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Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative.

Publication ,  Journal Article
Bartlett, JA; Wasserman, SS; Hicks, CB; Dodge, RT; Weinhold, KJ; Tacket, CO; Ketter, N; Wittek, AE; Palker, TJ; Haynes, BF
Published in: AIDS
July 30, 1998

OBJECTIVE: To evaluate the safety and immunogenicity of a polyvalent (PV) HIV envelope synthetic peptide immunogen, C4-V3. The immunogen comprised four peptides containing T-helper epitopes from the fourth constant region (C4) of gp120 of HIV-1MN, and T-helper, cytotoxic T-lymphocyte HLA-B7-restricted, and B-cell neutralizing epitopes from the gp120 third variable region (V3) of four clade B HIV-1 isolates, HIV-1MN, HIV-1RF, HIV-1EV91, and HIV-1Can0A. DESIGN: A pilot, Phase I controlled trial [Division of AIDS Treatment Research Initiative (DATRI) 010] conducted at a single center. METHODS: Ten HIV-infected, HLA-B7-positive patients with CD4 cells > 500 x 10(6)/l were enrolled. Eight patients received the C4-V3 PV immunogen emulsified in incomplete Freund's adjuvant in five intramuscular injections over 24 weeks, and two controls received incomplete Freund's adjuvant alone. All subjects were followed for 52 weeks. RESULTS: Four out of eight C4-V3 PV recipients generated at least fourfold rise in serum antibody titers to at least three immunogen peptides in contrast to none of the control subjects. Four out of eight C4-V3 PV recipients and none of the controls had an at least fourfold rise in neutralizing antibodies to either HIV-1MN, HIV-1RF, or HIV-1(4489-5) laboratory-adapted HIV isolates. 3H-Thymidine incorporation assays of peripheral blood mononuclear cells increased at least fivefold over the baseline stimulation index to at least one of the immunogen peptides in two consecutive post-immunization timepoints in five out of eight C4-V3 PV recipients versus none of the controls. CD4 cell counts and plasma HIV RNA levels did not change in patients who received either C4-V3 PV or adjuvant alone. Adverse events consisted primarily of grade 1 injection site reactions in six subjects (four C4-V3 recipients, two controls). CONCLUSIONS: C4-V3 PV synthetic peptides demonstrated both immunogenicity and safety in HIV-infected patients.

Duke Scholars

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Published In

AIDS

DOI

ISSN

0269-9370

Publication Date

July 30, 1998

Volume

12

Issue

11

Start / End Page

1291 / 1300

Location

England

Related Subject Headings

  • Virology
  • Vaccines, Synthetic
  • T-Lymphocytes, Cytotoxic
  • RNA, Viral
  • Pilot Projects
  • Neutralization Tests
  • Molecular Sequence Data
  • Middle Aged
  • Male
  • Lymphocytes
 

Citation

APA
Chicago
ICMJE
MLA
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Bartlett, J. A., Wasserman, S. S., Hicks, C. B., Dodge, R. T., Weinhold, K. J., Tacket, C. O., … Haynes, B. F. (1998). Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative. AIDS, 12(11), 1291–1300. https://doi.org/10.1097/00002030-199811000-00010
Bartlett, J. A., S. S. Wasserman, C. B. Hicks, R. T. Dodge, K. J. Weinhold, C. O. Tacket, N. Ketter, A. E. Wittek, T. J. Palker, and B. F. Haynes. “Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative.AIDS 12, no. 11 (July 30, 1998): 1291–1300. https://doi.org/10.1097/00002030-199811000-00010.
Bartlett JA, Wasserman SS, Hicks CB, Dodge RT, Weinhold KJ, Tacket CO, et al. Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative. AIDS. 1998 Jul 30;12(11):1291–300.
Bartlett, J. A., et al. “Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative.AIDS, vol. 12, no. 11, July 1998, pp. 1291–300. Pubmed, doi:10.1097/00002030-199811000-00010.
Bartlett JA, Wasserman SS, Hicks CB, Dodge RT, Weinhold KJ, Tacket CO, Ketter N, Wittek AE, Palker TJ, Haynes BF. Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative. AIDS. 1998 Jul 30;12(11):1291–1300.

Published In

AIDS

DOI

ISSN

0269-9370

Publication Date

July 30, 1998

Volume

12

Issue

11

Start / End Page

1291 / 1300

Location

England

Related Subject Headings

  • Virology
  • Vaccines, Synthetic
  • T-Lymphocytes, Cytotoxic
  • RNA, Viral
  • Pilot Projects
  • Neutralization Tests
  • Molecular Sequence Data
  • Middle Aged
  • Male
  • Lymphocytes