- Cunningham, Coleen K;
- Karron, Ruth;
- Muresan, Petronella;
- McFarland, Elizabeth J;
- Perlowski, Charlotte;
- Libous, Jennifer;
- Thumar, Bhagvanji;
- Gnanashanmugam, Devasena;
- Moye, Jack;
- Schappell, Elizabeth;
- Barr, Emily;
- Rexroad, Vivian;
- Aziz, Mariam;
- Deville, Jaime;
- Rutstein, Richard;
- Yang, Lijuan;
- Luongo, Cindy;
- Collins, Peter;
- Buchholz, Ursula;
- Team, International Maternal Pediatric Adolescent AIDS Clinical Trials 2012 Study
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 105 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 log10 PFU/mL by quantitative culture and 4.5 log10 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. Clinical Trial Numbers. NCT02890381, NCT02948127.
