Table 1. Dealings with replication competent vectors

Characteristics of the vector
Characteristics of donor nucleic acid (transgene)
Characteristics of the dealings
In vitro
In vivo
Regulations as amended July 2007
Regulations as amended Sept 2011*
Regulations as amended July 2007
Regulations as amended Sept 2011*
Any virus which meets the criteria of a Risk Group 4 microorganism in AS/NZS 2243.3:2010 with any genetic modification
Not differentiated from below
DNIR 3.1(p)
Not differentiated from below
DNIR 3.1(p)
Any replication competent vector
Toxin or uncharacterised gene from toxin producing organism
DNIR 3.1 (a), (b) or (c)
Genes whose expressed products are likely to increase the capacity of the virus/viral vector to induce an autoimmune response
DNIR
3.1 (g)
DNIR
3.1 (h)
DNIR
3.1 (g)
DNIR
3.1 (h)
Creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility
DNIR
3.1 (h)
DNIR
3.1 (i)
DNIR
3.1 (h)
DNIR
3.1 (i)
Non-pathogenic plant virus
Or
Baculovirus (Autographa californica nuclear polyhedrosis virus), polyhedrin minus
Not a toxin and not a pathogenic determinant and not an oncogenic modification
exempt
(PC2 NLRD
2.1 (f) if > 25L)
exempt
(PC2 NLRD
2.1 (f) if > 25L)
PC2 NLRD
2.1 (c)
Oncogenic modification
PC1 NLRD 1.1(b)
Exempt (PC2 NLRD 2.1 (f) if > 25L)
Pathogenic determinant
PC2 NLRD
2.1(e)
DNIR
3.1 (f)
DNIR
3.1 (g)
All others
(now including Avipox vectors)
Not a toxin and not a pathogenic determinant and not an oncogenic modification and not immunomodulatory in humans
PC2 NLRD
2.1 (c) or (d)
Oncogenic modification or immunomodulatory in human
DNIR
3.1(d)
DNIR
3.1(e)
DNIR
3.1(d)
DNIR
3.1(e)
Pathogenic determinant
DNIR
3.1 (e) or (f)
DNIR
3.1 (f) or (g)
DNIR
3.1 (e) or (f)
DNIR
3.1 (f) or (g)
Drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the viral vector
DNIR
3.1 (n)
DNIR
3.1 (o)
DNIR
3.1 (n)
DNIR
3.1 (o)

Table 2. Dealings with replication defective1 retroviral vectors

Characteristics of the vector
Characteristics of donor nucleic acid (transgene)
Characteristics of the dealings
Able to transduce human cells
SIN2
Accessory genes present3
In vitro
In vivo
Regulations as amended July 2007
Regulations as amended Sept 2011*
Regulations as amended July 2007
Regulations as amended Sept 2011*
Yes or no
Yes or no
Yes or no
Toxin or uncharacterised gene from toxin producing organism
DNIR 3.1 (a), (b) or (c)
Genes whose expressed products are likely to increase the capacity of the virus/viral vector to induce an autoimmune response
DNIR
3.1 (g)
DNIR
3.1 (h)
DNIR
3.1 (g)
DNIR
3.1 (h)
Creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility
DNIR
3.1 (h)
DNIR
3.1 (i)
DNIR
3.1 (h)
DNIR
3.1 (i)
No
Yes or no
Yes or no
Not a toxin and not a pathogenic determinant and not an oncogenic modification and not immunomodulatory in humans
exempt
(PC2 NLRD 2.1 (f) if > 25L)
PC2 NLRD
2.1 (c) & (d)
PC2 NLRD
2.1 (i)
Immunomodulatory in humans
DNIR
3.1 (d)
Oncogenic modification
PC1 NLRD
1.1 (b)
exempt
(PC2 NLRD 2.1 (f) if > 25L)
Pathogenic determinant
PC2 NLRD
2.1 (e)
PC2 NLRD
2.1 (c) & (d)
Yes
Yes
No
Not a toxin and not an oncogenic modification and not immunomodulatory in humans
PC2 NLRD
2.1 (i)
PC2 NLRD
2.1 (l)
PC2 NLRD
2.1 (d)
PC2 NLRD
2.1 (m)
Oncogenic modification or immunomodulatory in human
DNIR
3.1 (d)
DNIR
3.1 (d) & (j)
Yes
Not a toxin and not an oncogenic modification and not immunomodulatory in humans
DNIR
3.1 (i)
PC2 NLRD
2.1 (l)
DNIR
3.1 (i)
PC2 NLRD
2.1 (m)
Oncogenic modification or immunomodulatory in human
DNIR
3.1 (d) & (i)
DNIR
3.1 (d) & (i)
DNIR
3.1 (d) & (j)
No
No
Not a toxin and not an oncogenic modification and not immunomodulatory in humans
Lentiviral: DNIR 3.1 (i)
PC2 NLRD
2.1 (l)
Lentiviral: DNIR 3.1 (i)
PC2 NLRD
2.1 (m)
other: PC2 NLRD 2.1 (i)
other: PC2 NLRD 2.1 (i)
Oncogenic modification or immunomodulatory in human
Lentiviral: DNIR 3.1 (i)
DNIR
3.1 (d) & (i)
DNIR
3.1 (d) & (j)
other: PC2 NLRD 2.1 (i)
Yes
Not a toxin and not an oncogenic modification and not immunomodulatory in humans
DNIR
3.1 (i)
DNIR
3.1 (j)
DNIR
3.1 (i)
DNIR
3.1 (j)
Oncogenic modification or immunomodulatory in human
DNIR
3.1 (d) & (i)
DNIR
3.1 (d) & (j)
DNIR
3.1 (d) & (i)
DNIR
3.1 (d) & (j)

