Phase I/II, Open-Label Trial of Safety and Immunogenicity of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Human Immunodeficiency Virus-Infected Adolescents

A quadrivalent meningococcal polysaccharide conjugate vaccine (MCV4, Menactra) containing Neisseria meningitidis serogroups A, C, Y, and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein, was approved by the US Food and Drug Administration in 2005 for people aged 11 to 55 years and, then, in 2007 for children aged 2 years and older.1 Since 2005, the CDC Advisory Committee on Immunization Practices (ACIP) has recommended MCV4 as part of the routine immunization schedule for adolescents (11 years of age and older) in the United States.2 This recommendation was extended to 2 to 10-year-old children with conditions (eg, anatomic or functional asplenia) that increase their risk of meningococcal infection.1 Healthy youth make an immunogenic response to MCV4 at high rates (80%–97%), varying by meningococcal sero-group.3 Although acceptable rates of anticipated local and systemic adverse effects were observed during vaccine trials, cases of Guillain-Barre syndrome (GBS) reported in postmarketing surveil-lance raised concern for a potential association of MCV4 with GBS.4 Adolescent recipients of MCV4 appear to have a small increase in the rate of GBS as compared with the general population, but ongoing surveillance and analyses have not confirmed that MCV4 is causally related to these GBS cases; at present, pending additional results of those ongoing analyses, MCV4 is not recommended for people with a history of GBS.5 The ACIP has acknowledged the potential benefit of giving MCV4 to HIV-infected children and adolescents, since HIV infection likely increases the risk of meningococcal disease.1,2 In addition, most perinatally acquired and all new adolescent cases of HIV infection in the United States are age-eligible for MCV4. However, there are no data regarding the use of MCV4 in HIV-infected patients of any age. In HIV-infected patients, nonlive vaccines are generally safe and immunogenic but response to vaccines can be less reliable, of lower titer, qualitatively abnormal or of shorter duration, especially if HIV infection is advanced or poorly controlled.6-13 The objective of IMPAACT Protocol P1065 was to evaluate the safety and immunogenicity of MCV4 in HIV-infected children and youth. The short-term safety and immunogenicity results following administration of a single dose of MCV4 to HIV-infected youth are presented here.