title: M-M-R(®)II manufactured using recombinant human albumin (rHA) and M-M-R(®)II manufactured using human serum albumin (HSA) exhibit similar safety and immunogenicity profiles when administered as a 2-dose regimen to healthy children.
abstract: Prior to 2006, M-M-R(®)II (measles, mumps, and rubella virus vaccine live) was manufactured using human serum albumin (HSA) and each dose of the vaccine contained a relatively small amount (≤0.3mg) of HSA. Because of specific regulatory requirements and limited suppliers of HSA acceptable for human use, there was a need to replace HSA with recombinant human albumin (rHA) to mitigate any potential risk to the availability of M-M-R(®)II. Two different formulations of M-M-R(®)II manufactured using either rHA or HSA were clinically evaluated for safety and immunogenicity when administered as a 2-dose regimen to healthy children 12-18 months and 3-4 years of age. Adverse events, including those indicative of a possible hypersensitivity reaction, were collected for 42 days after each dose. Antibodies to measles, mumps, and rubella were measured before and approximately 6 weeks after dose 1. Antibodies to rHA were measured before and approximately 6 weeks after dose 1 and dose 2. Antibody seroconversion rates to measles, mumps, and rubella were 97.0%, 99.5%, and 99.7%, respectively, for recipients of M-M-R(®)II with rHA and 97.2%, 97.9%, and 99.6%, respectively, for recipients of M-M-R(®)II with HSA, and geometric mean titers to all 3 vaccine viral antigens were comparable between the 2 vaccination groups. The proportions of subjects who reported adverse events, including those suggestive of hypersensitivity reactions, after each dose of study vaccine were comparable between the 2 vaccination groups. No subject had detectable antibodies to rHA immediately prior to or following receipt of either the first or second dose of study vaccine. Given the comparable immunogenicity and safety profiles of both formulations, rHA is an acceptable replacement for HSA in the manufacture of M-M-R(®)II.
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: richard.wiedmann@merck.com.
authors: Richard T
authors: RT
authors: Wiedmann
authors: Primary Physicians Research, 1580 McLaughlin Run Road, Pittsburgh, PA 15241, USA. Electronic address: ksrppr@aol.com.
authors: Keith S
authors: KS
authors: Reisinger
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: jonathan.hartzel@merck.com.
authors: Jonathan
authors: J
authors: Hartzel
authors: Canton Pediatrics, 3120 Parkway Drive NW, Suite C, Canton, OH 44708, USA. Electronic address: eam4343@sbcglobal.net.
authors: Edgardo
authors: E
authors: Malacaman
authors: Senders Pediatrics, 2054 South Green Road, Cleveland, OH 44121, USA. Electronic address: ssenders@senderspediatrics.com.
authors: Shelly D
authors: SD
authors: Senders
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: kedgiacol@gmail.com.
authors: Katherine E D
authors: KE
authors: Giacoletti
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: eshaw1997@comcast.net.
authors: Eric
authors: E
authors: Shaw
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: barbara.kuter@merck.com.
authors: Barbara J
authors: BJ
authors: Kuter
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: florian_schodel@mac.com.
authors: Florian
authors: F
authors: Schödel
authors: Merck & Co., Inc., PO Box 4, West Point, PA 19486, USA. Electronic address: luwy.musey@merck.com.
authors: Luwy K
authors: LK
authors: Musey
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D008459:Measles virus / Q000276:immunology; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D009109:Mumps virus / Q000276:immunology; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins; D012412:Rubella virus / Q000276:immunology; D000069078:Seroconversion; D012709:Serum Albumin; D014611:Vaccination
chemical_list: D000914:Antibodies, Viral; D022542:Measles-Mumps-Rubella Vaccine; D011994:Recombinant Proteins; D012709:Serum Albumin
keywords: Albumin; M-M-R(®)(II); Measles; Mumps; Recombinant; Rubella; Vaccine