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Immunoglobulin for preventing respiratory syncytial virus infection
1Pediatrics, The Hospital for Sick Children, 555 University Avenue, Toronto, Canada, M5G 1X8. ew@sickkids.on.ca
Insights
Respiratory Syncytial Virus Immune Globulin (RSVIG) effectively prevents RSV hospitalizations and intensive care unit admissions in high-risk infants. However, it does not prevent mechanical ventilation and showed a trend towards increased mortality.
Area of Science:
- Pediatric Infectious Diseases
- Immunology
- Public Health
Background:
- Respiratory Syncytial Virus (RSV) is a leading cause of lower respiratory tract infections in infants.
- Premature infants, especially those with bronchopulmonary dysplasia or congenital heart disease, face increased morbidity from RSV.
- Passive prophylaxis with immune globulin has been explored for protection.
Purpose of the Study:
- To assess the efficacy of polyclonal RSV hyperimmune globulin or monoclonal antibodies in preventing RSV-related outcomes.
- To evaluate the impact on hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and mortality.
- To focus on high-risk populations including premature infants and those with specific comorbidities.
Main Methods:
- A meta-analysis of randomized controlled trials (RCTs) was conducted.
- Searches included Cochrane Acute Respiratory Infections trials register and MEDLINE up to March 1999.
- Data from four RCTs involving 2598 subjects were analyzed for pooled outcomes.
Main Results:
- RSV Immune Globulin (RSVIG) significantly reduced the incidence of RSV hospitalization (OR 0.48) and ICU admission (OR 0.47).
- The number needed to prevent one hospitalization was 17, and for one ICU admission was 50.
- No significant effect was observed in preventing mechanical ventilation (OR 0.99).
Conclusions:
- RSVIG is effective in preventing RSV hospitalizations and ICU admissions in vulnerable infants.
- RSVIG did not demonstrate efficacy in preventing the need for mechanical ventilation.
- A non-significant trend suggested a potential increase in mortality with RSVIG administration.
Background:
Respiratory Syncytial virus, the most important cause of lower respiratory tract infections in infants and young children in industrialized countries, is associated with increased morbidity in premature infants with or without bronchopulmonary dysplasia as well as those with congenital heart disease. Because of observations that lower rates of disease occur immediately after birth, presumably due to vertical transmission of maternal antibody, and animal studies where protection from pneumonia was observed through administration of immune globulin, the efficacy of passive prophylaxis in premature infants has been studied.
Objectives:
This meta-analysis was performed to assess the effects of polyclonal respiratory syncytial virus hyperimmune globulin or monoclonal antibody in preventing RSV hospitalization, receipt of intensive care, mechanical ventilation, and mortality in those with underlying prematurity, bronchopulmonary dysplasia, or congenital heart disease.
Search Strategy:
We searched the Cochrane Acute Respiratory Infections trials register and MEDLINE in March, 1999. In addition, abstracts on these topics were sought from the Pediatric Academies Meetings and the Intersciences Conference on Antimicrobial Agents and Chemotherapy for the years 1994 to 1997, inclusive.
Selection Criteria:
Randomized, controlled trials of prevention of RSV using immune globulin, respiratory syncytial virus immune globulin, or monoclonal RSV antibody in children with prematurity, bronchopulmonary dysplasia or congenital heart disease.
Data Collection And Analysis:
Two authors independently abstracted data and assessed study quality. Only incidences could be pooled because data for durations was summarized in a manner that did not allow combining results across the studies.
Main Results:
Four studies with a total of 2598 subjects were included in the main analysis. All were randomized controlled trials. Two trials were not blinded. Three studies examined RSV hyperimmune globulin and one examined monoclonal RSV antibody. A study of a different monoclonal RSV antibody could not be included because it has not been presented or published. The pooled Peto Odds Ratios favoring prophylaxis were 0.48 (95% CI 0.37, 0.64), 0.47 (0.29, 0. 77), and 0.99 (0.48, 2.07) for incidence of hospitalization, incidence of ICU admission, and incidence of mechanical ventilation, respectively. The numbers needed to prevent one hospitalization and one ICU admission are 17 and 50 respectively.
Reviewer'S Conclusions:
RSVIG is effective in preventing RSV hospitalizations and admission to the intensive care unit, but not in preventing mechanical ventilation. There was a non-significant trend towards a higher mortality in children given RSVIG.