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8. Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years

Author

Carlsson, R. M., Gustafsson, L., Hallander, H. O., Ljungman, M., Olin, P., Gothefors, L., Nilsson, Lennart, Netterlid, E., Carlsson, R. M., Gustafsson, L., Hallander, H. O., Ljungman, M., Olin, P., Gothefors, L., Nilsson, Lennart, and Netterlid, E.

Abstract

Prior study children from a DTaP efficacy trial were recruited at ages 5 and 15 years to randomized booster trials addressing immunogenicity and reactogenicity; 475 preschool children received mixed or separate injections of a reduced antigen vaccine (Tdap5, Sanofi Pasteur MSD) and an inactivated polio vaccine, and 230 adolescents received the same or another booster vaccine (Tdap1, SSI, Denmark). Pre-vaccination antibody concentrations against pertussis antigens were significantly higher at 15 than 5 years of age, probably due to natural boosting between the studies. Tdap5 induced comparable anti-PT concentrations at both ages, but antibody responses were significantly higher to filamentous haemagglutinin, pertactin and fimbriae 2/3 in adolescents. As expected, a higher amount of PT (Tdap1, 20 mu g) induced a stronger anti-PT response than a lower amount (Tdap5, 2.5 mu g). The frequency of adverse events was low and there were no serious adverse reactions. All local reactions had an early onset and a short duration. A large swelling or redness of more than half of the upper arm circumference was reported in 8/475 5-year-olds and in 6/230 15-year-olds. Children vaccinated with Tdap5 reported more moderate pain in adolescence than at preschool age, whereas itching was only reported in preschool children. Sweden introduced DTaP vaccines in 1996 after a 17-year hiatus with no general pertussis vaccination and pertussis was still endemic at the time of the studies. The frequency of adverse events was nevertheless low in both preschool children and adolescents and antibody responses were adequate. These studies document immunogenicity and reactogenicity in a trial cohort consecutively vaccinated with acellular pertussis vaccines from infancy to adolescence. (C) 2015 Elsevier Ltd. All rights reserved., Funding Agencies|Aventis Pasteur Limited, Toronto, Canada; Aventis Pasteur MSD A/S, Copenhagen, Denmark; Sanofi Pasteur MSD Sweden; Statens Serum Institut (SSI) Denmark

Published
2015
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9. Impact of community-acquired pediatric rotavirus gastroenteritis on family life: data from the REVEAL study

Author

Van der Wielen, M, Giaquinto, Carlo, Gothefors, L, Huelsse, C, Huet, F, Littmann, M, Maxwell, M, Talayero, Jm, Todd, P, Vila, Mt, Cantarutti, L, Van Damme, P, DA DALT, Liviana, and REVEAL Study Group, .

Subjects
Male, medicine.medical_specialty, Pediatrics, family, cost of illness, communicable disease, medicine.disease_cause, preschool child, Rotavirus Infections, absenteeism, Rotavirus, Research article, Epidemiology, medicine, Humans, Prospective Studies, human, child care, lcsh:R5-920, Communicable disease, psychological aspect, business.industry, Public health, Incidence (epidemiology), Infant, economics, Emergency department, Rotavirus infection, Family life, virology, Community-Acquired Infections, Europe, gastroenteritis, Child, Preschool, Female, Observational study, Human medicine, Family Practice, business, lcsh:Medicine (General)
Abstract

