Adjuvant Effect of Orally Applied Preparations Containing Non-Digestible Polysaccharides on Influenza Vaccination in Healthy Seniors: A Double-Blind, Randomised, Controlled Pilot Trial

Senior individuals can suffer from immunosenescence and novel strategies to bolster the immune response could contribute to healthy ageing. In this double-blind, randomised, controlled pilot trial, we investigated the ability of non-digestible polysaccharide (NPS) preparations to enhance the immune response in a human vaccination model. In total, 239 subjects (aged 50–79 years) were randomised to consume one of five different NPS (yeast β-glucan (YBG), shiitake β-glucan (SBG), oat β-glucan (OBG), arabinoxylan (AX), bacterial exopolysaccharide (EPS)) or control (CTRL) product daily for five weeks. After two weeks of intervention, subjects were vaccinated with seasonal influenza vaccine. The post-vaccination increases in haemagglutination inhibition antibody titres and seroprotection rate against the influenza strains were non-significantly enhanced in the NPS intervention groups compared to CTRL. Specifically, a trend towards a higher mean log2 fold increase was observed in the AX group (uncorrected p = 0.074) combined with a trend for an increased seroprotection rate, AX group (48.7%) compared to CTRL (25.6%) (uncorrected p = 0.057), for the influenza A H1N1 strain. Subjects consuming AX also had a reduced incidence of common colds compared to CTRL (1 vs. 8; p = 0.029 in Fisher exact test). No adverse effects of NPS consumption were reported. The findings of this pilot study warrant further research to study AX as an oral adjuvant to support vaccine efficacy.

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Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials

Yearbook of Pediatrics ◽

10.1016/s0084-3954(10)79772-4 ◽

2011 ◽

Vol 2011 ◽

pp. 270-271

Author(s):

J.A. Stockman

Keyword(s):

Immune Response ◽

Preliminary Report ◽

Influenza A ◽

Phase 2 ◽

Influenza A H1n1 ◽

Single Vaccination ◽

Randomised Controlled

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

The Journal of Infectious Diseases ◽

10.1086/655226 ◽

2010 ◽

Vol 202 (5) ◽

pp. 675-680 ◽

Cited By ~ 17

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

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Immune response to influenza A(H1N1)v in HIV-infected patients

The Journal of Infection in Developing Countries ◽

10.3855/jidc.3147 ◽

2014 ◽

Vol 8 (01) ◽

pp. 101-109 ◽

Cited By ~ 4

Author(s):

Paola Sansonetti ◽

Michela Sali ◽

Massimiliano Fabbiani ◽

Matteo Morandi ◽

Rosa Martucci ◽

...

Keyword(s):

Immune Response ◽

Hiv Infection ◽

Clinical Picture ◽

Influenza A ◽

Geometric Mean ◽

Haemagglutination Inhibition ◽

Hiv Positive ◽

Upper Respiratory Tract ◽

Influenza A H1n1 ◽

Hiv Negative

Introduction: HIV infection is considered a risk factor for severe outcomes of influenza A(H1N1)v infection. However, data on immune response against influenza A(H1N1)v virus in HIV-infected patients are lacking. Methodology: Data from seven HIV-positive and 14 HIV-negative patients infected with A(H1N1)v and from 23 HIV-positive and six HIV-negative asymptomatic controls were analyzed to evaluate the clinical picture, A(H1N1)v viral shedding, and the immune response against the virus. Results: Patients displayed mainly upper respiratory tract diseases (57.1%), while pneumonia was diagnosed only in HIV-negative patients (23.8% of subjects, of which 4.8% required intensive care unit admission). At day seven, 29% of HIV-infected patients were still positive for A(H1N1)v by RT-PCR on nasopharyngeal swabs. Interestingly, a persistence of CXCL10 secretion at high level and lower IL-6 levels was observed in HIV-positive subjects. The geometric mean haemagglutination inhibition titer (HI-GMT) and anti-influenza IgM levels were lower in HIV-positive individuals while anti-influenza IgG levels remained similar in the two groups. Conclusions: The immune impairment due to HIV infection could affect A(H1N1)v clearance and could lead to a lower antibody response and a persistent secretion of CXCL10 at high levels. However, the lower IL-6 secretion and treatment with highly active antiretroviral therapy (HAART) could result in a milder clinical picture.

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Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials

The Lancet ◽

10.1016/s0140-6736(09)62026-2 ◽

2010 ◽

Vol 375 (9708) ◽

pp. 41-48 ◽

Cited By ~ 186

Author(s):

Eric Plennevaux ◽

Eric Sheldon ◽

Mark Blatter ◽

Mary-Kate Reeves-Hoché ◽

Martine Denis

Keyword(s):

Immune Response ◽

Preliminary Report ◽

Influenza A ◽

Phase 2 ◽

Influenza A H1n1 ◽

Single Vaccination ◽

Randomised Controlled

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

Vaccine ◽

10.1016/j.vaccine.2011.09.040 ◽

2011 ◽

Vol 29 (48) ◽

pp. 8974-8981 ◽

Cited By ~ 12

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

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The importance of antineuraminidase antibodies in resistance to influenza A and immunologic memory for their synthesis

Journal of Hygiene ◽

10.1017/s0022172400060101 ◽

1983 ◽

Vol 91 (1) ◽

pp. 131-138 ◽

Cited By ~ 6

Author(s):

A. N. Naikhin ◽

I. M. Tsaritsina ◽

E. V. Oleinikova ◽

L. G. Syrodoeva ◽

N. L. Korchanova ◽

...

