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Safety and infectivity of two doses of live-attenuated recombinant cold-passaged human parainfluenza type 3 virus vaccine rHPIV3cp45 in HPIV3-seronegative young children
- Source :
- Vaccine
- Publication Year :
- 2013
- Publisher :
- Elsevier BV, 2013.
-
Abstract
- Human parainfluenza virus type 3 (HPIV3) is a common cause of upper and lower respiratory tract illness in infants and young children. Live-attenuated cold-adapted HPIV3 vaccines have been evaluated in infants but a suitable interval for administration of a second dose of vaccine has not been defined.HPIV3-seronegative children between the ages of 6 and 36 months were randomized 2:1 in a blinded study to receive two doses of 10⁵ TCID₅₀ (50% tissue culture infectious dose) of live-attenuated, recombinant cold-passaged human PIV3 vaccine (rHPIV3cp45) or placebo 6 months apart. Serum antibody levels were assessed prior to and approximately 4-6 weeks after each dose. Vaccine virus infectivity, defined as detection of vaccine-HPIV3 in nasal wash and/or a≥4-fold rise in serum antibody titer, and reactogenicity were assessed on days 3, 7, and 14 following immunization.Forty HPIV3-seronegative children (median age 13 months; range 6-35 months) were enrolled; 27 (68%) received vaccine and 13 (32%) received placebo. Infectivity was detected in 25 (96%) of 26 evaluable vaccinees following doses 1 and 9 of 26 subject (35%) following dose 2. Among those who shed virus, the median duration of viral shedding was 12 days (range 6-15 days) after dose 1 and 6 days (range 3-8 days) after dose 2, with a mean peak log₁₀ viral titer of 3.4 PFU/mL (SD: 1.0) after dose 1 compared to 1.5 PFU/mL (SD: 0.92) after dose 2. Overall, reactogenicity was mild, with no difference in rates of fever and upper respiratory infection symptoms between vaccine and placebo groups.rHPIV3cp45 was immunogenic and well-tolerated in seronegative young children. A second dose administered 6 months after the initial dose was restricted in those previously infected with vaccine virus; however, the second dose boosted antibody responses and induced antibody responses in two previously uninfected children.
- Subjects :
- Male
Drug-Related Side Effects and Adverse Reactions
Antibodies, Viral
Vaccines, Attenuated
Respirovirus Infections
Article
law.invention
Placebos
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Virus vaccine
law
Humans
Medicine
030212 general & internal medicine
Parainfluenza Vaccines
030304 developmental biology
Infectivity
Vaccines, Synthetic
0303 health sciences
Attenuated vaccine
General Veterinary
General Immunology and Microbiology
business.industry
Vaccination
Public Health, Environmental and Occupational Health
Infant
Virology
Parainfluenza Virus 3, Human
3. Good health
Human Parainfluenza Virus
Infectious Diseases
medicine.anatomical_structure
Child, Preschool
Immunology
Recombinant DNA
Molecular Medicine
Female
Nasal Cavity
business
Respiratory tract
Subjects
Details
- ISSN :
- 0264410X
- Volume :
- 31
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....e2df157a871e21fa4ea4b30e2d661918