Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)

Summary

This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There are no formal hypotheses.

Timeline

Start

2019-11-05

Primary completion

2021-05-03

Completion

2021-05-03

Publications

• Results Wilck M, Barnabas S, Chokephaibulkit K, Violari A, Kosalaraksa P, Yesypenko S, Chukhalova I, Dagan R, Richmond P, Mikviman E, Morgan L, Feemster K, Lupinacci R, Chiarappa J, Madhi SA, Bickham K, Musey L; V114-030 Study Group. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS. 2023 Jul 1;37(8):1227-1237. doi: 10.1097/QAD.0000000000003551. Epub 2023 Mar 17.

Drugs

Indications