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Vaccines in Argentina: a regulatory view.

In Argentina, vaccines for immuno-preventable diseases are regulated by the national regulatory agency, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (the National Administration of Drugs, Food and Medical Devices, or ANMAT) created in 1992 to ensure efficacy and safety of drugs, food and medical devices available in the country, according to Law 16,463 and Decree 150/92. ANMAT has licensed 84 out of 157 vaccines registered in Argentina. Since 1994, ANMAT evaluated, approved and inspected 20 clinical trials with vaccines (1.8% of the 1062 trials approved by the agency since that time). The National System of Pharmaco-vigilance has received 318 communications of eventual adverse post-vaccination events (0.3% of the total). In addition, ANMAT provides support to the National Immunisation Programme. The current procedure is to follow international guidelines in the field, to be prepared for new, rapidly changing scenarios.

Argentina↗

Adult outpatients with depression: worse quality of life than in other chronic medical diseases in Argentina.

Current research into the impact of major depressive illness on society goes beyond estimating its prevalence, complications or comorbidity patterns, to include research that seeks to establish how this disorder affects individuals' daily functioning and well-being. However, it is unclear whether depression affects such broadly defined quality of life (QOL) outcomes to a similar or an even greater extent than chronic physical illness. The present study assessed QOL in a sample of 48 ambulatory depressed patients who sought psychiatric assistance at a centre in La Plata, Argentina, during a 15-month period. All of them met DSM-IV criteria for current major depression, as diagnosed by clinicians. For the purposes of comparison, we also evaluated the QOL of additional samples of persons who were healthy or who had chronic physical illness. QOL was assessed with the WHOQOL-100, a generic and transcultural instrument developed simultaneously in 15 centres, by the World Health Organization (WHO). Results indicated that QOL was significantly poorer in depressed persons than in either healthy persons or individuals with other frequent chronic pathologies in Argentina. The impact of depression was also found to be related to the seriousness of the episode. We suggest that it is important to include QOL assessments of patients with depressive disorders when evaluating the course and progress of their treatment. Such assessments can be used in health care decision making and resource allocation.

Activities of Daily Living↗

Resistance of Cooperia to ivermectin treatments in grazing cattle of the Humid Pampa, Argentina.

A field experiment and a controlled efficacy trial were conducted to demonstrate resistance of cattle trichostrongylid nematodes to endectocidal compounds in grazing cattle on the Humid Pampa, Argentina. Male Polled Hereford calves, aged 9-11 months old, with a history of frequent treatments with compounds of the avermectin/milbemycin class, were used for the trial. The field experiment involved six groups of 10 animals each, which were subcutaneously treated with either ivermectin (IVM), long-acting ivermectin (LA-IVM), moxidectin (MXD) or doramectin (DRM) at a dosage of 0.2mg/kg BW. A fifth group was treated orally with fenbendazole at a dosage of 5mg/kg BW; the sixth group of calves served as non-treated control. Faecal samples were collected from each animal on the day of treatment and at 14 days after treatment. Nematode egg counts were performed to estimate the faecal egg count reduction test (FECRT). The FECRT showed that reductions were 65% (IVM), -20% (LA-IVM) and 85% (DRM). Egg counts from calves treated with MXD or fenbendazole were reduced by 95 and 100%, respectively. For the controlled efficacy trial, six animals with the highest egg counts from the IVM, LA-IVM and non-treated control groups, were necropsied on day 18 after treatment to determine numbers and nematode species in the abomasum and small intestine. The results indicated that efficacy against Cooperia oncophora was 62.7 and 48% for IVM and LA-IVM, respectively. Neither of the IVM formulations showed efficacy against Trichostrongylus spp. in the small intestine. However, the absence of Trichostrongylus spp. in some animals of both treated and control groups precluded a valid assessment of efficacy or resistance. It was concluded that resistance of trichostrongylid nematodes to the avermectin/milbemycin class of compounds in grazing cattle of the Humid Pampa, Argentina, may be strongly established on farms where cattle are treated at frequent intervals throughout the year.

Animal Husbandry↗

Seroepidemiology of beef and dairy herds and fetal study of Neospora caninum in Argentina.

