaccines are not allowed.
Chronic administration of immunosuppressants or other immune-modifying drugs within 3 months prior to the vaccine dose. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period.
Prior/Concurrent clinical study experience
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention
Other exclusions
Pregnant or lactating women. If a woman becomes pregnant/lactating during the study, she will be excluded from subsequent vaccine doses but will be followed for safety.
Women planning to become pregnant or planning to discontinue contraceptive precautions before 3 months after last study vaccination.
Participants with known high exposure risk for CMV transmission, to enable distinction of true vaccine effect from natural infection during the study.
Planned move to a location that will prohibit participating in the trial until study end.
Participants with current chronic alcohol consumption and/or drug abuse as defined by Diagnostic and Statistical Manual of Mental Disorders 5th edition.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

GSK Investigational Site
Anaheim, California, 92806
GSK Investigational Site
Austin, Texas, 78744-1645
GSK Investigational Site
Cedar Park, Texas, 78613
GSK Investigational Site
Dearborn, Michigan, 48127
GSK Investigational Site
Galveston, Texas, 77573
GSK Investigational Site
Hallandale, Florida, 33009
GSK Investigational Site
Las Vegas, Nevada, 89109
GSK Investigational Site
Lexington, Kentucky, 40536-0084
GSK Investigational Site
Lincoln, Nebraska, 68510
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Los Angeles, California, 90017
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
Newark, New Jersey, 07103
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Puyallup, Washington, 98371
GSK Investigational Site
Secaucus, New Jersey, 07094
GSK Investigational Site
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults

The purpose of this study is to assess the safety, reactogenicity and immune response of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study is conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine are administered in a step-wise dose escalation manner, based upon safety adjudication.

Conditions: Cytomegalovirus Infections
Being tested: Pentamer (low)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(med)/Adjuvant vaccine, Pentamer (high)/gB(med)/Adjuvant vaccine, Placebo (saline solution)
Keywords: Cytomegalovirus, First-Time-in Human, Safety, Reactogenicity, Immunogenicity, Healthy adults
Medical subject headings: Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pentamer (low)/gB(low)/Adjuvant vaccineBiological
Three doses of the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Pentamer (med)/gB(low)/Adjuvant vaccineBiological
Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Pentamer (med)/gB(med)/Adjuvant vaccineBiological
Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Pentamer (high)/gB(med)/Adjuvant vaccineBiological
Three doses of the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Placebo (saline solution)Combination product
Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.

Study groups in NCT05089630
Study group	Role	What they receive
Pentamer (low dose)/glycoprotein B (gB) (low dose)/Adjuvant group	Experimental	Participants received a dose of the candidate cytomegalovirus (CMV) vaccine consisting of a combination of low dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. Receives: Biological: Pentamer (low)/gB(low)/Adjuvant vaccine
Pentamer (medium dose)/gB (low dose)/Adjuvant group	Experimental	Participants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. Receives: Biological: Pentamer (med)/gB(low)/Adjuvant vaccine
Pentamer (medium dose)/gB (medium dose)/Adjuvant group	Experimental	Participants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. Receives: Biological: Pentamer (med)/gB(med)/Adjuvant vaccine
Pentamer (high dose)/gB (medium dose)/Adjuvant group	Experimental	Participants received a dose of the candidate CMV vaccine consisting of a combination of high dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly. Receives: Biological: Pentamer (high)/gB(med)/Adjuvant vaccine
Placebo Group	Placebo comparator	Participants received a dose of placebo at Day 1, Day 61 and Day 181 intramuscularly. Receives: Combination Product: Placebo (saline solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Solicited Administration Site Adverse Events Post Each Dose Administration
The assessed solicited administration site adverse events were erythema (injection site redness), pain and swelling.
Measured: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Solicited Systemic Adverse Events Post Each Dose Administration
The assessed solicited administration site adverse events were arthralgia, fatigue, headache, fever and myalgia. Fever was defined as body temperature ≥38.0°Celsius/100.4°Fahrenheit.
Measured: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited Adverse Events (AEs) Within 7 Days Post Each Dose Administration
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited AEs include both serious and non-serious AEs.
Measured: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited Serious Adverse Events (SAEs) Within 7 Days Post Each Dose Administration
An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. An unsolicited SAE is defined as an SAE that was not included in a list of solicited events using a Participant Diary.
Measured: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited AEs up to 30 Days Post Each Dose Administration
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. The solicited AEs that had an onset after 7 days post each dose administration are considered unsolicited AEs. Unsolicited AEs include both serious and non-serious AEs.
Measured: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Unsolicited SAEs up to 30 Days Post Each Dose Administration
Measured: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Medically Attended Events (MAEs) up to 30 Days Post Each Dose Administration
MAE is defined as an AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
Measured: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 1
The hematological and biochemical parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, white blood cells (WBC). Categories reported when comparing normal range and Day 1 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: On Day 1
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 8
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: On Day 8
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 61
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 61 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: On Day 61
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 68
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: On Day 68
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 181
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 181 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: On Day 181
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 188
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 188 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: On Day 188

