Is a Third Dose of MMRV Vaccine Beneficial for the Adult Population in Alberta?

NCT05923970 | Recruiting

• 1 other identifier: RES00059887
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in rubella antibody level.

  Change in immunoglobulin G (IgG) antibody level from baseline to post-receipt of a third dose of MMR vaccine.

  Change in level from baseline to 12 months.

Study Arms (2)

Women with low rubella antibodies

Women with rubella antibodies \<10 IU/mL

Diagnostic Test: Serology for antibody levels - Baseline; Diagnostic Test: Serology to assess cell mediated immune (CMI) response - Baseline; Diagnostic Test: Serology for antibody levels - Post third dose of MMR vaccine; Diagnostic Test: Serology to assess CMI - Post third dose of MMR vaccine

Women with high rubella antibodies

Women with rubella antibodies ≥10 IU/mL

Diagnostic Test: Serology for antibody levels - Baseline; Diagnostic Test: Serology to assess cell mediated immune (CMI) response - Baseline

Interventions

Serology for antibody levels - Baseline DIAGNOSTIC_TEST

Measurement of rubella IgG antibody levels at baseline

Women with high rubella antibodies; Women with low rubella antibodies

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

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

Women with high rubella antibodies; Women with low rubella antibodies

Serology for antibody levels - Post third dose of MMR vaccine DIAGNOSTIC_TEST

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

Women with low rubella antibodies

Serology to assess CMI - Post third dose of MMR vaccine DIAGNOSTIC_TEST

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

Women with low rubella antibodies

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women who undergo routine prenatal screening for rubella antibodies in Alberta are eligible to participate. The study population will include 100 women with rubella antibodies below 10 IU/ml, and 100 women with antibody levels \>=10 IU/ml.

You may qualify if:

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

You may not qualify if:

• Women younger than 18 years of age

Sponsors & Collaborators

• University of Alberta: lead
• Merck Canada Inc.: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and isolated cells

Central Study Contacts

Carmen Charlton, PhD

CONTACT

1 (780) 407-8975; carmen.charlton@albertahealthservices.ca

Michael H Mengel

CONTACT

17804925943; mmengel@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 28, 2023
• Study Start: November 9, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)