A subunit chicken pox vaccine in HIV+ patients
In a recent study from the Zoster-015 HZ/su study group headed by GSK, a Phase I/II randomized, placebo controlled study to evaluate the safety and immunogenicity of an investigational herpes zoster subunit vaccine was performed.
To briefly provide a background to the study, the incidence of shingles in HIV-infected adults is 10-20 times higher than in an age-matched general population. This reduced upon the introduction of anti-retroviral therapy but remains 3-5 times higher than in the general population. Vaccination offers protection against shingles and its complications in HIV-infected patients but the use of the vaccine in immunocompromised individuals is fraught with risk due to the potential to cause disease. This necessitated a need to develop a subunit vaccine against shingles.
Method:
Vaccine:
The subunit vaccine consisted of the VZv gE antigen along with an adjuvant. The vaccine was administered to HIV+ patients who were ART/high CD4, ART/low CD4 and ART naive/high CD4.
Subjects:
ART/high CD4: 94 subjects
ART/low CD4 : 14
ART naive/high CD4: 15
Assessment:
CD4 cells expressing 2 activation markers (IFNg, IL2, TNFa, CD40L): CD4(2+)
Results:
gE-specific CD4(2+) T cells increased frequency with vaccination.
100% subjects were seropositive for anti-gE antibodies before vaccination and were positive thereafter in vaccinated group compared to 97.2-100% in the control group.
Vaccination did not affect CD4 T cell counts or HIV viral loads.
Vaccine was safe despite reactogenicity to the vaccine.
Comments:
Previously, Varivax, a live attenuated vaccine was modestly immunogenic in HIV+ patients (Weinberg A, 2010).
Heat inactivated zoster vaccine induced low but significant VZV-specific T cell and antibody response.
Conclusion: Immunization with adjuvanted VZV-gE subunit vaccine can reduce the burden of shingles in HIV+patients.
To briefly provide a background to the study, the incidence of shingles in HIV-infected adults is 10-20 times higher than in an age-matched general population. This reduced upon the introduction of anti-retroviral therapy but remains 3-5 times higher than in the general population. Vaccination offers protection against shingles and its complications in HIV-infected patients but the use of the vaccine in immunocompromised individuals is fraught with risk due to the potential to cause disease. This necessitated a need to develop a subunit vaccine against shingles.
Method:
Vaccine:
The subunit vaccine consisted of the VZv gE antigen along with an adjuvant. The vaccine was administered to HIV+ patients who were ART/high CD4, ART/low CD4 and ART naive/high CD4.
Subjects:
ART/high CD4: 94 subjects
ART/low CD4 : 14
ART naive/high CD4: 15
Assessment:
CD4 cells expressing 2 activation markers (IFNg, IL2, TNFa, CD40L): CD4(2+)
Results:
gE-specific CD4(2+) T cells increased frequency with vaccination.
100% subjects were seropositive for anti-gE antibodies before vaccination and were positive thereafter in vaccinated group compared to 97.2-100% in the control group.
Vaccination did not affect CD4 T cell counts or HIV viral loads.
Vaccine was safe despite reactogenicity to the vaccine.
Comments:
Previously, Varivax, a live attenuated vaccine was modestly immunogenic in HIV+ patients (Weinberg A, 2010).
Heat inactivated zoster vaccine induced low but significant VZV-specific T cell and antibody response.
Conclusion: Immunization with adjuvanted VZV-gE subunit vaccine can reduce the burden of shingles in HIV+patients.
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