P1065 (10396): Phase I/II, Study of Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in HIV-Infected Youth (Versions 1.0–3.0) and Open-Label Immunogenicity Study of a Booster Dose of MCV4 in Previously Immunized HIV-Infected Children and Youth (Version 4.0)

Study Status Study Restriction


United States

What is P1065?

P1065 Version 4.0 is a Phase I/II, open label study of Meningococcal Conjugate Vaccine (MCV4) booster dose.  The study was designed to estimate the immunogenic response to MCV4, estimate the short- and long-term immunogenicity of the vaccine, and assess the safety of the vaccine among HIV-1 infected children; the current version aims to assess the level of protective antibody titers 3 years post-initial immunization with MCV4, estimate the proportion of subjects with evidence of immunologic memory to the booster dose, estimate the rates of immunologic primary response to the booster dose, and estimate the short-term immunogenicity of the booster dose.

Study Documents:

Sites where the study is implemented:

CRS ID Site Name City Country


Rush University Cook County Hospital Chicago NICHD CRS


United States of America

Study contacts:

No records returned.

CTS: Katie McCarthy


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.