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

NCT05089630 | Completed Phase 1 FDA Drug

• 1 other identifier: 209976
• Study Type: interventional
• Target: 339
• 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 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.

Conditions

Cytomegalovirus Infections

Keywords

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

Outcome Measures

Primary Outcomes (13)

• Number of participants reporting solicited administration site events

  The solicited administration site events include pain, redness and swelling.

  Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)

• 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.

  At Day 1

• 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.

  At Day 8

• 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.

  At Day 61

• 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.

  At Day 68

• 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.

  At Day 181

• 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.

  Day 188

Secondary Outcomes (6)

• Number of participants reporting unsolicited AEs from Dose 1 to end of study (Month 18)

  From Dose 1 (Day 1) to end of study (Month 18)

• Number of participants reporting MAEs from Dose 1 to end of study (Month 18)

  From Dose 1 (Day 1) to end of study (Month 18)

• Number of participants reporting SAEs from Dose 1 to end of study (Month 18)

  From Dose 1 (Day 1) to end of study (Month 18)

• Number of participants reporting potential immune-mediated disease (pIMDs) from Dose 1 to end of study (Month 18)

  From Dose 1 (Day 1) to end of study (Month 18)

• Neutralizing antibodies (nAbs) titers against epithelial cell infection

  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)

Study Arms (5)

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

EXPERIMENTAL

Participants receive the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546).

Biological: Pentamer (low)/gB(low)/Adjuvant vaccine

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

EXPERIMENTAL

Participants receive the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546).

Biological: Pentamer (med)/gB(low)/Adjuvant vaccine

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

EXPERIMENTAL

Participants receive the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546).

Biological: Pentamer (med)/gB(med)/Adjuvant vaccine

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

EXPERIMENTAL

Participants receive the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546).

Biological: Pentamer (high)/gB(med)/Adjuvant vaccine

Placebo Group

PLACEBO COMPARATOR

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

Combination Product: Placebo (saline)

Interventions

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

Placebo (saline) 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

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

Sodium Chloride

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (18)