Background Rotavirus is the leading cause of acute gastroenteritis (AGE) and the most frequent cause of severe diarrhoea in children aged less than 5 years. Although the epidemiology of rotavirus gastroenteritis (RVGE) is well documented, there are few data on the impact of RVGE on the families of affected children. Methods Data associated with the burden of RVGE, including number of working days lost, levels of parental stress, the need for alternative childcare arrangements and additional nappies used, were extracted from questionnaires completed by parents of children participating in a prospective, multicentre, observational study (Rotavirus gastroenteritis Epidemiology and Viral types in Europe Accounting for Losses in public health and society, REVEAL), conducted during 2004-2005 in selected areas of Belgium, France, Germany, Italy, Spain, Sweden, and the United Kingdom to estimate the incidence of RVGE in children aged less than 5 years seeking medical care as a result of AGE. Results 1102 children with RVGE were included in the present analysis. The proportion of RVGE cases that required at least one parent or other person to be absent from work was 39%-91% in the hospital setting, 44%-64% in the emergency department, and 20%-64% in primary care. Self-reported levels of parental stress were generally high (mean stress levels, ≥ 5 on a 10-point visual analogue scale). Additional childcare arrangements were required in up to 21% of RVGE episodes. The mean number of nappies used per day during RVGE episodes was approximately double that used when the child was not ill. Conclusions Paediatric RVGE cases cause disruption to families and parental stress. The burden of RVGE on children and their families could be substantially reduced by routine rotavirus vaccination of infants.

Published
2010

11. The impact of vaccines in low- and high-income countries

Author

Gothefors, L and Gothefors, L

Abstract

Vaccination has become the most effective public health measure for the control of infectious diseases after the provision of clean drinking water. The history of vaccination is marked with great hopes and some disappointments. In particular, the second half of the 20th century witnessed the development of remarkable vaccination projects. There is a possibility that polio and measles may be eradicated within a few years, but almost 3 million people - usually children <5 years of age - die each year from diseases that are preventable by vaccines. Developing countries are struggling to get the vaccines to children who desperately need them. However, in Europe and North America, people have become complacent about vaccines: 'these diseases are no longer a threat and the vaccine is more dangerous than the disease'. Those misconceptions have caused outbreaks of measles, diphtheria and pertussis. The international community must continue to devote the necessary resources, money and manpower to fully exploit the promise that vaccines hold for the relief of human misery.

Published
2008
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12. Infektionssjukdomar

Author

Gothefors, L and Gothefors, L

Abstract

not available

Published
2007

14. Infektioner hos nyfödda

Author

Engberg, S, Gothefors, L, Engberg, S, and Gothefors, L

Abstract

No abstract available

Published
2006

15. Treatment and prevention of influenza : Swedish recommendations

Author

Uhnoo, I., Linde, A., Pauksens, K., Lindberg, A., Eriksson, M., Norrby, R., Beermann, B., Brandt, C., Frydén, Aril, Gothefors, L., Hakansson, J., Claesson, B., Nivenius, K., Petersson, C., Schwan, A., Stahle, L., Trolin, I., Zweygberg, Wirgart B., Uhnoo, I., Linde, A., Pauksens, K., Lindberg, A., Eriksson, M., Norrby, R., Beermann, B., Brandt, C., Frydén, Aril, Gothefors, L., Hakansson, J., Claesson, B., Nivenius, K., Petersson, C., Schwan, A., Stahle, L., Trolin, I., and Zweygberg, Wirgart B.

Abstract

The introduction of the 2 neuraminidase inhibitors (NAIs) zanamivir and oseltamivir has offered new options for the prevention and treatment of influenza. This article summarizes a Swedish consensus guidance document on the rational use of antiviral drugs in the management of influenza virus infections. Vaccination remains the cornerstone for influenza prophylaxis. Target groups for the annual vaccination programme are the 'at-risk' individuals, i.e. elderly patients (= 65 y) and patients with chronic pulmonary disease or cardiovascular disease or other chronic diseases predisposing for a complicated course of influenza. Antiviral drugs are not a substitute for influenza vaccination, but could be used as adjuncts. Currently, 3 drugs have been approved for the treatment of influenza, including zanamivir and oseltamivir and the M2 inhibitor amantadin. Amantadin has come to very limited use, has recently been withdrawn from the Swedish market and is available only on a named patient basis. Compared with amantadin, the NAIs have clear advantages because of their broader anti-influenza activity against both type A and B, improved safety profiles and low potential for inducing drug resistance. The NAIs are therefore recommended as first options in the treatment of influenza. Oseltamivir can be taken orally, whereas zanamivir is for oral inhalation. Limited in vitro and in vivo data suggest that oseltamivir is less potent against influenza B, whereas zanamivir seems equally effective against influenza A and B. In influenza-positive healthy adults and children, treated within 48 h after symptom onset, the NAIs shorten the duration of illness by about 1 d. No significant effect on the duration of symptoms has been documented in treated at-risk patients with influenza. Owing to their limited therapeutic benefit, general use of the NAIs in the treatment of influenza is not recommended, but they can be advocated on an individualized basis for patients with severe influenza who

