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PubMed1992

Otologic effects of interferon beta serine in experimental rhinovirus colds.

To evaluate the efficacy and otologic effects of recombinant interferon beta serine for experimental rhinovirus colds, 38 healthy adults received nasal drops of recombinant interferon beta serine, 12 x 10(6) U, or placebo three times daily for 4.3 days beginning 36 hours after infection. Illness rates and severity did not differ between the groups, but the frequency of virus shedding was reduced on the fourth (37% vs 74%) and sixth (11% vs 42%) postchallenge days in recipients of recombinant interferon beta serine. Abnormal eustachian tube function in at least one ear was identified by the inflation-deflation test during 44% of observations in 13 infected recipients of recombinant interferon beta serine compared with 62% of observations in five placebo recipients. Tympanometry revealed middle-ear pressure abnormalities (less than -50 or greater than 20 mm H2O) in at least one ear during 18% of observations in recipients of recombinant interferon beta serine compared with 38% of observations in placebo recipients. These results suggest that antiviral therapy may alter the course of middle-ear dysfunction associated with experimental colds.

Administration, Intranasal↗

PubMed2005

A case-control study of acute respiratory tract infection in general practice patients in The Netherlands.

BACKGROUND: Acute respiratory tract infections (ARTIs) are responsible for considerable morbidity in the community, but little is known about the presence of respiratory pathogens in asymptomatic individuals. We hypothesized that asymptomatic persons could have a subclinical infection and thus act as a source of transmission. METHODS: During the period of 2000-2003, all patients with ARTI who visited their sentinel general practitioner had their data reported to estimate the incidence of ARTI in Dutch general practices. A random selection of these patients (case patients) and an equal number of asymptomatic persons visiting for other complaints (control subjects) were included in a case-control study. Nose and throat swabs of participants were tested for a broad range of pathogens. RESULTS: The overall incidence of ARTI was 545 cases per 10,000 person-years, suggesting that, in the Dutch population, an estimated 900,000 persons annually consult their general practitioner for respiratory complaints. Rhinovirus was most common in case patients (24%), followed by influenza virus type A (11%) and coronavirus (7%). Viruses were detected in 58% of the case patients, beta -hemolytic streptococci group A were detected in 11%, and mixed infections were detected in 3%. Pathogens were detected in approximately 30% of control subjects, particularly in the youngest age groups. CONCLUSION: This study confirms that most ARTIs are viral and supports the reserved policy of prescribing antibiotics. In both case and control subjects, rhinovirus was the most common pathogen. Of bacterial infections, only group A beta-hemolytic streptococci were more common in case patients than in control subjects. Furthermore, we demonstrated that asymptomatic persons might be a neglected source of transmission.

Acute Disease↗

PubMed2006

Seroprevalence of herpes simplex virus-1 and -2 in attendees of a sexually transmitted infection clinic in Singapore.

BACKGROUND: We studied the seroprevalance of HSV (herpes simplex virus)-1 and HSV-2 in outpatient attendees of a sexually transmitted infection (STI) clinic in Singapore and examined their knowledge and attitudes towards HSV infection. METHODS: Two hundred male and 200 female participants were recruited in the study. Questionnaires were administered and blood samples were taken and analysed using the HerpeSelect 1 and 2 enzyme-linked immunosorbent assay (ELISA) IgG assays (type-specific serological tests). RESULTS: HSV-1 was positive in 223 (55.8%) individuals, negative in 175 (43.8%) and indeterminate in two (0.5%), whereas HSV-2 was positive in 114 (28.5%) individuals, negative in 284 (71.0%) and indeterminate in two (0.5%). The seroprevalance of HSV-2 was 26% and 31% in males and females, respectively. The correlation between a previous history of cold sores and HSV-1 infection was poor. On univariate analysis, there was a significant association with age, marital status and years of sex (P < 0.05) but after adjusting for confounders, none of the variables were significantly associated with HSV-2 seroprevalance. Most of the respondents (65.8%) were aware that herpes is an STI, whereas only half of them were aware of the possibility of asymptomatic transmission. CONCLUSION: Although HSV-2 is a common infection among STI clinic attendees in Singapore, there is an unsatisfactory level of knowledge among the attendees about HSV infection and public education programs should be introduced to address this.

