Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women
| Autor: | M. Valentine, W. T. Shearer, J. Lambert, P. LaRussa, A. J. Melvin, Ross E. McKinney, M. Davi, Lynne M. Mofenson, K. Luzuriaga, Coleen K. Cunningham, K. A. Contello, M. Mirochnick, N. Deygoo, S. Laverty, K. M. Mohan, E. McBride, Minhee Kang, J. Pitt, L. Frenkel, Steven A Spector, M. Silio, Elizabeth J. McFarland, D. F. Cloutier, M. Lugo, M. Rivera, Diane W. Wara, T. Fenton, W. M. Dankner, B. Murante, S. Nachman, C. R. Salbenblatt, Marilyn Doyle, C. Vincent, William Borkowsky, D. Francis, T. Hastings, Alex Dorenbaum, M. J. Levin, N. Hutton, K. Mooney, R. Galvin, J L Sullivan, A. M. Duliege, E. Hawkins, Ellen G. Chadwick, J. McNamara |
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| Rok vydání: | 2000 |
| Předmět: |
Microbiology (medical)
Squalene medicine.medical_specialty medicine.medical_treatment Polysorbates HIV Infections HIV Envelope Protein gp120 Recombinant virus Gastroenterology Acquired immunodeficiency syndrome (AIDS) Adjuvants Immunologic Pregnancy Internal medicine Multicenter trial medicine Humans Pregnancy Complications Infectious Sida AIDS Vaccines Vaccines Synthetic biology business.industry Vaccination Infant Newborn biology.organism_classification medicine.disease Infectious Disease Transmission Vertical Infectious Diseases Immunization Immunology Female Viral disease business Adjuvant |
| Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 32(5) |
| ISSN: | 1058-4838 |
| Popis: | To determine the safety of 2 candidate vaccines against human immunodeficiency virus type 1 (HIV-1), a randomized, placebo-controlled, multicenter trial compared low, medium, and high doses of the vaccines or an adjuvant among infants born to HIV-infected women. No local or systemic reactions of grade 2 or greater were reported 48 h after the subjects underwent immunization. Grade 3 or 4 chemistry toxicities occurred in 5 (3%) and grade 3 or 4 hematologic toxicities in 17 (11%) of 154 vaccinated subjects (not significantly different from 29 adjuvant recipients). CD4(+) cell percentages of < or = 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4(+) cell percentages of < or = 20% occurred in 4 HIV-infected children. Fourteen infants (8%) were confirmed to be HIV-infected; median CD4(+) cell counts among these children were 2074, 1674, 1584, and 821 cells/mm(3) at birth and weeks 24, 52, and 104, respectively. Thus, both vaccines were safe and well tolerated in neonates, and there was no evidence of accelerated immunologic decline in HIV-infected infants. |
| Databáze: | OpenAIRE |
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