1 Replication defective retroviral vectors must include safety features to reduce the likelihood of recombination leading to replication competence being regained, including that all viral genes must be removed from the retroviral vector so that it cannot replicate or assemble into a virion without these functions being supplied in trans, and that viral genes needed for virion production must be expressed from independent, unlinked loci with minimal sequence overlap

2Indicates the presence of a ‘self inactivating’ deletion in the unique 3’ region of the long terminal repeat (LTR) that eliminates the LTR promoter activity after integration of the provirus into the host genome

3Only gagpol, env (and rev if a lentiviral vector) present in the packaging system


Table 3. Dealings with replication defective non-retroviral vectors

Characteristics of the vector
Characteristics of the donor nucleic acid (transgene)
Characteristics of the dealings
In vitro
In vivo
Regulations as amended July 2007
Regulations as amended Sept 2011*
Regulations as amended July 2007
Regulations as amended Sept 2011*
Any viral vector derived from a virus which meet the criteria of a Risk Group 4 microorganism in AS/NZS 2243.3:2010 with any donor nucleic acid
Not differentiated from below
DNIR 3.1(p)
Not differentiated from below
DNIR 3.1(p)
All replication defective non-retroviral vectors, able or not able to transduce human cells
Toxin or uncharacterised gene from toxin producing organism
DNIR 3.1 (a), (b) or (c)
Genes whose expressed products are likely to increase the capacity of the virus/viral vector to induce an autoimmune response
DNIR
3.1 (g)
DNIR
3.1 (h)
DNIR
3.1 (g)
DNIR
3.1 (h)
Creates novel replication competent virus with altered host range or mode of transmission, or increased virulence, pathogenicity or transmissibility
DNIR
3.1 (h)
DNIR
3.1 (i)
DNIR
3.1 (h)
DNIR
3.1 (i)
Not able to transduce human cells
Not a toxin and not a pathogenic determinant and not an oncogenic modification and not immunomodulatory in humans
exempt

(PC2 NLRD 2.1 (f) if > 25L)

PC2 NLRD
2.1 (c) & (d)
PC2 NLRD

2.1 (i)

Immunomodulatory in humans
DNIR
3.1 (d)
Oncogenic modification
PC1 NLRD
1.1 (b)
exempt
(PC2 NLRD 2.1 (f) if > 25L)
Pathogenic determinant
PC2 NLRD
2.1 (e)
PC2 NLRD
2.1 (c) & (d)
Able to transduce human cells,

Human adenovirus or

Adeno associated virus

Not a toxin and not an oncogenic modification and not immunomodulatory in humans
PC1 NLRD
1.1 (c)
PC2 NLRD
2.1 (d)
PC2 NLRD
2.1 (k)
Immunomodulatory in humans
PC1 NLRD
1.1 (c)
PC2 NLRD
2.1 (j)
DNIR
3.1 (d)
Oncogenic modification
PC2 NLRD
2.1 (i)
Drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the viral vector
DNIR
3.1 (n)
DNIR
3.1 (o)
DNIR
3.1 (n)
DNIR
3.1 (o)
Able to transduce human cells

(other viruses)

Not a toxin and not oncogenic modification and not immunomodulatory in humans
PC1 NLRD
1.1 (c)
PC2 NLRD

2.1 (j)

PC2 NLRD
2.1 (d)
PC2 NLRD
2.1 (k)
Immunomodulatory in humans
DNIR
3.1 (d)
Oncogenic modification
PC2 NLRD
2.1 (i)
Drug resistance genes or other nucleic acid that could impair practical treatment of any disease or abnormality caused by the viral vector
DNIR
3.1 (n)
DNIR
3.1 (o)
DNIR
3.1 (n)
DNIR
3.1 (o)


*Effective from 1 September 2011, incorporating amendments up to the Gene Technology Amendment Regulations 2011 (No. 1). This table provides guidance only and does not constitute legal advice. Users must refer to the complete applicable conditions and exclusions in the Gene Technology Regulations 2001, as amended.