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L P Rome

Publications and source records attributed to L P Rome.

9 recordsLinked to original sources
PubMed1997

A long-term prospective study of varicella vaccine in healthy children.

BACKGROUND: Studies in Japan and the United States have shown that varicella vaccine is both safe and efficacious. In 1984, we undertook a 10-year prospective study using a research lot of Oka/Merck varicella vaccine to assess antibody persistence and breakthrough chickenpox rates. In 1987, we began a similar prospective study with lots made in production facilities that ended after 6 years because many children were given a second dose. The purpose of this study is to report humoral antibody persistence and breakthrough chickenpox rates after 6 to 10 years of prospective follow-up. METHODS: One hundred forty-three seronegative children received a research lot (950 plaque-forming units/dose) with 97.9% seroconversion by an assay for fluorescent antibody to membrane antigen (FAMA). One hundred thirty-eight children received production lots (1145 to 3265 plaque-forming units/dose) with 93.5% seroconversion. Yearly chickenpox exposure surveys were completed by phone, and children were seen by a study nurse whenever chickenpox was suspected. A subset in each group had serum collected every 2 years and tested for FAMA antibody. RESULTS: In the research group there have been 25 cases of chickenpox in 137 seroconverters in a period of more than 10 years (yearly rate of 1.7%). In the production lot group there have been 22 cases of chickenpox in 129 seroconverters in a 6-year period (yearly rate of 2.8%). In the research group the median titer rose from 1:16 to 1:64 between 1 and 10 years. In the production group, the median titer did not change between 1, 2, and 4 years. Median antibody titers were compared between the research and production groups at 1, 2, and 4 years and did not differ. The rate of development of modified chickenpox has not increased with time since vaccination, and neither has the case severity. Children with FAMA titers </=8 at 6-weeks' postvaccination were four times more likely to develop chickenpox than those with titers >/=64. CONCLUSIONS: 1) Modified chickenpox has occurred in approximately 2% to 3% of vaccinees per year, regardless of the vaccine lot given. 2) FAMA titers have risen between 1 and 10 years in research lot recipients and remained the same in production lot recipients. 3) The likelihood of modified chickenpox developing is inversely related to the 6-week postvaccination FAMA titer.

Adolescent↗
PubMed1996

Antibody persistence after primary measles-mumps-rubella vaccine and response to a second dose given at four to six vs. eleven to thirteen years.

BACKGROUND: Since 1989 the American Academy of Pediatrics and the ACIP have recommended a second dose of measles-mumps-rubella vaccine (M-M-R-II) at either school entry or age 11 to 13 years. Unfortunately few studies are available to compare responses to vaccine at the two ages. We performed a prospective trial to determine the persistence of antibody to measles, mumps and rubella vaccination in two age groups and the response to a second dose given at either 4 to 6 or 11 to 13 years. METHODS: Thirty-eight children 4 to 6 years old and 57 children 11 to 13 years old were given a second dose of M-M-R-II as they presented for yearly examinations. All had received the first dose at > or = 15 months of age. Measles and rubella antibody were measured by enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody (NT) assay, and mumps antibody was measured by an ELISA method only. An IgM-ELISA antibody assay for measles was used in selected children. Prevaccination and 3- to 4-week post-vaccination sera were obtained. Measles ELISA, measles-neutralizing antibody (NT) and rubella-neutralizing antibody (NT) assays were performed in all children. Seventy-nine of the 95 children had sufficient sera for repeat measles tests, as well as mumps and rubella ELISA determinations. RESULTS: Before the second dose ELISA seropositivity rates for measles and mumps were not significantly different between the two groups. Rubella ELISA seropositivity was 67% in 11- to 13-year-olds, compared with 90% in 4- to 6-year-olds (P < 0.01), suggestive of waning immunity. Rubella NT seropositivity was also lower in 11- to 13-year-olds than in 4- to 6-year-olds (63% vs. 100%, P < 0.01). After revaccination, 100% of the children become seropositive for all 3 antibodies. We performed measles IgM-ELISA testing on all 17 measles-seronegative children, as well as 15 seropositive children and 19 children who were 1 month postvaccination with the first M-M-R-II at 15 months. The purpose was to determine whether the seronegative children were primary or secondary failures. Five of the 17 children with undetectable pre-second dose antibody made IgM measles antibody after revaccination, suggesting that they were primary vaccine failures. CONCLUSIONS: Because all children became seropositive after revaccination, the age of administration can be based on the convenience of vaccine scheduling. However, in view of the apparent decline in rubella antibodies at 11 to 13 years, future studies of rubella vaccination should address the issue of whether earlier boosting leads to greater susceptibility at the time of reproductive age.