Published
2003
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16. Booster immunization of children with an acellular pertussis vaccine enhances Th2 cytokine production and serum IgE responses against pertussis toxin but not against common allergens

Author

Ryan, EJ, Nilsson, Lennart, Kjellman, N-IM, Gothefors, L, Mills, KHG, Ryan, EJ, Nilsson, Lennart, Kjellman, N-IM, Gothefors, L, and Mills, KHG

Abstract

Acellular pertussis vaccines (Pa) protect against severe pertussis in children. However, serum antibody responses decline quickly after immunization. Studies in animal models suggest that cell-mediated immunity also contributes to protection against Bordetella pertussis, and it has already been demonstrated that Pa induce T cells that secrete type-1 and type-2 cytokines in children. In this study we examined the persistence of the T cell response and the effect of booster immunization in 4-6-year-old children. Cell-mediated immunity to B. pertussis antigens was detected in a high proportion of children more than 42 months after their last immunization. Peripheral blood mononuclear cells (PBMC) from the majority of children secreted interferon-gamma (IFN-?) and a smaller proportion IL-5, in response to specific antigen stimulation in vitro. However, following booster immunization, significantly higher concentrations of IL-5, but not IFN-?, were produced by PBMC in response to B. pertussis antigens. Furthermore, plasma IL-4 and IL-5 concentrations were increased, whereas IFN-? concentrations were reduced following booster immunization. It has been suggested that childhood immunization with Th2-inducing vaccines may predispose some children to atopic disease. Although we found that pertussis toxin (PT)-specific IgE was significantly increased after booster immunization in both atopic and non-atopic children, the levels of IgE to common allergens and the prevalence of positive skin prick test were unaffected by the booster vaccination. Thus, despite the enhancement of type-2 responses to B. pertussis antigens, booster vaccination with Pa does not appear to be a risk factor for allergy.

Published
2000
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26. Outbreak of Haemophilus influenzae type b meningitis in a day care center

Author

ROSEN, I. ANDERSSON VON, GOTHEFORS, L., SCHMEISSER, S., TÄRNVIK, A., and EDÉN, C. SVANBORG

Abstract

Three cases of Haemophilus influenzaetype b (Hib) meningitis in a Swedish day care center prompted the investigation of the nasopharyngeal carriage in attendees of that day care center (I), and among children in another day center (II) in the same city, but without meningitis cases. Because the evaluation of the spread of Haemophilus influenzae(Hi) isolates through a population, such as children in day care centers, requires stable identification markers for the bacteria, this study used multilocus enzyme electrophoresis to separate Hib carried by day care attendees from the disease-associated Hib clone. The three meningitis episodes were caused by the same clone of Hib (ET14). This and other Hib clones occurred in the healthy carriers. The frequency of H. influenzaecarriage and composition of the H. influenzaeflora differed between the two day care centers. Center I with the meningitis cases had a lower overall frequency of H. influenzaecarriage, 11 of 40 (28) compared with both the control day care center (57) and previous studies. The main difference between the two day care centers was in the nontypable H. influenzae(HiNT) flora. The frequency of HiNT was higher in the center without Hib disease, and there was a higher degree of sharing of HiNT isolates among the children in Center II. This raised the question of an inverse relationship between carriage of HiNT and Hib infection. The results emphasized the importance of accurate identification of the disease isolate in order to estimate the risk of acquisition and dissemination to secondary cases.