Adolescent↗

PubMed1984

Sites of virus recovery and antigen detection in epithelial cells during experimental rhinovirus infection.

Detection of infectious virus and viral antigen from selected sites in the nose was done in 20 volunteers with experimental rhinovirus colds and in 10 sham inoculated controls. For five days after virus inoculation, repeated samples were collected both by swabbing the nose and pharynx and by epithelial biopsy of localized areas in the nose with a sheltered cytology brush. All samples were cultured for virus. Cells in the biopsy specimens were examined with immunoperoxidase staining for detection of rhinovirus antigen in epithelial cells. Not all parts of the nasal lining were infected. While 60% of the nose/throat swabs samples were positive by culture, only 32% of the brush biopsies were positive. With the biopsy specimens, the number of positive cultures was lower in the anterior part of the nose (nasal septum) than in the middle part of the cavity (turbinates), and there was a tendency for an increased number of sites to become positive during the course of the illness. Eight (16%) of 51 specimens from infected volunteers had rhinovirus antigen detected in ciliated epithelial cells. These findings indicate that the entire nasal epithelium is not infected at the time of peak symptoms during experimental rhinovirus colds.

Adult↗

PubMed1993

Reactivated herpes simplex virus infection as a possible cause of dry socket after tooth extraction.

This study was designed to evaluate a possible association between reactivated herpes simplex virus type 1 (HSV-1) infection after lower third molar extraction and development of dry socket (DS). The HSV-1 antibody response was analyzed before and after tooth removal by enzyme-linked immunosorbent assay and immunoblotting in 208 patients. History of previous possible oral herpes reactivation was evaluated by a questionnaire that was based on self-rated frequency of oral cold sores. Tobacco users were identified. The anatomic proximity of the root apex to the mandibular nerve canal was classified radiographically before extraction. Fifteen patients (7%) developed DS after tooth extraction. Eleven of the 15 DS patients (73%) were HSV seropositive as compared with 7 of 15 (47%) in the matched control group. Seven of the 11 seropositive DS patients have shown HSV-1 reactivation by an increase of specific polypeptides, predominantly gB, gC, gD and ICP 4 and 6, in the immunoblot test. No change in HSV-1 reactivity was observed in control sera. DS patients reported a high frequency of oral cold sores (64%) compared with the controls (33%). Tobacco use was not found to influence the frequency of cold sores or the development of DS. A close radiographic proximity between the mandibular canal and root apex was more common (P < .05) in DS patients. The results indicate that extraction of a mandibular third molar could be a possible cause of reactivation and recurrence of an HSV-1 infection.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1988

Is histamine responsible for the symptoms of rhinovirus colds? A look at the inflammatory mediators following infection.

In an attempt to identify inflammatory mediators that may contribute to rhinorrhea, nasal congestion and other cold symptoms, we recruited 40 healthy young adults (median age, 20) for provocative rhinovirus challenge. Mediators measured included histamine, kinins and enzymes with arginine esterase activity. Volunteers were inoculated with rhinovirus or a sham inoculum. Nasal secretions for viral culture were obtained daily, and volunteers were deemed infected if they shed virus or had a 4-fold or greater increase in serum antibody titer. The virus-infected group was subdivided using the Jackson criteria into an ill or non-ill group; each group was compared to the control group. Of the 27 virus-inoculated subjects, 25 had positive cultures for the challenge virus, and 15 became ill. None of the controls had a positive culture. All variables measured--except histamine--grew stronger in direct relationship with the symptoms as the cold increased in severity. In the infected-ill group, the mean kinin level increased more than 10-fold over baseline. The kinin level remained relatively unchanged in the control and non-ill groups. Similar results were found for levels of albumin and enzymes with arginine esterase activity. Histamine levels remained constant in both the infected-ill and non-ill groups, which suggests that mast cells and basophils do not participate in the pathophysiology of rhinovirus infections and that antihistamines should be ineffective in treating rhinovirus colds. Since volunteers who developed cold symptoms exhibited a notable increase in kinin, a potent inflammatory mediator, we recommend further study of a kinin antagonist in reducing nasal symptoms.