Adolescent↗
PubMed1989

Humoral immunity and clinical reinfections following varicella vaccine in healthy children.

The duration of immunity following varicella-zoster vaccination in healthy children remains a critical issue. In a 3-year study of 140 OKA/Merck vaccine recipients, duration of immunity was assessed by two measures. The first was persistence of varicella-zoster antibody measured by modified fluorescent antibody to membrane antigen test. Thirty-six toddler vaccinees 12 to 24 months of age had sera obtained at 6 weeks, 1 year, and 2 years. Geometric mean titer +/- SD at 6 weeks was 57.7 +/- 2.9; at 1 year, it was 12.4 +/- 3.9; at 2 years, it was 9.9 +/- 3.9. Repeated-measures analysis of variance showed a significant overall decrease in antibody titer with time (F = 30.62, P less than .001). Post hoc comparisons indicated that the 6-week and 1-year titers were significantly different (P less than .001), but the difference between 1 and 2 years was not (P = .138). Clinical reinfections were also examined for 3 years after vaccination. Suspected varicella cases were confirmed by a fourfold or more increase in titer. Of 84 toddlers, 68 were exposed one or more times, and 6 became reinfected. Of 49 siblings, 45 were exposed, and one became reinfected. All 7 children had less than 70 vesicles and 6 of 7 were afebrile. No cases of zoster occurred. It is concluded that OKA/Merck varicella-zoster vaccination leads to antibody persistence for 2 years and the few reinfections that do occur are greatly attenuated.

Antibodies, Viral↗
PubMed1988

Live attenuated varicella vaccine in healthy 12- to 24-month-old children.

We studied live attenuated Oka/Merck varicella vaccine in 147 seronegative children 12 to 24 months of age and their 94 seronegative older siblings 2 to 12 years of age. The vaccine side effects were mild, consisting of a papular rash in 15 of 147 (10.2%) children 12 to 24 months and seven of 94 (7.4%) siblings. In a subset of 12- to 24-month-old children, modified fluorescent antibody test for membrane antigen was not detectable at seven days postimmunization but was detectable in 50% by 14 days and in 100% by 21 days. Within 6 weeks, 96.6% of children 12 to 24 months and 94.7% of siblings seroconverted. The geometric mean titer did not vary with age at immunization. One-year blood samples were obtained from 70 children 12 to 24 months of age who seroconverted; 92.9% retained detectable antibody. The geometric mean titer had decreased from 55.7 to 18.6. Of these 70 children, 34% had been exposed to varicella since immunization, and two cases of varicella were observed in seroconverters. Both cases were mild, with less than 50 vesicles. Oka/Merck varicella vaccine appears to be safe, highly immunogenic, and protective against 96% of exposures to natural varicella during the first year after vaccination in infants. Those cases of varicella that develop in immunized children appear substantially reduced in severity.

Antibodies, Viral↗
PubMed1975

Pediatric clinical faculty structure and teaching hospital function.

An organization of clinical faculty has been formed at Rainbow Babies and Childrens Hospital, Cleveland, Ohio, to help coordinate the mutual goals but sometimes conflicting needs of practicing pediatricians and a teaching hospital. The organization has been active in developing and conducting educational experiences for students, house officers, and practitioners. It has contributed to efforts to improve ambulatory and inpatient care. Collaborative clinical research projects involving practitioners and academicians are planned. We know of no other existing similar organization. We propose that other institutions with similar needs consider this mechanism to help improve their academic and patient care programs.

Ambulatory Care↗