Evaluation of Combined Live, Attenuated Respiratory Syncytial Virus and Parainfluenza 3 Virus Vaccines in Infants and Young Children

• Published in: The Journal of infectious diseases 2004-12, Vol.190 (12), p.2096-2103
• Main Authors: Belshe, Robert B., Newman, Frances K., Anderson, Edwin L., Wright, Peter F., Karron, Ruth A., Tollefson, Sharon, Henderson, Frederick W., Meissner, H. Cody, Madhi, Shabir, Roberton, Don, Marshall, Helen, Loh, Richard, Sly, Peter, Murphy, Brian, Tatem, Joanne M., Randolph, Valerie, Hackell, Jill, Gruber, William, Tsai, Theodore F.
• Format: Article
• Language: English
• Subjects: Administration, Intranasal; Antibodies; Antibodies, Viral - blood; Applied microbiology; Biological and medical sciences; Children; Diseases; Dosage; Double-Blind Method; Fundamental and applied biological sciences. Psychology; Human parainfluenza virus 3; Human respiratory syncytial virus; Humans; Infant; Infections; Infectious diseases; Medical sciences; Microbiology; Miscellaneous; Parainfluenza Vaccines - administration & dosage; Parainfluenza Vaccines - adverse effects; Parainfluenza Vaccines - immunology; Parainfluenza Virus 3, Human - immunology; Paramyxoviridae infections; Placebos; Respiratory syncytial virus; Respiratory Syncytial Virus Infections - immunology; Respiratory Syncytial Virus Infections - prevention & control; Respiratory Syncytial Virus Vaccines - administration & dosage; Respiratory Syncytial Virus Vaccines - adverse effects; Respiratory Syncytial Virus Vaccines - immunology; Respirovirus Infections - immunology; Respirovirus Infections - prevention & control; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Combined - adverse effects; Vaccines, Combined - immunology; Virology; Virus Shedding; Viruses
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/425981

We evaluated a combination respiratory syncytial virus (RSV) and parainfluenza 3 virus (PIV3) live, attenuated intranasal vaccine for safety, viral replication, and immunogenicity in doubly seronegative children 6–18 months old. RSV cpts-248/404 and PIV3-cp45 vaccines were combined in a dose of 105 plaque-forming units of each per 0.5-mL dose and compared with monovalent vaccines or placebo. The virus shedding pattern of RSV was not different between monovalent RSV cpts-248/404 vaccine and combination vaccine. Modest reductions in the shedding of PIV3-cp45 vaccine virus were found after the administration of RSV cpts-248/404 and PIV3-cp45 vaccine, relative to monovalent PIV3 vaccine; 16 (76%) of 21 children given combination vaccine shed PIV3- cp45 versus 11 (92%) of 12 of those given monovalent PIV3 vaccine. Both vaccines were immunogenic, and antibody responses were similar between the monovalent groups and the combination group. Combined RSV/ PV3 vaccine is feasible for simultaneous administration, and further studies are warranted.