Keyword(s):

Protective Effect ◽

Influenza A ◽

Natural Infection ◽

Haemagglutination Inhibition ◽

Surface Antigens ◽

Antigenic Structure ◽

Immunologic Memory ◽

Antibody Synthesis ◽

Influenza A H1n1 ◽

Simplified Method

SUMMARYEight hundred and seventy-seven sera from 360 adults aged 18–50 who were under permanent observation from October 1980 to March 1981 have been studied by haemagglutination-inhibition (HI) and erythrocyte elution-inhibition (EI) tests – a simplified method of antineuraminidase antibody titration. It was demonstrated in some subjects infected with influenza A H1N1 and H3N2 viruses that the antibody rise was to one of the surface antigens only – haemagglutinin or neuraminidase. These subjects made up 5·2–25·8% of all examinees. The protective effect of antibodies to neuraminidase was similar to that of antihaemagglutinins. Interaction of both types of antibodies was observed in protection against the disease. Data have been obtained on the influence of antineuraminidase antibodies in decreasing the severity of natural infection with influenza A.A study of heterologous immunologic responses to haemagglutinin and neuraminidase among persons immunized with live influenza A H1N1 and H3N2 vaccines and among children naturally infected with influenza A H3N2 demonstrated the presence of immunologic memory for antineuraminidase antibody synthesis. Thus, the suggestion of a common antigenic structure for neuraminidase Nl and N2 is made.

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Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009–10 influenza season: a multicentre, randomised controlled trial

Yearbook of Pediatrics ◽

10.1016/s0084-3954(10)79771-2 ◽

2011 ◽

Vol 2011 ◽

pp. 272-274

Author(s):

J.A. Stockman

Keyword(s):

Randomised Controlled Trial ◽

Influenza Vaccine ◽

Influenza A ◽

Seasonal Influenza ◽

Influenza Season ◽

Controlled Trial ◽

H1n1 Vaccine ◽

Seasonal Influenza Vaccine ◽

Influenza A H1n1 ◽

Randomised Controlled

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Effect of a yoghurt drink containing Lactobacillus strains on bacterial vaginosis in women – a double-blind, randomised, controlled clinical pilot trial

Beneficial Microbes ◽

10.3920/bm2017.0018 ◽

2018 ◽

Vol 9 (1) ◽

pp. 35-50 ◽

Cited By ~ 16

Author(s):

C. Laue ◽

E. Papazova ◽

A. Liesegang ◽

A. Pannenbeckers ◽

P. Arendarski ◽

...

Keyword(s):

Bacterial Vaginosis ◽

Pilot Trial ◽

Group Versus ◽

Lactobacillus Delbrueckii ◽

Control Group ◽

Fisher Exact Test ◽

Intervention Period ◽

Double Blind ◽

Increased Risk ◽

Amsel Criteria

Bacterial vaginosis (BV) is characterised by a depletion of lactobacilli in favour of an overgrowth of anaerobic bacteria. It is associated with increased risk for urogenital infections and abortion. In this study we assessed the effect of a yoghurt drink containing Lactobacillus strains on BV. The strains had been isolated from healthy pregnant women and selected for acidification capacity, production of H2O2, glycogen utilisation, bile salt tolerance and inhibition of pathogens. Using Amsel criteria BV was diagnosed in 36 women aged ≥18 years with stable menstrual cycle or menopause. They were treated with oral metronidazole for 7 days (2×500 mg/d). Starting with the treatment, women consumed twice daily either verum or placebo during 4 weeks. Verum was 125 g yoghurt containing (besides Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus thermophilus) living strains Lactobacillus crispatus LbV 88 (DSM 22566), Lactobacillus gasseri LbV 150N (DSM 22583), Lactobacillus jensenii LbV 116 (DSM 22567) and Lactobacillus rhamnosus LbV96 (DSM 22560), each 1×107 cfu/ml; placebo was 125 g chemically acidified milk. After 4 weeks of intervention 0 of 17 had BV in the verum group versus 6 of 17 in the s.a. control (0.018 in Fisher Exact test). Amsel score decreased during the intervention period by 4.0 (median) (4.0; 3.0) (25th; 75th percentile) in the verum group compared to 2.0 (4.0; 0.0) in the control group (P=0.038 in Mann-Whitney test). Discharge and odour (Amsel criteria 2+3) also decreased by 2.0 (2.0; 1.0) in the verum compared to 1.0 (2.0; 0.0) in the control group (P=0.01) and differed after 4 weeks intervention between the groups 0.0 (0.0; 0.0) versus 1.0 (0.0; 2.0) (P=0.001). Nugent score decreased during the intervention period by 5.5 (7.0;2.3) in the verum compared to 3.0 (6.0;0.5) in the control group (P=0.158). Additional intake of yoghurt containing these probiotic strains improved the recovery rate and symptoms of BV and tended to improve the vaginal microbial pattern.

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