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Biomedical subjects

P García-Corbeira

Publications and source records attributed to P García-Corbeira.

At least 19 recordsLinked to original sources
PubMed2003

Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine, mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in two simultaneous injections to infants at 2, 4 and 6 months of age.

An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of a pentavalent DTPa-IPV vaccine mixed with a Hib vaccine (DTPa-IPV/Hib), simultaneously administered with HBV (Group 2) in two injections in opposite thighs, as a primary vaccination course, to healthy infants at 2, 4 and 6 months of age. A total of 235 completed the study, 120 from Group 1 and 115 from Group 2. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1: 40; Group 2: 31) to assess the immune response to vaccination. Local and general solicited symptoms were recorded by parents on diary cards. Seven hundred and five diary cards (Group 1: 360; Group 2: 345) were collected. The clinically relevant and most commonly reported local reaction was pain (infant cried when the limb was moved) in 2.5% (Group 1) and 1.2% (Group 2) of diary cards. Fever was more frequently reported in Group 1 (21% of diary cards) than in Group 2 (12% of diary cards). However only 3 and 2% of doses in Groups 1 and 2, respectively, were responsible for a rectal temperature between 38.6 and 39.5 degrees C and only one case (Group 2) had > or =39.5 degrees C. Other clinically relevant general symptoms were rarely recorded: irritability (2-2.8%), loss of appetite (0.3-0.6%) and drowsiness (0.3-0.3%). All subjects included in the immunogenicity analysis had seroprotective titres to diphtheria, tetanus, polio virus types 1 and 3, Hib. Almost all subjects were seroprotected for anti-polio type 2 and hepatitis B (with the exception of 1 subject in Group 1 for each antigen). The vaccines response rates to pertussis antigens were over 97 and 90% in Groups 1 and 2, respectively. This study shows that, from a clinical perspective, the DTPa-HBV-IPV/Hib vaccine given in a single injection has a similar reactogenicity and safety profile to that of two licensed vaccines (DTPa-IPV/Hib, HBV) given in two simultaneous injections to infants at 2, 4 and 6 months of age. This is a valuable advantage, since in some countries, such as Spain and the UK, an additional injection (for the administration of meningococcal C conjugate vaccine) has been recently included in the infants' vaccination calendars.

Antibodies, Bacterial↗
PubMed2001

Reactogenicity of DTPa-HBV/Hib vaccine administered as a single injection vs DTPa-HBV and Hib vaccines administered simultaneously at separate sites, to infants at 2, 4 and 6 months of age.

An open, randomised, multicentre trial was performed to assess the reactogenicity and safety profile of the administration of a candidate Haemophilus influenzae type b (Hib) conjugate vaccine with a quadrivalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTPa-HBV) vaccine as a single injection (Group 1) versus the simultaneous administration of the latter vaccine (DTPa-HBV) and an available Hib conjugate vaccine (Group 2) in opposite thighs, as a primary vaccination course to healthy infants at 2, 4 and 6 months of age. Eight hundred and eighty five infants (9.3+/-1.4 weeks old) were randomly allocated to Group 1 (n=665) and Group 2 (n=221). Oral polio vaccine was given concomitantly to all subjects. Blood samples (pre-vaccination and 1 month after the third dose) were obtained from a subset of infants (Group 1, 73; Group 2, 22) for serological determinations. Local and general symptoms were recorded by parents on diary cards. 2614 diary cards (Group 1, 1966; Group 2, 648) were collected. There were no statistically significant differences in the incidence of local and general symptoms between groups. Pain such that the infant cried when limb was moved was reported in 0.6 and 0.2% in groups 1 and 2, respectively. Redness and swelling (>20 mm in diameter) were recorded between 2.1 and 3% in both groups. Fussiness preventing normal activities was the most frequently reported general symptom in both groups (1.6 and 1.9% in groups 1 and 2, respectively). Fever (rectal temperature >39.5 degrees C) was reported in 0.4% (Group 1) and 0.3% (Group 2). All subjects included in the immunogenicity analysis had seroprotective or seropositive titres to the diphtheria, tetanus, hepatitis B and pertussis components of the vaccines. About 99 and 100% of infants had anti-PRP titres > or =0.15 mcg/ml in groups 1 and 2, respectively. This study indicates that DTPa-HBV vaccine given in a single injection with a candidate Hib conjugate vaccine has a similar reactogenicity profile to that of two commercially available vaccines (DTPa-HBV, Hib) given in two simultaneous injections to infants 2, 4 and 6 months of age.

