. 2012 Sep 7;9:72. doi: 10.1186/1742-4690-9-72

Table 2.

HIV-antigen specific therapeutic vaccinations

a) Non dendritic cell-based
Name Trial	Species	Baseline patients characteristics	Type of immune therapy	Route and frequency of administration	Number of patients	Outcome	References
Uncontrolled clinical trial	Human	Therapy naïve	Remune®	iv	2527	Increased HIV-specific T cell responses. Positive impact on controlling the virus.	[78]
P2101B (thai open label trial)	Human	Therapy naïve	Remune®	iv every 12 weeks for 132 weeks	223	Increasing CD4 and CD8 T cell counts and stable viral load.	[79]
Randomized double blind placebo controlled trial	Human	HAART	ALVAC, ALVAC + Remune, placebo	iv injections Alvac @w 8, 12, 16, 20. Remune@w 0, 4, 12, 20	79	Safe and immunogenic. No difference between the three groups after STI on viral rebound.	[80]
Placebo controlled	Indian rhesus macaque	Chronic SIV HAART	SIV mac239 gag and env DNA vaccine	im 3 injections	23	Increase in HIV specific cellular responses and lower viral rebound in vaccinated animals.	[81]
	Indian rhesus macaque	Chronic SIV HAART	SIV mac239 gag and env DNA vaccine + IL-15	In vivo electroporation	3	Sustained polyfunctional T cells. One log decrease in VL.	[82]
	Human	HAART	DNA vaccine consisting of CTL epitopes	im injections w 0, 4, 8, 16	41	Safe and tolerable. In some persons weak responses. Overall no differences with placebo group.	[83]
VRC HIV DNA 009-00-VP double blind placebo controlled	Human	HAART	plasmid DNA encoding subtype B Gag-Pol-Nef and multiclade env	im injections w 0, 4, 8, 24	20	Poorly immunogenic. No effect on viral rebound after ATI.	[84]
	Human	HAART	Plasmid DNA multiclade	Patch	12	Broader and higher HIV specific T-cell responses. No effect on viral rebound after ATI.	[85]
ANRS 094 single arm open	Human		ALVAC vCP1433	im injections w 0, 4, 8, 12	50	Safe and immunogenic. Delay in treatment resumption of ATI.	[86]
ANRS 093	human	HAART	ALVAC + lipo 6T 4 injections followed by 3 cycles sc IL2	im injections of ALVAC w 0, 4, 8, 12. IL-2@w 16, 24, 32	71	Lower viral set point after ATI, correlated with HIV specific CD4 T cell responses.	[87]
ACTG (A5024) randomized partially blinded phase II	Human	HAART	ALVAC ALVAC + sc IL2 sc IL2 alone placebo	im injections of ALVAC w 0, 4, 8, 12. IL-2 sc for5 days in 8 week cycles	19	Lower viral rebound after ATI in ALVAC vaccines. IL-2 + vaccine boosted CD4 T cell count but had no influence on VL.	[88]
Double blind placebo controlled	Human	HAART (acute phase)	ALVAC ALVAC + Remune	iv injection of ALVAC w8, 12, 16, 20. remune w 0, 4, 12, 20	79	No influence on VL after ATI. Increased CD4 and CD8 T cell responses	[80]
CTN173 randomized controlled	Human	HAART	ALVAC, ALVAC + remune, placebo	im injections of ALVAC w8, 12, 16, 20. Remune w0, 12, 20. ATI w24	52	No lower viral setpoint. Tendency towards delay of rebound	[89]
ORVACS	Human	HAART	ALVAC vcp1420 placebo	im injections w 0, 4, 8, 20	65	Higher viral rebound in vaccines	[90]
	Human	HAART	Fowlpox gag/pol (PC)	3 im injections (w 0,4, 12). ATI w20	35	Lower man viral rebound in FC group and this is associated with IgG2 antibodies to HIVp24	[91][92]
			Fowlpox gag/pol IFN-y (FC
			placebo
	Indian rhesus macaque	Chronic SIV HAART	MVA gag pol and MVA env	im injections w10, 16. STI w20	18	Tendency lower viral rebound after ATI but not significant.	[93]
	Rhesus macaque	Chronic SIV HAART	MVA + Ad5 gag and env	im injection of Ad5/35 on day 74 and MVA-SIV on day 134		Vaccinated animals had higher CD4 T cell counts, SIV-specific cell-mediated immunity and anti-SIV-neutralizing antibodies. After ATI there was a sustained reduction in VL and increased CD4 T cell responses.	[94]
