Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam. Issue 46 (12th November 2018)

• Record Type: Journal Article
• Authors: Thang, Ho Vinh; Huong, Vu Minh; Victor, John C.; Van, Cao Bao; Nga, Nguyen Tuyet; Be, Le Van; Cuong, Nguyen Phu; Tsvetnitsky, Vadim; Neuzil, Kathleen M.; Power, Maureen; Flores, Jorge
• Is Part Of: Vaccine. Volume 36:Issue 46(2018)
• Page Start: 6918
• Page End: 6925
• Publication Date: 2018-11-12
• Subjects: Influenza -- A/H1N1 -- Vaccine safety -- Vaccine immunogenicity -- Vietnam -- IVAC; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2018.10.013
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Increased capacity for pandemic influenza vaccines production is critical. The H1N1 vaccine developed by IVAC in Vietnam has proven to be safe and immunogenic. IVAC's H1N1 vaccine is comparable to similar products and warrants further development. 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.