Adult↗

PubMed2003

Null mutations in a Nudix gene, ygdP, implicate an alarmone response in a novel suppression of hybrid jamming.

Induction of the toxic LamB-LacZ protein fusion, Hyb42-1, leads to a lethal generalized protein export defect. The prlF1 suppressor causes hyperactivation of the cytoplasmic Lon protease and relieves the inducer sensitivity of Hyb42-1. Since prlF1 does not cause a detectable change in the stability or level of the hybrid protein, we conducted a suppressor screen, seeking factors genetically downstream of lon with prlF1-like phenotypes. Two independent insertions in the ygdP open reading frame relieve the toxicity of the fusion protein and share two additional properties with prlF1: cold sensitivity and the ability to suppress the temperature sensitivity of a degP null mutation. Despite these similarities, ygdP does not appear to act in the same genetic pathway as prlF1 and lon, suggesting a fundamental link between the phenotypes. We speculate that the common properties of the suppressors relate to secretion defects. The ygdP gene (also known as nudH) has been shown to encode a Nudix protein that acts as a dinucleotide oligophosphate (alarmone) hydrolase. Our results suggest that loss of ygdP function leads to the induction of an alarmone-mediated response that affects secretion. Using an epitope-tagged ygdP construct, we present evidence that this response is sensitive to secretion-related stress and is regulated by differential proteolysis of YgdP in a self-limiting manner.

Bacterial Outer Membrane Proteins↗

PubMed1999

Bronchoalveolar lavage fluid cellularity and soluble intercellular adhesion molecule-1 in children with colds.

Viral colds are an important cause of respiratory symptoms in normal children. Studies in adults suggest that inflammation in the lower respiratory tract is associated with viral colds, but there are no data regarding inflammation and viral infection in the lower airway of normal children with colds. We, therefore, studied the lower airway of two groups of children: Group I, those with active coryzal symptoms and a respiratory virus isolated from bronchoalveolar lavage fluid (BALF); and Group II: asymptomatic children who had had a clinical cold within the previous 2 weeks and no respiratory virus in BALF. Both groups were compared to age- and weight-matched normal noninfected controls, who had had no coryzal symptoms for at least 8 weeks. Viruses isolated from BALF of Group I (n = 7) were: respiratory syncytial virus (n = 2), rhinovirus (n = 3), parainfluenza I (n = 1), and echovirus 11 (n = 1). Compared to normal controls, Group I had an increased BALF lymphocyte and neutrophil differential count (P < 0.05), a concomitant depressed alveolar macrophage differential count (P < 0.05), and increased BALF concentrations of soluble intercellular adhesion molecule-1 (sICAM-1) (P < 0.05, n = 6), total protein (P < 0.05, n = 6) and albumin (P < 0.05, n = 7). Similar changes were seen in Group II (n = 22), with an increased BALF neutrophil (P < 0.05) and lymphocyte (P < 0.01) differential count, and increased concentrations of sICAM-1 (P < 0.01, n = 15), total protein (P < 0.0001, n = 9) and albumin (P = 0.05, n = 17). Our results suggest that inflammation and viral infection in the lower airway are present during active colds, and that inflammation is also present during the convalescent period.

Adolescent↗

PubMed2002

Cost burden of viral respiratory infections: issues for formulary decision makers.

