NIH study will gauge immunogenicity of adjuvanted seasonal flu vaccines
The National Institutes of Health (NIH) yesterday announced that researchers have started enrolling participants in a phase 1 clinical trial to evaluate immunogenicity and safety of two licensed seasonal flu vaccines given with and without novel adjuvants.
In a statement, the NIH said volunteers will be randomly assigned to receive one dose of 2018-2019 Fluzone or Flublok quadrivalent vaccine, both made by Sanofi, alone or with the AF03 or Advax-CpG55.2 adjuvant.
The trial will enroll 240 healthy volunteers aged 18 to 45 years old at eight clinical trial sites funded by the National Institute of Allergy and Infectious Diseases (NIAID) and is expected to last about 18 months. Researchers will monitor participants for at least 57 days. Ninety days after vaccination all volunteers will receive a dose of unadjuvanted 2019-2020 flu vaccine and be monitored for adverse effects.
Anthony Fauci, MD, director of NIAID, said that as part of efforts to develop more effective and durable flu vaccines NIAID is supporting the development of new ones as well as efforts to improve existing ones. "We hope this trial will increase our understanding of how adjuvants could help confer better protection from seasonal influenza."
The adjuvant AF03, a squalene-based emulsion developed by Sanofi, has been shown to improve immune response with avian influenza vaccines. Advax-CpG55.2 was developed by Australia-based Vaxine Pty Ltd and is a sugar-based adjuvant that has been shown to increase immune response to flu vaccine in humans.
Aug 8 NIH press release
Polio infects one more in Pakistan
In the latest polio developments, Pakistan reported one more wild poliovirus type 1 (WPV1) case, according to the latest weekly update from the Global Polio Eradication Initiative (GPEI).
The patient is from Killa Abdullah district in Balochistan province and had a Jul 2 paralysis onset. Pakistan has now recorded 48 WPV1 cases for 2019.
Earlier this week, media reports said the country had reported an additional five WPV1 cases, all from Khyber Pakhtunkhwa province, which would push the total for the year to 53.
Elsewhere, health officials in the Democratic Republic of Congo (DRC) reported one positive circulating vaccine-derived poliovirus type 2 sample in a close contact in Tshuapa province, along with two positive community isolates, one from Sankuru province and the other from Tshuapa province.
Aug 7 GPEI weekly update
Aug 8 The News International story
Study links antibiotic use with onset of rheumatoid arthritis
A new study in BMC Medicine suggests a possible link between antibiotic use and the onset of rheumatoid arthritis (RA).
In a nested case-control study conducted using data from a large database of UK primary care medical records, a team of British researchers identified 22,677 patients with a diagnosis of RA from 1990 through 2017 and matched them with 90,013 control patients. Conditional logistic regression was used to examine previous antibiotic prescriptions and RA onset after controlling for confounding factors.
The analysis found that the odds of developing RA were 60% higher in those exposed to antibiotics than in those not exposed (odds ratio [OR], 1.60; 95% confidence interval [CI], 1.51 to 1.68). A dose- or frequency-dependent association was observed between the number of previous antibiotic prescriptions and RA, with the magnitude of association with RA rising with an increasing number of unique antibiotic prescriptions. The odds of RA were also higher in those last exposed to antibiotics 1 to 2 years before the index date than in those exposed 5 to 10 years before the index date.
All classes of antibiotics were associated with higher odds of RA, with bactericidal antibiotics carrying higher risk than bacteriostatic (45% vs 31%). RA cases were more likely to have a record of infection before their diagnosis, with increased odds of RA among those with a previous infection ranging from 7% for urinary tract infections to 37% for those with lower respiratory tract infections. In addition, those with antibiotic-treated upper respiratory tract infections were more likely to be RA cases. Antifungal (OR, 1.27; 95% CI, 1.20 to 1.35) and antiviral (OR, 1.19; 95% CI, 1.14 to 1.24) prescriptions were also associated with increased odds of RA.
The authors of the study suggest the association between RA and antibiotic use could be linked to disruption of the gut microbiota, but they caution that more research is needed, as it is unclear at this point whether the major driver is antibiotic use or the underlying infection. "These observations require extensive additional studies (both case-controlled and mechanistic) to determine direct causation," they write.
Aug 7 BMC Med study
Congress members ask GAO to investigate new bioweapons detection system
A bipartisan group of lawmakers on Aug 7 sent a letter to the Government Accountability Office (GAO) to do an in-depth analysis of a new system for detecting airborne bioterror threats, the Los Angeles Times reported yesterday.
The GAO has signaled that it will open an inquiry into the controversial BioDetection 21 system, which has already been initially installed in 12 cities as a replacement for BioWatch, which was plagued by problems. However, reports have said some of the trigger devices in the new system failed to detect anthrax spores and had little success identifying small particles of viral material.
Members of the House Energy and Commerce Committee asked the GAO to assess if the Department of Homeland Security has implemented recommendations from a 2015 GAO report to thoroughly assess BioWatch capabilities. Also, lawmakers questioned if the new system would be less reliable than the old system.
James McDonnell, assistant secretary of Homeland Security, said his goal is to replace BioWatch in the next 2 years and has been quoted as saying that problems with BioDetection 21 could be fixed along the way.
Aug 8 LA Times story