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Clin Infect Dis. 2013 Feb 1. [Epub ahead of print]
Safety and Immunogenicity of 2009 pH1N1 Vaccination in HIV-Infected Pregnant Women.
Abzug MJ, Nachman SA, Muresan P, Handelsman E, Watts DH, Fenton T, Heckman B, Petzold E, Weinberg A, Levin MJ; for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team.
Source
Department of Pediatrics (Infectious Diseases), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA.
Abstract
Background. HIV-infected, pregnant women may have particular vulnerability to 2009 pH1N1 infection. The safety and immunogenicity of pH1N1 vaccination in HIV-infected, pregnant women are unknown.Methods. HIV-infected women between 18-39 years old and 14-34 weeks gestation on antiretroviral therapy received two 30 mcg doses of unadjuvanted, inactivated pH1N1 vaccine 21 days apart. Hemagglutination inhibition titers were measured at entry, 21 days post-dose #1, and 10 and 21 days post-dose #2, and, in mothers and infants, at delivery and three and six months post-delivery.Results. No severe vaccine-related adverse events were observed among 127 subjects. At entry, 21% had seroprotective (≥1:40) titers. Seroprotection and seroresponse (≥4-fold rise) occurred in 73% and 66% post-dose #1 and 80% and 72% post-dose #2, respectively. Of women lacking seroprotection at entry, 66% attained seroprotective titers after dose #1 and 75% after dose #2. Seroprotective titers were present in 67% of mothers and 65% of infants at delivery (median 66 days post-dose #2), 60% of mothers and 26% of infants at three months post-delivery, and 59% of mothers and 12% of infants at six months post-delivery. Vaccine response was associated with maternal CD4%.Conclusions. Two 30 mcg doses of pH1N1 vaccine were moderately immunogenic in HIV-infected, pregnant women. No concerning vaccine-related safety signals were observed. Seroprotection persisted in most women post-partum. Efficient transplacental antibody transfer occurred, but seroprotection in infants waned rapidly. Vaccination to protect HIV-infected, pregnant women and their newborns from new influenza strains is feasible, but more immunogenic platforms should be evaluated.Clinical Trials Registration. NCT00992017 (www.clinicaltrials.gov).
PMID:
23378284
[PubMed - as supplied by publisher]
Safety and Immunogenicity of 2009 pH1N1 Vaccination in HIV-Infected Pregnant Women.
Abzug MJ, Nachman SA, Muresan P, Handelsman E, Watts DH, Fenton T, Heckman B, Petzold E, Weinberg A, Levin MJ; for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team.
Source
Department of Pediatrics (Infectious Diseases), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA.
Abstract
Background. HIV-infected, pregnant women may have particular vulnerability to 2009 pH1N1 infection. The safety and immunogenicity of pH1N1 vaccination in HIV-infected, pregnant women are unknown.Methods. HIV-infected women between 18-39 years old and 14-34 weeks gestation on antiretroviral therapy received two 30 mcg doses of unadjuvanted, inactivated pH1N1 vaccine 21 days apart. Hemagglutination inhibition titers were measured at entry, 21 days post-dose #1, and 10 and 21 days post-dose #2, and, in mothers and infants, at delivery and three and six months post-delivery.Results. No severe vaccine-related adverse events were observed among 127 subjects. At entry, 21% had seroprotective (≥1:40) titers. Seroprotection and seroresponse (≥4-fold rise) occurred in 73% and 66% post-dose #1 and 80% and 72% post-dose #2, respectively. Of women lacking seroprotection at entry, 66% attained seroprotective titers after dose #1 and 75% after dose #2. Seroprotective titers were present in 67% of mothers and 65% of infants at delivery (median 66 days post-dose #2), 60% of mothers and 26% of infants at three months post-delivery, and 59% of mothers and 12% of infants at six months post-delivery. Vaccine response was associated with maternal CD4%.Conclusions. Two 30 mcg doses of pH1N1 vaccine were moderately immunogenic in HIV-infected, pregnant women. No concerning vaccine-related safety signals were observed. Seroprotection persisted in most women post-partum. Efficient transplacental antibody transfer occurred, but seroprotection in infants waned rapidly. Vaccination to protect HIV-infected, pregnant women and their newborns from new influenza strains is feasible, but more immunogenic platforms should be evaluated.Clinical Trials Registration. NCT00992017 (www.clinicaltrials.gov).
PMID:
23378284
[PubMed - as supplied by publisher]