Bacterial Capsules↗
PubMed2001

Herpes simplex virus type 2 seroepidemiology in Spain: prevalence and seroconversion rate among sexually transmitted disease clinic attendees.

BACKGROUND: Only limited data on the seroprevalence of herpes simplex virus type 2 (HSV-2) are available from European countries. Until recently, serologic tests for HSV-2 serotyping have been hampered by cross-reactivity to type-common antigens. The present study aims at providing data on the prevalence of HSV-2 infection in a group of STD clinic attendees using a reliable type-specific immunoassay. GOAL: To evaluate the seroprevalence of HSV-2 and the accumulated incidence of clinical genital herpes infection in a sample of Spanish sexually transmitted disease (STD) clinic attendees. STUDY DESIGN: The study consisted of two parts. First, a cross-sectional study of HSV-2 seroprevalence was conducted in patients with STDs. Second, a prospective cohort study was undertaken to evaluate the accumulated incidence of infection by HSV-2 and of clinical episodes of genital herpes in HSV-2-negative patients included in the first study during a follow-up period of 6 to 18 months. RESULTS: Of the 374 patients (129 men, 245 women) studied, 25% were seropositive for HSV-2 (12% of men, 30% of women). Antibodies to HSV-2 were related to female gender (odds ratio, 2.7; P < 0.001) and to the number of sexual partners (odds ratio, 4.1; P < 0.001). Fifty-two percent of patients (145 of 281 patients) who were initially seronegative returned to the clinic for a second serologic testing, of whom 1% (2 of 145 patients) had seroconverted. None of the patients developed genital herpes during the follow-up period. CONCLUSION: The relatively high seroprevalence (25%) and the low rate (4%) of HSV-2 previously reported in the general population in Spain suggest that the virus circulation may be restricted to certain risk groups. Therefore, future healthcare measures may target specific groups, such as patients with STDs.

Antibodies, Viral↗
PubMed2000

Seroepidemiology of Bordetella pertussis infections in the Spanish population: a cross-sectional study.

A study was conducted on a representative sample (n=4084) of the Spanish population to assess the prevalence of antibodies to pertussis toxin (PT) and filamentous hemagglutinin (FHA). A total of 1982 men and 2102 women aged 5-59 years were stratified by sex and age (5-12, 13-19, 20-29, 30-39, 40-49 and 50-59 years). Antibodies to PT were found in 46% samples and to FHA in 74% and increased with age (p<0.0001), ranging from 35% in the 5-12 year age group to 52% in the 50-59 year age group for anti-PT and from 65 to 80% for anti-FHA, respectively. As vaccine induced-immunity wanes over time, the observed age distribution of antibodies suggests that Bordetella pertussis infection is widespread in the Spanish population and that pertussis booster vaccination in adolescents and adults with the newly developed acellular vaccines, should be considered if it is deemed necessary to control the circulation of the organism.

Adhesins, Bacterial↗
PubMed2000

A large percentage of the Spanish population under 30 years of age is not protected against hepatitis A.

A seroepidemiological study was conducted to assess the seroprevalence of hepatitis A (HAV) antibodies in the Spanish general population in 1992-93. A total of 2744 subjects (1337 men and 1437 women) in the 5-59 years age range were stratified by gender and age (5-12, 13-19, 20-29, 30-39, 40-49, 50-59 years). The presence of total anti-HAV antibodies was investigated using a commercial enzyme immunoassay. Fifty-five percent (95% CI: 53.5-57. 2%) of the subjects were positive for anti-HAV antibodies, the age-standardized anti-HAV prevalence being 65.4%. Prevalence of seropositive subjects increased with increasing age (chi(2) = 996, 17; P < 0.0001), being 11%, 25% and 54% for the 5-12, 13-19 and 20-29 age groups respectively. The results from this study showed a remarkable decline in seroprevalence rates among children, adolescents and young adults. The large number of susceptible subjects in these groups of the population has public health implications in a country with intermediate HAV prevalence.

