TABLE 1:

PREVENTATIVE AIDS VACCINE CANDIDATES STUDIED BY THE AVEG

 

PHASE I STUDIES: ENVELOPE PROTEINS

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)

REFERENCES
VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
rgp160 (LAI)
Baculovirus/insect cells (MicroGeneSys)
003, 003A, 003B
1-2
40, 80, 160, 640 µg (IM)
Aluminum Phosphate
77/51
0, 1, 6 (12 or 18)
rgp160 (IIIB)
Vaccinia/Vero cells (IMMUNO-AG)
004, 004A, 004B
3-4
12.5, 50, 200 µg (IM)
Aluminum Hydroxide + Deoxycholate
90/25
0, 1, 6 (12 & 18)

or 0, 1, 2, 3, 4, 5 (18)
ENV 2-3 (SF-2)
Yeast (BIOCINE)
005A, 005B, 005C
5
30, 100 µg (IM)
MF59 ± MTP-PE
48/30
0, 1, 6 (12)
rgp120 (IIIB)

rgp120 (MN)
CHO cells (Genentech)
006
6
100, 300 µg (IM)

300 µg (IM)
Aluminum Hydroxide

Aluminum Hydroxide
20/8
0, 1, 8 (13, 20, 30, 31)
rgp120 (SF-2)
CHO cells (BIOCINE)
007A, 007B, 007C
7
15, 50, 200 µg (IM)
MF59 ± MTP-PE
50/13
0, 1, 6 (12) or 0, 1, 2, 3, 4 (12)
rgp120 (MN)

rgp120 (IIIB)
CHO cells (Genentech)
009
8
100, 300, 600 µg (IM)

300 µg (IM)
Aluminum Hydroxide

Aluminum Hydroxide
48/9
0, 1, 6, 12

(24, 25, 32)
rgp160 (MN)
Vaccinia/Vero cells (IMMUNO-AG)
013A
9
200 µg (IM)
Aluminum Hydroxide + Deoxycholate
20/4
0, 1, 6 (18) or 0, 2, 8 (18)
rgp160 (MN)


rpg120 (MN)
Vaccinia/Vero cells (IMMUNO-AG)

CHO cells (Genentech)
013B
10
800 µg (IM)


600 µg (IM)
Aluminum Hydroxide +
Deoxycholate

Aluminum Hydroxide
16/4
0, 1, 6, 12 or 0, 2, 8, 14

(22, 24)
rgp120 (SF-2)
CHO cells (BIOCINE)
015
11
50 µg (IM)
Multiple Adjuvantsa
107/5
0, 2, 6 (18)
rgp120 (MN)
CHO cells (Genentech)
016

016A

016B
11-12
100, 300, 600 µg (IM)

300 µg (IM)

3, 30 µg (IM)
QS-21 and/or Aluminum Hydroxide
69/12

86/30

20/4
0, 1, 10 or 0, 1, 6

0, 1, 2 or 0, 1, 6

0, 1, 6

rgp120 (MN)

rgp 120 (bivalent AIDSVAX TM B/E)

CHO cells (VAXGEN)

036

NA

0.5, 3 µg (IM)

QS-21 with/without Aluminum Hydroxide

52/8
0, 1, 6
rgp120 (SF-2)
CHO cells (BIOCINE)
024
NA
50 µg (IM)
MF59
24/6
0, 1, 6, 9, 12
Table notes & References

 

 

PHASE I STUDIES - continued: PEPTIDES/POLYPEPTIDES

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)
REFERENCES

VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
V3 loop of gp120 (MN)
Synthetic octameric peptide (United Biomedical, Inc.)
011
13
20, 100, 500 µg (IM)
Aluminum Hydroxide
34/6
0, 1, 6

 
V3 loop of gp120 (15 strains)
Synthetic octameric peptide (United Biomedical, Inc.)
017

 
14
300, 1200 µg (IM)
Aluminum Hydroxide
24/4
0, 1, 6 (9)

