Immunogenicity and Safety Assessments After One and Two Doses of a Refrigerator-Stable Tetravalent Measles-Mumps-Rubella-Varicella Vaccine in Healthy Children During the Second Year of Life

Schuster, Volker; Otto, Walter; Maurer, Lothar; Tcherepnine, Patricia; Pfletschinger, Ulrich; Kindler, Klaus; Soemantri, Peter; Walther, Uta; Macholdt, Ute; Douha, Martine; Pierson, Patrice; Willems, Paul

doi:10.1097/inf.0b013e318170bb22

Cited by 50 publications

(59 citation statements)

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“…The tolerability results for both IM and SC groups in this study were comparable to previous studies of MMRV vaccine for local reactions of pain, redness and swelling [25,30,33]. The subjects vaccinated in the present study also had a similar incidence of 'any fever' from days 0 to 42 after dose 1 (IM group, 72.9%; SC group, 70.4%) to subjects of a similar age vaccinated in other studies, where the incidence of 'any fever' ranged from 67.7% to 78.0% [25,33,37].…”

Section: Discussionsupporting

confidence: 87%

“…Seroconversion rate for measles were 99.3% in the IM group (one out of 138 subject seronegative) and 98.6% in the SC group (two out of 140 subjects seronegative). The high seroconversion rates (approaching or equal to 100% after two doses) and GMTs for all components support similarly high rates observed in previous studies using this MMRV vaccine [11,25,30,32,33,37].…”

Section: Discussionsupporting

confidence: 86%

“…Priorix-Tetra™ (GlaxoSmithKline Biologicals) is a combined MMRV vaccine with an immunogenicity profile similar to separately administered MMR + V vaccines and a high degree of antibody persistence [11,18,25,30,32,37]. Live attenuated vaccines such as the MMRV vaccine are usually given subcutaneously, whereas most paediatric vaccines are inactivated vaccines and typically given intramuscularly.…”

Section: Introductionmentioning

confidence: 99%

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Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

et al. 2010

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This study compared intramuscular and subcutaneous administration of two doses of measles-mumps-rubella-varicella (MMRV) combination vaccine (Priorix-Tetra, GlaxoSmithKline Biologicals) in children. Healthy children (N = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0-3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42-56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 86%

Section: Introductionmentioning

confidence: 99%

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Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

et al. 2010

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“…For mumps, the antibody response ranged from 72 to 99.5% (4,11,(13)(14)(15)(16)(17)(18). In our study, the prevalence of mumps antibody after vaccination in 6.5 years old children was in this range but the percent of immune children to mumps in 18 months old children was lower than what was expected.…”

Section: Discussioncontrasting

confidence: 48%

Seroprevalence of measles, mumps and rubella Antibodies in 18 months and 6.5 years old children: 6 months after measles-mumps-rubella (MMR) vaccination

Shamsizadeh

Nikfar

Makvandi

et al. 2012

Jundishapur J Microbiol

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This study determined the level of immunity after MMR vaccination in 18 months and 6 years old children.Background: Mumps, measles and rubella viruses lead to various kinds of complications such as meningoencephalitis, deafness, congenital abnormalities and even cause mortality in malnourished patients,. Since 2004, MMR vaccination in two series of one year of age and four to six years has been administered to Iranian children as a part of routine vaccination program. Recently, MMR vaccination schedule has been changed to one year and 18 months series. Objectives: Since MMR vaccine has been recently entered childhood vaccination program, this study was performed to determine immunity response against mumps, measles and rubella six months after one year and four to six years of age vaccination. Patients and Methods:In a cross-sectional study, antibody titers after MMR vaccination at 18 months (six months after dose of one year) in 70 children, and at 6.5 years (six month after dose of six years) in 90 children referred to Ahvaz Abuzar Children's Hospital Vaccination Clinic during 2007-2008 were detected by ELISA method. Results: In 70 children (34 boys and 36 girls) who were vaccinated at one year, 30 (42.9 %) had antibody against measles, 63 (90 %) against rubella and 41 (58.6 %) against mumps. In 90 children (54 boys and 36 girls at 6.5 years of age (six months after vaccination), 41 (45.6%) children had antibody against measles, 79 (87.8 %) against rubella and 69 (76.7%) against mumps. Conclusions: the results of this study showed that after MMR vaccination, the level of antibody for measles was about 45 % and for mumps about 50-80 %. This level of immunity is not acceptable for successful vaccination. while the level of antibody against rubella was sufficient. For better evaluation of MMR vaccination, further studies and from other parts of the country is needed.