Viral respiratory infections (VRIs) are a common malady associated with considerable costs in terms of decreased productivity and time lost from work or school, visits to health-care providers, and the amount of drugs prescribed. Both total respiratory illness and rhinovirus infection peak during the fall and spring seasons, although the average percentage of office visits by patients with a rhinovirus infection is moderately high throughout the year. Most common cold remedies are relatively ineffective and may produce side effects that contribute to increased health-care costs. Antibiotic therapy is widely overused and misused despite evidence that antibiotics fail to treat the cause of VRI or prevent secondary bacterial infections. Increasing use of antibiotics has a significant impact on health-care costs and the emergence of antimicrobial resistance. Reasons for overprescribing antibiotics are varied, but they often involve physician and patient attitudes and expectations. Although treatment of VRIs poses challenges for effective formulary management, several steps can be taken to facilitate the introduction of antiviral agents, including patient and provider education, the development of rapid diagnostic tests, and medical-economics studies to determine the true cost of antiviral therapy.

Anti-Bacterial Agents↗

PubMed1985

Cross-reactive recognition of mouse cells expressing the bm3 and bm11 mutations within H-2Kb by H-2Kb-restricted herpes simplex virus-specific cytotoxic T lymphocytes.

Cytotoxic T lymphocytes, generated in C57BL/6 mice in response to herpes simplex virus type 1 (HSV) and known to be restricted in their recognition of HSV-encoded antigen(s) in association with the class I H-2Kb gene product, were consistently found to contain a subpopulation that recognized and lysed uninfected, SV40-transformed cells that expressed the H-2Kbm3 and H-2Kbm11 mutant class I gene products on their cell surface. The mutant cell lines, designated Lgbm3SV and Kbm11SV, share a common amino acid substitution at position 77, with the bm3 mutation having an additional amino acid substitution at position 89. Cross-reactive lysis was observed only after in vivo priming with HSV, suggesting an important role for an antigen-dependent driving step in the expansion of these cross-reactive CTL. The phenotype of the cross-reactive effector population was further confirmed as a T lymphocyte by negative-selection techniques. Limiting dilution analysis of the frequency of cross-reactive CTL precursors suggested that cross-reactivity was mediated by a subpopulation of HSV-specific CTL, and this was confirmed by clonal analysis of the reactivity patterns of short-term, HSV-specific CTL clones. However, analysis of the specificity of the cross-reactive CTL population by cold-target inhibition of bulk culture-derived CTL, or by Spearman ranking analysis of limiting dilution-derived CTL, indicated that the specificity of the cross-reactive population for HSV-infected H-2b target cells and for uninfected bm3 or bm11 target cells was quite distinct. These findings suggested that the cross-reactive CTL population played little, if any, role in the HSV-specific CTL response as measured in vitro. The findings also suggested that the HSV-specific CTL clones able to mediate cross-reactive recognition of the bm3 and bm11 targets had a higher intrinsic avidity for the foreign target than for the inducing antigen.

Amino Acids↗

PubMed1999

Living related liver transplantation: histopathologic analysis of graft dysfunction in 304 patients.

Between June 1990 and August 1997, 304 mainly pediatric patients underwent a total of 311 orthotopic living related liver transplantations (LRLTs) under tacrolimus immunosuppression at Kyoto University Hospital. Congenital biliary atresia was the most common underlying disease. The donor was a parent, and the left lateral segments were used as grafts in most cases. The average number of loci of HLA-A, -B, and -DR mismatches between the donor and the recipient were 2.1. Forty-three transplants were ABO-incompatible. Liver histology at the time of abnormal liver function after transplantation was analyzed. Preservation injury was rare and mild. Acute cellular rejection (ACR) occurred in 36% of transplants during the first 6 months. Average rejection activity index (the Banff schema) was 4.2 and severe rejection was rarely seen. The number of mismatching HLA loci and immunosuppression regimens affected the incidence of ACR. Chronic rejection (CR) occurred in 2% of transplants. Concerning humoral rejection, no hyperacute rejection was seen. However, hepatic artery thrombosis (delayed hyperacute rejection) was seen in an ABO-incompatible transplant. Acute hepatitis, including those related to cytomegalovirus and Epstein-Barr virus, occurred in 17% of transplants. Chronic hepatitis, including hepatitis B and C, developed in 3%. Acute or chronic cholangitis occurred in 16%, and a significantly higher incidence of cholangitis was found in ABO-incompatible transplants. Posttransplantation lymphoproliferative disease developed in 2%. In LRLT, milder preservation injury and less frequent ACR and CR were suggested, probably because of the short cold-ischemia time and the advantages of HLA histocompatibility, respectively.