Adolescent↗
PubMed2000

Reactogenicity profile of tetanus-diphtheria (adult-type) vaccine: results of a naturalistic study performed at an adult vaccination center.

A prospective observational naturalistic study was conducted at a vaccination center to assess the reactogenicity of tetanus-diphtheria (adult-type) (Td) vaccine. In 1 year, 3072 adult subjects were invited to participate, of whom 1977 (62% women, mean age [+/- SD]: 39 [+/- 14.5] years [range: 18-85 years]) actively did so. A follow-up diary card was provided to all subjects to record all local and general symptoms experienced during the following 4 days after vaccination. Of the study population (n = 1977), 280 received a second Td dose, and 30 received a third dose: the total number of diary cards collected was 2287. Td was always administered (i.m. route) in the left arm. The study population was grouped by age: 52%, 41%, and 7% were ages 18 to 35, 36 to 65, and > 65 years, respectively, most of them being travelers to developing countries. Close to two-thirds of subjects received up to nine different vaccines (mainly hepatitis B, hepatitis A, and typhoid) in addition to Td. Adverse reactions were classified as mild, moderate, and severe. Overall, 50% of subjects reported some type of adverse reaction. Pain, discomfort with arm movement, swelling, malaise, and fever (axillary temperature > or = 38 degrees C) were recorded in 43%, 14%, 3.8%, 5.1%, and 1.7% of all diary cards, respectively. Local and general reactions were considered as mild by almost two-thirds of vaccinees and lasted < or = 48 hours in about three-fourths of them. The incidence of moderate plus severe local reactions was significantly (p < 0.01) more commonly reported in the 18- to 35-year-old group than in the 36- to 65-year-old group. No statistically significant differences were observed when comparing the incidence of general adverse reactions of those receiving Td alone with those receiving additional vaccines or when comparing the duration and intensity by age groups. Only 5.2% of subjects required analgesic/antipyretic treatment. In conclusion, this study shows that Td vaccine is reasonably well tolerated when given alone or with other vaccines. Similar studies should be conducted with other vaccines routinely recommended to adults to assess how they are administered in usual clinical practice and the reactogenicity profile perceived by the vaccinees.

Adolescent↗
PubMed1999

Low prevalence of diphtheria immunity in the Spanish population: results of a cross-sectional study.

A seroepidemiological study was conducted on a representative sample (n = 3944) of the Spanish population to assess the immune status to diphtheria. A total of 1907 men and 2037 women in the 5-59 years age range were stratified by sex and age (5-12, 13-19, 20-29, 30-39, 40-49, 50-59 years). Concentrations of toxin antibodies were measured using a commercial ELISA kit. Samples with titres > or = 0.1 IU/ml were considered to show full protection. Only 26% (95% CI: 25-28%) of the overall population studied was fully protected. The highest number of subjects with uncertain or no protection was found in the 20-39 age group (> 85%). The prevalence of fully protected subjects progressively declined from 51% for the 5-12 year age group, to 14% for the 30-39 year age group, whereas it increased to 20% and 35% for the 40-49 and the 50-59 year age groups, respectively (p < 0.0001). These results stress the need to intensify vaccination programs in adolescents and adults with periodic booster doses of diphtheria toxoid.

Adolescent↗
PubMed1999

Is sexual transmission an important pattern for herpes simplex type 2 virus seroconversion in the Spanish general population?