The purpose of the present work was to study the epidemiology of Neospora caninum in beef and dairy herds in the Humid Pampas of Argentina. The seroprevalence of N. caninum was evaluated in 2414 serum samples of cows from beef and dairy farms. An indirect fluorescent antibody test (IFAT) was used to determine specific antibodies. The sera was screened at a dilution >or=1:200 and >or=1:600 in cows with reproductive disease antecedents and without them, respectively. Cows without history of reproductive diseases from nine beef and fifteen dairy farms were grouped according to the percentage (> or or <or= to 50%) of seropositive dogs. The analysis of 966 serum samples from aborted cows, demonstrated positive 18.9% (41/216) and 43.1% (323/750) from beef and dairy herds, respectively. Microscopic lesions compatible with N. caninum were observed in 43 of 188 (22.8%) fetuses and/or placentas evaluated. The protozoan was identified in 29 of 43 (67.4%) aborted specimens, being the largest number of positive results in dairy fetuses. The results obtained demonstrate a high association between neosporosis and dairy herds, however, our data also reveals that N. caninum is an important risk factor for reproductive losses in the extensively farmed beef cattle in the Humid Pampas of Argentina.

Aborted Fetus↗

Natural Besnoitia sp. infection in domestic rabbits from Argentina.

Besnoitia sp. are apicomplexan coccidian parasites affecting several species of mammals and cold-blooded animals in several countries. Besnoitia sp. tissue cysts were seen in several tissues of five rabbits from a rabbit breeder in La Plata, Argentina. Bradyzoites released from macroscopic tissue cysts were inoculated onto bovine monocytes, and into interferon gamma gene knockout (KO) mice. Besnoitia sp. tachyzoites were seen in the peritoneal exudate of KO mice on day 10 pi and these tachyzoites were infective to other KO mice. Tachyzoites grown in cell culture were infective to gerbils (Meriones unguiculatus). This is the first report of Besnoitia sp. infection in any host in Argentina.

Animals↗

Comparative efficacy of moxidectin 2% equine oral gel and ivermectin 2% equine oral paste against Onchocerca cervicalis (Railliet and Henry, 1910) microfilariae in horses with naturally acquired infections in Formosa (Argentina).

On the basis of positive skin snips for Onchocerca cervicalis microfilariae (MF), 45 horses were chosen from 48 in a total of 257 screened on 12 locations in the northeast Province of Formosa (Argentina), and randomly assigned to two treatment groups of 20 horses each, and a nontreated control group of five horses. On Day 14 post-treatment (PT), skin snip samples in the ivermectin-treated (0.2 mg/kg) group were negative for normal viable microfilariae (MF), while horses in the control group maintained their pretreatment level of infection. On the same Day in the moxidectin-treated (0.4 mg/kg) group, 18 horses were negative for MF, but the remaining two had a total of 1 and 2 MF, respectively (equivalent to 10 and 20 MF/g of skin), but all three parasites showed marked cuticular and structural damage. Both horses were negative in a repeat biopsy on Day 21. From Day 3 PT, one ivermectin-treated horse (5%) evidenced an approximate 15 x 2 x 3 cm-sized, apparently nonpainful, oedematous swelling on the ventral midline, 20 cm in front of the navel, which remained unchanged on Day 14 PT. Adverse reactions were not observed in the moxidectin-treated group. Parasitaemia was found in 18.7% of sampled horses (48 of 257), and the number of MF varied between 10-1820/g of skin snip (mean 172). Similar prevalence and total counts had been described previously in 1985 and 1986 in cattle-farm horses in the same area of Argentina; in surveys in Texas (1974) and Louisiana (1995) in the USA, infection rates were also similar, but total counts much higher. It is concluded that moxidectin 2% equine oral gel and ivermectin 2% equine oral paste, were equally 100% effective in the control of O. cervicalis MF. Contrary to ivermectin, moxidectin did not cause post-treatment dermal reactions.

Administration, Oral↗

Detection of antibodies to Toxoplasma gondii in stillborn piglets in Argentina.

Fetal fluids of 738 stillborn piglets from three swine farms in Argentina were examined for antibodies to Toxoplasma gondii. Antibodies were detected in 15 samples at a 1:20 dilution in the indirect fluorescent antibody test and 10 samples were positive in the modified agglutination test (MAT) at a dilution of 1:25; four of these samples had a MAT titer of > or = 1:100. This survey indicates a low rate of congenital T. gondii infection in stillborn pigs in Argentina.

Agglutination Tests↗

Prevalence of antibodies to Sarcocystis neurona, Toxoplasma gondii and Neospora caninum in horses from Argentina.