Adolescent↗

PubMed2006

Longitudinal observation of enterovirus and adenovirus in stool samples from Norwegian infants with the highest genetic risk of type 1 diabetes.

BACKGROUND: Enterovirus and adenovirus are common in infancy, causing mostly asymptomatic infections. However, even an asymptomatic infection may be associated with increased risk of development of certain chronic non-infectious diseases, as has been suggested for enterovirus and type 1 diabetes. Data on occurrence and course of the infections in infancy are therefore important for designing effective approaches towards study of the association. OBJECTIVES: To estimate the frequency of enterovirus and adenovirus infections in Norwegian infants, to evaluate the duration of the infections, to investigate their association with symptoms, and to establish a robust procedure that will be used to study the association between these viruses and the development of auto-immunity leading to type 1 diabetes. STUDY DESIGN: Parents of infants, recruited for a study on environmental triggers of type 1 diabetes, submitted monthly samples of infant faeces, as well as information on symptoms of infection. The samples were analysed for enterovirus and adenovirus using quantitative real-time PCR, and enterovirus-positive samples were sequenced. RESULTS: Enteroviruses were found in 142/1,255 (11.3%), and adenoviruses in 138/1,255 (11.0%) of stool samples. Approximately half of the infants were exposed to these viruses at least once during the first year of observation (period 3-14 months of age). The presence of adenovirus was associated with fever and with symptoms of cold but not with diarrhoea and vomiting. The enterovirus positivity was not associated with any symptoms. CONCLUSIONS: The prevalence of enterovirus and adenovirus in longitudinally obtained faecal samples from infants is sufficiently high to enable studies of their association with chronic diseases. The present protocol for evaluating exposure to these viruses is well suited for large-scale efforts aimed at assessing possible long-term consequences, particularly in relation to type 1 diabetes.

Adenovirus Infections, Human↗

PubMed2006

Enterovirus meningitis in Greece from 2003-2005: diagnosis, CSF laboratory findings, and clinical manifestations.

Enteroviruses (EVs) are the most commonly identified cause of aseptic meningitis. Rapid detection and characterization of EV meningitis is essential in making decisions for patient management and treatment. A total of 52 cases of acute aseptic meningitis that occurred from March 2003 to April 2005 were investigated for EVs using viral culture and/or molecular methods directly in the cerebrospinal fluid (CSF). EVs were detected in 21 out of 52 (40.4%) patients using reverse transcription-PCR (RT-PCR) and/or tissue culture. EVs were isolated from six out of 37 (16.2%) cultured specimens, while 20 out of 52 (38.4%) specimens yielded positive results when 5'non-coding region (5'NCR) RT-PCR assay was used. One specimen that was culture-positive was RT-PCR-negative. Using the VP1-2A RT-PCR and sequence analysis, 14 of the 21 positive EVs were identified as: four strains of Coxsackie virus B5, five echovirus 11, two echovirus 9, one echovirus 5, one echovirus 14, and one Coxsackie virus A9. Fever, headache, vomiting, and stiff neck were the most pronounced symptoms. Pleocytosis with the predominance of lymphocytes and mild elevated protein levels characterized the CSF specimens. Coxsackie virus B5 and echovirus 11 were the predominant serotypes during the study period. Although there was seasonal enteroviral activity (April-November), cases also occurred in the cold months. The 5'NCR and VP1-2A RT-PCR with sequence analysis were found to be superior to conventional methods for direct diagnosis and the typing of EVs.