Herpes simplex type 2 (HSV-2) seroprevalence within a community is determined by sexual and perinatal transmission from mother to baby, the two main sources of virus shedding. A seroepidemiological study of HSV-2 was undertaken on a representative sample (n = 3974) of the Spanish population to assess indirectly the relative relevance of these two transmission routes. The sample comprised 1922 men and 2052 women in the age range 5-59 years, stratified by sex and age (5-12, 13-19, 20-29, 30-39, 40-49, and 50-59 years). Sera were screened for HSV-2 specific Ig G antibodies by an enzyme-linked immunoabsorbent assay based on recombinant glycoprotein G2 (gG2). The overall prevalence of antibodies to HSV-2 was 3.6% (95% CI: 3. 1-4.2%). Prevalence by gender did not differ: males (3.6%; 95% CI: 2. 8-4.6%) and females (3.6%; 95% CI: 2.8-4.5%). There were no significant differences between age groups with respect to seropositivity rates. Detection of HSV-2 antibodies was not associated with increasing age, as is expected for a sexually transmitted disease. The fact that seroprevalence rates among the different age groups did not differ suggests that the virus is not circulating in the general population and may be restricted to risk groups only. Similar positivity rates found in the group of females of childbearing age and in the youngest population indicate that perinatal viral shedding is the main source of HSV-2 seroconversion in the Spanish population.

Adolescent↗
PubMed1999

Whole cell lysate enzyme immunoassays vs. recombinant glycoprotein G2-based immunoassays for HSV-2 seroprevalence studies.

Seroepidemiology studies of herpes simplex virus type 2 (HSV-2) infections have been difficult to carry out because antibodies to HSV type 1 (HSV-1) show an extensive cross-reactivity with HSV-2 antigens. Many kits available currently are not entirely type specific for serodiagnosis of HSV-2 infections and therefore do not allow reliable discrimination of past exposure to these closely related alphaherpes viruses. Attempts to develop type-specific antigens have focused on the envelope glycoproteins, particularly glycoprotein G (gG). A cross-sectional study was carried out to examine the seroprevalence of antibodies to HSV-2 among healthy university students, using different methods: a whole cell lysate enzyme-linked immunosorbent assay (ELISA), two different ELISAs, and a newly developed immunoblot assay, the last three based on recombinant gG2. HSV-2 prevalence was 24 times higher with the whole cell lysate ELISA (31%; 95% confidence interval [CI]: 27-35%) than the ELISAs and the immunoblot assay based on recombinant gG2 (1.3%; 95% CI: 0.1-2.5%), thus showing the inaccuracy of commercial tests based on whole-antigen preparations for epidemiological studies. Laboratories should be cautious and ensure that commercial tests for HSV typing are based on type-specific glycoproteins.

Adolescent↗
PubMed1996

Inoculum effect and bactericidal activity of cefditoren and other antibiotics against Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis.

The inoculum effect on minimum inhibitory and minimum bactericidal concentrations of cefditoren, benzylpenicillin, ampicillin, cefotaxime, ceftriaxone, and meropenem against six clinical isolates each of Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis was studied using inocula of approximately 10(4) to 10(5) and 10(7) to 10(8) cfu/ml. Vancomycin was also studied against Streptococcus pneumoniae. The inoculum effect was observed only with benzylpenicillin and ampicillin against five of six strains of Haemophilus influenzae. All antibiotics tested were bactericidal.

Anti-Bacterial Agents↗
PubMed1996

Clinical spectrum of urinary tract infections due on nontyphoidal Salmonella species.

We performed a retrospective analysis of 28 cases of bacteriuria due to nontyphoidal Salmonella (NTS). Twenty-one patients (75%) had symptoms of urinary tract infection (16, cystitis; 3, pyelonephritis; and 2, renal abscess), and 7 remained asymptomatic. In 24 cases NTS was the sole pathogen isolated from urine. Salmonella enteritidis (a Salmonella subgroup 1 serotype) was the serotype most frequently isolated (16 cases), followed by Salmonella enteritidis serotype typhimurium (5 cases). Sixteen patients (57%) were severely immunocompromised, and 14 (52%) had urologic abnormalities. Recurrence of bacteriuria occurred in four patients. It is suggested that in cases of urinary salmonellosis one must consider the existence of an occult urologic problem or severe immunosuppression.

Abscess↗
PubMed1996

Classifying extraintestinal non-typhoid Salmonella infections.