Published
1990

27. Enterotoxigenic Escherichia coli diarrhea in an endemic area prepares the intestine for an anamnestic immunoglobulin A antitoxin response to oral cholera B subunit vaccination

Author

Holmgren, J, Svennerholm, A M, Gothefors, L, Jertborn, M, and Stoll, B

Abstract

We examined whether infection with enterotoxigenic Escherichia coli (ETEC) producing the heat-labile enterotoxin (LT) can prime the gut immune system to respond more efficiently to the immunologically related cholera B subunit component of a recently developed oral B subunit-whole-cell cholera vaccine (B-WCV). Nine Bangladeshi adults who had been hospitalized for watery diarrhea caused by LT-producing ETEC were given a single oral immunization with B-WCV on day 28 after hospital admission. The vaccine preparation used was adjusted to contain a lower-than-usual dose of B subunit, which had been found in previous studies to elicit a significant gut mucosal immunoglobulin A antitoxin response mainly in individuals with previous toxin-specific priming of their gut immune system. For comparison, nine patients convalescing from severe cholera disease and eight healthy subjects with no recent history of either cholera or ETEC infection were given the same oral vaccination with B-WCV. Vaccination in the ETEC convalescents induced an immunoglobulin A antitoxin response in intestinal lavage fluid which was comparable with that in the vaccinated cholera convalescents and superior to that in the vaccinated, previously uninfected controls. By contrast, only the cholera patients responded with anamnestic-type anti-cholera lipopolysaccharide antibody titer rises in the intestine after vaccination. These data support the specificity of the anamnestic anti-cholera toxin response in the ETEC patients after vaccination with cholera B-WCV.

Published
1988
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28. Transmission of Lactobacillus jensenii and Lactobacillus acidophilus from mother to child at time of delivery

Author

Carlsson, J and Gothefors, L

Abstract

The presence of Lactobacillus jensenii and Lactobacillus acidophilus has been studied in specimens from the rectum and vagina of the mother, from the mouth of the infant at the time of delivery, and from the mouth and rectum of infants six days of age. L. jensenii could be differentiated from other species of lactobacilli by the following combination of characteristics: production of only D-lactate, hydrolysis of arginine, and fermentation of cellobiose, galactose, and ribose, but not of lactose. L. jensenii and L. acidophilus were common inhabitants of the vagina. In spite of a contamination of the infant's mouth by L. jensenii and L. acidophilus during delivery, neither of these organisms became established in the mouth of the newborn infants.

Published
1975
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29. Serum antibody response to capsular polysaccharide, outer membrane, and lipooligosaccharide in children with invasive Haemophilus influenzae type b infections

Author

Claesson, B A, Lagergård, T, Trollfors, B, Gothefors, L, and Jodal, U

Abstract

Serum antibodies against capsular polysaccharide (CPS), outer membrane (OM), and lipooligosaccharide (LOS) from Haemophilus influenzae type b were measured by enzyme-linked immunosorbent assay in acute- and convalescent-phase sera from 21 children between 3 months and 4 years of age with invasive H. influenzae type b infections. As expected, the levels of anti-CPS antibodies in the acute-phase serum samples were low or not detectable, as were the levels of antibodies against LOS. In contrast, all children had detectable antibodies against the OM in the acute-phase serum sample, indicating that they are of little or no importance for protection. An antibody response to CPS was noted in 13 of the 21 patients, mainly in the older children. An antibody response to the OM was seen in 16 patients, with no evident relation to age. The antibody response to the OM preparation, which consisted of proteins and LOS, was probably directed mainly against the OM proteins, since only six children showed a response, usually of low magnitude, of antibodies to LOS.