Sera from 76 horses from Argentina were examined for antibodies to Sarcocystis neurona, Toxoplasma gondii and Neospora caninum. Antibodies to S. neurona were found in 27 (35.5%) of 76 horses using immunoblots with culture derived merozoites as antigen. Antibodies to T. gondii were found in 10 (13.1%) of 76 horses by using the modified agglutination test with formalin-fixed tachyzoites and mercaptoethanol; titers were 1:25 (two horses), 1:50 (six horses), 1:100 (two horses), and 1:200 (one horse). Antibodies to N. caninum were not found in any of the 76 horses by the use of N. caninum agglutination test. This is the first report of S. neurona infection in horses in Argentina.

Agglutination Tests↗

Genetic typing of bovine viral diarrhea virus isolates from Argentina.

Genetic typing of 29 Bovine Viral Diarrhea Virus (BVDV) isolates from Argentina was carried out by sequencing 245 nucleotides of the RT-PCR products of the 5'-UTR region. Sequence analysis shows that these Argentinean BVDV include types 1 and 2. The majority (26/29) of the isolates are type 1, which comprises subtypes 1a and 1b, together with an additional subgroup within subtype 1a. This subgroup is close to the South African subgroup Ic of 1a viruses, and to the deer pestivirus strain "Deer". The three type 2 BVDV were isolated from fetal tissues or serum during the 7-8 years before a clinical outbreak in Argentina had been reported. Only inactivated vaccines are used in bovines of the country, thus the analysed viruses are authentic field strains. The long term circulation of type 2 BVDV (situation similar to that of North America before the epidemic of 1993), and the existence of viral populations which differ from the reference strains commonly used in vaccine elaboration should be considered by manufacturers of diagnostic reagents and vaccines.

Animals↗

Toxigenic Escherichia coli isolated from pigs in Argentina.

The presence of porcine toxigenic E. coli (ETEC, VTEC) in 28 piggeries (5% of total) of the central and northeast region of Argentina was studied for a better understanding of the epidemiology of porcine strains. Samples were taken by rectal swabs from healthy piglets and from those with diarrhoea, in addition to their dams. Between 5-10 colonies were isolated from each one of 223 animals sampled from 1992 to 1997. By using specific primers each strain was screened by PCR for VT1, VT2all, VT2e, STIa, and LTI toxin genes. Only strains positive for any of the toxins mentioned above were screened for STb. Their O serogroups were determined by agglutination. All of the above enterotoxins and verocytotoxins were found in E. coli isolated from the animals. The STIa gene was detected in E. coli isolated from 27/127 piglets with diarrhoea, in comparison with LTI (4/127 pigs). No toxin gene was amplified from E. coli isolated from either healthy piglets or their dams. When strains isolated from 48 piglets without diarrhoea but showing delayed growth were analysed by PCR, their toxin profile was determined to be VT1 (1/48 piglets), VT2all (5/48), STIa (1/48), LTI (3/48) and VT2e (3/48). Serogroup O64 prevailed among ETEC; O138 prevailed for ETEC/VTEC strains. This is the first extensive study regarding porcine toxigenic E. coli in Argentina and constitutes an important database for the implementation of prevention measures.

Agglutination Tests↗

Screening of antibacterial activity of Amaicha del Valle (Tucumán, Argentina) propolis.

Propolis is extensively used in Argentine folk medicine. Alcoholic extracts of propolis from four localities of Amaicha del Valle (El Paraiso, La Banda Este, La Banda Oeste and El Molino), Province of Tucumán and from Cerrillos, Province of Santiago del Estero, Argentina were prepared. All showed antibacterial activity against Gram positive bacteria, the propolis from La Banda Este being the most active (MIC = 7.8 microg/ml) against Streptococcus piogenes, an antibiotic resistant bacterium. Thin layer chromatographic (TLC) separation profiles of propolis from Amaicha del Valle region were similar but differ from the alcoholic extract of the propolis from Cerrillos, another phytogeographical region of Argentina (provincia chaqueña). Bioautographic assays of the TLC profiles showed that several separated compounds of the Amaicha del Valle propolis have antibacterial activity. The difference in composition between Amaicha del Valle and Cerrillos propolis coincides with a different phytogeographical formation.

Anti-Bacterial Agents↗

Insects of forensic significance in Argentina.

