Immunotherapy with an HIV-DNA Vaccine in Children and Adults
Abstract
:1. Introduction
2. Experimental
2.1. Study Subjects and Trial Design
Characteristics | Paediatric Study (N = 20) | Adult Study (N = 12) |
---|---|---|
Age ± SD, year | 11.6 ± 2.6 | 41.7 ± 6.8 |
Sex, no. male/female | 7/13 | 12/0 |
Caucasian race, no. (%) | 18 (90%) | 10 (83%) |
Placebo/HIV-DNA vaccine, no. | 10/10 | 4/8 |
CD4+ T-cells/mm3 at baseline, mean ± SD | 763.6 ± 231.1 | 685.9 ± 137.7 |
CD4+ T-cells/mm3 at last visit, mean ± SD | 803.1 ± 237.5 | 545.4 ± 148.1 |
HIV-RNA level at baseline copies/mL, mean | <50 | <50 |
HIV-RNA level at last visit copies/mL, mean | <50 | <50 |
Duration of vaccination: duration of study weeks | 36:96 | 28:60 |
Antiretroviral therapy during study, weeks | 96 | 21 |
Observation period, weeks | 156 | 300 |
2.2. Vaccine Formulation and Administration Technology
2.3. Safety Evaluation
2.4. Laboratory Assays
2.4.1. CD4+ T-Cell Counts, Plasma HIV-1 RNA Levels and Cell-Associated HIV-DNA Quantification
2.4.2. Cellular Immune Responses
2.4.3. Humoral Immune Responses
2.5. Ethics
2.6. Statistical Analysis
3. Results
3.1. Patients Enrolled
3.2. Safety
Grade 1 | Grade 2 | Grade 3 | ||||
---|---|---|---|---|---|---|
Local | Systemic | Local | Systemic | Local | Systemic | |
Vaccinated children (n = 10) | 12 | 16 | 2 | 6 | 0 | 0 |
Vaccinated adults (n = 8) | 39 | 17 | 0 | 4 | 1 | 0 |
3.3. CD4+ T-Cell Counts, Plasma HIV-1 RNA Levels and Cell-Associated HIV-DNA Quantification
3.4. HIV-Specific Immune Responses
3.4.1. Cellular Immune Responses
3.4.2. Humoral Responses
4. Discussion
5. Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Appendix
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Palma, P.; Gudmundsdotter, L.; Finocchi, A.; Eriksson, L.E.; Mora, N.; Santilli, V.; Aquilani, A.; Manno, E.C.; Zangari, P.; Romiti, M.L.; et al. Immunotherapy with an HIV-DNA Vaccine in Children and Adults. Vaccines 2014, 2, 563-580. https://doi.org/10.3390/vaccines2030563
Palma P, Gudmundsdotter L, Finocchi A, Eriksson LE, Mora N, Santilli V, Aquilani A, Manno EC, Zangari P, Romiti ML, et al. Immunotherapy with an HIV-DNA Vaccine in Children and Adults. Vaccines. 2014; 2(3):563-580. https://doi.org/10.3390/vaccines2030563
Chicago/Turabian StylePalma, Paolo, Lindvi Gudmundsdotter, Andrea Finocchi, Lars E. Eriksson, Nadia Mora, Veronica Santilli, Angela Aquilani, Emma C. Manno, Paola Zangari, Maria Luisa Romiti, and et al. 2014. "Immunotherapy with an HIV-DNA Vaccine in Children and Adults" Vaccines 2, no. 3: 563-580. https://doi.org/10.3390/vaccines2030563