Preliminary Assessment of Safety and Immunogenicity of an Inactivated Whole-Virion Vaccine against Influenza А (H1N1) Pdm09 Containing Aluminum Hydroxide Adjuvant: A Randomized, Blinded Phase I Clinical Study
Kaissar Tabynov1*, Berik Khairullin1, Zhailaubay Kydyrbayev1, Nurlan Sandybayev1, Marina Stukova2, Marianna Erofeeva2, Anna Polina Shurygina2, Oleg Kiselev2, Seidigapbar Mamadaliev1 and Abylai Sansyzbay1
- *Corresponding Author:
- Kaissar Tabynov
080409, Republic of Kazakhstan, Zhambulskaya oblast
Kordaiskiy rayon, Gvardeiskiy, Kazakhstan
Tel: + 7 (72636) 7-22-28
E-mail: [email protected]
Received date: July 24, 2013; Accepted date: October 09, 2013; Published date: October 13, 2013
Citation: Tabynov K, Khairullin B, Kydyrbayev Z, Sandybayev N, Stukova M, et al. (2013) Preliminary Assessment of Safety and Immunogenicity of an Inactivated Whole-Virion Vaccine against Influenza A (H1N1) Pdm09 Containing Aluminum Hydroxide Adjuvant: A Randomized, Blinded Phase I Clinical Study. J Vaccines Vaccin 4:205. doi: 10.4172/2157-7560.1000205
Copyright: © 2013 Tabynov K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
We performed a randomized, blinded, dose-dependent placebo-controlled phase I clinical study of single administration of Refluvac®, a monovalent inactivated whole-virion vaccine against pandemic influenza А (Н1N1) pdm09 containing aluminum adjuvant, in healthy volunteers aged 18-60. Single intramuscular injection at doses of 3.75, 7.5, or 15.0 μg hemagglutinin (НА) identified no safety issues in adult volunteers (n=12 per group); no severe or serious vaccination-related adverse events were observed. Only mild/moderate local adverse events (n= 3/12, 25% in 7.5 μg НА arm,) and one moderate systemic reaction (n=1/12, 8.3% in 15.0 μg НА arm) were observed. In volunteers vaccinated at 3.75 μg HA, the proportion of subjects with 4-fold seroconversion was 75%, the level of seroprotection was also 75%, the antibody titer increase was 10.7-fold, and the geometric mean titer (GMT) of antibodies to А/H1N1pdm09 was 53.4; for the 7.5 μg HA dose, the proportion of 4-fold seroconversion was 75%, the antibody titer increase was 32.0-fold, the GMT was 160.0, and the level of seroprotection was 75%. When administered at a higher dose (15 μg HA), the proportion of subjects with protective antibody titers increased from 75% to 83%; however, the GMT and antibody titer increase were not significantly different (P>0.05) to the group vaccinated at 7.5 μg HA. Phase II clinical studies of the 3.75 and 7.5 μg HA doses of Refluvac® vaccine should be performed in a larger cohort of healthy volunteers aged 18-60. The effective immunogenicity of low doses of Refluvac® vaccine may enable increased production of pandemic influenza vaccines, and thus provide more people with a safe, effective vaccine.