Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
A Phase 2 Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A(H7N9) Inactivated Influenza Virus Vaccines Administered With and Without AS03 Adjuvant in Healthy US Adults.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03589807 (A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A/H7N9 Inactivated Influenza Vaccines Administered Intramuscularly With or Without AS03 Adjuvant in Healthy Adults 19-50 Years of Age), which is not on this map. Cited by 13 papers.
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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 II Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A/H7N9 Inactivated Influenza Vaccines Administered Intramuscularly With or Without AS03 Adjuvant in Healthy Adults 19-50 Years of Age
Who cites it
13 citing papers in PubMed, 8 citations in OpenAlex.
- Immunogenicity and safety of AS03-adjuvanted A/Astrakhan/3212/2020 (H5N8)-like influenza vaccine in adults: Phase 1/2, observer-blinded, randomized trial.Human vaccines & immunotherapeutics · 2026Trial
- A Phase 1/2 Dose-Ranging Safety and Immunogenicity Study of mRNA-Based Candidate Pandemic Influenza Vaccines in Healthy Adults.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- A Phase 1 Double-Blinded Trial to Evaluate Safety, Immunogenicity, and Dosing of Measles-Vectored Chikungunya Virus Vaccine (MV-CHIK) in Healthy Adults.The Journal of infectious diseases · 2026Trial
- Anti-neuraminidase and anti-hemagglutinin stalk responses to different influenza a(H7N9) vaccine regimens.Vaccine · 2025Trial
- Safety and immunogenicity of ascending doses of influenza A(H7N9) inactivated vaccine with or without MF59®.Vaccine · 2025Trial
- Article
- Influenza.Nature reviews. Disease primers · 2026Review
- Emerging Viral Zoonoses: Epidemiology, Vaccination Strategies, and Implications for Global Public Health.Vaccines · 2026Review
- Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Vaccine Treatment and Evaluation Units: Why Support a "Ready Base" of Clinical Trial Sites?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- The Relationship between Immunogenicity and Reactogenicity of Seasonal Influenza Vaccine Using Different Delivery Methods.Vaccines · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 7 institutions in 1 country.
Funding
Abstract
introductionA surge of human influenza A(H7N9) cases began in 2016 in China from an antigenically distinct lineage. Data are needed about the safety and immunogenicity of 2013 and 2017 A(H7N9) inactivated influenza vaccines (IIVs) and the effects of AS03 adjuvant, prime-boost interval, and priming effects of 2013 and 2017 A(H7N9) IIVs.
methodsHealthy adults (n = 180), ages 19-50 years, were enrolled into this partially blinded, randomized, multicenter phase 2 clinical trial. Participants were randomly assigned to 1 of 6 vaccination groups evaluating homologous versus heterologous prime-boost strategies with 2 different boost intervals (21 vs 120 days) and 2 dosages (3.75 or 15 μg of hemagglutinin) administered with or without AS03 adjuvant. Reactogenicity, safety, and immunogenicity measured by hemagglutination inhibition and neutralizing antibody titers were assessed.
resultsTwo doses of A(H7N9) IIV were well tolerated, and no safety issues were identified. Although most participants had injection site and systemic reactogenicity, these symptoms were mostly mild to moderate in severity; injection site reactogenicity was greater in vaccination groups receiving adjuvant. Immune responses were greater after an adjuvanted second dose, and with a longer interval between prime and boost. The highest hemagglutination inhibition geometric mean titer (95% confidence interval) observed against the 2017 A(H7N9) strain was 133.4 (83.6-212.6) among participants who received homologous, adjuvanted 3.75 µg + AS03/2017 doses with delayed boost interval.
conclusionsAdministering AS03 adjuvant with the second H7N9 IIV dose and extending the boost interval to 4 months resulted in higher peak antibody responses. These observations can broadly inform strategic approaches for pandemic preparedness. Clinical Trials Registration. NCT03589807.
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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.