Evaluation of oral health status and oral disorders of children with autism spectrum disorders by gender.

AIM: The aim of this study was to evaluate whether there is a relationship between gender and oral health status of children with autism spectrum disorders (CASD). MATERIAL-METHODS: The study was carried out with 348 children. The children were separated into two groups to evaluate the prevalence of caries and to assess oral disorders in terms of gender. The following factors were evaluated: mean dmft (decayed missed filled permanent tooth in primary dentition), mean DMFT (decayed missed filled permanent tooth in permanent dentition), plaque index, caries prevalence scores, dental crowding, open bite, deep palate, drooling of saliva, tongue thrusting habit, bruxism, dental and soft tissue trauma, tooth wear, delayed eruption, and hypodontia. RESULTS: The results showed that the mean dmft in boys with CASD (BCASD) was lower than the mean dmft in healthy boys. The mean dmft of the girls with CASD (GCASD) was also lower than that of the healthy girls. The prevalence of dental caries and mean DMFT in GCASD were higher than those of BCASD in permanent dentition. While the plaque index value of BCASD was higher than that of healthy boys, the plaque index value of GCASD was lower than that of healthy girls. The plaque index value of BCASD was higher than that of GCASD. GCASD were reported to have significantly more bruxism than their healthy counterparts. However, no statistically significant difference was found between BCASD and healthy boys regarding bruxism. Moreover, there was no significant difference between BCASD and GCASD in terms of bruxism. Drooling of saliva in BCASD was less than GCASD. CONCLUSION: There were significant gender differences between CASD and healthy children in terms of dental caries and oral disorders in this study. There were also significant differences regarding dental caries and oral disorders between GCASD and BCASD.

Caries experience, oral disorders, oral hygiene practices and socio-demographic characteristics of autistic children.

AIM: The aim of the present study was to comparatively evaluate the oral health status and influential factors, brushing, developmental and orthodontic disorders, bruxism, drug intake, sweet eating habits, sociodemographic factors and lifestyles of autistic and healthy children. Participants in this study were greater in number compared to the previous studies investigating the same phenomenon. Furthermore, it was a more comprehensive study than other studies in the literature in terms of number of variables included. METHODS: The study was carried out with a total of 407 participants, 285 autistic (test group) and 122 healthy children (control group). The ages ranged from 5 to 16. A total of 407 children were examined. DMFT, dmft, plaque index, dental trauma, oral symptoms, developmental and orthodontic disorders of these children were recorded. Participants were also asked to fill a two-part questionnaire. The first part included questions related to the child's and parents' demographics such as the child's age, gender, number of siblings, the mother's and father's age, education, occupation and income. The second part included questions related to systemic diseases, drug intake, the dental history of children and their parents, brushing and nutrition habits. RESULTS: The results from the inferential statistics showed that both DMFT and dmft indices values of the autistic children were lower than those of the healthy children. Caries prevalence of the autistic children was lower compared to the control group. There was also no difference in the plaque index values between the two groups. Drooling of saliva of the autistic children was higher than that of the healthy children. The results showed statistically significant differences between the two groups regarding bruxism, deep-palate and tongue thrusting, though no statistically significant differences were found between the two groups regarding open bite. However, significant differences were observed in terms of dental crowding between the two groups in that the healthy children had more dental crowding than the autistic children. CONCLUSION: One of the main findings of the study was observed in relation to caries prevalence in that autistics had lower caries prevalence values than controls. Another main finding was that no statistically significant differences were found in terms of plaque index values when the groups were compared. When the findings related to deep palate, open bite and dental crowding were examined, it was seen that deep palate was higher but dental crowding was lower in the autistic children. However, in this study there were no statistically significant differences between the two groups in terms of open bite.

Economic burden of varicella in children 1-12 Years of age in Hungary, 2011-2015.

