Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women

C. K. Cunningham; D. W. Wara; M. Kang; T. Fenton; E. Hawkins; J. McNamara; L. Mofenson; A. M. Duliege; D. Francis; E. J. McFarland; W. Borkowsky; T. Hastings; N. Deygoo; M. Lugo; M. Rivera; K. Contello; S. Nachman; M. Davi; C. R. Salbenblatt; M. J. Levin; R. Galvin; M. Mirochnick; A. Dorenbaum; S. A. Spector; W. M. Dankner; L. Frenkel; A. J. Melvin; K. M. Mohan; K. Mooney; C. Vincent; M. Silio; E. McBride; J. Pitt; P. LaRussa; E. G. Chadwick; D. F. Cloutier; J. Lambert; N. Hutton; B. Murante; S. Laverty; J. Sullivan; K. Luzuriaga; R. McKinney; M. Valentine; W. T. Shearer; M. Doyle

doi:10.1086/319215

Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women

C. K. Cunningham, D. W. Wara, M. Kang, T. Fenton, E. Hawkins, J. McNamara, L. Mofenson, A. M. Duliege, D. Francis, E. J. McFarland, W. Borkowsky, T. Hastings, N. Deygoo, M. Lugo, M. Rivera, K. Contello, S. Nachman, M. Davi, C. R. Salbenblatt, M. J. LevinR. Galvin, M. Mirochnick, A. Dorenbaum, S. A. Spector, W. M. Dankner, L. Frenkel, A. J. Melvin, K. M. Mohan, K. Mooney, C. Vincent, M. Silio, E. McBride, J. Pitt, P. LaRussa, E. G. Chadwick, D. F. Cloutier, J. Lambert, N. Hutton, B. Murante, S. Laverty, J. Sullivan, K. Luzuriaga, R. McKinney, M. Valentine, W. T. Shearer, M. Doyle

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Abstract

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 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4⁺ cell percentages of 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/mm³ 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.

Original language	English (US)
Pages (from-to)	801-807
Number of pages	7
Journal	Clinical Infectious Diseases
Volume	32
Issue number	5
DOIs	https://doi.org/10.1086/319215
State	Published - Mar 1 2001
Externally published	Yes

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

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10.1086/319215

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Cunningham, C. K., Wara, D. W., Kang, M., Fenton, T., Hawkins, E., McNamara, J., Mofenson, L., Duliege, A. M., Francis, D., McFarland, E. J., Borkowsky, W., Hastings, T., Deygoo, N., Lugo, M., Rivera, M., Contello, K., Nachman, S., Davi, M., Salbenblatt, C. R., ... Doyle, M. (2001). Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women. Clinical Infectious Diseases, 32(5), 801-807. https://doi.org/10.1086/319215

Cunningham, CK, Wara, DW, Kang, M, Fenton, T, Hawkins, E, McNamara, J, Mofenson, L, Duliege, AM, Francis, D, McFarland, EJ, Borkowsky, W, Hastings, T, Deygoo, N, Lugo, M, Rivera, M, Contello, K, Nachman, S, Davi, M, Salbenblatt, CR, Levin, MJ, Galvin, R, Mirochnick, M, Dorenbaum, A, Spector, SA, Dankner, WM, Frenkel, L, Melvin, AJ, Mohan, KM, Mooney, K, Vincent, C, Silio, M, McBride, E, Pitt, J, LaRussa, P, Chadwick, EG, Cloutier, DF, Lambert, J, Hutton, N, Murante, B, Laverty, S, Sullivan, J, Luzuriaga, K, McKinney, R, Valentine, M, Shearer, WT & Doyle, M 2001, 'Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women', Clinical Infectious Diseases, vol. 32, no. 5, pp. 801-807. https://doi.org/10.1086/319215

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title = "Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women",

abstract = "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 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4+ cell percentages of 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/mm3 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.",

author = "Cunningham, {C. K.} and Wara, {D. W.} and M. Kang and T. Fenton and E. Hawkins and J. McNamara and L. Mofenson and Duliege, {A. M.} and D. Francis and McFarland, {E. J.} and W. Borkowsky and T. Hastings and N. Deygoo and M. Lugo and M. Rivera and K. Contello and S. Nachman and M. Davi and Salbenblatt, {C. R.} and Levin, {M. J.} and R. Galvin and M. Mirochnick and A. Dorenbaum and Spector, {S. A.} and Dankner, {W. M.} and L. Frenkel and Melvin, {A. J.} and Mohan, {K. M.} and K. Mooney and C. Vincent and M. Silio and E. McBride and J. Pitt and P. LaRussa and Chadwick, {E. G.} and Cloutier, {D. F.} and J. Lambert and N. Hutton and B. Murante and S. Laverty and J. Sullivan and K. Luzuriaga and R. McKinney and M. Valentine and Shearer, {W. T.} and M. Doyle",

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AU - Cunningham, C. K.

AU - Wara, D. W.

AU - Kang, M.

AU - Fenton, T.

AU - Hawkins, E.

AU - McNamara, J.

AU - Mofenson, L.

AU - Duliege, A. M.

AU - Francis, D.

AU - McFarland, E. J.

AU - Borkowsky, W.

AU - Hastings, T.

AU - Deygoo, N.

AU - Lugo, M.

AU - Rivera, M.

AU - Contello, K.

AU - Nachman, S.

AU - Davi, M.

AU - Salbenblatt, C. R.

AU - Levin, M. J.

AU - Galvin, R.

AU - Mirochnick, M.

AU - Dorenbaum, A.

AU - Spector, S. A.

AU - Dankner, W. M.

AU - Frenkel, L.

AU - Melvin, A. J.

AU - Mohan, K. M.

AU - Mooney, K.

AU - Vincent, C.

AU - Silio, M.

AU - McBride, E.

AU - Pitt, J.

AU - LaRussa, P.

AU - Chadwick, E. G.

AU - Cloutier, D. F.

AU - Lambert, J.

AU - Hutton, N.

AU - Murante, B.

AU - Laverty, S.

AU - Sullivan, J.

AU - Luzuriaga, K.

AU - McKinney, R.

AU - Valentine, M.

AU - Shearer, W. T.

AU - Doyle, M.

PY - 2001/3/1

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N2 - 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 20% occurred at least once in 9 vaccinated subjects and 1 control subject. Sustained CD4+ cell percentages of 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/mm3 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.

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Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women

Abstract

ASJC Scopus subject areas

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