Immunogenicity and Safety of 1 vs 2 Doses of Quadrivalent Meningococcal Conjugate Vaccine in Youth Infected with Human Immunodeficiency Virus
The Journal of Pediatrics, 05/31/2012
Lujan–Zilbermann J et al. – In youth infected with HIV with a CD4% >15, a second dose of MCV4 given 6 months after the initial dose significantly improves response rates at 28 and 72 weeks. Subjects with CD4% <15 at entry had lower response rates despite 2 doses of MCV4.Methods
- P1065 was a phase I/II immunogenicity and safety trial of MCV4 in 324 youth infected with HIV performed at 27 sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group network in the US.
- At entry subjects received 1 dose of MCV4. At 24 weeks, those with screening cluster of differentiation 4 (CD4)% 15 were randomized to receive a second dose or not, and all with screening CD4% <15 received a second dose.
- Immunogenicity was evaluated as the proportion of subjects with a 4-fold rise from entry in serum bactericidal antibody against each meningococcal serogroup (SG) at weeks 28 and 72.
- Logistic regression models adjusting for HIV disease severity were used to evaluate the effect of 1 vs 2 MCV4 doses among those with screening CD4% 15.
- Subjects randomized to receive 2 vs 1 MCV4 dose had significantly higher response rates to all SGs at week 28 and to all except Neisseria meningitidis SG Y at week 72, with adjusted ORs of 2.5-5.6.
- In 31 subjects with screening CD4% <15 who received 2 MCV4 doses, response rates ranged from 22%-55% at week 28 and 6%-28% at week 72.