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Table 2 Characteristics of DNA vaccine studies

From: Human T-cell lymphotropic virus type 1 (HTLV-1) proposed vaccines: a systematic review of preclinical and clinical studies

Author

Year

Country

Type of study

Host

Vaccine immunogen content

Vaccine dose

Route

Prescribed number

Laboratory method

Main findings

Nakamura, Hideo

1987

Japan

in vivo

Cynomolgus monkeys (Macaca fascicularis)

env gene products of HTLV-I produced in E.coli

different (100 or 150 microg)

ID/IV

different for each group

SDS–polyacrylamide gel electrophoresis, Western blot, IFA

Ab against HTLV-I gp68 and gp46, strong inhibition of syncytium formation, humoral immunity

Grange, M. P

1997

France

in vivo

6 to 8 week old male BALB/c mice

complete HTLV-I envelope

10 microg for protein

IM (vector)/IP(protein)

[different protocls were used]

Mice were immunized IP with 10 µg of gp62 Baculovirus recombinant protein in complete Freund's adjuvant followed by three boosting doses of 10 microg of recombinant protein in incomplete Freund's adjuvant at 2-week intervals. Two mice of each DNA-primed group were immunized with protein at 14 weeks post-DNA inoculation. For comparative studies, two naive mice were immunized with protein with the same protocol

ELISA, IFA, syncytium formation assay, CTLL assay

high antibody response in response to protein boosts in mice primed with DNA expressing HTLV-I envelop proteins, high neutralizing antibody titers, memory B-cell clone stimulation via single inoculation of DNA expressing HTLV-I env gene, specific cellular helper cell response in mice

Kazanji, M

1997

France

in vivo and in vitro

WKY and Fischer F-344 rats

The complete human T-cell leukemia virus type I (HTLV-I) env gene was inserted into an expression cassette containing the adenovirus 5 major late promoter (Ad5-MLP). (Recombinant Ad5-HTLV-I-env)

Fischer F-344 rats: 107 PFU of WR-SFB5 env or control HA-WR/ WKY rats: 200 µl PBS containing 109 PFU of Ad5-HTLV-I-env (or Ad5-HTLV-I-gp46 for boosting) or 100 µg of the naked DNA expression vector pMLP-HTLV-I-env. Booster injections with baculovirus-derived recombinant gp46 (1 µg) were delivered subcutaneously together with 50 µg of saponin as adjuvant

IM/intradermally

different for host groups

IFA, western blot, PCR, SIA, CTL assay

WKY rats: No detectable Ab against HTLV-I, recovery of HTLV-I-specific cytotoxic T lymphocytes in all immunized groups but not from controls, Fischer F-344 rats: Ab against the HTLV-I env gp21 and gp46 (non-neutralizing), partial protection in both immunization regimens after challenge with human HTLV-I-producing cells (MT-2)

Ohashi, T

2000

Japan

NA

Female F344/N Jcl-rnu/rnu (nu/nu) rats and F344/N Jcl-rnu/1 (nu/1) rats

Tax-coding DNA

10 μg

The Helios Gene Gun system

twice, with a 1-week interval

Cr-release cytotoxicity assay, SDS-PAGE,

Tax-specific CTL induction, CTLs ability to lyse HTLV-1 infected syngeneic T cells in vitro, in vivo growth inhibition of HTLV-1-transformed tumor, efficient anti-tumor immunity induction

Armand, M. A

2000

France

in vivo

female BALB/c mice

two types of plasmids for DNA: 1) coding DNA of the complete env gene of HTLV-I under the control of the CMV promoter with (CMVenvLTR) or without (CMVenv) the tax/rex genes, 2) coding DNA of the complete env gene of HTLV-I under the control of the human desmin muscle specific promoter (DesEnv)

100 microg

IM

3 immunizations were performed with 2 weeks intervals

PCR, Flow-cytometry, ELISA and neutralization assays

detectable and neutralizing humoral response, higher humoral response with better neutralization properties in response to the DesEnv construct compared to CMVenvLTR or CMVenv plasmids