Published
1987
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30. Comparison of methods for detection of colonization factor antigens on enterotoxigenic Escherichia coli

Author

Ahrén, C M, Gothefors, L, Stoll, B J, Salek, M A, and Svennerholm, A M

Abstract

Fecal Escherichia coli isolates from 196 patients with watery diarrhea and 68 healthy individuals (controls) were analyzed in Bangladesh immediately after isolation for the presence of colonization factor antigen (CFA) I or II (CFA/I or CFA/II, respectively) by a mannose-resistant hemagglutination (MRHA) test with six species of erythrocytes and by a slide agglutination test with absorbed CFA/I or CFA/II antisera. The presence of CFAs was confirmed by immunodiffusion analyses done in Sweden. By these methods, it was found that 49 of 69 enterotoxin-producing E. coli strains isolated from patients carried CFA/I or CFA/II, whereas none of the nonenterotoxigenic E. coli isolates or the three toxin-positive strains isolated from healthy individuals carried these adhesins. All E. coli strains retained their MRHA ability after transportation to Sweden followed by one subculture and after storage at -70 degrees C (but not at room temperature) for 1 to 2 years without further subculturing. After 5 to 10 subcultures of the fresh isolates, however, 70% of the initially CFA/I- and 80% of the initially CFA/II-carrying strains analyzed did not hemagglutinate. The efficacy of different methods for detecting CFAs on the fresh isolates was compared with that of immunodiffusion. The sensitivity of MRHA with human blood group A erythrocytes for the detection of CFA/I was high (97%), but the specificity was only 69%. The sensitivity of MRHA with bovine erythrocytes for the detection of CFA/II in Bangladesh was very low but increased considerably when chicken erythrocytes were also used. Whereas both false-positive and false-negative reactions were obtained when absorbed CFA antisera were used for agglutination, antisera against purified CFAs were equally effective as immunodiffusion in identifying CFA/I and CFA/II-carrying strains.

Published
1986
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31. Local and systemic antibody responses and immunological memory in humans after immunization with cholera B subunit by different routes

Author

Svennerholm, A. -M., Gothefors, L., Sack, D. A., Bardhan, P. K., and Holmgren, J.

Subjects
Adult, Cholera Toxin, Research, Administration, Oral, biochemical phenomena, metabolism, and nutrition, Injections, Intramuscular, Pregnancy, Immunoglobulin G, Antibody Formation, Immunoglobulin A, Secretory, Intestine, Small, bacteria, Humans, Female, Antitoxins, Immunologic Memory, Gastric Lavage
Abstract

A single oral or intramuscular immunization with purified cholera B subunit induced an intestinal secretory immunoglobulin A (IgA) antitoxin response in, respectively, 10 out of 11 and 9 out of 12 Bangladeshi volunteers. The IgA titre rise in intestinal lavage fluid was similar by either route of immunization, but the duration of the response was usually longer after the oral dose. A second immunization by either route, given 25 days after the first, and a third dose (oral only), given 15 months later, resulted in intestinal immune responses which did not differ in magnitude from that induced by the initial immunization but were observed significantly earlier, usually by day 3. Both the first oral and intramuscular immunizations induced significant antitoxin titre rises, mainly IgG, in the serum in most vaccinees but the magnitude of the response was considerably higher after the intramuscular dose. Significant IgA antitoxin titre rises in saliva and breast milk were seen after both oral and intramuscular immunization.

Published
1984

34. Bordetella pertussis-specific Th1/Th2 cells generated following respiratory infection or immunization with an acellular vaccine: comparison of the T cell cytokine profiles in infants and mice

Author

Ryan, M., Gothefors, L., Storsaeter, J., and Kingston Mills

Subjects
Adult, Immunity, Cellular, Whooping Cough, Vaccination, Infant, Th1 Cells, Diphtheria-Tetanus-acellular Pertussis Vaccines, Antibodies, Bacterial, Bordetella pertussis, Mice, Th2 Cells, Animals, Cytokines, Humans, Diphtheria-Tetanus-Pertussis Vaccine
Abstract

