HIVconsv |
14 highly conserved cross-clade regions presented by many distinct HLAs encoding 778 amino acids |
Gag, Pol, Vif, Env |
NCT01024842 (HIV-CORE001) |
MVA.HIVconsv |
19 virologically suppressed ART-treated HIV-infected patients |
Modest immunogenicity |
No significant change in the viral reservoir |
NCT01712425 (BCN01) |
ChAdV63.HIVconsv prime/ MVA.HIVconsv boost |
24 newly HIV-1 infected patients on HAART |
Safe and immunogenic |
Redirection pre-existing HIV-1-specific T-cell responses to vaccine-encoded conserved segments in all participants |
No effect on viral reservoir in volunteers |
NCT02616874 (BCN02) |
MVA.HIVconsv + Romidepsin |
15 HIV-1 infected patients from BCN01 trial with sustained viral suppression |
Broad HIVconsv-specific T-cells |
Significant reduction of the viral reservoir |
Durable suppression of viremia in 23% of recipients |
No significant pro-viral reduction |
NCT02336074 (RIVER) |
ChAdV63.HIVconsv prime/ MVA.HIVconsv boost + Vorinostat |
60 newly HIV-1 infected patients on ART |
Safe |
Induction HIV-specific T-cell response |
No significant pro-viral reduction |
tHIVconsvX |
Bivalent complementary mosaic immunogens contain 6 protective conserved fragments encoding 895 amino acids with maximum number of PTEs |
Gag, Pol |
NCT03844386 |
MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) alone or in combination (M3+M4) |
24 HIV-infected patients with durable viral suppression on ART |
Safe and well tolerated |
No serious adverse reaction |
LIPO-5 |
Five HIV peptides containing multiple CD8+ and CD4+ T-cell epitopes and coupled to a palmitoyl tail |
Nef, Gag, Pol |
NCT00796770 (DALIA Trial) |
Ex vivo-generated dendritic cells (DCs) loaded with LIPO-5 |
12 chronic HIV-infected patients on HAART |
Safe |
Induction of HIV-1 specific immune responses |
Expansion in HIV-specific CD8+ T cells |
Virus rebound was observed after 14 days ATI |
NCT01492985 |
ART + DNA GTU-MultiHIV vaccine prime/ LIPO-5 peptide-mix boost |
105 chronic asymptomatic HIV-infected patients |
Safe and immunogenic |
No viral replication control after a 12-week ATI |
AFO-18 |
Peptides containing 15 subdominant conserved CTL epitopes bound to the HLA supertype + 2 HTL and 1 universal HTL peptide |
Gag, Pol, Nef, Env, Vpu, Vif |
NCT01141205 (HIV-BIS) |
AFO-18 peptide mixed with CAF01 adjuvant |
18 untreated chronic HIV-1 infected patients |
Safe |
Induction of new vaccine-specific T-cell responses in 42% of recipients |
No significant pro-viral reduction |
NCT01009762 (HIV-VAC) |
AFO-18 peptide mixed with CAF01 adjuvant |
11 untreated chronic HIV-1 infected patients |
Induction of new CD4+ and CD8+ T-cell responses |
No significant viral load reduction |
No significant change in CD4+ T-cell counts |
HIV-v |
Peptides containing short, conserved T-cell multiepitope domains |
Nef, Rev, Vif, Vpr |
NCT01071031 |
HIV-v peptide-mixed with ISA-51 adjuvant |
54 untreated HIV-infected patients |
Safe |
Induction T- and B-cell responses in 75% and 45% of participants, respectively |
Viral load reduction |
|
HTI |
16 regions containing more than 50 CD4+ and CD8+ T-cell potentially beneficial and mutational intolerant epitopes restricted by broad HLA-I and HLA-II joined by poly-alanine enriched linkers encoding 529 amino acids |
Gag, Pol, Vif Nef |
NCT02413645 (iHIVARNA-01) |
mRNA encoding HTI with TriMiX mRNAs |
