CompletedPhase 1/2

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

United States333 participantsStarted 2021-10-14

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 sym…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Within 30 days post each dose (doses administered on Day 1, Day 61 and Day 181)

Trial details

NCT IDNCT05089630

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-02

Results submitted2026-03-31

View on ClinicalTrials.gov More Cytomegalovirus Infections trials