 
V3 loop of gp120 (MN)
Synthetic octameric peptide ± encapsulation (United Biomedical, Inc.)
018

 
NA
1 or 3 mg (oral)

500 µg (IM)
-----

Aluminum Hydroxide
24/8
0, 1, 6

9
Ty p17/p24 VLP
Yeast transposon (British Biotech PLC)
019

 
NA

 
500 µg (IM)

500 µg (oral or rectal)
None or Aluminum Hydroxide
-----
30/6
0, 2, 6

11, 12
gag lipopeptide P3C541b
Synthetic octameric peptide (United Biomedical, Inc.)
021

 
NA

 
70 or 350 µg (Subcutaneous)
-----
25/6
0, 1, 2, 3

(9-12)
HIV-1 gp120 C4-V3 peptides (MN, EV91, RF, CANO)
Hybrid polyvalent synthetic peptides (Wyeth-Lederle Vaccines and Pediatrics)
020
NA
250, 1000 µg (IM)
Mineral oil + mannose monooleate (IFA)
24/4
0, 1 (suspended one month)
V3 loop of gp120 (MN)
Synthetic octameric peptide ± encapsulation (United Biomedical, Inc.)
023

 
NA

 
500 µg (IM - deltoid or anterior thigh)
3 mg (oral)
Aluminum Hydroxide

-----
28/8
0

1, 2, 8
Table notes & References

 

 

PHASE I STUDIES - continued: DNA VACCINES

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)
REFERENCES

VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
APL 400-047 HIV-1 gag/pol structural proteins (LAI)

 

Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)

 

vCP1452 - same as vCP205 + nef and pol gene products + 2 vaccinia virus coding sequences
GeneVax® DNA plasmid backbone (Apollon)

 

 

Recombinant canarypox (Pasteur Merieux Connaught)

 

 

Recombinant canarypox (Pasteur Merieux Connaught)
031

 
15

 
100, 300, 1000, 3000 µg (needle/syringe) or 300 µg (Biojector®)

1000 µg (needle/syringe)

106.7 TCID50

 

 

 

3000 µg needle/syringe

106.3 TCID50
Bupivacaine

 

 

Bupivacaine

----

 

 

 

Bupivacaine

----
42/10

 

 

24/6

(300 and 1000 µg groups)

 

 

12/2

(3000 µg group)
0, 1, 2, 6

 

 

 (24)

(25, 26)

 

 

 

(24)

(25, 26)
Table notes & References

 

 

PHASE I STUDIES - continued: POX VIRUS RECOMBINANTS/COMBINATIONS

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)
REFERENCES

VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
Vaccinia-gp160 [HIVAC-1e] (LAI)


rgp160 (LAI)
Recombinant vaccinia (Bristol-Myers Squibb/ Oncogen)

Baculovirus/insect cells (MicroGeneSys)
002, 002A, 002B
16-18
107, 108, 109 pfu/ml (Scarification)


160 or 640 µg (IM)
-----



Aluminum Hydroxide
84/18
0 or 0, 2 or 2, 6 or 21



2 or 10 or 0, 2, 6, 12 or 0, 12 or 6, 12 or 12
Vaccinia-gp160 [HIVAC-1e] (LAI)


rgp120 (SF-2) or ENV 2-3 (SF-2)
Recombinant vaccinia (Bristol-Myers Squibb/ Oncogen)

CHO cells or yeast (BIOCINE)
008

 
NA
109 pfu/ml (Scarification)



50 or 100 µg (IM)
-----



MF59
56/0
0, 8



8 and/or 12
Vaccinia-gp160 [HIVAC-1e] (LAI)


rgp120 (SF-2) or

rgp120 (IIIB) or

rgp120 (MN) or

rgp160 (MN)
Recombinant vaccinia (Bristol- Myers Squibb/ Oncogen)

CHO cells (BIOCINE) or

CHO cells (Genentech) or|

CHO cells (Genentech) or

Vaccinia/Vero cells (IMMUNO-AG)
010

 
19
109 pfu/ml (Scarification)