Adolescent↗

PubMed2004

Graft and patient survival after adult live donor liver transplantation compared to a matched cohort who received a deceased donor transplantation.

Live donor liver transplantation (LDLT) has become increasingly common in the United States and around the world. In this study, we compared the outcome of 764 patients who received LDLT in the United States and compared the results with a matched population that received deceased donor transplantation (DDLT) using the United Network for Organ Sharing (UNOS) database. For each LDLT recipient (n = 764), two DDLT recipients (n = 1,470), matched for age, gender, race, diagnosis, and year of transplantation, were selected from the UNOS data after excluding multiple organ transplantation or retransplantation, children, and those with incomplete data. Despite our matching, recipients of LDLT had more stable liver disease, as shown by fewer patients with UNOS status 1 or 2A, in an intensive care unit, or on life support. Creatinine and cold ischemia time were also lower in the LDLT group. Primary graft nonfunction, hyperacute rejection rates, and patient survival by Kaplan-Meier analysis were similar in both groups (2-year survival was 79.0% in LDLT vs. 80.7% in case-controls; P = .5), but graft survival was significantly lower in LDLT (2-year graft survival was 64.4% vs. 73.3%; P < .001). Cox regression (after adjusting for confounding variables) analysis showed that LDLT recipients were 60% more likely to lose their graft compared to DDLT recipients (hazard ratio [HR] 1.6; confidence interval 1.1-2.5). Among hepatitis C virus (HCV) patients, LDLT recipients showed lower graft survival when compared to those who received DDLT. In conclusion, short-term patient survival in LDLT is similar to that in the DDLT group, but graft survival is significantly lower in LDLT recipients. LDLT is a reasonable option for patients who are unlikely to receive DDLT in a timely fashion.

Adult↗

PubMed1991

Common expression of melanoma tumor-associated antigens recognized by human tumor infiltrating lymphocytes: analysis by human lymphocyte antigen restriction.

Major histocompatibility complex (MHC) class I antigens (Ag), particularly human lymphocyte antigen (HLA)-A2, have been shown to function as restriction elements in human cytotoxic T lymphocyte recognition of tumor. This study was undertaken to determine the function of non-A2 MHC class I Ag in tumor recognition by tumor-infiltrating lymphocytes (TILs) cultured from six melanomas, and to find evidence for shared or unique tumor-associated Ag. Four predominantly CD8+ and two mixed CD4+, CD8+ population TIL cultures were tested for lysis in short-term 51Cr-release assays against a panel of targets including 29 fresh melanomas, 2 fresh sarcomas, 11 cultured melanoma lines, and 14 nonmelanoma cell lines derived from HLA-typed patients. All six melanoma TILs lysed the autologous melanoma. Two of three TILs from HLA-A2+ patients lysed allogeneic melanomas matched for HLA-A2, giving evidence for shared tumor Ag; one of these TILs also used HLA-B44 as a restriction element. The third HLA-A2+ TIL lysed autologous melanoma but not autologous Epstein-Barr virus-transformed B cells nor 14 HLA-A2 matched allogeneic melanomas, suggesting the possibility of a unique tumor Ag in this system. The three HLA-A2- TILs each lysed multiple HLA-matched melanomas, using HLA-A24, HLA-A31, and HLA-Cw7 as restriction elements. Blocking of autologous and allogeneic melanoma lysis by TILs with mAb w6/32 (anti-MHC class I) and anti-CD3, as well as cold target inhibition assays, confirmed that specific interaction of the T-cell receptor with MHC class I Ag and the relevant tumor Ag on the target cell surface is required for tumor lysis. These data provide evidence for specific recognition of shared melanoma Ag by human TILs.

Antibodies, Monoclonal↗

PubMed1997

Detection of rhinovirus RNA in lower airway cells during experimentally induced infection.