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“…The incidence of disease caused by measles, mumps, rubella, and varicella-zoster virus (MMRV) has been significantly reduced in developed countries due to the implementation of effective immunization programs (1,6). However, outbreaks of disease continue to occur in the United States and worldwide due to vaccine failure, declining immunization rates, and waning immunity (2,3,5).…”

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confidence: 99%

Evaluation of the Bio-Rad BioPlex Measles, Mumps, Rubella, and Varicella-Zoster Virus IgG Multiplex Bead Immunoassay

Binnicker

Jespersen

Rollins

2011

Clin. Vaccine Immunol.

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The goal of this study was to compare the BioPlex 2200 measles, mumps, rubella, and varicella-zoster virus (MMRV) IgG multiplex assays (Bio-Rad Laboratories, Hercules, CA) to routine testing by enzyme immunoassay (EIA). Serum specimens (n ‫؍‬ 500) submitted to our reference laboratory for routine MMRV IgG testing by EIA were also tested by the BioPlex assays. Following testing, the BioPlex measles, mumps, rubella, and varicella-zoster virus assays demonstrated agreements of 91.6% (95% confidence interval [CI], 88.8% to 93.7%), 94.2% (95% CI, 91.7% to 95.7%), 94.4% (95% CI, 92.0% to 96.1%), and 91.8% (95% CI, 89.0% to 93.9%), respectively, compared to the results of EIA. Timing studies showed that the BioPlex MMRV assay could provide complete analysis of 100 serum specimens in 1.7 h, compared to 5.5 h by EIA. These data indicate that the BioPlex MMRV IgG assays exhibit comparable performance (93% overall agreement [1,860/2,000 results];‫؍‬ 0.67) to routine testing by EIA. The BioPlex assays allow for the simultaneous detection of all four analytes, thereby eliminating potential aliquot errors and reducing turnaround time.The incidence of disease caused by measles, mumps, rubella, and varicella-zoster virus (MMRV) has been significantly reduced in developed countries due to the implementation of effective immunization programs (1, 6). However, outbreaks of disease continue to occur in the United States and worldwide due to vaccine failure, declining immunization rates, and waning immunity (2, 3, 5).Laboratory testing for IgG class antibodies to MMRV plays an important role in the management of patients and health care workers. For example, testing for IgG class antibodies to rubella virus is routinely performed during the prenatal period (7), and detection of rubella IgG during the first trimester indicates that the mother is protected from primary infection. Furthermore, immunocompromised hosts (e.g., transplant recipients) are commonly screened for immunity to varicella, which may cause devastating disease in the immunosuppressed population if a primary infection occurs (8).Until recently, most clinical laboratories have used methods such as indirect immunofluorescence (IFA), enzyme immunoassay (EIA), and enzyme-linked fluorescence assay (ELFA) for the detection of IgG class antibodies to MMRV. These methods have demonstrated reliable performance; however, they are labor-intensive, time-consuming, and, in the case of IFA, subjective. In addition, these conventional methods require four separate assays to test for IgG class antibodies to MMRV, thereby increasing sample volume requirements as well as hands-on time. These limitations have led to the recent development of multiplex flow immunoassay (MFI) technology, which allows for multiple analytes (e.g., antibodies) to be detected in a single reaction.The Bio-Rad BioPlex MMRV IgG assays (Bio-Rad Laboratories, Hercules, CA) recently received FDA approval for the simultaneous detection of IgG class antibodies to MMRV in human serum or EDTA/heparinized plasma sample...

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Immunogenicity and Safety Assessments After One and Two Doses of a Refrigerator-Stable Tetravalent Measles-Mumps-Rubella-Varicella Vaccine in Healthy Children During the Second Year of Life

Abstract: Both after 1 dose and after 2 doses, the MMRV vaccine was at least as immunogenic as concomitant MMR and varicella vaccination suggesting that it could be suitable for use according to current vaccination schedules.

Cited by 50 publications

References 24 publications

Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

Seroprevalence of measles, mumps and rubella Antibodies in 18 months and 6.5 years old children: 6 months after measles-mumps-rubella (MMR) vaccination

Evaluation of the Bio-Rad BioPlex Measles, Mumps, Rubella, and Varicella-Zoster Virus IgG Multiplex Bead Immunoassay

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