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

NCT05089630 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 209976
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 18

Brief Summary

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

Keywords

Cytomegalovirus; First-Time-in Human; Safety; Reactogenicity; Immunogenicity; Healthy adults

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  Day 1 to Day 546

• Geometric Mean Titers (GMT) of Neutralizing Antibodies (nAbs) Against Epithelial Cell Infection (CMV Status: Sero-positive)

  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)

  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)

  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)

  On Day 1, Day 31, Day 61, Day 91, Day 181, Day 211, Day 361 and Day 546

Study Arms (5)

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.

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.

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.

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.

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.

Combination Product: Placebo (saline solution)

Interventions

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.

Placebo Group

Pentamer (low)/gB(low)/Adjuvant vaccine BIOLOGICAL

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 (low dose)/glycoprotein B (gB) (low dose)/Adjuvant group

Pentamer (med)/gB(low)/Adjuvant vaccine BIOLOGICAL

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 (medium dose)/gB (low dose)/Adjuvant group

Pentamer (med)/gB(med)/Adjuvant vaccine BIOLOGICAL

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 (medium dose)/gB (medium dose)/Adjuvant group

Pentamer (high)/gB(med)/Adjuvant vaccine BIOLOGICAL

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.

Pentamer (high dose)/gB (medium dose)/Adjuvant group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Anaheim, California, 92806, United States

Location

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Los Angeles, California, 90017, United States

Location

GSK Investigational Site

Hallandale, Florida, 33009, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40536-0084, United States

Location

GSK Investigational Site

Dearborn, Michigan, 48127, United States

Location

GSK Investigational Site

Springfield, Missouri, 65802, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68510, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89109, United States

Location

GSK Investigational Site

Newark, New Jersey, 07103, United States

Location

GSK Investigational Site

Secaucus, New Jersey, 07094, United States

Location

GSK Investigational Site

New York, New York, 10065, United States

Location

GSK Investigational Site

Austin, Texas, 78744-1645, United States

Location

GSK Investigational Site

Cedar Park, Texas, 78613, United States

Location

GSK Investigational Site

Galveston, Texas, 77573, United States

Location

GSK Investigational Site

Puyallup, Washington, 98371, United States

Location

Related Publications (1)

• 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.

  PMID: 38503664 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: October 14, 2021
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: July 17, 2026
• Results First Posted: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

US (18)