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

Primary Purpose

Cytomegalovirus Infections

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infections focused on measuring Cytomegalovirus, First-Time-in Human, Safety, Reactogenicity, Immunogenicity, Healthy adults

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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:
  • 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.

Exclusion Criteria:

Medical conditions

  • • Any history of or planned receipt of a CMV vaccine other than the study intervention (CMVsu) at any time point.
  • Use of other investigational or non-registered product during the period beginning 30 days before the first dose, or their planned use during the study period.
  • Planned administration or administration of any vaccine not foreseen by the study protocol 30 days before and 30 days after each study vaccination administration, with the exception of any licensed influenza vaccine which may be administered > 15 days before or after vaccination.
  • In case of emergency mass vaccination for an unforeseen public health threat organized by public health authorities outside the routine immunization program, 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. However, this interval can be reduced to > 14 days, if emergency vaccination is recommended by public health authorities, in line with the applicable local/national guidance per COVID-19 vaccine platform type under emergency use authorization.
    • Candidate COVID-19 vaccines that have not received Emergency Use Authorization, and are only in use as part of a clinical trial, 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Pentamer(low)/gB(low)/Adjuvant Group

Pentamer (med)/gB(low)/Adjuvant Group

Pentamer (med)/gB(med)/Adjuvant Group

Pentamer (high)/gB(med)/Adjuvant Group

Placebo Group

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of participants reporting solicited administration site events
The solicited administration site events include pain, redness and swelling.
Number of participants reporting solicited systemic events
The solicited systemic events include fever, myalgia, fatigue, arthralgia and headache. The preferred location for measuring temperature is the oral cavity. Fever is defined as body temperature ≥38.0°C/100.4°F by any route.
Number of participants reporting unsolicited adverse events (AEs) within 7 days after each dose
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Number of participants reporting serious adverse events (SAEs) within 7 days after each dose
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Number of participants reporting unsolicited AEs up to 30 days after each dose
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Number of participants reporting SAEs up to 30 days after each dose
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Number of participants reporting medically attended AEs (MAEs) up to 30 days after each dose
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 8
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 61
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 68
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 188
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.

Secondary Outcome Measures

Number of participants reporting unsolicited AEs from Dose 1 to end of EPOCH 1 (Month 18)
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Number of participants reporting MAEs from Dose 1 to end of EPOCH 1 (Month 18)
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Number of participants reporting SAEs from Dose 1 to end of EPOCH 1 (Month 18)
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Number of participants reporting potential immune-mediated disease (pIMDs) from Dose 1 to end of EPOCH 1 (Month 18)
PIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Neutralizing antibodies (nAbs) titers against epithelial cell infection
The humoral immune response is measured in terms of nAbs against epithelial cell infection and expressed as geometric mean titers (GMT). Serological assays for the determination of antibodies against CMV are performed by neutralization assay.
Anti-pentamer immunoglobulin G (IgG) and anti-gB IgG concentrations
The vaccine-induced anti-gB and anti-pentamer humoral immune response is measured in terms of anti-pentamer IgG and anti-gB IgG geometric mean concentrations (GMCs) determined by enzyme linked immunosorbent assay (ELISA) and expressed in EU/ml.
CMV specific cluster of differentiation (CD)4+ T-cells frequency
The vaccine-induced cellular immune response is measured in terms of CD4+ T-cells frequency per million PBMCs.
CMV specific CD8+ T-cells frequency
The vaccine-induced cellular immune response is measured in terms of cytokine expressing CD4+ T-cells per million PBMCs.
Concordance of CMV sero-status results
Concordance of CMV sero-status results (positive/negative) obtained with both assays will be assessed at screening visit (Day -59) and 1 month post-dose 1 and 2 (D31, D91).
Individual anti-tegument IgG result
The individual anti-tegument IgG result (positive/negative) assessed by ELISA is obtained 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]

