1. Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam.
- Author
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Thang HV, Huong VM, Victor JC, Van CB, Nga NT, Be LV, Cuong NP, Tsvetnitsky V, Neuzil KM, Power M, and Flores J
- Subjects
- Adolescent, Adult, Antibodies, Neutralizing blood, Antibodies, Viral blood, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions pathology, Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Influenza Vaccines administration & dosage, Influenza Vaccines isolation & purification, Male, Neutralization Tests, Placebos administration & dosage, Treatment Outcome, Vietnam, Young Adult, Influenza A Virus, H1N1 Subtype isolation & purification, Influenza Vaccines adverse effects, Influenza Vaccines immunology, Influenza, Human prevention & control
- Abstract
We tested a new A/H1N1 inactivated influenza vaccine (IIV) manufactured by Institute of Vaccines and Medical Biologics (IVAC), Vietnam in 48 adults in a Phase 1, double-blinded, randomized, placebo-controlled trial. Two doses of unadjuvanted vaccine or placebo were administered three weeks apart. The vaccine was well tolerated with only transient mild local reactions and low-grade fever in a small proportion of the subjects. One serious adverse event considered unrelated to the study product was reported. The IVAC vaccine proved to be highly immunogenic with 91 percent (95% CI: 0.78, 1) of the subjects developing a ≥4 fold immune responses by hemagglutination inhibition (HAI) assay, and 96 percent (95% CI: 0.78, 1) by the microneutralization (MN) assay. Post-vaccination geometric mean titers (GMTs) were 283.7 (95% CI: 161.7, 497.5) in the HAI and 725.7 (95% CI: 411.3, 1280.3) in the MN assay. These promising results merit further development of the vaccine. ClinicalTrials.gov number: NCT01507779., (Copyright © 2018 Elsevier Ltd. All rights reserved.)
- Published
- 2018
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