About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who are pregnant and have undergone routine prenatal screening for rubella antibodies.
Disqualifiers
Women younger than 18 years of age
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Serology for antibody levels - Baseline
Diagnostic testMeasurement of rubella IgG antibody levels at baseline
Serology to assess cell mediated immune (CMI) response - Baseline
Diagnostic testAssessment of cell mediated immune (CMI) response to measles, mumps, rubella, and varicella at baseline.
Serology for antibody levels - Post third dose of MMR vaccine
Diagnostic testMeasurement of rubella IgG antibody levels post third dose of MMR vaccine
Serology to assess CMI - Post third dose of MMR vaccine
Diagnostic testAssessment of cell mediated response (CMI) to measles, mumps, rubella, and varicella post third dose of MMR vaccine.
Treatment groups
Trial outcomes
Primary outcomes
Change in rubella antibody level.
Change in immunoglobulin G (IgG) antibody level from baseline to post-receipt of a third dose of MMR vaccine.
Sponsors and contacts
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University of Alberta
Lead sponsor
Merck Canada Inc.
Collaborator