Administration of high doses of respiratory syncytial virus immune globulin is a safe and effective means of preventing lower respiratory tract infection in infants and young children at high risk for this disease.

The serum antibody response of infants mud children immuule wlth Formalin-inactlvated respiratory * Corresponding author.

An approximate 10% suspension in water of the first available stool sample from 411 infants and young children with acute gastroenteritis was examined by electron microscopy (EM) after 2 min of negative staining. This procedure enabled the detection of 88% of the 199 rotavirus infections, all of the 22 adenovirus infections, and 47% of the 15 approximately 27-nm virus infections ultimately detected by a combination of techniques, including immune electron microscopy (IEM) and rotavirus enzyme-linked immunosorbent assay (ELISA). Of the 204 infections detected by direct EM of stools, 76% were detected within 2 min of viewing, and 94% were detected within 6 min of viewing. Type 1 and type 2 rotavirus particles were visualized with approximately equal efficiency, although type 2 rotavirus infections were more common. Rectal swab preparations were clearly inferior to stool preparations for the detection of virus infection by direct EM. IEM examination was required for efficient visualization of viruses in rectal swab specimens. ELISA was the most sensitive method for the detection of rotaviruses; with this method, all infections in which rotavirus particles were visualized by EM or IEM were detected. However, 73% of the 1,834 specimens which were presumptively positive for rotavirus by conventional indirect ELISA proved to be falsely positive on the basis of EM, IEM, blocking ELISA, confirmatory ELISA, or a combination of these methods. False-positive rotavirus ELISA reactions apparently were eliminated when fecal specimens were tested in a modified confirmatory ELISA with a lower dilution of rotavirus-negative (pre-immunization) than rotavirus-positive (post-immunization) capture antibody from the same animal.

RSVIG treatment was safe but not efficacious in the treatment of children with bronchopulmonary dysplasia, congenital heart disease, or premature gestation who were hospitalized with RSV LRI.

Respiratory syncytial virus (RSV)-infected cotton rats (Sigmadon hispidus) and owl monkeys (Aotus trivirgatus) showed significant reductions in RSV shedding from their respiratory tracts following parenteral therapy with human intravenous immunoglobulin (IVIG) containing high titers of RSV-neutralizing antibody. Because this therapy was well tolerated and appeared safe, a double-blind, placebo-controlled IVIG immunotherapy pilot study was performed on 35 hospitalized, RSV-infected infants and children. The treatment was well tolerated and resulted in significant reductions in nasal RSV shedding and in improvements in transcutaneous oximetry readings. However, the mean duration of hospitalization was not reduced by IVIG treatment. Followup to date has revealed no harmful effects resulting from immunotherapy of RSV infections. These studies appear to refute the hypothesis that passively acquired antibody may exacerbate RSV bronchiolitis or pneumonia in infants. Studies with larger numbers of seriously ill children will be required to determine if immunoglobulin G immunotherapy of RSV infections in infants is of clinical value.Respiratory syncytial virus (RSV) is an important respiratory pathogen of infants and young children. The virus produces annual epidemics of bronchiolitis and pneumonia in children throughout the world and causes numerous hospital admissions, substantial morbidity, and some mortality (2,5,7,15,17,30,31). Efforts to produce an effective vaccine for prevention of these infections have thus far been unsuccessful (16,19,35). Only recently, with the introduction of ribavirin, has treatment other than supportive therapy been available for children with serious RSV infections (1,6,11,12,29,32).The current studies were prompted by a series of observations: (i) pups of RSV-immune cotton rat mothers were protected from RSV infection, presumably by transplacental antibody (25); (ii) injection of serum from RSV-immune cotton rats protected nonimmune cotton rats from RSV infection (26); (iii) high-titered RSV-immune human serum and human immunoglobulin prepared for intravenous administration (IVIG) were effective for both prophylaxis and therapy of RSV infections in cotton rats and owl monkeys (13, 24); (iv) some lots of human IVIG contained substantial titers of neutralizing antibody to RSV (14); and (v) careful pathological studies of the lungs of RSV-infected animals treated with IVIG revealed no evident microscopic pulmonary abnormalities characteristic of the formation of antigenantibody complexes or other untoward pulmonary reactions (13,24). The current study was designed to determine if IVIG containing substantial levels of RSV-neutralizing antibody could be safely administered and if it would hasten clinical recovery when infused into RSV-infected, hospitalized children.