Safety, immunogenicity, and protective efficacy of NYVAC-JEV and ALVAC-JEV recombinant Japanese encephalitis vaccines in rhesus monkeys.

Two poxvirus-vectored vaccines for Japanese encephalitis (JE), NYVAC-JEV and ALVAC-JEV, were evaluated in rhesus monkeys for safety, immunogenicity, and protective efficacy. The vaccines were given to four monkeys each on study days 0 and 28 along with saline placebo on day 7. For controls, the licensed BIKEN JE vaccine and a saline placebo were given to other groups of four monkeys on days 0, 7, and 28. No systemic effects were observed. All injection site reactions were mild. All vaccines elicited appreciable JE-specific neutralizing antibody responses. However, a more rapid increase and higher peak level of antibody were seen in the BIKEN group as compared with the NYVAC-JEV and ALVAC-JEV groups. The peak neutralizing antibody level in the NYVAC-JEV group was higher than that of the ALVAC-JEV group. Antibody persisted in all four BIKEN recipients through 273 days of follow-up, whereas, the antibody level decreased to the threshold of detection in two NYVAC-JEV and all four ALVAC-JEV recipients by day 120. On day 273, all monkeys were given a booster dose. A rapid increase in neutralizing antibody was seen in all vaccine recipients by seven days. Two months after the booster dose, all monkeys were challenged intranasally with one 90% effective dose of JE virus. Four recipients of saline, three of ALVAC-JEV, one of NYVAC-JEV, and one of BIKEN experienced encephalitis. This study suggests that the NYVAC-JEV and ALVAC-JEV vaccines are safe and immunogenic in monkeys and that the NYVAC-JEV and BIKEN vaccines are effective in protecting monkeys from encephalitis.

[1]  E. Paoletti,et al.  Immunogenicity and protective efficacy of a human immunodeficiency virus type 2 recombinant canarypox (ALVAC) vaccine candidate in cynomolgus monkeys. , 1996, The Journal of infectious diseases.

[2]  E. Paoletti,et al.  NYVAC-Pf7: a poxvirus-vectored, multiantigen, multistage vaccine candidate for Plasmodium falciparum malaria , 1996, Infection and immunity.

[3]  P. Arlien‐Søborg,et al.  Neurological complications and Japanese encephalitis vaccination , 1996, The Lancet.

[4]  E. Paoletti,et al.  Human safety and immunogenicity of a canarypox-rabies glycoprotein recombinant vaccine: an alternative poxvirus vector system. , 1996, Vaccine.

[5]  T. Matsuishi,et al.  Acute disseminated encephalomyelitis after treatment with Japanese B encephalitis vaccine (Nakayama-Yoken and Beijing strains). , 1995, Journal of neurology, neurosurgery, and psychiatry.

[6]  E. Paoletti,et al.  Biological and immunogenic properties of a canarypox-rabies recombinant, ALVAC-RG (vCP65) in non-avian species. , 1995, Vaccine.

[7]  E. Paoletti,et al.  Avipox virus-vectored Japanese encephalitis virus vaccines: use as vaccine candidates in combination with purified subunit immunogens. , 1994, Vaccine.

[8]  N. Begg,et al.  Systemic allergic reactions to Japanese encephalitis vaccines. , 1994, Vaccine.

[9]  E. Paoletti,et al.  Induction of cytotoxic T lymphocytes by recombinant canarypox (ALVAC) and attenuated vaccinia (NYVAC) viruses expressing the HIV-1 envelope glycoprotein. , 1993, Virology.

[10]  E. Paoletti,et al.  A highly attenuated host range-restricted vaccinia virus strain, NYVAC, encoding the prM, E, and NS1 genes of Japanese encephalitis virus prevents JEV viremia in swine. , 1992, Virology.

[11]  M. Perkus,et al.  Highly attenuated poxvirus vectors. , 1992, AIDS research and human retroviruses.

[12]  E. Paoletti,et al.  Mice immunized with a subviral particle containing the Japanese encephalitis virus prM/M and E proteins are protected from lethal JEV infection. , 1992, Virology.

[13]  M. Perkus,et al.  NYVAC: a highly attenuated strain of vaccinia virus. , 1992, Virology.

[14]  D. Vaughn,et al.  The epidemiology of Japanese encephalitis: prospects for prevention. , 1992, Epidemiologic reviews.

[15]  E. Paoletti,et al.  Comparison of protective immunity elicited by recombinant vaccinia viruses that synthesize E or NS1 of Japanese encephalitis virus. , 1991, Virology.

[16]  T. Ruff,et al.  Adverse reactions to Japanese encephalitis vaccine , 1991, The Lancet.

[17]  H. Robinson,et al.  Japanese encephalitis vaccine and adverse effects among travellers. , 1991, Canada diseases weekly report = Rapport hebdomadaire des maladies au Canada.

[18]  T. Rønne,et al.  Side-effects with Japanese encephalitis vaccine , 1991, The Lancet.

[19]  E. Paoletti,et al.  Japanese encephalitis virus-vaccinia recombinants produce particulate forms of the structural membrane proteins and induce high levels of protection against lethal JEV infection. , 1991, Virology.

[20]  A. Nisalak,et al.  An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. , 1989, The American journal of tropical medicine and hygiene.

[21]  D. Trent,et al.  Japanese encephalitis virus live-attenuated vaccine, Chinese strain SA14-14-2; adaptation to primary canine kidney cell cultures and preparation of a vaccine for human use. , 1988, Vaccine.

[22]  R. Chanock,et al.  Passive transfer of respiratory syncytial virus (RSV) antiserum suppresses the immune response to the RSV fusion (F) and large (G) glycoproteins expressed by recombinant vaccinia viruses , 1988, Journal of virology.

[23]  A. Nisalak,et al.  Protection against Japanese encephalitis by inactivated vaccines. , 1988, The New England journal of medicine.

[24]  Y. Xin,et al.  Safety of a live-attenuated Japanese encephalitis virus vaccine (SA14-14-2) for children. , 1988, The American journal of tropical medicine and hygiene.

[25]  B. Moss,et al.  Immunization with a vaccinia virus recombinant expressing herpes simplex virus type 1 glycoprotein D: long-term protection and effect of revaccination , 1988, Journal of virology.

[26]  A. Budak.  [Japanese encephalitis]. , 1975, Fel'dsher i akusherka.

[27]  A. Nisalak,et al.  A plaque reduction test for dengue virus neutralizing antibodies. , 1967, Journal of immunology.