21 chronic HIV-infected patients on stable ART |
Safe, moderately immunogenic |
Moderated induction of |
HIV-1-specific T-cell responses |
NCT02888756 |
mRNA encoding HTI with TriMiX mRNAs |
70 chronic HIV-infected patients on stable ART |
No significant immunogenicity |
NCT03204617 (AELIX-002) |
DNA.HTI (D) MVA.HTI (M) ChAdOx1.HTI (C) DDDMM followed by CCM |
45 newly HIV-infected patients early treated with ART |
Safe |
Highly immunogenic in 97% of recipients |
HIV-specific T-cell response with a prolonged time off ART in 40% of recipients |
NCT04385875 |
48-weeks ATI extension of AELIX-002 study |
6 AELIX-002 participants with pVL less than 2000 copies/mL |
Completed |
NCT04364035 (AELIX-003) |
ChAdOx1.HTI prime/ MVA.HTI boost + Vesatolimod |
57 HIV-infected patients early treated with ART |
Not completed |
NCT03619278 (HIVACAR) |
mRNA encoding HTI with TriMiX mRNAs prime/ MVA.HTI boost + 10-1074 Abs + Romidepsin |
56 HIV-infected patients on stable ART |
Unknown |
NCT05208125 (BCN03) |
ChAdOx1.HTI and MVA.HTI + ConM SOSIP.v7 gp140 with MPLA liposome adjuvant |
30 virologically suppressed ART-treated HIV-infected patients |
Not completed |
Gag and Pol conserved peptides |
Peptides containing ultra-conserved elements included at least 5 PTEs |
Gag and Pol |
NCT03758625 (DC-HIV04) |
Autologous matured DCs loaded with autologous-inactivated HIV or conserved HIV Gag and Pol peptide pool |
40 HIV-1 infected patients on HAART |
Not completed |
Vacc-4x |
Conserved regions from p24 |
Gag |
NCT00659789 |
Peptide vaccine (Vacc-4x: combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13 peptides) with Leukine adjuvant |
137 HIV-infected patients on ART |
Induction of proliferative T-cell responses |
Significant difference in viral load between placebo and vaccine recipients |
NCT01712256 |
Re-boosting study using Vacc-4x with Leukine adjuvant |
33 HIV-infected patients from NCT00659789 who have maintained an adequate response to ART |
Significant reduction in pvDNA (49%) |
Similar T-cell proliferation responses to NCT00659789 study |
NCT01473810 |
Peptide vaccine (Vacc-4x: combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13 peptides) with Endocin adjuvant |
24 HIV-infected patients on stable ART |
Induction of proliferative T-cell responses |
Significant difference in viral load between placebo and vaccine recipients |
NCT01704781 (IMID) |
Peptide vaccine (Vacc-4x: combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13 peptides) with Leukine adjuvant + Lenalidomide |
36 HIV-infected patients on ART |
Significant enhancement of CD4+ T-cell counts in patients with low pre-ART CD4+ counts |
|
NCT02092116 (REDUC) |
Peptide vaccine (Vacc-4x: combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13 peptides) with Leukine adjuvant + Romidepsin |
26 HIV-infected patients on ART |
Reduction of the latent HIV reservoir |
No significant reduction in integrated HIV DNA |
p24CE1/2 |
Seven highly conserved elements of p24 associated with viremia control |
Gag |
NCT03560258 |
DNA vaccine (pDNA) p24CE1/2 alone or mixed with the full-length pDNA55^gag vaccine |
45 HIV-infected patients on ART |
Safe and well tolerated |
No serious adverse reaction |
|
NCT04357821 |
DNA vaccine (pDNA) p24CE1/2 + IL-12 Prime/ MVA/HIV62B boost + Lefitolimod + VRC07-523LS and 10-1074 Abs |
11 HIV-infected patients on ART |
Not completed |