Issue: December 2011
December 01, 2011
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MCV4 appeared safe, immunogenic in children with HIV

Siberry GK. Pediatr Infect Dis J. 2011;doi:10.1097/INF.0b013e318236c67b.

Issue: December 2011
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Children aged 2 to 10 years with HIV responded well with few adverse events to the quadrivalent meningococcal vaccine, according to study results.

The trial was conducted because children with HIV are more likely to acquire meningococcal disease and less likely to have an adequate response to the quadrivalent meningococcal conjugate vaccine (MCV4; Menactra, Sanofi-Pasteur). However, this vaccine has not been studied in preadolescent children with HIV.

Eligible children had HIV with CD4 of at least 25%. The median age was 6 years, and all children received MCV4 at entry and at week 24.

The researchers evaluated sera at entry and weeks 4, 24, 28 and 72 and adverse events 6 weeks after each MCV4 dose. They measured rate of response — defined as an at least fourfold increase in rabbit serum bactericidal antibody against the four serogroups (A, C, Y, W-135) — geometric mean titers and rates of seroprotection (rabbit serum bactericidal antibody titer >1:128).

Eighty-eight percent of children were receiving antiretroviral therapy at study outset, and 75% had a viral load of less than 400 copies/mL.

All vaccination reactions were mild and yielded no serious adverse events within 6 weeks of dosing.

After a single dose, response to serogroup A was 92% and response to W-135 was 98%. Serogroup C had a 43% response rate after the first dose and an 80% response rate after the second (P<.0001). An increase in response to serogroup Y from dose one to dose two also was observed (76%-84%; P=.38).

Results at 72 weeks indicated that seroprotection rates were 93% for serogroup W-135, 91% for Y, 78% for A and 46% for C.

“Two doses of MCV4 were safe and immunogenic in 2- to 10-year-old HIV-infected children,” the researchers wrote. “The second dose increased the proportion of children who made a response to serogroup C. Seroprotection waned substantially for serogroups A and C within 1 year of last MCV4 dose.”

PERSPECTIVE

This article demonstrates the importance of a two-dose primary series for children with HIV who are recommended to be vaccinated. The second dose is especially critical for protection against serogroup C, which is serogroup that causes about one-third of disease in the US. Eighty percent of children achieved antibody levels that are considered protective against serogroup C meningococcal disease after the second dose. However, about a year later, only 45% of those children still had antibody levels that were protective. Waning circulating antibody levels, which are a critical component of long-term protection, are a concern for populations with HIV. The authors indicate in the discussion that the study will be extended and will look at a booster dose of MCV4 in children with HIV. This will be very important in ensuring that these children and adolescents, who are at increased risk for meningococcal disease, are protected through their period of increased risk.

Amanda Cohn, MD
CDR, US Public Health Service
Meningitis and Vaccine Preventable Diseases
National Center for Immunizations and Respiratory Diseases

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