Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial

The Lancet ◽  
2010 ◽  
Vol 375 (9708) ◽  
pp. 56-66 ◽  
Author(s):  
Xiao-Feng Liang ◽  
Hua-Qing Wang ◽  
Jun-Zhi Wang ◽  
Han-Hua Fang ◽  
Jiang Wu ◽  
...  
Keyword(s):  
Pandemic Influenza ◽  
Influenza A ◽  
Controlled Trial ◽  
Double Blind ◽  
Influenza A H1n1

A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems

Vaccine ◽  
2011 ◽  
Vol 29 (48) ◽  
pp. 8974-8981 ◽  
Author(s):  
Alexander R. Precioso ◽  
João L. Miraglia ◽  
Lúcia Maria A. Campos ◽  
Alessandra C. Goulart ◽  
Maria do Carmo S.T. Timenetsky ◽  
...  
Keyword(s):  
Phase I ◽  
Influenza A ◽  
Controlled Trial ◽  
Double Blind ◽  
Influenza A H1n1

scholarly journals A Rapid Immune Response to 2009 Influenza A(H1N1) Vaccines in Adults: A Randomized, Double‐Blind, Controlled Trial

2010 ◽  
Vol 202 (5) ◽  
pp. 675-680 ◽  
Author(s):  
Jiang Wu ◽  
Wei Li ◽  
Hua‐Qing Wang ◽  
Jiang‐Ting Chen ◽  
Min Lv ◽  
...  
Keyword(s):  
Immune Response ◽  
Influenza A ◽  
Controlled Trial ◽  
Double Blind ◽  
Influenza A H1n1

scholarly journals Long-Acting Neuraminidase Inhibitor Laninamivir Octanoate (CS-8958) versus Oseltamivir as Treatment for Children with Influenza Virus Infection

2010 ◽  
Vol 54 (6) ◽  
pp. 2575-2582 ◽  
Author(s):  
Norio Sugaya ◽  
Yasuo Ohashi
Keyword(s):  
Virus Infection ◽  
Influenza A ◽  
H1n1 Virus ◽  
Controlled Trial ◽  
Influenza Virus Infection ◽  
Neuraminidase Inhibitor ◽  
Double Blind ◽  
Influenza A H1n1 ◽  
B Virus ◽  
Long Acting

ABSTRACT We conducted a double-blind, randomized controlled trial to compare a long-acting neuraminidase inhibitor, laninamivir octanoate, with oseltamivir. Eligible patients were children 9 years of age and under who had febrile influenza symptoms of no more than 36-h duration. Patients were randomized to 1 of 3 treatment groups: a group given 40 mg laninamivir (40-mg group), a group given 20 mg laninamivir (20-mg group), and an oseltamivir group. Laninamivir octanoate was administered as a single inhalation. Oseltamivir (2 mg/kg of body weight) was administered orally twice daily for 5 days. The primary end point was the time to alleviation of influenza illness. The primary analysis included 184 patients (61, 61, and 62 in the 40-mg group, 20-mg group, and oseltamivir group, respectively). Laninamivir octanoate markedly reduced the median time to illness alleviation in comparison with oseltamivir in patients infected with oseltamivir-resistant influenza A (H1N1) virus, and the reductions were 60.9 h for the 40-mg group and 66.2 h for the 20-mg group. On the other hand, there were no significant differences in the times to alleviation of illness between the laninamivir groups and oseltamivir group for patients with influenza A (H3N2) or B virus infection. Laninamivir octanoate was well tolerated. The most common adverse events were gastrointestinal events. Laninamivir octanoate was an effective and well-tolerated treatment for children with oseltamivir-resistant influenza A (H1N1) virus infection. Further study will be needed to confirm clinical efficacy against influenza A (H3N2) or B virus infection. Its ease of administration is noteworthy, because a single inhalation is required during the course of illness.

scholarly journals Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model

2020 ◽  
Author(s):  
Alison Han ◽  
Lindsay Czajkowski ◽  
Luz Angela Rosas ◽  
Adriana Cervantes-Medina ◽  
Yongli Xiao ◽  
...  
Keyword(s):  
Influenza A ◽  
Controlled Trial ◽  
Influenza Infection ◽  
Area Under The Curve ◽  
Surface Protein ◽  
Healthy Human ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Influenza A H1n1 ◽  
Clinically Significant

Abstract Background It is imperative to identify new targets for improved vaccines and therapeutics against influenza and one such target is the relatively conserved stalk region of the influenza A hemagglutinin (HA) surface protein. Methods We conducted a randomized, double-blind, Phase II placebo-controlled trial of a monoclonal antibody that targets the HA stalk (CR6261) in a H1N1pdm09 healthy volunteer human challenge model. A single 50mg/kg dose of CR6261 was infused 24 hours after challenge and the primary efficacy outcome was area under the curve of viral RNA detection over time. Results Ninety-one healthy volunteers were randomized and underwent influenza challenge; 49 received CR6261 and 42 placebo. CR6261 had no statistically significant effect on AUC (AUC 48.56 log (copies/mL) x days, IQR 202 vs. AUC 25.53 log (copies/mL) x days, IQR 155), P=0.315), and no clinically significant effect on influenza disease measures including number of symptoms, duration of symptoms, or FLU-PRO scores. Preexisting anti-NA antibody titers were most predictive of reduced influenza disease. CR6261 reached a mean peak serum concentration of 1x10 6 ng/ml 15 minutes after infusion, and a mean peak of 5.97x10 2 ng/ml in the nasal mucosa 2-3 days after infusion. Conclusions The results of this study suggest that a monoclonal anti-stalk approach to prevent or treat influenza infection may be limited in efficacy. Future approaches should consider including and evaluating anti-stalk antibodies as part of a multi-faceted strategy rather than as a standalone therapeutic.

