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Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia
- Source :
- Human Vaccines & Immunotherapeutics
- Publication Year :
- 2017
- Publisher :
- Taylor & Francis, 2017.
-
Abstract
- Ebola hemorrhagic fever, also known as Ebola virus disease or EVD, is one of the most dangerous viral diseases in humans and animals. In this open-label, dose-escalation clinical trial, we assessed the safety, side effects, and immunogenicity of a novel, heterologous prime-boost vaccine against Ebola, which was administered in 2 doses to 84 healthy adults of both sexes between 18 and 55 years. The vaccine consists of live-attenuated recombinant vesicular stomatitis virus (VSV) and adenovirus serotype-5 (Ad5) expressing Ebola envelope glycoprotein. The most common adverse event was pain at the injection site, although no serious adverse events were reported. The vaccine did not significantly impact blood, urine, and immune indices. Seroconversion rate was 100 %. Antigen-specific IgG geometric mean titer at day 42 was 3,277 (95 % confidence interval 2,401–4,473) in volunteers immunized at full dose. Neutralizing antibodies were detected in 93.1 % of volunteers immunized at full dose, with geometric mean titer 20. Antigen-specific response in peripheral blood mononuclear cells was also detected in 100 % of participants, as well as in CD4+ and CD8+ T cells in 82.8 % and 58.6 % of participants vaccinated at full dose, respectively. The data indicate that the vaccine is safe and induces strong humoral and cellular immune response in up to 100 % of healthy adult volunteers, and provide a rationale for testing efficacy in Phase III trials. Indeed, the strong immune response to the vaccine may elicit long-term protection. This trial was registered with grls.rosminzdrav.ru (No. 495*), and with zakupki.gov.ru (No. 0373100043215000055).
- Subjects :
- 0301 basic medicine
CD4-Positive T-Lymphocytes
Male
Volunteers
viruses
CD8-Positive T-Lymphocytes
medicine.disease_cause
Antibodies, Viral
prime-boost
Russia
0302 clinical medicine
vaccine
Immunology and Allergy
030212 general & internal medicine
Drug Carriers
Vaccines, Synthetic
biology
Immunogenicity
Middle Aged
Research Papers
Healthy Volunteers
Vesicular stomatitis virus
VSV
Ebola
ZEBOV
Female
Antibody
Adult
Adolescent
Drug-Related Side Effects and Adverse Reactions
Immunology
Heterologous
Ebola virus disease
Pain
Ad5
Adenoviridae
03 medical and health sciences
Young Adult
medicine
Animals
Humans
Seroconversion
Ebola Vaccines
Adverse effect
Pharmacology
Ebola virus
Ebola vaccine
business.industry
heterologous vaccination
Vesiculovirus
Hemorrhagic Fever, Ebola
biology.organism_classification
Virology
Antibodies, Neutralizing
030104 developmental biology
Immunoglobulin G
biology.protein
Leukocytes, Mononuclear
business
Subjects
Details
- Language :
- English
- ISSN :
- 2164554X and 21645515
- Volume :
- 13
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- Human Vaccines & Immunotherapeutics
- Accession number :
- edsair.doi.dedup.....673f070445acfe3074bb02d8bac944b7