50 µg (IM) or

600 µg (IM) or

600 µg (IM) or

200 µg (IM)
-----

MF59

Aluminum Hydroxide

Aluminum Hydroxide

Aluminum Hydroxide + Deoxycholate
59/0
0 or 0, 4

8, 12
Canarypox-gp160 (MN) (vCP125)

rgp120 (SF-2)
Recombinant canarypox (Pasteur Merieux Connaught)

CHO cells (Chiron/BIOCINE)
012A, 012B
20
106, 107 TCID50 (IM)

50 µg (IM)
-----


MF59
121/12
0, 1 or 0, 2 or 0, 1, 9, 12


9, 12 or 0, 1, 6, 12
Vaccinia-HIV env/gag/pol (TBC-3B)
Recombinant vaccinia (Therion Biologics)
014A

 
NA
109 pfu/ml (Scarification)
-----
14/4
0, 2
Vaccinia-HIV env/gag/pol (TBC-3B)





rgp120 (MN)
Recombinant vaccinia (Therion Biologics)






CHO cells (VaxGen)
014C

 
21
106, 106 pfu/dose (Scarification);
106, 108 pfu/dose (Intradermal);
106, 108 pfu/dose (Subcutaneous)

300 µg (IM)
-----







Aluminum Hydroxide
30/6
0, 2







8, 12
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)

rgp120 (SF-2)
Recombinant canarypox (Pasteur Merieux Connaught)

CHO cells (Chiron Vaccines)
022, 022A
22
106, 107 TCID50 (IM)




50 µg (IM)
-----

MF-59
182/42
0, 1; or 2, 3, 5; or 0, 1, 3, 6; or 0, 1, 6; or 0, 1, 3, 6, 9, 12; or 0, 1, 6, 9, 12



9, 12; or 0, 1, 6, 9, 12; or 3, 6, 9, 12; or 0, 1, 3, 6, 9, 12
Canarypox-HIV gp120, TM gp41, gag, protease, CTL epitopes in pol and nef (MN/LAI) (vCP300)

rgp120 (SF-2)
Recombinant canarypox (Pasteur Merieux Connaught)




CHO cells (Chiron Vaccines)
026

 
23
106 TCID50 (IM)





50 µg (IM)
-----






MF59
119/21
0, 1, 6, 9 or 0, 1, 3, 6






6, 9 or 3, 6 or 0, 1, 6, 9
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)rgp120 (MN)
Recombinant canarypox (Pasteur Merieux Connaught)

CHO cells (VaxGen)
027

 
NA
107 TCID50 (IM and/or alternate mucosal routesb)

(IN)

300 µg (IM)
-----
56/28
0, 1, 3, 6

 

 

9, 15
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)

rgp120 (SF-2)
Recombinant canarypox (Pasteur Merieux Connaught)

CHO cells (Chiron Vaccines)
029

 
24
107 TCID50 (IM)




50 µg (IM)
-----

MF59
28/7
Days 0, 7, 14, 21

Days 28, 84

Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)



rgp120 (SF-2)

HIV-1 SF-2 p24

Recombinant canarypox (Pasteur Merieux Connaught)





CHO cells (Chiron Vaccines)

Saccharomyces cerevisiae

032

NA

106.6 TCID50 (IM)







50 µg (IM)

50 µg (IM)

-----









MF59

MF 59

56/8

0, 1, 3, 6









3, 6

0, 1, 3, 6 or 3, 6
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)


APL-400-047 HIV-1 gag/pol structural proteins (LAI)
Recombinant canarypox (Pasteur Merieux Connaught)




GeneVax® DNA plasmid backbone (Apollon)
033
NA
106.3 TCID50 (IM)






1000 µg (IM)

 
GM-CSF c (Immunex)







Bupivicaine

 
30/6

 
0, 1, 3, 6







(12, 13)

 
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)

vCP1433 - same as vCP205 + nef and pol gene products

vCP1452 - same as vCP1433 + 2 vaccinia virus coding sequences

rgp160 MN/LAI-2
Recombinant canarypox (Pasteur Merieux Connaught)