Rhinovirus (RV) infections are presumed to be localized to the upper airway, yet can cause severe lower airway symptoms in children and adults with asthma. To test the hypothesis that rhinovirus infection of the upper airway may be associated with the presence of virus in lower airway cells, we used the techniques of reverse transcription-polymerase chain reaction (RT-PCR) and Southern blotting to detect RV RNA in lower airway cells from eight allergic volunteers experimentally infected with RV16. Bronchoscopy with bronchoalveolar lavage (BAL) was done 1 mo before, and 2 and 4 d after an experimental infection with RV16. All subjects developed cold symptoms, and infection was confirmed by culturing RV16 from nasal secretions. Rhinovirus RNA was detected in both nasal lavage and lower airway cells from all eight subjects 2 to 4 d after an experimental inoculation, but not in any of the precold specimens from either the nose or the lower airway. These findings suggest that RV can infect cells of the lower airway, and raise the possibility that such an effect can promote asthma exacerbations in the susceptible host through direct enhancement of local inflammation.

Adolescent↗

PubMed2001

Psychosocial factors, respiratory viruses and exacerbation of asthma.

The aim of this research was study the role of psychosocial factors in exacerbations of asthma in adults induced by upper respiratory tract infections (URTIs). It involved a longitudinal study (one year) of 92 adults with asthma. The volunteers were 27 men and 65 women 19-46 years of age with a mean duration of wheeze of 19 years. The main outcome measure was symptomatic colds producing asthma exacerbations (infections confirmed by laboratory assays and exacerbation of asthma confirmed by objective changes in peak expiratory flow rate). The results showed that about 20% of the sample did not report an episode. This sub-group had a high proportion of males, low negative affectivity scores and consumed more alcohol. When volunteers with at least one episode were considered it was found that those who reported more negative life events and had low levels of social support had more episodes. Smokers were more likely to have to visit their doctor when they developed a cold-induced exacerbation of asthma. Overall, these results show that health-related behaviours, demographic and psychosocial factors influence susceptibility to and severity of exacerbations of asthma by URTIs.

Adult↗

PubMed1998

The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children.

BACKGROUND: Influenzavirus vaccine is used infrequently in healthy children, even though the rates of influenza in this group are high. We conducted a multicenter, double-blind, placebo-controlled trial of a live attenuated, cold-adapted, trivalent influenzavirus vaccine in children 15 to 71 months old. METHODS: Two hundred eighty-eight children were assigned to receive one dose of vaccine or placebo given by intranasal spray, and 1314 were assigned to receive two doses approximately 60 days apart. The strains included in the vaccine were antigenically equivalent to those in the inactivated influenzavirus vaccine in use at the time. The subjects were monitored with viral cultures for influenza during the subsequent influenza season. A case of influenza was defined as an illness associated with the isolation of wild-type influenzavirus from respiratory secretions. RESULTS: The intranasal vaccine was accepted and well tolerated. Among children who were initially seronegative, antibody titers increased by a factor of four in 61 to 96 percent, depending on the influenza strain. Culture-positive influenza was significantly less common in the vaccine group (14 cases among 1070 subjects) than the placebo group (95 cases among 532 subjects). The vaccine efficacy was 93 percent (95 percent confidence interval, 88 to 96 percent) against culture-confirmed influenza. Both the one-dose regimen (89 percent efficacy) and the two-dose regimen (94 percent efficacy) were efficacious, and the vaccine was efficacious against both strains of influenza circulating in 1996-1997, A(H3N2) and B. The vaccinated children had significantly fewer febrile illnesses, including 30 percent fewer episodes of febrile otitis media (95 percent confidence interval, 18 to 45 percent; P<0.001). CONCLUSIONS: A live attenuated, cold-adapted influenzavirus vaccine was safe, immunogenic, and effective against influenza A(H3N2) and B in healthy children.

Administration, Intranasal↗