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Figure 1.

Composition of the LIPO-4 vaccine.

The amino acid sequences correspond to the four antigenic segments of HIV proteins (red) covalently linked to the T-helper–stimulating epitope of tetanus toxin (TT, black) and linker residues (green). The lines under the HIV sequences represent 12 previously reported CD8+ T-cell–stimulating epitopes (peptide numbers in brown); the HLA class-I molecules (A or B in blue) restricting the T-cell responses are also indicated.

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Figure 2.

ANRS VAC16 Participant flow chart.

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Table 1.

Demographic characteristics of trial participants as a function of vaccination route.

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Table 2.

Frequencies, by maximum severity, of local symptoms and systemic reactions possibly, probably or certainly related to vaccination, as a function of immunization route.

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Figure 3.

CD8+ T-cell responses (ELISpot IFNγ) to HIV peptides as a function of vaccination route, expressed as individual response.

Panel A, all responders (N = 68), and Panel B, responders given 3 injections (N = 44°. For each responder, the magnitude of the response against individual HIV peptides, expressed as the total spot-forming units per million peripheral blood mononuclear cells (SFU/106 PBMC), evaluated at times 1–4 corresponding to weeks 2, 6, 14 and 24.

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Figure 4.

CD8+ T-cell responses (ELISpot IFNγ) to HIV peptides as a function of vaccination route, expressed as cumulative percentages.

Panel A, all volunteers (N = 68), and Panel B, volunteers who received 3 injections (N = 44). The numbers of volunteers who had mounted responses to at least one HIV peptide at weeks 2, 6, 14, 24 are given above the columns: after intradermal (ID, crosshatched) or intramuscular (IM, empty) injections.

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Figure 5.

Summary of responses induced in vaccinated volunteers after 1, 2 or 3 intradermal (Panel A, N = 33) or intramuscular (Panel B, N = 35) injections.

Responses were evaluated at weeks 2, 6, 14 and 24 as follows: CD8+ T-cell responses to HIV peptides, assessed with ELISpot IFNγ (total SFU/106 PBMC defined as total SFU of positive responses minus the background: nonresponder empty; <100 crosshatched; 100–<500 solid squares; 500+ dotted); CD4+ T-cell proliferation against TT peptide (stimulation index: <3 empty; 3–<5 crosshatched; 5–<10 dotted; >10 solid) and induration present 48–72 hours postinjection (diameter (mm): none open; <5 crosshatched; 5–<10 dotted; >10 solid). Subjects in each panel are ordered as follows: CD8+ T-cell nonresponders (ELISpot IFNγ), CD4+ T-cell responders (proliferation) and, finally, CD4+ T-cell responders. Injections were given at weeks 0 and 4 to all 68 subjects and also at week 12 to 44 subjects ND, not done; NA, not applicable.

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