BACKGROUND: Although live-attenuated varicella-zoster virus (VZV) vaccines have been proven to be safe and effective in preventing varicella and real-word evidence shows routine childhood immunization programs are effective in dramatically reducing varicella associated morbidity and mortality, varicella vaccine is not included in the National Immunization Program (NIP) in Hungary. The purpose of this study was to evaluate the clinical and economic burden associated with varicella in Hungary. METHODS: This was a multicenter, retrospective, chart review study of patients aged 1-12 years with a primary varicella diagnosis between 2011 and 2015. Healthcare resource utilization (HCRU) associated with varicella, unit costs, and work loss were used to estimate direct and indirect costs. All costs are presented in 2015 HUF / Euros (€). RESULTS: 156 children with varicella were included (75 outpatients, 81 inpatients), with a mean age of 4.4 (SD: 2.0) and 3.7 (SD: 2.1) years, respectively. One or more complications were reported by 12.0% of outpatients and 92.6% of inpatients, the most common being dehydration, skin and soft tissue infections, pneumonia, keratoconjunctivitis, and cerebellitis. HCRU estimates included use of over-the-counter (OTC) medications (96.0% outpatients, 53.1% inpatients), prescription medications (9.3% outpatients, 70.4% inpatients), tests/procedures (4.0% outpatients, 97.5% inpatients), and consultation with allied health professionals (2.7% outpatients, 30.9% inpatients). The average duration of hospital stay (inpatients) was 3.6 (95% CI: 3.2, 4.1) days. The total combined direct and indirect cost per varicella case was 228,146.7 Hungarian Forint (HUF)/€ 736.0 for inpatients and 49,790.6 HUF/€ 106.6 for outpatients. The overall annual cost of varicella in Hungary for children aged <15 years in 2015 was estimated at 1,903,332,524.3 HUF/ € 6,139,980.4. CONCLUSION: Varicella is associated with substantial clinical burden in Hungary, resulting in the utilization of a significant amount of healthcare resources. These results support the need for routine vaccination of all healthy children to reduce the varicella-associated disease burden.

The effect of heat on the mechanical properties of glass ionomer cements.

AIM: The objective of this study was to assess the effect of heat application on the mechanical properties of glass ionomer cements. STUDY DESIGN: experimental design. The effect of heat on glass ionomer cements during their setting was evaluated by measuring compressive strength, flexural strength and microhardness. Moroever, temperature changes from one surface of the glass ionomer cement specimens 2, 4, and 6 mm thick to the other surface were measured. A condensable glass ionomer cement (Fuji IX) and a ceramic-reinforced glass ionomer cement (Amalgomer CR) were used as test materials. Heat was applied with soldering iron for 2 minutes at 80±2oC. All mechanical tests were carried out 24 hours after the setting of glass ionomer cements. RESULTS: No significant differences in compressive strength were found between the control groups and the heated groups. There were no statistically significant differences in the flexural strength value for both groups of Fuji IX. On the contrary, when heat was applied to Amalgomer, its mean flexural strength reached a value that was higher than that of Amalgomer control. Significant differences in microhardness were found between the control groups and the heated groups and between Fuji IX and Amalgomer CR. Temperature rising in both glass ionomer cements was also noted. STATISTICS: two-way ANOVA was used where appropriate and independent samples t-test was used in case of interaction. CONCLUSION: It is established that heat application improved the surface mechanical properties of conventional glass ionomer cements.

Administration of hepatitis A vaccine at 6 and 12 months of age concomitantly with hexavalent (DTaP-IPV-PRP approximately T-HBs) combination vaccine.

BACKGROUND: Administration of two doses of hepatitis A (HA) vaccine to children > or = 2 years of age has been shown to be protective. The present study assessed whether HA vaccine can be administered as early as 6 months of age and whether it can be administered concomitantly with a hexavalent (HV) vaccine at this age. METHODS: In an open label, randomized, parallel group study, the liquid HV vaccine (HEXAVAC) (diphtheria, tetanus, 2-component acellular pertussis, inactivated poliomyelitis vaccine, Haemophilus influenzae type b conjugated to tetanus protein and hepatitis B) was administered at 2, 4, 6, and 12 months of age to all children. HA vaccine (VAQTA) was given at 7 and 13 months in the separate administration group (Group 1) and at 6 and 12 months in the concomitant administration group (Group 2). Serum samples were obtained at 2, 7, 12, and 14 months in Group 1 and at 2, 7, 12, and 13 months in Group 2. The primary immunogenicity outcomes were the seroconversion rates for HA 1 month after the second dose of HA vaccine in initially seronegative subjects, and the seroconversion rates for each HV antigen 1 month after the third dose of the HV vaccine (both at 7 months of age). RESULTS: HA seropositivity rates 1 month after the second dose were 100% in both groups, regardless of initial serostatus. The responses to each HV antigen 1 month after the third dose were similar in both groups. The vaccines were generally well tolerated in both groups regardless of vaccine(s) administered. CONCLUSIONS: A schedule of two doses of HA vaccine, 6 months apart beginning at 6 months of age is highly immunogenic and well tolerated when administered alone or concomitantly with HV vaccine at 6 and 12 months of age.

