This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4 month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P\[8\] serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2, G3, G4 and P\[8\] SNA and serum rotavirus IgA GMTs will be compared between children receiving RV5 according to the alternate dosing schedule and the standard recommended schedule. The safety and tolerability of RV5 in children receiving vaccine according to the alternate dosing schedule will be described.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
66
Duke University Health System
Durham, North Carolina, United States
G1 Serum-neutralizing Antibody
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
Time frame: 1 month following vaccine series completion
G2 Serum-neutralizing Antibody
Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time frame: 1 month following vaccine series completion
G3 Serum-neutralizing Antibody
Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time frame: 1 month following vaccine series completion
G4 Serum-neutralizing Antibody
Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time frame: 1 month following vaccine series completion
P1 Serum-neutralizing Antibody
Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Time frame: 1 month following vaccine series completion
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