Non-typhoid Salmonella infection in man has been divided into five clinical groups: gastroenteritis, enteric fever, bacteraemia, chronic carrier state and localized infection. This classification has neither pathogenic nor prognostic significance. We retrospectively reviewed the charts of 183 patients with extraintestinal salmonellosis who presented to our institution during a period of 32 years. Patients were classified into four groups: primary bacteraemia (PB), enteritis-associated bacteraemia (secondary bacteraemia) (SB), digestive focal infection (DI) and non-digestive focal infection (NDI). Sex, age, acquisition, underlying disease and outcome were compared between patients with bacteraemia and diseases with focal infection. The differences found between PB and SB were: community acquisition (66% in PB and 85% in SB, p = 0.06) severe immunosuppression (53% in PB and 15% in SB, p < 0.001) and mortality (37% in PB and 3% in SB, p < 0.001). The differences found between NDI and DI were: age over 60 years (45% in NDI and 18% in DI, p < 0.05), severe immunosuppression (51% in NDI and 12% DI, p < 0.001) and associated bacteraemia (38% in NDI and 6% in DI, p < 0.001). This classification of extraintestinal salmonellosis may have pathogenic and prognostic implications, and could help us to understand the clinical significance of this disease.

Aged↗
PubMed1996

Correlation of pharmacodynamic parameters of five beta-lactam antibiotics with therapeutic efficacies in an animal model.

The MIC is the main microbiologic parameter used to predict the efficacies of antibiotics. However, it is well known that MICs may vary according to the inoculum size used (inoculum effect), especially with some beta-lactam antibiotics. In order to correlate the pharmacologic and microbiologic properties of some beta-lactams, an experimental model of intraperitoneal infection caused by Escherichia coli in nonneutropenic and neutro-penic mice was developed. The animals were treated with three different doses of either ampicillin, piperacillin, aztreonam, cefazolin, or cefotaxime. The linear regression analysis obtained in our model shows a better correlation between in vitro activity and efficacy when the MICs considered were those obtained with a large inoculum (ca. 1 x 10(8) CFU/ml) instead of the standard inoculum (5 x 10(5) CFU/ml). The correlations for the MICs obtained with the large inoculum were 0.78 for log2 maximum concentration of drug in serum (Cmax)/ MIC, 0.72 the time that the concentrations exceeded the MIC, and 0.79 for log2 area under the serum concentration-time curve (AUC)/MIC at 24 h in nonneutropenic mice. The corresponding values in neutropenic mice, also for the MICs obtained with the large inoculum, were 0.54, 0.68, and 0.64, respectively, at 24 h. A good correlation was also obtained for the same parameters in nonneutropenic mice at 48 h. The values of Cmax, AUC, and the time that the concentrations exceeded the MIC were parallel among the antibiotics studied, and our study confirms that the time that the levels in serum exceed the MIC is a significant parameter determining the efficacies of beta-lactam antibiotics, but the correlation is much better when the MICs obtained with the large inoculum instead of those obtained with the standard (low) inoculum are considered.

Ampicillin↗
PubMed1994

[The clinical spectrum of focal infection due to nontyphoid Salmonella: 32 years' experience].

BACKGROUND: The aim of this study was to analyze the manifestations of the syndromes which constitute focal infection by Salmonella no typhi (SNT). METHODS: Ninety-one episodes of SNT infections studied over a period of 32 years in the Fundación Jiménez Díaz (Madrid, Spain) were retrospectively analyzed. RESULTS: Of the 1,892 patients with SNT infection studied during this period, 91 (5%) presented some focal form (57 males and 34 females) with a mean age of 49 years (SD +/- 21.6 years). Sixty percent of the episodes were acquired within the community. The localization of the focal infections by SNT was as follows: urologic tract (24%), intraabdominal (20%), soft tissues (16%), respiratory tract (15%), osteoarticular (14%), cardiovascular (10%) and central nervous system (1%). On comparison with the remaining patients, those with urinary, osteoarticular and respiratory infections were found to be the most frequently immunosuppressed (47%) vs 18%, p < 0.01) with a greater frequency of unfavorable evolution (57% vs 15%; p < 0.001). Mortality ranged between 7% for the osteoarticular forms to 64% for the pleuropulmonary forms of infection. CONCLUSIONS: Focal infection by Salmonella no typhi may be localized in any organ usually occurring in immunosuppressed patients or those with predisposing local factors. The osteoarticular, pulmonary, and urologic infections have a particularly unfavorable course and their presence may suggest the existence of immunosuppression.

Adolescent↗