Secondary outcomes (7)

Number of Participants With Unsolicited Events, SAEs, MAEs and Potential Immune Mediated Diseases (pIMDs) From Day 1 to Day 546 (End of Study)
Unsolicited AE=AE that was not included in a list of solicited events using a Participant Diary; the solicited AEs that had an onset after 7 days post each dose administration are considered unsolicited AEs; both serious and non-serious AEs are included. SAE=any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. MAE=AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason. pIMDs=a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
Measured: Day 1 to Day 546
Geometric Mean Titers (GMT) of Neutralizing Antibodies (nAbs) Against Epithelial Cell Infection (CMV Status: Sero-positive)
Neutralizing antibodies (nAbs) against epithelial cell infection were measured with neutralizing assay and the results were expressed as GMT.
Measured: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMT of nAbs Against Epithelial Cell Infection (CMV Status: Sero-negative)
Measured: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
Geometric Mean Concentration (GMC) of Anti-pentamer Immunoglobulin G (IgG) (CMV Serostaus: Sero-positive)
The vaccine-induced humoral immunity was quantified by measuring the concentration of the anti-pentamer by enzyme-linked immunosorbent assay (ELISA).
Measured: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-pentamer IgG (CMV Serostatus: Sero-negative)
Measured: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-glycoprotein B (gB) IgG (CMV Serostaus: Sero-positive)
The vaccine-induced humoral immunity was quantified by measuring the concentration of the anti-gB IgG binding antibodies by ELISA.
Measured: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-gB IgG (CMV Serostatus: Sero-negative)
Measured: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 20212 Apr 2025

First posted22 Oct 2021
Study start14 Oct 2021
Primary completion2 Apr 2025
Study completion2 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05089630
Sponsor's protocol ID: 209976
Status last verified: Jul 2026
First submitted: 11 Oct 2021
Last updated: 17 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf

Publications

Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.
PubMed 38503664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
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All Cytomegalovirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults
ClinicalTrials.gov ID: NCT05089630
Acronym / sponsor ID: 209976
Conditions: Cytomegalovirus Infections
Keywords: Cytomegalovirus, First-Time-in Human, Safety, Reactogenicity, Immunogenicity, Healthy adults
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Oct 2021 (actual)
Primary completion: 2 Apr 2025 (actual)
Study completion: 2 Apr 2025 (actual)
First posted: 22 Oct 2021 (actual)
Results: Posted 17 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Pentamer (low dose)/glycoprotein B (gB) (low dose)/Adjuvant group	Experimental	Biological: Pentamer (low)/gB(low)/Adjuvant vaccineParticipants received a dose of the candidate cytomegalovirus (CMV) vaccine consisting of a combination of low dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
Pentamer (medium dose)/gB (low dose)/Adjuvant group	Experimental	Biological: Pentamer (med)/gB(low)/Adjuvant vaccineParticipants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and low dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
Pentamer (medium dose)/gB (medium dose)/Adjuvant group	Experimental	Biological: Pentamer (med)/gB(med)/Adjuvant vaccineParticipants received a dose of the candidate CMV vaccine consisting of a combination of medium dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
Pentamer (high dose)/gB (medium dose)/Adjuvant group	Experimental	Biological: Pentamer (high)/gB(med)/Adjuvant vaccineParticipants received a dose of the candidate CMV vaccine consisting of a combination of high dose of pentamer and medium dose of gB antigens, adjuvanted, at Day 1, Day 61 and Day 181 intramuscularly.
Placebo Group	Placebo comparator	Combination Product: Placebo (saline solution)Participants received a dose of placebo at Day 1, Day 61 and Day 181 intramuscularly.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (35 listed)