	Human	HAART	MVA nef	sc injections w 0, 4, 16. ATI w 18	14	Well tolerated. Induction HIV specific responses. Lower viral rebound.	[95]
	Human	HAART	MVA clade A p24/17 + CD8 T cell epitopes	id 4 week interval	18	Amplification and broadening of CD8 and CD4 T cell responses. Induction of CD8 T cell responses with capacity to inhibit viral replication in vitro	[96][97]
	Indian rhesus macaque	Chronic SIV HAART	Ad5 and Ad35 SIV gag, env, nef + IL15	im injections	15	Increased T cell responses no effect on viral rebound.	[98]
	Indian rhesus macaque	Chronic SIV HAART	Ad5 and Ad35 SIV gag, env, nef + IL15	w 16, 22, 36, 42	15	Increased T cell responses no effect on viral rebound.	[98]
	Human	HAART	rAd5 gag	im injections	114	Safe and well tolerated. 0.5 log lower VL 16 weeks after A-STI	[99]
				w 0, 4, 26.
				ATI w 38 to 54
b) Dendritic cell-based
Species	Number and baseline characteristics	Loading strategy	Antigen	Results			References
Human	6 therapy- naïeve	Pulsing	Recombinant HIV-1 MN gp160 or synthetic peptides corresponding to HLA-A2- restricted cytotoxic epitopes of envelope, Gag, and Pol proteins	Well tolerated and no effect on viral load. HIV specific responses were enhanced.			[100]
Human	4 HAART	Pulsing	Seven CTL peptides with HLA-A*2402 restriction	Well tolerated, discontinuation of HAART after vaccination failed to lower viral set points. CD8 T cell responses induced in 2 out of 4 patients.			[101]
Pigtail macaque	36 HAART	Pulsing of whole blood	Gag proteins or peptides spanning all 9 SIV proteins	SIV-specific CD4 and CD8T cell responses during antiretroviral cover and off treatment. Virus levels were 10-fold lower in immunized animals for 1 year.			[102]
Chinese rhesus macaques	HAART	Pulsing	AT-2 inactivated virus	Effective and durable SIV-specific cellular and humoral immunity is elicited. At week 34 of the study: 50-fold decrease of SIV DNA and a 1,000-fold decrease of SIV RNA.			[103]
Human	18 therapy naieve	Pulsing	AT-2-inactivated virus	Plasma viral load levels were decreased by 80% (median) over the first 112 days following immunization. The suppression of viral load was positively correlated with HIV-1-specific interleukin-2 or IFN-γ expressing CD4 T cells and with HIV-1 gag-specific perforin-expressing CD8 effector cells.			[104]
Human	12 HAART	Pulsing	Heat-inactivated virus	Safe and well tolerated. Partial viral control 24 weeks after ATI .			[105]
Human	24 therapy- naïeve	Pulsing	Heat-inactivated virus	Feasible, safe and well tolerated. Modest decrease in viral load 24 weeks after first vaccination compared to controls.			[106]
Human	29 HAART	Live virus	ALVACvcp1452	Viral load rebounded in both groups no differences in HIV-specific immune responses.			[107]
			ALVACvcp1452 + KLH
			KLH
Human	9 HAART	Electroporation	Autologous mRNA encoding Gag, Vpr, Rev and Nef	Mild adverse events. Full or partial HIV-specific immune responses in 7/9 subjects.			[108]
Human	9 HAART	Electroporation	Autologous mRNA encoding Gag, Vpr, Rev and Nef	Partial viral control .			[109]
Human	17 HAART	Electroporation	mRNA encoding tat rev nef	Vaccine was safe, 69 weeks after STI 6/17 patients remains off therapy.			[110]
Human	6 HAART	Electroporation	mRNA encoding gag and mRNA encoding tat rev nef	Vaccine was safe. HIV-specific responses against Gag were broader, higher and polyfunctional after vaccination. CD8 T-cells could inhibit superinfection of CD4 T-cells.			[111]