Phase 1 clinical tests of influenza MDP-virosome vaccine (KD-5382).

Abstract

MDP-virosome vaccine, which contains haemagglutinin (HA) and neuraminidase (NA) antigens isolated from influenza virus combined with 6-O-(2-tetradecylhexadecanoyl)-N-acetylmuramoyl-L-alanyl-D-isoglutamine) (B30-MDP) and cholesterol was tested, in comparison with a currently used HA vaccine, for immunogenicity and adverse reactions on 77 adult male volunteers. The volunteers were divided into eight groups, and each individual was injected subcutaneously once, or twice at a 4 week interval, in their upper arm with one of seven different MDP-virosome vaccine preparations or with HA vaccine as control. Of the three virus strains used as vaccine antigens, MDP-virosome vaccines induced higher haemagglutination inhibiting (HI) antibody to A/Yamagata/120/86 (H1N1) and A/Fukuoka/C29/86 (H3N2) than did HA vaccine, whereas it induced lower HI antibody to B/Nagasaki/1/87, comparable with that induced by HA vaccine. Regarding local adverse reactions, MDP-virosome vaccinees frequently developed mild local pain, reddening and swelling, which disappeared within 5 days; as regards systemic no adverse reactions, leucocytosis developed among the MDP-virosome vaccines, but no other reactions were observed. The leucocytosis may have been caused by the pharmacoimmunological activity of B30-MDP derivatives.

• Authors: M Kaji, Y Kaji, M Kaji, K Ohkuma, T Honda, T Oka, M Sakoh, S Nakamura, K Kurachi, M Sentoku
• Journal: Vaccine (Vaccine) Vol. 10 Issue 10 Pg. 663-7 ( 1992) ISSN: 0264-410X [Print] Netherlands
• PMID: 1523876 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Adjuvants, Immunologic
• Antibodies, Viral
• Hemagglutinins
• Influenza Vaccines
• Vaccines, Inactivated
• Ether
• Acetylmuramyl-Alanyl-Isoglutamine
• B 30-muramyl dipeptide
• Neuraminidase

Topics

• Acetylmuramyl-Alanyl-Isoglutamine (administration & dosage, analogs & derivatives)
• Adjuvants, Immunologic (administration & dosage)
• Adult
• Antibodies, Viral (biosynthesis)
• Drug Evaluation
• Ether
• Hemagglutinins (immunology)
• Hematologic Tests
• Humans
• Influenza Vaccines (adverse effects, pharmacology)
• Male
• Molecular Structure
• Neuraminidase (immunology)
• Vaccines, Inactivated (isolation & purification)