Immunizing children to protect against the increasing risk of hepatitis A in adolescents and young adults in South Korea.

We evaluated the CR326F strain (VAQTA) derived hepatitis A vaccine in Korean children and adolescents >2 years of age to consider a future immunization program. In our study, the pediatric two-dose regimen of VAQTA was found to be generally well tolerated and resulted in 100% (95% CI 94.8, 100.0) seroconversion after 2 doses. Immunizing children with the HAV vaccine routinely should be considered in South Korea, particularly in areas where recent outbreaks have occurred.

Control of hepatitis A through routine vaccination of children.

CONTEXT: The impact of routine hepatitis A vaccination of children living in large communities with elevated disease rates has not been evaluated. OBJECTIVE: To determine the effect of routine vaccination of children on disease incidence in a community with recurrent hepatitis A epidemics. DESIGN, SETTING, AND PARTICIPANTS: Community-based demonstration project conducted from January 12, 1995, through December 31, 2000, in Butte County, California, among children aged 2 to 17 years. INTERVENTION: In 1995, vaccination was offered to children aged 2 to 12 years during vaccination clinics conducted on 2 occasions 6 to 12 months apart at most schools in the county. In 1996-2000, vaccine was distributed to community health care clinicians, who vaccinated eligible children without charge. Vaccine was also available at health department clinics, selected child care centers, and other sites. MAIN OUTCOME MEASURES: Hepatitis A vaccination coverage, hepatitis A incidence, and vaccine effectiveness. RESULTS: During the study period, 29 789 (66.2%) of an estimated 44 982 eligible children received at least 1 vaccine dose; 17 681 (39.3%) received a second dose. The number of hepatitis A cases among the entire county population declined 93.5% during the study period, from 57 cases in 1995 to 4 in 2000, the lowest number of cases reported in the county since hepatitis A surveillance began in 1966. The 2000 incidence rate of 1.9 per 100 000 population was the lowest of any county in the state. Of the 245 cases reported during the 6-year period, 40 (16.3%) occurred among children 17 years of age or younger, of which 16 (40%) occurred in 1995 and only 1 in 2000. One of the 27 case patients eligible for vaccination had been vaccinated, having received the first dose 3 days before symptom onset. The estimated protective vaccine efficacy was 98% (95% confidence interval, 86%-100%). CONCLUSIONS: In this population, hepatitis A vaccine was highly effective in preventing disease among recipients. Childhood vaccination appears to have decreased hepatitis A incidence among children and adults and controlled the disease in a community with recurrent epidemics.

A randomized study of a flexible booster dosing regimen of VAQTA in adults: safety, tolerability, and immunogenicity.

BACKGROUND: VAQTA (hepatitis A vaccine inactivated, Merck & Co., Inc., West Point, PA) is licensed for use in healthy adults in a two-dose schedule at 0 and 6 months. OBJECTIVE: to determine whether the responses to a booster dose of VAQTA administered to adults 12 or 18 months after the first dose were similar to the response when the booster dose was administered 6 months after the first dose. METHODS: healthy adults were randomized to receive 50-U of VAQTA at 6 (Group I), 12 (Group II), or 18 months (Group III) following receipt of Dose 1 on Day 0. Blood samples were collected immediately prior to Doses 1 and 2 and then, 4 weeks following Dose 2. Seropositivity rates (SPRs), geometric mean titers (GMTs) in milli-international units per milliliter (mIU/ml) and booster response rates (BRRs) were compared among treatment groups. Safety data were collected on Vaccination Report Cards. RESULTS: no serious adverse experiences were reported, and the vaccine was well-tolerated by subjects in the three treatment groups. One month following the booster dose, SPRs and GMTs for Groups I, II, and III, respectively, were, 100% (102/102) and 6726.4 mIU/ml; 97.9% (93/95) and 4863.8 mIU/ml; 100% (86/86) and 6068.3 mIU/ml. The BRRs were 88.2% (Group I), 90.2% (Group II) and 94.2% (Group III). CONCLUSION: responses to the booster dose were comparable regardless of the timing (i.e. 6, 12, or 18 months following Dose 1). Flexibility in the timing of the booster dose of VAQTA in adults would allow the vaccination schedule to be the same for adults, adolescents, and children and may increase the likelihood that adults receive the booster dose.

