Background: The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations.
Methods: RSV-seronegative children aged 6-24 months received a single intranasal dose of 10 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed.
Results: Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log PFU/mL by quantitative culture and 4.5 log copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%).
Conclusions: RSV LIDcpΔM2-2 is overattenuated. NCT02890381, NCT02948127.
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| http://dx.doi.org/10.1093/ofid/ofz212 | DOI Listing |
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