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Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: A phase I clinical trial (RISVAC02).
- Source :
-
Vaccine [Vaccine] 2011 Oct 26; Vol. 29 (46), pp. 8309-16. Date of Electronic Publication: 2011 Sep 09. - Publication Year :
- 2011
-
Abstract
- Background: To investigate the safety and immunogenicity of a modified vaccinia virus Ankara vector expressing HIV-1 antigens from clade B (MVA-B), a phase-I, doubled-blind placebo-controlled trial was performed.<br />Methods: 30 HIV-uninfected volunteers at low risk of HIV-1 infection were randomly allocated to receive 3 intramuscular injections (1×10(8)pfu/dose) of MVA-B (n=24) or placebo (n=6) at weeks 0, 4 and 16. All volunteers were followed 48 weeks. Primary end-points were adverse events and immunogenicity.<br />Results: A total of 169 adverse events were reported, 164 of grade 1-2, and 5 of grade 3 (none related to vaccination). Overall 75% of the volunteers showed positive ELISPOT responses at any time point. The magnitude (median) of the total responses induced was 288SFC/10(6)PBMC at week 18. Antibody responses against Env were observed in 95% and 72% of vaccinees at week 18 and 48, respectively. HIV-1 neutralizing antibodies were detected in 33% of volunteers.<br />Conclusions: MVA-B was safe, well tolerated and elicited strong and durable T-cell and antibody responses in 75% and 95% of volunteers, respectively. These data support further exploration of MVA-B as an HIV-1 vaccine candidate. Clinical Trials.gov identifier: NCT00679497.<br /> (Copyright © 2011 Elsevier Ltd. All rights reserved.)
- Subjects :
- AIDS Vaccines administration & dosage
AIDS Vaccines genetics
Adolescent
Adult
Cytokines metabolism
Double-Blind Method
Enzyme-Linked Immunospot Assay
Female
HIV Antibodies blood
HIV-1 genetics
Human Experimentation
Humans
Injections, Intramuscular
Leukocytes, Mononuclear immunology
Male
Middle Aged
Placebos administration & dosage
Vaccines, Synthetic administration & dosage
Vaccines, Synthetic genetics
Vaccines, Synthetic immunology
Viral Proteins genetics
Young Adult
AIDS Vaccines adverse effects
AIDS Vaccines immunology
Drug Carriers
Genetic Vectors
HIV-1 immunology
Vaccinia virus genetics
Viral Proteins immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 29
- Issue :
- 46
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 21907749
- Full Text :
- https://doi.org/10.1016/j.vaccine.2011.08.098