Trial reportThe Journal of infectious diseases2012
Direct comparison of an inactivated subvirion influenza A virus subtype H5N1 vaccine administered by the intradermal and intramuscular routes.
Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00439335 (A Phase I/II Randomized, Double-Blinded Placebo-Controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Subvirion Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults), which is not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I/II Randomized, Double-Blinded Placebo-Controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Subvirion Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults
Who cites it
13 citing papers in PubMed.
- Topical Imiquimod Does Not Provide an Adjuvant Effect When Administered With Inactivated Influenza A/H5N1 Vaccine in Healthy Young Adults.The Journal of infectious diseases · 2021Trial
- Cell mediated immune responses following revaccination with an influenza A/H5N1 vaccine.Vaccine · 2016Trial
- Microneedles: An Emerging Vaccine Delivery Tool and a Prospective Solution to the Challenges of SARS-CoV-2 Mass Vaccination.Pharmaceutics · 2023Review
- Challenges in the Vaccination of the Elderly and Strategies for Improvement.Pathophysiology : the official journal of the International Society for Pathophysiology · 2023Review
- Article
- Article
- Fighting against a protean enemy: immunosenescence, vaccines, and healthy aging.NPJ aging and mechanisms of disease · 2018Article
- Priming Vaccination With Influenza Virus H5 Hemagglutinin Antigen Significantly Increases the Duration of T cell Responses Induced by a Heterologous H5 Booster Vaccination.The Journal of infectious diseases · 2016Article
- Local innate immune responses in the vaccine adjuvant-injected muscle.Clinical & translational immunology · 2016Review
- Effect of receptor binding specificity on the immunogenicity and protective efficacy of influenza virus A H1 vaccines.Virology · 2014Article
- Vaccine strategies to enhance immune responses in the aged.Current opinion in immunology · 2013Review
- Cross-protection against drifted influenza viruses: options offered by adjuvanted and intradermal vaccines.Human vaccines & immunotherapeutics · 2013Review
- Evaluations for in vitro correlates of immunogenicity of inactivated influenza a H5, H7 and H9 vaccines in humans.PloS one · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundDirect comparisons of similar doses of a novel influenza virus antigen administered by the intradermal route and the intramuscular route have not been reported.
methodsA total of 227 healthy adults aged 18-49 years were randomized to receive 2 doses 1 month apart of a subvirion inactivated influenza A virus subtype H5N1 (rgA/Vietnam/1203/2004) vaccine containing 38.7 μg of H5N1 hemagglutinin (HA), by the intramuscular route or by the intradermal route using the Mantoux technique. Clinical and serologic responses were assessed.
resultsInjection site reactions were more frequent in the intradermal group. Immune responses and the geometric mean titer of serum hemagglutination inhibition and neutralizing antibodies 1 month after receipt of the first dose were similar and low but were significantly higher after 2 doses of vaccine in both groups.
conclusionsIntramuscular and intradermal delivery of vaccine were both well tolerated. Immune responses after 2 doses of this influenza A/H5N1 HA (38.7 μg) were low and not significantly different when given by the intradermal or intramuscular route. Evaluation of higher dosages, alternative intradermal delivery methods, and the addition of adjuvants will be needed to enhance the immunogenicity of inactivated influenza A/H5N1 vaccines by the intradermal route. CLINICAL TRIALS REGISTRATION: NCT00439335.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.