A Review of the Safety and Efficacy of Vaccines as Prophylaxis for Clostridium difficile Infections

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 2 September 2017)

Review
A Review of the Safety and Efficacy of Vaccines as Prophylaxis for Clostridium difficile Infections
by Mackenzie Henderson, Amanda Bragg, Germin Fahim, Monica Shah and Evelyn R. Hermes-DeSantis
Vaccines 2017, 5(3), 25; doi:10.3390/vaccines5030025 (registering DOI) – 2 September 2017
Abstract
This review aims to evaluate the literature on the safety and efficacy of novel toxoid vaccines for the prophylaxis of Clostridium difficile infections (CDI) in healthy adults. Literature searches for clinical trials were performed through MEDLINE, ClinicalTrials.gov, and Web of Science using the keywords bacterial vaccines, Clostridium difficile, and vaccine. English-language clinical trials evaluating the efficacy and/or safety of Clostridium difficile toxoid vaccines that were completed and had results posted on ClinicalTrials.gov or in a published journal article were included. Six clinical trials were included. The vaccines were associated with mild self-reported adverse reactions, most commonly injection site reactions and flu-like symptoms, and minimal serious adverse events. Five clinical trials found marked increases in antibody production in vaccinated participants following each dose of the vaccine. Clinical trials evaluating C. difficile toxoid vaccines have shown them to be well tolerated and relatively safe. Surrogate markers of efficacy (seroconversion and geometric mean antibody levels) have shown significant immune responses to a vaccination series in healthy adults, indicating that they have the potential to be used as prophylaxis for CDI. However, more research is needed to determine the clinical benefits of the vaccines.

 

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

International Journal of Epidemiology
Published: 31 August 2017
The duration of protection of school-aged BCG vaccination in England: a population -based case–control study
Punam Mangtani Patrick Nguipdop-Djomo Ruth H Keogh Jonathan AC Sterne Ibrahim Abubakar Peter G Smith Paul EM Fine Emilia Vynnycky John M Watson David Elliman … Show more
, dyx141, https://doi.org/10.1093/ije/dyx141
Abstract
Background: Evidence of protection from childhood Bacillus Calmette-Guerin (BCG) against tuberculosis (TB) in adulthood, when most transmission occurs, is important for TB control and resource allocation.
Methods: We conducted a population-based case–control study of protection by BCG given to children aged 12–13 years against tuberculosis occurring 10–29 years later. We recruited UK-born White subjects with tuberculosis and randomly sampled White community controls. Hazard ratios and 95% confidence intervals (CIs) were estimated using case–cohort Cox regression, adjusting for potential confounding factors, including socio-economic status, smoking, drug use, prison and homelessness. Vaccine effectiveness (VE = 1 – hazard ratio) was assessed at successive intervals more than 10 years following vaccination.
Results: We obtained 677 cases and 1170 controls after a 65% response rate in both groups. Confounding by deprivation, education and lifestyle factors was slight 10–20 years after vaccination, and more evident after 20 years. VE 10–15 years after vaccination was 51% (95% CI 21, 69%) and 57% (CI 33, 72%) at 15–20 years. Subsequently, BCG protection appeared to wane; 20–25 years VE = 25% (CI –14%, 51%) and 25–29 years VE = 1% (CI –84%, 47%). Based on multiple imputation of missing data (in 17% subjects), VE estimated in the same intervals after vaccination were similar [56% (CI 33, 72%), 57% (CI 36, 71%), 25% (–10, 48%), 21% (–39, 55%)].
Conclusions: School-aged BCG vaccination offered moderate protection against tuberculosis for at least 20 years, which is longer than previously thought. This has implications for assessing the cost-effectiveness of BCG vaccination and when evaluating new TB vaccines.
 