Medical conditions
Known documented medical history of or viral hepatitis B or C infection.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Any confirmed or suspected immunosuppressive or immunodeficient condition.
Family history of congenital or hereditary immunodeficiency.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pentamer (low)/gB(low)/Adjuvant vaccineThree doses of the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.	Biological	Pentamer (low dose)/glycoprotein B (gB) (low dose)/Adjuvant group
Pentamer (med)/gB(low)/Adjuvant vaccineThree doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.	Biological	Pentamer (medium dose)/gB (low dose)/Adjuvant group
Pentamer (med)/gB(med)/Adjuvant vaccineThree doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.	Biological	Pentamer (medium dose)/gB (medium dose)/Adjuvant group
Pentamer (high)/gB(med)/Adjuvant vaccineThree doses of the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.	Biological	Pentamer (high dose)/gB (medium dose)/Adjuvant group
Placebo (saline solution)Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.	Combination product	Placebo Group

Primary outcome

Number of Participants With Solicited Administration Site Adverse Events Post Each Dose Administration
Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
The assessed solicited administration site adverse events were erythema (injection site redness), pain and swelling.
Number of Participants With Solicited Systemic Adverse Events Post Each Dose Administration
Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
The assessed solicited administration site adverse events were arthralgia, fatigue, headache, fever and myalgia. Fever was defined as body temperature ≥38.0°Celsius/100.4°Fahrenheit.
Number of Participants With Unsolicited Adverse Events (AEs) Within 7 Days Post Each Dose Administration
Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited AEs include both serious and non-serious AEs.
Number of Participants With Unsolicited Serious Adverse Events (SAEs) Within 7 Days Post Each Dose Administration
Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)
An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. An unsolicited SAE is defined as an SAE that was not included in a list of solicited events using a Participant Diary.
Number of Participants With Unsolicited AEs up to 30 Days Post Each Dose Administration
Time frame: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant Diary. The solicited AEs that had an onset after 7 days post each dose administration are considered unsolicited AEs. Unsolicited AEs include both serious and non-serious AEs.
Number of Participants With Unsolicited SAEs up to 30 Days Post Each Dose Administration
Time frame: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
Number of Participants With Medically Attended Events (MAEs) up to 30 Days Post Each Dose Administration
Time frame: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)
MAE is defined as an AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 1
Time frame: On Day 1
The hematological and biochemical parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, white blood cells (WBC). Categories reported when comparing normal range and Day 1 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 8
Time frame: On Day 8
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 61
Time frame: On Day 61
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 61 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 68
Time frame: On Day 68
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 181
Time frame: On Day 181
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 181 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.
Number of Participants With Hematological and Biochemical Laboratory Abnormalities on Day 188
Time frame: On Day 188
The hematological and biochemical parameters included ALT, AST, creatinine, eosinophils, hemoglobin, lymphocytes, neutrophils, platelets, WBC. Categories reported when comparing normal range and Day 188 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at timing> (e.g. Hemoglobin, Below). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Missing = No results are available for the corresponding laboratory parameter at the specific timepoint.

7 secondary outcomes

Number of Participants With Unsolicited Events, SAEs, MAEs and Potential Immune Mediated Diseases (pIMDs) From Day 1 to Day 546 (End of Study)
Time frame: Day 1 to Day 546
Geometric Mean Titers (GMT) of Neutralizing Antibodies (nAbs) Against Epithelial Cell Infection (CMV Status: Sero-positive)
Time frame: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMT of nAbs Against Epithelial Cell Infection (CMV Status: Sero-negative)
Time frame: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
Geometric Mean Concentration (GMC) of Anti-pentamer Immunoglobulin G (IgG) (CMV Serostaus: Sero-positive)
Time frame: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-pentamer IgG (CMV Serostatus: Sero-negative)
Time frame: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-glycoprotein B (gB) IgG (CMV Serostaus: Sero-positive)
Time frame: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546
GMC of Anti-gB IgG (CMV Serostatus: Sero-negative)
Time frame: On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546

Results and safety

Results posted to the registry on 17 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group	69	44
Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group	61	38
Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group	60	37
Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group	60	43
Placebo Group	79	44

Primary outcome: Number of Participants With Solicited Administration Site Adverse Events Post Each Dose Administration

Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181). Count of participants. Unit: Participants