Childhood vaccination against varicella: persistence of antibody, duration of protection, and vaccine efficacy.

OBJECTIVE: To document the duration of protection afforded by Oka/Merck varicella vaccine over a 7-year period. STUDY DESIGN: The subjects were healthy children 1 to 12 years of age originally enrolled in clinical studies to evaluate the primary immune response to varicella vaccine 6 weeks after vaccination. Each was monitored for antibody persistence, breakthrough infection, and household exposure to varicella to produce estimates of vaccine efficacy. RESULTS: The 6-year cumulative varicella antibody persistence rate was 99.5% (95% CI: 98.9%, 100.0%). The annual breakthrough rate through 7 years ranged from 0.2% to 2.3% per year; the estimated cumulative event rate was 6.5%. Comparison of the observed average annual breakthrough rate with the age-adjusted expected annual incidence rate of varicella in unvaccinated children corresponded to an estimated vaccine efficacy of 93.8% to 94.6%. Eighty vaccinated children were exposed to varicella in the household, resulting in 8 (10%) cases of infection. When compared with the historical attack rate of 86.8% in unvaccinated susceptible persons exposed to varicella in the household, this yields an estimated vaccine efficacy of 88.5% (95% CI: 80.9%, 96.1%). Varicella cases in vaccinated children generally were mild. CONCLUSION: The live attenuated varicella vaccine is highly effective in inducing persistent immunity and long-term protection against breakthrough varicella infection.

An open study of subcutaneous administration of inactivated hepatitis A vaccine (VAQTA) in adults: safety, tolerability, and immunogenicity.

A number of patients in clinical practice would be candidates for hepatitis A vaccine administered subcutaneously (SC), including patients with inherited and acquired coagulopathies. To assess the safety, tolerability, and immunogenicity of VAQTA (Hepatitis A Vaccine, Inactivated, Merck and Co. Inc., West Point, PA) was administered SC to healthy adults. A total of 114 healthy adults received two doses of vaccine SC 24 weeks apart. No serious vaccine-related adverse experiences were reported. Four weeks after dose 1, the seropositivity rate (SPR) was 77.9% (CI, 69.1, 85.1%). The geometric mean titer (GMT) was 21.0 mIU/ml. Twenty-four weeks after dose 1 (just prior to dose 2) and 28 weeks after dose 1 (4 weeks following dose 2), the SPRs were 95.3% [corrected] and 100%, respectively; the GMTs were 153.2 and 1563.9 mIU/mL, respectively [corrected]. Although the kinetics of the immune response were slower when VAQTA was administered SC compared to intramuscular injection, SPRs and GMTs increased over time, indicating that the vaccine administered SC demonstrated immunogenicity.

Randomized, double-blind study in healthy adults to assess the boosting effect of Vaqta or Havrix after a single dose of Havrix.

A randomized, double-blind, multicenter study was conducted to investigate the boosting effect of Vaqta or Havrix in 537 healthy adults 18-53 years of age who had received a single dose of Havrix either 24 or 52 weeks earlier. Subjects were randomized in a 2 : 1 ratio to receive either Vaqta or Havrix for their second dose of vaccine and followed for clinical reactions for 14 days after dose 2 was administered. Serum samples were collected immediately before dose 2 was administered and again 4 weeks later and evaluated for hepatitis A antibody (modified hepatitis A virus antibody assay). The booster response rate after administration of the second dose of either vaccine was similar (86.1% for Vaqta vs. 80.1% for Havrix). The geometric mean titers were also similar: 3274 mIU/mL (95% confidence interval [CI], 2776-3858) for Vaqta versus 2423 mIU/mL (95% CI, 1911-3074) for Havrix. The proportion of subjects who reported > or =1 injection-site adverse experiences was lower in the patients receiving Vaqta than in those receiving Havrix (36.6% vs. 59.7%; P<.001). The results of this study indicate that a regimen of Havrix followed by Vaqta is generally well tolerated and highly immunogenic.

