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

NCT05089630 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2026-03-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

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.

BIOLOGICAL

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

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.

BIOLOGICAL

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

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.

BIOLOGICAL

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

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.

COMBINATION_PRODUCT

Placebo (saline)

Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2025-04-02
Completion
2025-04-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089630 on ClinicalTrials.gov