Measure	Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group n = 68	Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group n = 61	Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group n = 59	Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group n = 60	Placebo Group n = 79
Erythema, Within 7 days from dosing at Day 1	3	3	3	2	0
Erythema, Within 7 days from dosing at Day 61	4	3	1	2	1
Erythema, Within 7 days from dosing at Day 181	1	4	3	0	1
Pain, Within 7 days from dosing at Day 1	39	40	37	41	2
Pain, Within 7 days from dosing at Day 61	37	38	39	39	2
Pain, Within 7 days from dosing at Day 181	29	28	28	29	1
Swelling, Within 7 days from dosing at Day 1	3	2	1	2	0
Swelling, Within 7 days from dosing at Day 61	4	3	1	4	0

Population analysed: The analysis was performed on the Solicited Safety Set which included all participants who received at least 1 dose of the study intervention (Exposed Set) who have solicited safety data. Only the participants with solicited administration site adverse events data available at the specified time period were reported in this outcome measure.

Primary outcome: Number of Participants With Solicited Systemic Adverse Events Post Each Dose Administration

Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181). Count of participants. Unit: Participants

Measure	Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group n = 68	Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group n = 61	Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group n = 59	Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group n = 60	Placebo Group n = 79
Arthralgia, Within 7 days from dosing at Day 1	5	4	7	9	1
Arthralgia, Within 7 days from dosing at Day 61	13	5	12	12	0
Arthralgia, Within 7 days from dosing at Day 181	5	2	3	7	3
Fatigue, Within 7 days from dosing at Day 1	29	28	29	24	14
Fatigue, Within 7 days from dosing at Day 61	30	30	32	32	4
Fatigue, Within 7 days from dosing at Day 181	26	20	21	19	8
Fever, Within 7 days from dosing at Day 1	0	1	1	2	1
Fever, Within 7 days from dosing at Day 61	3	4	2	2	1

Population analysed: The analysis was performed on the Solicited Safety Set. Only the participants with solicited systemic adverse events data available at the specified timepoints were reported in this outcome measure.

Primary outcome: Number of Participants With Unsolicited Adverse Events (AEs) Within 7 Days Post Each Dose Administration

Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181). Count of participants. Unit: Participants

Measure	Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group n = 69	Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group n = 61	Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group n = 60	Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group n = 60	Placebo Group n = 79
Within 7 days from dosing at Day 1	4	8	3	6	4
Within 7 days from dosing at Day 61	9	7	4	5	3
Within 7 days from dosing at Day 181	5	0	3	3	1

Population analysed: The analysis was performed on the Unsolicited Safety Set, which included all participants who received at least 1 dose of the study intervention (Exposed Set) that report unsolicited AEs/report not having unsolicited AEs. Only the participants with unsolicited AEs data available at the specified time period were reported in this outcome measure.

Primary outcome: Number of Participants With Unsolicited Serious Adverse Events (SAEs) Within 7 Days Post Each Dose Administration

Time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181). Count of participants. Unit: Participants

Measure	Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group n = 69	Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group n = 61	Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group n = 60	Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group n = 60	Placebo Group n = 79
Within 7 days from dosing at Day 1	0	0	0	0	0
Within 7 days from dosing at Day 61	0	0	0	0	0
Within 7 days from dosing at Day 181	1	0	0	0	0

Population analysed: The analysis was performed on the Unsolicited Safety Set. Only the participants with unsolicited SAEs data available at the specified time period were reported in this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited events: within 7 days post-dose (doses administered on Day 1, Day 61 and Day 181); All-cause mortality, unsolicited AEs, SAEs, MAEs and pIMDs: from Day 1 to Day 546. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pentamer (Low Dose)/Glycoprotein B (gB) (Low Dose)/Adjuvant Group	3 of 69 (4.3%)	62 of 69 (89.9%)	0 of 69
Pentamer (Medium Dose)/gB (Low Dose)/Adjuvant Group	1 of 61 (1.6%)	58 of 61 (95.1%)	0 of 61
Pentamer (Medium Dose)/gB (Medium Dose)/Adjuvant Group	0 of 60 (0%)	56 of 60 (93.3%)	0 of 60
Pentamer (High Dose)/gB (Medium Dose)/Adjuvant Group	3 of 60 (5%)	56 of 60 (93.3%)	1 of 60
Placebo Group	2 of 79 (2.5%)	46 of 79 (58.2%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38503664Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.
Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Administration Site Adverse Events Post Each Dose Administration (time frame: Within 7 days post each dose (doses administered on Day 1, Day 61 and Day 181)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05089630, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.