Measuring injection-site pain associated with vaccine administration in adults: a randomised, double-blind, placebo-controlled clinical trial.

BACKGROUND: Pain at the injection site is one of the most commonly-reported local reactions associated with administration of a vaccine, but it has not been quantified by a validated instrument for pain measurement. We conducted a randomised, double-blind clinical trial to evaluate the measurement characteristics of two commonly-used pain questionnaires, the McGill Present Pain Intensity (PPI) and the Brief Pain Inventory (BPI) Current Pain Question, in the assessment of intramuscular injection-site pain associated with vaccine administration. The PPI measures pain on a scale of 0 (no pain) to 5 (excruciating pain) and the BPI measures pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). METHODS: Two hundred healthy adults were randomised to one of the five regimens: tetanus and diphtheria toxoids adsorbed (Td), aluminum hydroxide adjuvant (alum), physiological saline, or one of the two licensed hepatitis A vaccines, VAQTA, or HAVRIX. Pain assessment was made at eight time-points over a 2-day period after injection. RESULTS: The differences in the time-averaged pain (+/- standard deviation) on the PPI were statistically significant between Td (0.58+/-0.59) and either saline (0.14+/-0.23) (p < 0.005) or alum (0.22+/-0.35) (p < 0.01). Reported time-averaged pain were significantly lower for VAQTA than HAVRIX (p = 0.028). Similar differences were observed for the BPI. CONCLUSIONS: Both instruments have sufficient discriminative validity to distinguish between different levels of injection-site pain in adults.

Safety, tolerability and immunogenicity of concomitant injections in separate locations of M-M-R II, VARIVAX and TETRAMUNE in healthy children vs. concomitant injections of M-M-R II and TETRAMUNE followed six weeks later by VARIVAX.

OBJECTIVES AND STUDY DESIGN: The primary objectives of this study were to compare immunologic responses, antibody persistence, safety and varicella breakthrough rates when VARIVAX (varicella vaccine) is given at the same time as M-M-R II (measles, mumps, rubella vaccine) and TETRAMUNE (conjugate Haemophilus influenzae type b, diphtheria, tetanus and whole cell pertussis vaccine) at separate injection sites (Group A) vs. VARIVAX given 6 weeks after M-M-R II and TETRAMUNE (Group B). Six hundred nine healthy children, 12 to 23 months of age, were randomized to one of two treatment (immunization) groups (Group A and Group B). Blood for antibody titers was drawn on the day of immunization, 6 weeks after each injection and 1 year later. Local and systemic adverse reactions were recorded. Exposure and cases of varicella were documented through a 1-year follow-up period. RESULTS: Measles, mumps and rubella seroconversion rates and geometric mean titers (GMTs) were similar for both treatment groups. Varicella seroconversion rates were also similar between groups. However, varicella GMTs and percent with a varicella-protective level [> or =5.0 glycoprotein (gp) enzyme-linked immunosorbent assay (ELISA) units] did not meet the prespecified criteria for similarity were lower for Group A (GMT 10.5; 82.8% > or =5.0 gp ELISA units) than for Group B (GMT 14.5; 91.2% > or =5.0 gp ELISA units). The GMTs between groups for other antibodies were similar. At the 1-year follow-up antibody titers were comparable in both groups and breakthrough varicella cases appeared generally similar. There were fewer local adverse events (AEs) at the VARIVAX injection sites (9.8% and 2.9%, Group A and B, respectively) than at the TETRAMUNE sites (27.9% and 24.0%). Systemic AEs were not statistically different when M-M-R II was administered alone (8.6%) or concomitantly with VARIVAX (8.9%). When VARIVAX was given alone AEs were 1.8%. The rate of fever > or =102 degrees F after M-M-R II and TETRAMUNE administered together was 10.7% on Days 0 to 3 and 23.7% on Days 7 to 21. When VARIVAX was administered alone, the rate of fever was 5.4% on Days 0 to 3 (P = 0.018) and 10.8% on Days 7 to 21 (P<0.001). CONCLUSION: Because the varicella titers were comparable and varicella breakthrough rates generally similar at 1 year in both groups, we expect that the concomitant administration of VARIVAX with M-M-R II and TETRAMUNE has clinical effectiveness similar to that with VARIVAX 6 weeks after the administration of these other two vaccines. VARIVAX appears to be less reactogenic than M-M-R II and TETRAMUNE.

