Key result
Intramuscular injection of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine achieved stronger serological responses and less severe local adverse events than subcutaneous injection.
Why the study?
Does intramuscular injection of an inactivated whole-virion influenza A (H5N1) vaccine improve immunogenicity and safety compared to subcutaneous injection in healthy men?
RCT (n=120)
Does intramuscular injection of an inactivated whole-virion influenza A (H5N1) vaccine improve immunogenicity and safety compared to subcutaneous injection in healthy men?
Intramuscular injection of an inactivated whole-virion H5N1 influenza vaccine with alum adjuvant provides better immunogenicity and fewer local adverse events than subcutaneous injection.
Answers are grounded in this paper and cite their sources.
May favor IM over SC delivery for this H5N1 vaccine in healthy men; hypothesis-generating for efficacy trials.
The immunogenicity and safety profile of an inactivated whole-virion influenza A (H5N1, NIBRG-14) vaccine with alum adjuvant that was administered by IM or SC injection in a phase I clinical study involving 120 healthy Japanese men aged 20-40 years is described. The serological response of the IM group was stronger than that of the SC group. Local adverse events were less severe with IM injection than with SC injection, while similar systemic adverse events were seen in both groups. These results indicate that, when administering an inactivated whole virion vaccine with alum adjuvant for pandemic influenza, IM injection may achieve better immunogenicity and safety than SC injection.
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Ikeno et al. (2009) conducted an RCT in Healthy (n=120). Inactivated whole-virion influenza A (H5N1, NIBRG-14) vaccine with alum adjuvant (IM injection) vs. Subcutaneous (SC) injection was evaluated on Immunogenicity and safety profile. Intramuscular injection of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine achieved stronger serological responses and less severe local adverse events than subcutaneous injection.
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