A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease.

Children with hemodynamically significant congenital heart disease (CHD) are at risk for serious respiratory syncytial virus (RSV) disease. This study was designed to assess the safety and tolerability of motavizumab versus palivizumab in children with CHD and was not powered for efficacy. Patients (n = 1236) aged ≤24 mo were randomized to receive five monthly doses (15 mg/kg) of motavizumab or palivizumab during the RSV season. Adverse events (AEs) and serious AEs (SAEs) were recorded through 30 d after the last dose. RSV hospitalizations and RSV outpatient medically attended lower respiratory tract infections (MALRI; season 2) were summarized. Approximately 93 and 50% of patients reported an AE or SAE, respectively. Skin events occurred in 19.3% of motavizumab recipients and 16.2% of palivizumab recipients. Rates of hospitalizations and RSV MALRI were similar between treatment groups [relative risk (RR): 0.75; 95% CI, 0.34-1.59 and RR: 0.49; 95% CI, 0.10-1.99, respectively; both p > 0.05]. Motavizumab and palivizumab had similar safety profiles in children with hemodynamically significantly CHD; with the exception of skin events which were increased in motavizumab recipients. Safety and efficacy were consistent with another study comparing motavizumab with palivizumab in premature infants without CHD.

Humoral, mucosal, and cellular immune responses to oral Norwalk virus-like particles in volunteers.

Norwalk virus-like particles (VLPs), made from recombinant capsid protein, are a promising vaccine. Thirty-six healthy adult volunteers received 250 microg (n = 10), 500 microg (n = 10), or 2000 microg (n = 10) of orally administered VLP or placebo (n = 6). All vaccinees developed significant rises in IgA anti-VLP antibody-secreting cells. Ninety percent who received 250 microg developed rises in serum anti-VLP IgG; neither the rates of seroconversion nor geometric mean titers increased at the higher doses. About 30-40% of volunteers developed mucosal anti-VLP IgA. Lymphoproliferative responses and IFN-gamma production were observed transiently among those who received 250 microg or 500 microg but not 2000 microg of VLP. Studies to increase immunogenicity using a mucosal adjuvant are planned.