scholarly journals 1522. Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S763-S763
Author(s):  
Alison Han ◽  
Lindsay Czajkowski ◽  
Luz Angela Rosas ◽  
Adriana Cervantes-Medina ◽  
Yongli Xiao ◽  
...  
Keyword(s):  
Pharmaceutical Company ◽  
Influenza A ◽  
Controlled Trial ◽  
Influenza Infection ◽  
Healthy Human ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Viral Shedding ◽  
Influenza A H1n1 ◽  
Significant Difference

Abstract Background Influenza virus infections cause significant morbidity and mortality during yearly seasonal epidemics and during sporadic pandemics. It is imperative to identify new targets for vaccines and therapeutics. One such target is the relatively conserved stalk region of the influenza A hemagglutinin (HA) surface protein. Methods We conducted a randomized, double-blind, Phase II placebo-controlled trial of a monoclonal antibody that targets the HA stalk (CR6261) in a H1N1pdm09 healthy volunteer human challenge model. CR6261 was infused 24 hours after challenge with H1N1pdm09 and the primary efficacy outcome was area under the curve (AUC) of viral shedding. Results Between March 2015-May 2018, 104 healthy volunteers were enrolled and randomized with 91 undergoing influenza challenge, of which 49 participants (54%) received treatment with CR6261 and 42 participants (46%) received placebo. A mean of 1x106 ng/mL of serum CR6261 was detected by 24 hours after infusion. Nasal CR6261 levels reached a peak mean of 5.97x102 ng/ml 2 days after infusion. There was no statistically significant difference in the primary outcome measure between the CR6261 group and placebo (median AUC 48.56 and 25.53 respectively, P=0.31). The severity of illness was compared between the two groups, and no significant difference was observed in number of symptoms, duration of symptoms, or FLU-PRO scores. Conclusion CR6261 had no statistically significant effect on AUC of viral shedding, and no clinically significant effect on overall influenza disease. Preexisting anti-neuraminidase (NA) antibody titers were most predictive of reduced influenza disease. Nasal CR6261 levels were much lower compared to serum, which may be a factor in the limited effect of CR6261 on this upper respiratory infection. These results suggest that a monoclonal anti-stalk approach to prevent or treat influenza infection may have limited efficacy. Future approaches should consider including and evaluating anti-stalk antibodies as part of a multi-faceted strategy rather than as a standalone therapeutic or vaccine strategy. Funding This study was funded in part by the intramural program of NIAID, NIH, by the NCI Contract No. 75N910D00024, Task Order No. 75N91019F00130, and through a CRADA with Janssen Infectious Diseases and Vaccines. Disclosures Amy Lwin, RN, BSN, Janssen Pharmaceutical Company of J&J (Employee) Jerald Sadoff, MD, Janssen Pharmaceutical Company of J&J (Employee)

scholarly journals Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico

Vaccine ◽  
2011 ◽  
Vol 29 (44) ◽  
pp. 7826-7834 ◽  
Author(s):  
Constantino López-Macías ◽  
Eduardo Ferat-Osorio ◽  
Alejandra Tenorio-Calvo ◽  
Armando Isibasi ◽  
Juan Talavera ◽  
...  
Keyword(s):  
Pandemic Influenza ◽  
Influenza A ◽  
Controlled Trial ◽  
Virus Like Particle ◽  
Influenza A H1n1

scholarly journals Expression of Surfactant protein D (SP-D) distinguishes severe pandemic influenza A(H1N1) from COVID-19

2021 ◽  
Author(s):  
José Alberto Choreño-Parra ◽  
Luis Armando Jiménez-Álvarez ◽  
Gustavo Ramírez-Martínez ◽  
Alfredo Cruz-Lagunas ◽  
Mahima Thapa ◽  
...  
Keyword(s):  
Pandemic Influenza ◽  
Influenza A ◽  
Alveolar Epithelium ◽  
Surfactant Protein ◽  
High Serum ◽  
Surfactant Protein D ◽  
Diagnostic Challenge ◽  
Moderate Disease ◽  
Influenza A H1n1 ◽  
Novel Biomarkers

Abstract The differentiation of influenza and COVID-19 could constitute a diagnostic challenge during the ongoing winter due to their clinical similitude. Thus, novel biomarkers that enable distinguishing both diseases are required. Here, we evaluated whether the surfactant protein D (SP-D), a collectin produced at the alveolar epithelium with known immune properties, was useful to differentiate pandemic influenza A(H1N1) from COVID-19 in critically ill patients. Our results revealed high serum SP-D levels in severe pandemic influenza but not COVID-19 patients. This finding was validated in a separate cohort of mechanically ventilated COVID-19 patients who also showed low plasma SP-D levels. However, plasma SP-D levels did not distinguish seasonal influenza from COVID-19 in mild-to-moderate disease. Finally, we found that high serum SP-D levels were associated with mortality and renal failure among severe pandemic influenza cases. Thus, our studies have identified SP-D as a unique biomarker expressed during severe pandemic influenza but not COVID-19.

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