In an investigation of cell-mediated immunity against Bordetella pertussis, we found that B. pertussis infection in infants and in mice was associated with the induction of antigen-specific T cells that secrete IFN-g and IL-2, but not IL-4 or IL-5. This cytokine profile is characteristic of Th1 cells that mediate cellular immune responses against a range of intracellular pathogens. An examination of cytokine production following immunization with a three-component acellular vaccine, comprising inactive PT, FHA and pertactin adsorbed to alum, demonstrated that spleen cells from vaccinated mice produced high levels of IL-5, but no detectable IFN-g and low levels of IL-2. In contrast, peripheral blood mononuclear cells from vaccinated infants produced IL-2, IL-5 and IFN-g. These findings highlight significant differences in the immune responses generated by vaccination and natural infection with B. pertussis and demonstrate that the T-cell response induced with an acellular vaccine, although dominated by type 2 cytokines in mice, is more heterogeneous in infants with a Th0 or mixed Th1/Th2 cytokine profile.

43. ANTIMICROBIAL PROPERTIES OF BREAST MILK

Author

Gothefors, L, primary, Ahlestedt, S, additional, Bronnestam, R, additional, Carlsson, B, additional, Hanson, L A, additional, Johansson, B, additional, Marklund, S, additional, and Winberg, J, additional

Published
1974
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48. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial.

Author

Povey M, Henry O, Riise Bergsaker MA, Chlibek R, Esposito S, Flodmark CE, Gothefors L, Man S, Silfverdal SA, Štefkovičová M, Usonis V, Wysocki J, Gillard P, and Prymula R

Subjects
Chickenpox Vaccine administration & dosage, Chickenpox Vaccine adverse effects, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Europe, Female, Follow-Up Studies, Humans, Immunization Schedule, Infant, Male, Single-Blind Method, Treatment Outcome, Vaccines, Combined administration & dosage, Vaccines, Combined adverse effects, Vaccines, Combined immunology, Chickenpox prevention & control, Chickenpox Vaccine immunology
Abstract

Background: The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella., Methods: This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499., Findings: Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths., Interpretation: The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination., Funding: GlaxoSmithKline Biologicals., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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49. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine versus one dose of monovalent varicella vaccine: a multicentre, observer-blind, randomised, controlled trial.

Author

Prymula R, Bergsaker MR, Esposito S, Gothefors L, Man S, Snegova N, Štefkovičova M, Usonis V, Wysocki J, Douha M, Vassilev V, Nicholson O, Innis BL, and Willems P

Subjects
Adolescent, Child, Europe, Female, Guideline Adherence, Humans, Male, Treatment Outcome, Vaccines, Combined administration & dosage, Young Adult, Chickenpox immunology, Chickenpox prevention & control, Chickenpox Vaccine administration & dosage, Measles-Mumps-Rubella Vaccine administration & dosage
Abstract

