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Dose-Response Study of a Quadrivalent Measles, Mumps, Rubella and Varicella Vaccine in Healthy Children

Shinefield, Henry MD*; Williams, Wendy R. BS**; Marchant, Colin MD#; Reisinger, Keith MD, MPH; Stewart, Tracy MD§; Meissner, H Cody MD; Guerrero, Juan MD; Klopfer, Stephanie Olsen PhD**; Schödel, Florian MD**; Kuter, Barbara J. MPH, PhD**the Dose Selection Study Group for Proquad

The Pediatric Infectious Disease Journal: August 2005 - Volume 24 - Issue 8 - p 670-675
doi: 10.1097/01.inf.0000172901.29621.e9
Original Studies

Background: A combined measles, mumps, rubella and varicella (MMRV) vaccine would facilitate universal immunization against 4 diseases by decreasing the number of injections and thus enhancing compliance and coverage rates. If a second dose of varicella vaccine were to be recommended, MMRV could be used to administer a routine second dose of M-M-R®II with the added advantage of boosting varicella-zoster virus (VZV) antibody titers.

Methods: Subjects 12–23 months of age received a single injection of 1 of 3 lots of an MMRV vaccine (ProQuad) containing high, middle or low VZV potency, or VARIVAX given concomitantly with M-M-R®II. Recipients of MMRV received a second injection of MMRV ∼90 days later.

Results: We enrolled 1559 subjects in the study. Antibody response rates to VZV 6 weeks after 1 injection of high potency MMRV (88.6%) or 2 injections of MMRV of any varicella potency (99.7–100%) were similar to the response rates after concomitant administration of M-M-R®II and VARIVAX (93.1%). The second injection of MMRV boosted VZV antibody titers. Antibody responses to measles, mumps and rubella were ≥98%, similar to the control, after 1 or 2 injections of MMRV. MMRV was generally well-tolerated during the 42 days after vaccination.

Conclusions: One injection of high potency MMRV resulted in antibody responses to the 4 vaccine components equivalent to those found after concomitant administration of M-M-R®II and VARIVAX. A second injection of MMRV resulted in a significant boost in VZV antibody. This boost may translate into enhanced immunogenicity against varicella, which is known to correlate with increased protection.

From the *The University of California San Francisco, San Francisco, CA; the †Kaiser Permanente Vaccine Study Center, Oakland, CA; ‡Primary Physicians Research, Pittsburgh, PA; §Little Rock Children's Clinic, Little Rock, AR; ∥Tufts-New England Medical Center, Boston, MA; ¶Center for Clinical Research, Austin, TX; # Boston Medical Center and Boston University School of Medicine, Boston, MA; and **Merck Research Laboratories, West Point, PA

Accepted for publication May 11, 2005.

Supported by a grant from Merck & Co., Inc.

Address for reprints: Steve Black, MD, Kaiser Permanente Vaccine Study Center One Kaiser Plaza, 16th Floor, Oakland, CA 94612. E-mail

© 2005 Lippincott Williams & Wilkins, Inc.