Records from forensic expertises and trappings with beef baits conducted in Buenos Aires, Argentina (34 degrees 36'S), show that the dominating species are widespread ones (Calliphora vicina and Phaenicia sericata), with different behaviour in each large latitudinal zone. It is suggested that the range of the yearly photoperiod variation has an influence in the behaviour of the blowflies, making up for differences in the succession patterns. The Calliphorid blowflies Cochliomyia macellaria and Chysomya albiceps were found on indoors corpses; the latter also on outdoors corpses when blood was shed, and in that case as primary. Three species of beetles of the genus Dermestes, which had been associated with mummified remains, appeared 10-30 days after death. The Silphid beetle Hyponecrodes sp. cf. erythrura was found on outdoor copses in rural environments. The Nitidulid beetle Carpophilus hemipterus was found in association with the cheese skipper Piophila sp. (Diptera: Piophilidae) in medullar cavities of bones after ca. 30 days; to this association is often added the Clerid Necrobia rufipes. Lepidoptera Tineidae appear on the head of mummified indoors corpses. North of parallel 32 degrees S, the Muscid grave-fly Ophyra sp. was found breeding on a corpse outdoors in summer. A division by latitude and climate is proposed for Argentina, and an extended system is proposed for the world.

Animals↗

STRs data for the loci D3S1385, vWA, FGA, D8S1179, D21S11, D18S51, D5S818, D13S317 and D7S820 from Córdoba (Argentina).

Allele and genotype frequencies for nine STRs loci included in the AmpFlSTR Profiler Plus kit (D3S1385, vWA, FGA, D8S1179, D21S11, D18S51, D5S818, D13S317 and D7S820), were determined from urban and countryside population of Córdoba (Argentina). All loci meet the Hardy-Weinberg expectation, and there is little evidence for alleles association between these nine loci. The results demonstrate that these loci can be useful for databasing purposes in human identification and parentage testing in the population of Córdoba (Argentina).

Argentina↗

Overt and latent HIV 1 and HTLV-I infection in cohorts of at high risk individuals in Argentina.

We conducted a survey using serology and polymerase chain reaction assays to detect HIV 1 and/or HTLV-I antibodies and viral DNA, respectively, in 113 intravenous drug abusers and in 62 sexually active high risk individuals attending two Drug Addict Centres and a Centre for Venereal Diseases in Buenos Aires, Argentina. At the time of the survey 137 of these subjects were known to be HIV 1 seropositive but none of them was symptomatic. Serological tests for HTLV-I were found to be positive in 38 (21.7%) of the HIV 1 positive individuals, whereas all of the 38 HIV 1 seronegative subjects were also seronegative for HTLV-I antibodies. Gene amplification assays carried out in blood sample DNA from the 38 HIV 1/HTLV-I seronegative individuals, revealed HIV 1 DNA in six out of 28 intravenous drug abusers (21.5%). One subject (2.6%) was positive for both HIV 1 and HTLV-I DNA sequences, whereas four (10.5%) showed HTLV-I DNA only. To determine whether these individuals were infected with HTLV-I and/or HTLV-II, DNA samples were also amplified with HTLV-II specific primers and no evidence of HTLV-II infection was observed. None of the subjects seroconverted according to conventional serological tests during the 2 year follow-up period. The 10 seronegative subjects belonging to the sexual risk group were negative for both HIV 1 and HTLV-I in polymerase chain reaction assays. We conclude that not only HIV 1, but also HTLV-I is a widely spread infection in intravenous drug abusers and sexually active high risk individuals in Argentina.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Acute lower respiratory infections due to respiratory syncytial virus and adenovirus among hospitalized children from Argentina.

BACKGROUND: Acute lower respiratory infection (ALRI) is one of the main causes of morbidity and mortality in small children. OBJECTIVE: The aim of this study was to determine the frequency, seasonality and association with clinical entities of respiratory syncytial virus (RSV) and adenoviruses in children with ALRI. STUDY DESIGN: During 2 consecutive years (1991-1992), 168 children under 2 years of age hospitalized due to ALRI in a public pediatric hospital of Buenos Aires, Argentina, were studied. RSV and adenoviruses were investigated on nasopharyngeal aspirates (NPA) by indirect immunofluorescence (IIF). HEp-2 cells were used for adenovirus isolation. RESULTS: RSV was detected in 36.3% and adenoviruses in 14.3% of the cases (P < 0.0001). All adenoviruses detected by IIF were also isolated in culture. Out of 61 RSV cases, 57% corresponded to bronchiolitis and 43% to pneumonia. Ninety-two per cent of children with RSV were less than 1 year old and 70% were less than 5 months. The highest number of RSV cases were observed during winter, with a clear peak in July. Seventy-one per cent of adenovirus cases were associated with pneumonia and only 24% with bronchiolitis (P < 0.02), and predominated in children older than 5 months of age (P < 0.0001). Adenoviruses were detected in almost all months of the year with a small peak at the end of winter and beginning of spring. No significant differences in clinical features at admission, breast feeding or malnutrition were observed among children with RSV or adenovirus diagnosis versus those with no viral etiology. The overall fatality rate was 2.4%. In all fatal cases adenovirus was detected in NPA. Thus, fatality rate among patients with adenoviruses reached 16.7%. CONCLUSIONS: Our findings show the importance of RSV and adenoviruses associated with ALRI in hospitalized children under 2 years of age and the different epidemiological patterns of the two viruses in Buenos Aires, Argentina.