Background: Rates of varicella have decreased substantially in countries implementing routine varicella vaccination. Immunisation is possible with monovalent varicella vaccine or a combined measles-mumps-rubella-varicella vaccine (MMRV). We assessed protection against varicella in naive children administered one dose of varicella vaccine or two doses of MMRV., Methods: This study was done in ten European countries with endemic varicella. Healthy children aged 12-22 months were randomised (3:3:1 ratio, by computer-generated randomisation list, with block size seven) to receive 42 days apart (1) two doses of MMRV (MMRV group), or (2) MMR at dose one and monovalent varicella vaccine at dose two (MMR+V group), or (3) two doses of MMR (MMR group; control). Participants and their parents or guardians, individuals involved in assessment of any outcome, and sponsor staff involved in review or analysis of data were masked to treatment assignment. The primary efficacy endpoint was occurrence of confirmed varicella (by detection of varicella zoster virus DNA or epidemiological link) from 42 days after the second vaccine dose to the end of the first phase of the trial. Cases were graded for severity. Efficacy analyses were per protocol. Safety analyses included all participants who received at least one vaccine dose. This trial is registered with ClinicalTrials.gov, number NCT00226499., Findings: Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. In the efficacy cohort of 5285 children, the mean duration of follow-up in the MMRV group was 36 months (SD 8·8), in the MMR+V group was 36 months (8·5) and in the MMR group was 35 months (8·9). Varicella cases were confirmed for 37 participants in the MMRV group (two moderate to severe), 243 in the MMR+V group, and 201 in the MMR group. Second cases occurred for three participants (all in the MMR+V group). Varicella cases were moderate to severe for two participants in the MMRV group, 37 in the MMR+V group (one being a second case that followed a mild first case); and 117 in the MMR group. Efficacy of two-dose MMRV against all varicella was 94·9% (97·5% CI 92·4-96·6), and against moderate to severe varicella was 99·5% (97·5-99·9). Efficacy of one-dose varicella vaccine against all varicella was 65·4% (57·2-72·1), and against moderate to severe varicella (post hoc) was 90·7% (85·9-93·9). The most common adverse event in all groups was injection-site redness (up to 25% of participants). Within 15 days after dose one, 57·4% (95% CI 53·9-60·9) of participants in the MMRV group reported fever of 38°C or more, by contrast with 44·5% (41·0-48·1) with MMR+V, and 39·8% (33·8-46·1) with MMR. Eight serious adverse events were deemed related to vaccination (three MMRV, four MMR+V, one MMR). All resolved within the study period., Interpretation: These results support the implementation of two-dose varicella vaccination on a short course, to ensure optimum protection from all forms of varicella disease., Funding: GlaxoSmithKline Vaccines., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Published
2014
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50. Burden of severe rotavirus disease leading to hospitalization assessed in a prospective cohort study in Sweden.

Author

Rinder M, Tran AN, Bennet R, Brytting M, Cassel T, Eriksson M, Frithiof D, Gothefors L, Storsaeter J, Trollfors B, Valdimarsson S, Wennerström M, and Johansen K

Subjects
Child, Preschool, Community-Acquired Infections epidemiology, Community-Acquired Infections virology, Cross Infection epidemiology, Cross Infection virology, Female, Hospitalization statistics & numerical data, Humans, Incidence, Infant, Infant, Newborn, Male, Prospective Studies, Rotavirus genetics, Rotavirus isolation & purification, Sweden epidemiology, Gastroenteritis epidemiology, Gastroenteritis virology, Rotavirus Infections epidemiology, Rotavirus Infections virology
Abstract

Background: The aim of this prospective cohort study was to estimate the burden of severe disease caused by rotavirus-induced gastroenteritis in Swedish children aged < 5 y., Methods: Rotavirus-positive children admitted to hospitals serving 3 geographical regions with 155,838 children aged < 5 y, were offered inclusion in this 1-year study. Rotavirus strains identified were genotyped using multiplex PCR. Disease progression was documented through interviews and chart reviews., Results: In total, 604 children with rotavirus-induced gastroenteritis were included in the study. Forty-nine of 604 (8.1%) fulfilled the criteria for nosocomial infection. The minimum incidence was 388 per 100,000, with significant variability between study regions, ranging from 280 to 542 per 100,000. In all regions, the peak season occurred in February-April, but the season start varied, with first cases observed in October in the eastern region and December in the northern region. Genotypes identified differed between the regions: G1[P8] was most prevalent in all regions (77%), while the most varied pattern was observed in the western region, with G1[P8] observed in 61%, G4[P8] in 13%, G9[P8] in 10%, G2[P4] in 8%, and G3[P8] in 8% of the children. The median age of hospitalized children was 14 months and the median total duration of diarrhoea was 6.9 days. Sixty-eight percent reported a temperature > 38.5°C upon admission. Complications occurred in > 10% of the children, with hypertonic dehydration (32/604) and seizures (10/604) occurring most frequently., Conclusions: Rotaviruses may cause severe febrile acute gastroenteritis leading to dehydration requiring acute rehydration in hospital. In addition, further complications occurred in > 10% of hospitalized children.

Published
2014
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