Full Information

First Posted
October 11, 2021
Last Updated
October 17, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05089630
Brief Title
A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
June 19, 2029 (Anticipated)
Study Completion Date
June 19, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity 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 will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
Cytomegalovirus, First-Time-in Human, Safety, Reactogenicity, Immunogenicity, Healthy adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
329 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pentamer(low)/gB(low)/Adjuvant Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pentamer (med)/gB(low)/Adjuvant Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pentamer (med)/gB(med)/Adjuvant Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pentamer (high)/gB(med)/Adjuvant Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pentamer (low)/gB(low)/Adjuvant vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Pentamer (med)/gB(low)/Adjuvant vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Pentamer (med)/gB(med)/Adjuvant vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Pentamer (high)/gB(med)/Adjuvant vaccine
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo (saline)
Intervention Description
Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.
Primary Outcome Measure Information:
Title
Number of participants reporting solicited administration site events
Description
The solicited administration site events include pain, redness and swelling.
Time Frame
Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting solicited systemic events
Description
The solicited systemic events include fever, myalgia, fatigue, arthralgia and headache. The preferred location for measuring temperature is the oral cavity. Fever is defined as body temperature ≥38.0°C/100.4°F by any route.
Time Frame
Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting unsolicited adverse events (AEs) within 7 days after each dose
Description
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Time Frame
Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting serious adverse events (SAEs) within 7 days after each dose
Description
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time Frame
Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting unsolicited AEs up to 30 days after each dose
Description
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Time Frame
Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting SAEs up to 30 days after each dose
Description
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time Frame
Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting medically attended AEs (MAEs) up to 30 days after each dose
Description
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame
Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Title
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1
Description
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time Frame
At Day 1
Title
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 8
Description
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time Frame
At Day 8
Title
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 61
Description
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time Frame
At Day 61
Title
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 68
Description
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time Frame
At Day 68
Title
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181
Description
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time Frame
At Day 181
Title
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 188
Description
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
Time Frame
Day 188
Secondary Outcome Measure Information:
Title
Number of participants reporting unsolicited AEs from Dose 1 to end of EPOCH 1 (Month 18)
Description
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
Time Frame
From Dose 1 (Day 1) to end of EPOCH 1 (Month 18)
Title
Number of participants reporting MAEs from Dose 1 to end of EPOCH 1 (Month 18)
Description
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame
From Dose 1 (Day 1) to end of EPOCH 1 (Month 18)
Title
Number of participants reporting SAEs from Dose 1 to end of EPOCH 1 (Month 18)
Description
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time Frame
From Dose 1 (Day 1) to end of EPOCH 1 (Month 18)
Title
Number of participants reporting potential immune-mediated disease (pIMDs) from Dose 1 to end of EPOCH 1 (Month 18)
Description
PIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame
From Dose 1 (Day 1) to end EPOCH 1 (Month 18)
Title
Neutralizing antibodies (nAbs) titers against epithelial cell infection
Description
The humoral immune response is measured in terms of nAbs against epithelial cell infection and expressed as geometric mean titers (GMT). Serological assays for the determination of antibodies against CMV are performed by neutralization assay.
Time Frame
On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546) [EPOCH 1] and Year 2.5, Year 3.5, Year 4.5, Year 5.5 [EPOCH 2]
Title
Anti-pentamer immunoglobulin G (IgG) and anti-gB IgG concentrations
Description
The vaccine-induced anti-gB and anti-pentamer humoral immune response is measured in terms of anti-pentamer IgG and anti-gB IgG geometric mean concentrations (GMCs) determined by enzyme linked immunosorbent assay (ELISA) and expressed in EU/ml.
Time Frame
On the day of each dose (Day 1, Day 61, Day 181), 30 days post each dose (Day 31, Day 91 and Day 211), 6- and 12-months post-Dose 3 (Day 361, Day 546) [EPOCH 1] and Year 2.5, Year 3.5, Year 4.5, Year 5.5 [EPOCH 2]
Title
CMV specific cluster of differentiation (CD)4+ T-cells frequency
Description
The vaccine-induced cellular immune response is measured in terms of CD4+ T-cells frequency per million PBMCs.
Time Frame
Before each dose (Day 1, Day 61, Day 181), 1-month post-dose 2 and dose 3 (Day 91, Day 211), 6- and 12-months post-dose 3 (Day 361, Day 546) [EPOCH 1] and Year 2.5, Year 3.5, Year 4.5, Year 5.5 [EPOCH 2]
Title
CMV specific CD8+ T-cells frequency
Description
The vaccine-induced cellular immune response is measured in terms of cytokine expressing CD4+ T-cells per million PBMCs.
Time Frame
Before each dose (Day 1, Day 61, Day 181), 1-month post-dose 2 and dose 3 (Day 91, Day 211), 6- and 12-months post-dose 3 (Day 361, Day 546)
Title
Concordance of CMV sero-status results
Description
Concordance of CMV sero-status results (positive/negative) obtained with both assays will be assessed at screening visit (Day -59) and 1 month post-dose 1 and 2 (D31, D91).
Time Frame
At screening (Day -59) and 1 month post-dose 1 and 2 (Day 31, Day 91).
Title
Individual anti-tegument IgG result
Description
The individual anti-tegument IgG result (positive/negative) assessed by ELISA is obtained 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]
Time Frame
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]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For participants in EPOCH 1: 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: 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. For participants in EPOCH 2: Participation in Epoch 1 of the study with receipt of 2 or 3 doses of study intervention. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits). Written informed consent obtained from the participant prior to performance of any study specific procedure. Participants with active infections, including COVID-19 may be rescheduled within the window period, if they no longer have signs or symptoms of active infection in the judgment of the investigator. Exclusion Criteria: For participants in EPOCH 1: 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. 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. For Participants in EPOCH 2: Any confirmed/suspected immunosuppressive/immunodeficient condition including malignancy (excluding effectively treated non-melanotic skin cancer). Known documented medical history of HIV or hepatitis B or C. Use or anticipated use of immunosuppressants/ or immune modifying drugs during the whole study period. Hypersensitivity to latex. Any acute or chronic clinically significant disease that , might pose additional risk to the participant due to participation in the study. Any history of planned receipt of a CMV vaccine other than the study intervention (CMVsu) at any time point. Use of other investigational or non-registered product or their planned use during the study period. Concurrently participating in another clinical study, in which the participant has been/ will be exposed to an investigational or a/ non-investigational intervention.
Facility Information:
Facility Name
GSK Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
GSK Investigational Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
GSK Investigational Site
City
Dearborn Heights
State/Province
Michigan
ZIP/Postal Code
48127
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
GSK Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
GSK Investigational Site
City
Secaucus
State/Province
New Jersey
ZIP/Postal Code
07094
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744-1645
Country
United States
Facility Name
GSK Investigational Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
GSK Investigational Site
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
GSK Investigational Site
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98371
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

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

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