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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Alberta

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Serology for antibody levels - Baseline

    Diagnostic test

    Measurement of rubella IgG antibody levels at baseline

  • 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.

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

    Diagnostic test

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

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Women with low rubella antibodies4 interventions
Group B: Women with high rubella antibodies2 interventions

Trial outcomes

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.

Time frame
Change in level from baseline to 12 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Merck Canada Inc.

Collaborator