Recruiting

MMRV Vaccine

Sponsor:

University of Alberta

Code:

NCT05923970

Conditions

Vaccination Failure

Vaccine Response Impaired

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Serology for antibody levels - Baseline

Serology to assess cell mediated immune (CMI) response - Baseline

Serology for antibody levels - Post third dose of MMR vaccine

Serology to assess CMI - Post third dose of MMR vaccine

Study Details

Brief summary:

The current recommendation for a full course of measles-mumps-rubella-(varicella) vaccine (MMR(V)) is two doses. The problem is, many individuals within the vaccinated cohort show antibody levels that are below the level considered to be protective, even after two doses of vaccine. Because of these waning antibody levels, it is currently unknown whether highly vaccinated populations are protected from infection against measles, mumps, rubella, or varicella should they be exposed to any of these viruses. The uncertainty of a woman's immune status is partly due to the type of testing that is used to indicate protection. While immunity to viral infection requires both a humoral and a cell mediated immune (CMI) response, only humoral (antibody) responses are measured routinely in the laboratory. This study will examine CMI responses and the role of a third dose of vaccine for previously vaccinated women whose antibody levels are below the cut off. This study will not administer vaccine, but rather will include women who have received a third dose of vaccination through routine health care follow up in the study cohort.

Conditions

Vaccination Failure

Vaccine Response Impaired

Study ID

NCT05923970

Start date

Nov 9, 2024

Status verified date

Mar, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women who are pregnant and have undergone routine prenatal screening for rubella antibodies.

Exclusion Criteria:

  • Women younger than 18 years of age

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Women with low rubella antibodies

Women with rubella antibodies <10 IU/mL

Women with high rubella antibodies

Women with rubella antibodies ≥10 IU/mL

Interventions

Serology for antibody levels - Baseline

Measurement of rubella IgG antibody levels at baseline

Serology to assess cell mediated immune (CMI) response - Baseline

Assessment of cell mediated immune (CMI) response to measles, mumps, rubella, and varicella at baseline.

Serology for antibody levels - Post third dose of MMR vaccine

Measurement of rubella IgG antibody levels post third dose of MMR vaccine

Serology to assess CMI - Post third dose of MMR vaccine

Assessment of cell mediated response (CMI) to measles, mumps, rubella, and varicella post third dose of MMR vaccine.

Primary outcome measure

  • Change in rubella antibody level. [ Time Frame: Change in level from baseline to 12 months. ]

Central Contacts and Locations

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2R3

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-16.