Safety and immunogenicity of concurrent administration of measles-mumps-rubella-varicella vaccine and PedvaxHIB vaccines in healthy children twelve to eighteen months old. The MMRV Study Group.

OBJECTIVE: To determine the safety and immunogenicity of concurrent administration of measles-mumps-rubella-varicella vaccine (MMRV) and PedvaxHIB (Haemophilus influenzae type b conjugate vaccine) vs. M-M-R II and PedvaxHIB followed by an optional dose of VARIVAX 6 weeks later. DESIGN: Healthy children, 12 to 18 months of age, were randomly assigned to two groups to receive (1) MMRV and PedvaxHIB given concurrently or (2) M-M-R II and PedvaxHIB followed by an optional dose of VARIVAX 6 weeks later. SUBJECTS: The study group included 294 healthy children, ages 12 to 18 months, with a negative history of measles, mumps, rubella and varicella. MAIN OUTCOME MEASURES: The seroconversion rate and magnitude of antibody responses when MMRV was given concurrently with PedvaxHIB compared with the antibody responses when VARIVAX was given 6 weeks after M-M-R II and PedvaxHIB. RESULTS: Healthy children, 12 to 18 months of age, who received MMRV and PedvaxHIB concurrently showed immune responses similar to those in the control group who received M-M-RII vaccine with PedvaxHIB followed by VARIVAX 6 weeks later. Antibody titers for varicella were significantly lower when MMRV was administered than when varicella vaccine was given separately (0.712-fold difference, P = 0.028). No vaccine-related serious adverse reactions were reported, and no clinically significant differences were seen in the safety profiles of the two treatment groups. CONCLUSIONS: There were no statistically significant differences in the seroconversion rates between the two treatment groups for any of the antigens tested at 6 weeks and 1 year. Significantly lower geometric mean titers for varicella were noted in the group who received MMRV compared to VARIVAX given alone. Six-week seroconversion rates, persistence of immune responses at 1 year and the frequency of local and systemic reactions were comparable when MMRV was administered with PedvaxHIB compared with M-M-R II and PedvaxHIB followed by VARIVAX 6 weeks later.

Measles, mumps, rubella, and varicella combination vaccine: safety and immunogenicity alone and in combination with other vaccines given to children. Measles, Mumps, Rubella, Varicella Vaccine Study Group.

Eight hundred and twelve children, 12 months to 3.5 years of age, were enrolled in two clinical studies to evaluate the safety and immunogenicity of a live, attenuated combination vaccine for measles, mumps, rubella, and varicella (MMRV). Children were enrolled in one of two randomized, multicenter studies, involving administration of (1) MMRV and placebo vs. measles, mumps, and rubella vaccine (M-M-R(II)) and varicella-zoster virus vaccine (VARIVAX), given at separate anatomic sites at the same office visit; or (2) MMRV, DTaP (diphtheria, tetanus, and acellular pertussis vaccine) and OPV (oral polio vaccine) vs. M-M-R(II), DTaP, and OPV, with VARIVAX given 6 weeks later. All vaccine regimens were generally well tolerated. More than 95% of vaccinees seroconverted for measles, mumps, rubella, and varicella, regardless of the vaccine or regimen used. In each study, the level of antibody titer to varicella virus was significantly lower in vaccinees receiving MMRV than in those who received VARIVAX in a separate syringe.

Duration of protection from clinical hepatitis A disease after vaccination with VAQTA.