 

 

 

 

 

 

Vaccinia/BHK21 cells (Pasteur Merieux Connaught)
034
NA
106.3 TCID50 (IM)

 

 

106.6 TCID50 (IM)

 

 

106.7 TCID50 (IM)

 

50 µg (IM)
-----

 

 

-----

 

 

-----

 

Polyphosphazine (PCPP)
90/10
0, 1, 3, 6

 

 

 

 

 

 

 

3, 6

Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)

vCP1452 - same as vCP205 + nef and pol gene products + 2 vaccinia virus coding sequences

Recombinant canarypox (Pasteur Merieux Connaught)

034A

NA

106.3 TCID50 (IM)

 

 

106.7 TCID50 (IM)

-----

 

 

-----

55/5

0, 1, 3, 6
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)
Recombinant canarypox (Aventis Pasteur)

038
NA

106.3 TCID50 (IM)

-----
60/0

(20 - former 014C;

30 - former 022A;

10 - naive to HIV vaccine studies)
0
Table notes & References

 

 

PHASE I STUDIES - continued: SALMONELLA TYPHI RECOMBINANT/COMBINATION

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)
REFERENCES

VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
Salmonella typhi CVD 908 - HIV-1 LAI rgp120 (VVG 203)

rgp120 (MN)
Live attenuated recombinant Salmonella typhi (University of Maryland Center for Vaccine Development)

CHO cells (VaxGen)
028

 
NA
105, 106 cfu (oral)

107 cfu (oral)


300 µg (IM)
-----

-----


Aluminum hydroxide
20/0

24/3
0

0; or 0, 2, 6; or 6


2, 6; or 0, 2
Table notes & References

 

 

PHASE II STUDIES: ENVELOPE PROTEINS

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)
REFERENCES

VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
rgp120 (SF-2)
CHO cells (BIOCINE)
201
25
50 µg (IM)
MF59
129/20
0, 1, 6 (12 or 18)
rgp120 (MN)
CHO cells (Genentech)
201
25
600 µg (IM)
Aluminum Hydroxide
128/19
0, 1, 6 (12 or 18)
Table notes & References

 

 

PHASE II STUDIES: POX VIRUS RECOMBINANTS/COMBINATIONS

VACCINE CANDIDATE (STRAIN)

PRODUCTION METHOD (VACCINE DEVELOPER) d

AVEG PROTOCOL NUMBER(S)
REFERENCES

VACCINE DOSE (ROUTE)

ADJUVANT

#VACCINES/ #CONTROLS

VACCINATION SCHEDULE-MONTH (EXTENSION)
Canarypox-HIV gp120, TM gp41, gag, protease (MN/LAI) (vCP205)

rgp120 (SF-2)
Recombinant canarypox (Pasteur Merieux Connaught)



CHO cells (Chiron Vaccines)
202
29
106.3 TCID50 (IM)




50 µg (IM)
-----





MF59
280/140
0, 1, 3, 6
Table notes & References

 

TABLE NOTES

a rgp120(SF-2) administered with one of seven adjuvants (Aluminum Hydroxide, Monophosphoryl lipid A [MPL, Ribi ImmunoChem Research], liposome-encapsulated MPL with Alum [Walter Reed Army Institute of Research], MF59 [Chiron Vaccines], MF59 + MTP-PE [Chiron Vaccines], SAF/2 [Chiron Vaccines], SAF/2 with MDP [Chiron Vaccines]) to 15-16 volunteers. The rgp120 (SF-2) + MPL group was not offered an 18-month immunization.
b Alternate routes of administration: IM, oral, intranasal, intrarectal, intravaginal, IM+intranasal, IM+intrarectal
c GM-CSF = Granulocyte Macrophage-Colony Stimulating Factor
d Note that the vaccine developer is listed as the company name at the time of protocol initiation. Refer to the participant listings section for changes to company names which have occurred over time.