Acute Disease↗

With everything exposed: cruelty in post-abortion care in Rosario, Argentina.

At the suggestion of a social worker who witnessed abusive post-abortion care at a public hospital in Rosario, Argentina, two human rights NGOs collaborated to investigate women's experiences seeking treatment for abortion complications at area public hospitals. During the year-long enquiry, more than 300 women took part. Role play was successfully used to surmount women's initial reluctance to reveal pervasive discriminatory and humiliating mistreatment. Thirty-one women later gave personal testimonies about their experiences, which were contained in the report of the research and later dramatised in a public meeting and video. The report, Con Todo al Aire (With Everything Exposed), was disseminated widely, including to the media, and a formal complaint was made to the local Ombudsman, who called for high-level action to resolve the problems. Initial denial by some health professionals that there was a serious problem was replaced by critical self-assessment within the provincial government, hospitals and medical and nursing schools, who made commitments to reform hospital practices and the medical school curriculum. Women participants also gained an understanding of their right to appropriate and humane health care. The findings from Rosario are not isolated. They are now being shored with activists and researchers in other provinces of Argentina and other countries.

Abortion, Induced↗

Molecular diversity of Moraxella bovis isolated from Brazil, Argentina and Uruguay over a period of three decades.

The molecular profile of 30 Moraxella bovis strains, recovered from outbreaks of infectious bovine keratoconjunctivitis in Argentina, Brazil and Uruguay between 1974 and 2001, was determined through randomly applied polymorphic DNA (RAPD) analysis. Molecular profiles of nine strains recovered after 1990 varied from those recovered before 1990. The profiles of 13 strains (48%) differed from those of three vaccinal strains extensively used since 1984 in Argentina and Uruguay. Eight Argentinean strains, one from Brazil and two from Uruguay had identical RAPD profiles. Strains belonging to different serogroups had identical RAPD profiles, demonstrating that this technique was not able to discriminate among strains with low cross-reactivity indices. RAPD may be helpful in the primary characterization of M. bovis strains, but it does not replace serological characterization.

Animals↗

Three-year surveillance study of nosocomial bacterial resistance in Argentina. The Antimicrobial Committee; and the National Surveillance Program (SIR) Participants Group.

INTRODUCTION: A national surveillance program (SIR) was introduced in 1996 in Argentina by the Antimicrobial Committee of the Argentinean Society for Microbiology to assess bacterial resistance. The present study reports the rates of nosocomial bacterial resistance found by this program. METHODS: A 2-month point-prevalence study was conducted twice yearly (i.e., April-May and October-November) from 1996 to 1998, by 27 Argentinean centers. Susceptibility testing was carried out by the disk diffusion method following the National Committee for Clinical Laboratory Standards guidelines. RESULTS: In all, 6343 isolates recovered from 5603 inpatients (> or =48-hr hospitalization) were included. Methicillin resistance was 58% and 56% in Staphylococcus aureus and coagulase-negative staphylococci (CNS), respectively. Although no vancomycin resistance was found in staphylococci, 2% and 8% of the S. aureus and CNS strains, respectively, proved resistant to teicoplanin. No ampicillin resistance was displayed by Enterococcus faecalis. High-level gentamicin and streptomycin resistance in enterococci were 33% and 37%, respectively. Acquired glycopeptide resistance in enterococci emerged in 1997 (2%). Imipenem resistance in Acinetobacter spp and Pseudomonas aeruginosa was 9% and 21%, respectively. Among Enterobacteriaceae, 1% and 5% of the Klebsiella pneumoniae and Enterobacter cloacae isolates, respectively, proved resistant to imipenem. Ceftazidime and cefepime resistance was found in 63% and 33% of the E. cloacae strains. Resistance to extended-spectrum cephalosporins was shown by 48%, 26%, and 8% of the K. pneumoniae, Proteus mirabilis, and Escherichia coli isolates, respectively. CONCLUSIONS: The alarming rates of resistance found in this study provide compelling evidence of the need for more rational use of antimicrobial agents in Argentina.

Anti-Bacterial Agents↗