Recent papers examining the expected persistence of anti-hepatitis A virus antibody following vaccination with inactivated hepatitis A vaccine have estimated that geometric mean antibody levels will remain above cut-off levels for 10-30 years. However, the methodology used in these papers did not take into account any estimates of variability between subjects. In this paper data from the persistence of antibody after the administration of another vaccine, VAQTA (hepatitis A vaccine, inactivated; MSD), were used to develop further models of antibody decay. Using individual subject estimates instead of group means allowed the estimation of time to negativity for various percentiles of the population (including the median), and the construction of confidence intervals on estimates of time to negativity. Data from studies of subjects who seroreverted to negativity, and subsequently received a booster dose, were also considered to show that subjects who lose detectable antibody are likely to remain protected from hepatitis A disease by persistent immune memory and rapid anamnestic response soon after exposure to hepatitis A virus. The estimates of duration of protection suggest that VAQTA will provide protection for many years, first through presence of antibody and further through an anamnestic response based on persistent immune memory.

Safety and immunogenicity of a combined live attenuated measles, mumps, rubella, and varicella vaccine (MMR(II)V) in healthy children.

An investigational tetravalent combined measles, mumps, rubella, and varicella vaccine and measles-mumps-rubella and varicella vaccines at separate injection sites given at the same visit were evaluated with respect to safety and cell-mediated and humoral immune responses at 6 weeks and 1 year after vaccination. Varicella seroconversion rates and lymphocyte proliferation responses were 100% for both vaccine groups at 6 weeks and 1 year. However, the antibody titer to varicella was lower in the combined vaccine group at 6 weeks, but there was no statistical difference in cell-mediated immune responses. One-year geometric mean titers were not statistically different. Seroconversion rates for measles, mumps, and rubella were 100% for both vaccine at 6 weeks and 1 year. Long-term follow-up of these immune responses is planned.

Safety and immunogenicity of one vs. two injections of Oka/Merck varicella vaccine in healthy children.

OBJECTIVE: To compare the safety and immunogenicity of a one- vs. two-dose regimen of Oka/Merck varicella vaccine in approximately 2000 healthy children 12 months to 12 years of age. METHODOLOGY: Subjects with a negative history of varicella were randomized to receive either one or two injections of the vaccine given 3 months apart and were followed for clinical reactions and serologic response (glycoprotein-based enzyme-linked immunosorbent assay). RESULTS: Both one- and two-dose vaccine regimens were generally well-tolerated. The incidences of varicelliform rash and fever were less frequent after the second injection. However, a slight increase in the incidence of injection site reactions was noted after the second injection; these were generally mild. Seroconversion rates by glycoprotein-based enzyme-linked immunosorbent assay were 98.2% (1700 of 1731) after one injection and 99.9% (717 of 718) after two injections. A significant (P < 0.001) boost in geometric mean titers was observed in children who received a second injection of vaccine 3 months after the first injection. Of the children who seroconverted at 6 weeks postregimen (one or two doses as assigned), 99.8% (528 of 529) of the one-dose group and 99.8% (473 of 474) of the two-dose group maintained antibody to varicella at 1 year with geometric mean titers of 19.5 and 31.2, respectively. CONCLUSIONS: Administration of a one- or two-dose regimen of the live Oka/Merck varicella vaccine (VARIVAX) is immunogenic and is generally well-tolerated in healthy children 1 to 12 years old. Antibody to varicella persists in > 99% of vaccinees 1 year after vaccination regardless of a one- or two-dose regimen. Long-term follow-up studies of this cohort of children may determine whether a two-dose regimen offers superior protection against chickenpox.

Safety, tolerability, and immunogenicity of two regimens of Oka/Merck varicella vaccine (Varivax) in healthy adolescents and adults. Oka/Merck Varicella Vaccine Study Group.

A multicenter clinical trial was conducted among 757 healthy adolescents and adults, 13-54 years, to compare two regimens of Oka/Merck varicella vaccine with respect to safety, tolerability, and immunogenicity. Participants were randomized to receive two injections of vaccine either four or eight weeks apart and were followed for clinical reactions and serologic response. The two vaccine regimens were equally well tolerated. The seroconversion rates (gpELISA) four weeks after injection 1 and 2 were 72 and 99%, respectively, for those who received vaccine four weeks apart and 78 and 99%, respectively, for those who received vaccine eight weeks apart. The differences in seroconversion rates were not statistically significant. However, delaying the second dose to eight weeks resulted in a higher antibody titer one month after the second injection. Administration of a two-dose regimen of varicella vaccine to susceptible adolescents and adults is well tolerated and highly immunogenic.