PLOS ONE
Published: August 25, 2017
Religion and HPV vaccine-related awareness, knowledge, and receipt among insured women aged 18-26 in Utah
J Bodson, A Wilson, EL Warner, D Kepka –
https://doi.org/10.1371/journal.pone.0183725
Abstract
Introduction
We investigate the associations between religious practice and human papillomavirus (HPV) vaccine-related awareness, knowledge, and receipt among young women in Utah.
Methods
We surveyed 326 insured women aged 18–26 by mail. Fisher’s Exact Tests and multivariable logistic regression models were used to evaluate the relations between religious practice and HPV vaccine-related outcomes. Data collection occurred January-December 2013; analyses were conducted June-September 2015.
Results
Multivariable analyses reveal that when controlling for age, educational attainment, and marital status, participants who practiced an organized religion were significantly less likely to have heard of HPV (aOR=0.25, p=0.0123), to have heard of the HPV vaccine (aOR=0.41, p=0.0368), to know how HPV is spread (aOR=0.45, p=0.0074), to have received a provider recommendation for the HPV vaccine (aOR=0.36, p=0.0332), and to have received at least one (aOR=0.50, p=0.0073) or all three (aOR=0.47, p=0.0026) doses of the HPV vaccine. Bivariate analyses produce parallel results.
Conclusions
Results indicate that religious young women in Utah are not only under-vaccinated, but are also under-informed about HPV and the HPV vaccine. These results suggest that suboptimal vaccine coverage among religious young women may present a serious health risk for the community. Strategies for educational interventions targeted to this population are discussed.

Media/Policy Watch

Media/Policy Watch

This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

Forbes
http://www.forbes.com/
Accessed 2 September 2017
A Serious Reaction After Vaccination Rarely Occurs Again With Later Immunization, Study Finds
Tara Haelle, Contributor
Aug 28, 2017
Very few serious adverse events after a vaccination occur with another vaccination, a new study finds.

New Yorker
http://www.newyorker.com/
Accessed 2 September 2017
Annals of Medicine
August 22, 2016 Issue
The Race for a Zika Vaccine
In the throes of an epidemic, researchers investigate how to inoculate against the disease.
By Siddhartha Mukherjee

New York Times
http://www.nytimes.com/
Accessed 2 September 2017
Court Dismisses Remaining Lawsuit Against U.N. on Haiti Cholera
24 August 2017
The last remaining class-action lawsuit against the United Nations over the cholera epidemic in Haiti was thrown out Thursday by a federal judge, who upheld the organization’s assertion of diplomatic immunity.
In an order filed in Federal District Court in Brooklyn, Judge Sandra L. Townes said the lawsuit, which accused the United Nations of responsibility because the cholera was introduced into Haiti by infected United Nations peacekeepers from Nepal seven years ago, had been dismissed for “lack of subject-matter jurisdiction.”…

Washington Post
http://www.washingtonpost.com/
Accessed 2 September 2017
FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients
28 August 2017
The Food and Drug Administration on Monday announced a crackdown on stem-cell clinics offering on “unapproved and potentially dangerous” treatments, including an outfit in California that has been using the smallpox vaccine on seriously ill cancer patients.
U.S. marshals on Friday raided San Diego-based StemImmune Inc. and seized the vaccine, which the FDA said had been combined with stem cells derived from fat to create an unapproved product. The concoction was injected intravenously and directly into patients’ tumors at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the agency said.
FDA Commissioner Scott Gottlieb, in a statement on the case, said the agency “will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work.”…
In the California case, the FDA said it had “serious concerns” about how StemImmune obtained the smallpox vaccine, which is not commercially available. The vaccine typically is reserved for people at high risk for smallpox, such as members of the military.
The vaccine is made from a live virus called vaccinia, which is a poxvirus that is similar to smallpox but less harmful. The vaccine can’t cause smallpox, but for people with compromised immune systems — as is the case with many cancer patients — exposure can result in life-threatening medical problems, including myocarditis, which is an inflammation of the heart muscle.
StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, which controls the civilian supply. Thomas Skinner, a CDC spokesman said that the company had requested the vaccine to inoculate researchers who were doing cancer research involving the vaccinia virus.
In recent years, the vaccine, which was used to stamp out smallpox, has increasingly been tested as an anti-cancer tool, including as a way to prompt the immune system to attack malignancies…

Think Tanks et al

Think Tanks et al

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 2 September 2017
Research in the Time of Ebola: How We Can Do Better
Blog Post
8/29/17
Mead Over and Roxanne Oroxom
The 2014-2015 Ebola outbreak in West Africa was a disturbing demonstration of the inadequacy of international institutions to assist the affected peoples or learn how to better treat and prevent their illness. Experts on a CGD panel discussed their experiences working on crisis response during the Ebola outbreak—and how we can do better.