title: Clinical testing of an inactivated influenza A/H5N1 vaccine candidate in a double-blinded, placebo-controlled, randomized trial in healthy adults in Vietnam.
abstract: We tested an inactivated egg-grown whole virus influenza A/H5N1 vaccine candidate developed by the Institute of Vaccines and Medical Biologicals (IVAC), a state-run vaccine manufacturer in Vietnam, in a Phase 1, placebo controlled, double blinded, randomized trial. The vaccine was adjuvanted with aluminum hydroxide. The trial enrolled 75 subjects who were randomized to receive two injections of one of the following: low-dose of vaccine (7.5 mcg HA), high-dose of vaccine (15 mcg HA), or placebo. The vaccine candidate was well tolerated with minimal local reactogenicity consisting of mild, short-lived injection site pain and/or tenderness. No systemic reactogenicity was observed other than transient low-grade fever in about 13% of the subjects and no unsolicited adverse events were attributable to product administration. Immune responses were assessed at baseline and after the first and second dose by hemagglutination inhibition (HAI) and microneutralization (MN) assays, with 72% of the high-dose and 68% of the low-dose vaccine recipients presenting a ⩾4-fold response in the HAI assay and 72% of the high-dose and 61% of the low-dose vaccine recipients exhibiting a ⩾4-fold response in the MN assay. These promising results support further development. ClinicalTrials.gov number NCT02171819, June 20, 2014.
authors: Pasteur Institute, Ho Chi Minh City, Viet Nam.
authors: Trong Lan
authors: TL
authors: Phan
authors: Pasteur Institute, Ho Chi Minh City, Viet Nam.
authors: Vinh Thang
authors: VT
authors: Ho
authors: PATH, Hanoi, Viet Nam.
authors: Minh Huong
authors: MH
authors: Vu
authors: PATH, Hanoi, Viet Nam.
authors: Tuyet Nga
authors: TN
authors: Nguyen
authors: Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.
authors: Huu Thai
authors: HT
authors: Duong
authors: PATH, Seattle, United States.
authors: Renee
authors: R
authors: Holt
authors: PATH, Seattle, United States.
authors: Rahnuma
authors: R
authors: Wahid
authors: PATH, Seattle, United States.
authors: John
authors: J
authors: Donnelly
authors: PATH, Seattle, United States. Electronic address: jeflores@path.org.
authors: Jorge
authors: J
authors: Flores
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000276:immunology; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D000071497:Immunogenicity, Vaccine; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D009500:Neutralization Tests; D010919:Placebos; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014744:Vietnam
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated; D000536:Aluminum Hydroxide
keywords: Clinical trial; IVAC; Pandemic influenza vaccine; Vietnam