IAVI International AIDS Vaccine Initiative [to 28 November 2015]

IAVI International AIDS Vaccine Initiative [to 28 November 2015]

Updated Guidelines Released to Respect, Protect and Fulfill the Needs of Men Who Have Sex with Men (MSM) in HIV Research
November 25, 2015
Experience consistently shows that better collaboration is needed between researchers and community-based organizations (CBOs) around studies of HIV treatment and prevention interventions involving gay men and other men who have sex with men (MSM). This is, especially true in resource-constrained settings. In addition, working with MSM in these contexts presents unique challenges from the often prevalent stigma, discrimination, and security concerns.

To meet this ongoing need, a group led by amfAR, The Foundation for AIDS Research; the International AIDS Vaccine Initiative (IAVI); the John Hopkins University – Center for Public Health and Human Rights (JHU-CPHHR); and the United Nations Development Program (UNDP) has updated important guidance to help researchers and CBOs maximize the benefits and minimize any potential risks of working together on this critically needed research.

The revised “Respect, Protect, Fulfill” will be released on 28 November, at the Key Populations Pre-conference of the 18th International Conference on HIV/AIDS and other STIs in Africa (ICASA), which takes place in Harare, Zimbabwe, from 29 November through 4 December 2015…

FDA [to 28 November 2015]

FDA [to 28 November 2015]

FDA approves first seasonal influenza vaccine containing an adjuvant
November 24, 2015 – The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.

Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. Squalene, a naturally occurring substance found in humans, animals and plants, is highly purified for the vaccine manufacturing process. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.

According to the Centers for Disease Control and Prevention, in recent years, it is estimated that 80 to 90 percent of seasonal influenza-related deaths and 50 to 70 percent of seasonal influenza-related hospitalizations have occurred among people 65 years of age and older.

FDA approves vaccine for use after known or suspected anthrax exposure
November 23, 2015 – The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

Anthrax disease, especially the inhalation form, is often fatal if not promptly treated. Anthrax is considered one of the more likely agents to be used in a biological attack, primarily because its spores are very stable and easy to disperse. Although it is rare, people may contract anthrax disease through natural exposures, such as contact with infected animals or contaminated animal products.

“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

IVI [to 28 November 2015]

IVI [to 28 November 2015]

IVI Statement: “It is a matter of time before dengue in Southeast Asia becomes endemic in South Korea”
An interview with Dr. In-Kyu Yoon, Director of the Dengue Vaccine Initiative and IVI’s Deputy Director General of Science was recently featured in Dong-A Ilbo, South Korea’s third largest daily newspaper and publisher of Dong-A Science, the top science magazine in the nation. In the interview he talks about the possibility of dengue spreading to South Korea. The interview, which was published in Korean, has been translated into English. Read the original interview here (Korean only): http://news.donga.com/3/all/20151124/74977500/1

European Vaccine Initiative [to 28 November 2015]

European Vaccine Initiative [to 28 November 2015]

EVI Scientific Advisory Committee (SAC) takes on two new members
25 November 2015
The two new EVI SAC members are: Chetan Chitnis, Professor and Head of Malaria Parasite Biology & Vaccines Unit, Institut Pasteur, Paris, and Nancy Le Cam Bouveret, Independent Clinical Development and Regulatory Consultant.

EDCTP [to 28 November 2015]

EDCTP [to 28 November 2015]
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.

24 November 2015
New EDCTP-TDR Clinical Research and Development Fellowships awarded
24 November 2015
A total of 18 product development clinicians from 9 low- and middle-income countries have been awarded clinical research and development fellowships. These fellows are supported by TDR, the Special Programme for Research and Training in Tropical Diseases, and will be placed with 10 host institutions by early 2016.

Health care workers in Pearl River Delta Area of China are not vaccinated adequately against hepatitis B: a retrospective cohort study

BMC Infectious Diseases
(Accessed 28 November 2015)

Research article
Health care workers in Pearl River Delta Area of China are not vaccinated adequately against hepatitis B: a retrospective cohort study
Yu-Bao Zheng, Yu-Rong Gu, Min Zhang, Ke Wang, Zhan-lian Huang, Chao-Shuang Lin, Zhi-Liang Gao BMC Infectious Diseases 2015, 15:542 (22 November 2015)
Health-care workers’ (HCWs) exposure to bodily fluids puts them at risk of hepatitis B virus HBV infection. This study investigated HBV vaccination practices and outcomes in HCWs and assessed postvaccination seroprotection across HCWs in different departments.
A survey of HCWs in a Chinese public general hospital was carried out with a retrospective cohort of 1420 hospital HCWs (458 males and 962 females). HBV vaccination status (10-μg/dose used) was investigated in the cohort from vaccination records from the period of 1988 to 2008. Blood samples were collected and tested for hepatitis B surface antigen (HBsAg) and HBV antibodies (anti-HBs).
The overall vaccination (complete course) and HBsAg carrier rates among HCWs were 40.42 % (574/1420) and 6.13 % (87/1420), respectively. Vaccination rates differed by department, with HCWs in internal medicine (39.5 %) and emergency (42.0 %) departments having particularly low rates. The natural infection rate was 7.53 % (107/1420) among HCWs. HCWs in the department of infectious diseases (vaccination rate, 57.8 %) had the highest rate of antibody produced by natural infection (88.2 %).
The vaccination rate was a disappointingly low among HCWs in Pearl River Delta Area of China. HCWs working in infectious diseases departments and technicians were at particularly likely to have been infected with HBV. A concerted effort is needed to bring vaccination rates up among Chinese HCWs in Pearl River Delta Area of southern China.

Direct observation of respectful maternity care in five countries: a cross-sectional study of health facilities in East and Southern Africa

BMC Pregnancy and Childbirth
(Accessed 28 November 2015)

Research article
Direct observation of respectful maternity care in five countries: a cross-sectional study of health facilities in East and Southern Africa
Heather Rosen, Pamela Lynam, Catherine Carr, Veronica Reis, Jim Ricca, Eva Bazant, Linda Bartlett, on behalf of the Quality of Maternal and Newborn Care Study Group of the Maternal and Child Health Integrated Program
BMC Pregnancy and Childbirth 2015, 15:306 (23 November 2015)
Poor quality of care at health facilities is a barrier to pregnant women and their families accessing skilled care. Increasing evidence from low resource countries suggests care women receive during labor and childbirth is sometimes rude, disrespectful, abusive, and not responsive to their needs. However, little is known about how frequently women experience these behaviors. This study is one of the first to report prevalence of respectful maternity care and disrespectful and abusive behavior at facilities in multiple low resource countries.
Structured, standardized clinical observation checklists were used to directly observe quality of care at facilities in five countries: Ethiopia, Kenya, Madagascar, Rwanda, and the United Republic of Tanzania. Respectful care was represented by 10 items describing actions the provider should take to ensure the client was informed and able to make choices about her care, and that her dignity and privacy were respected. For each country, percentage of women receiving these practices and delivery room privacy conditions were calculated. Clinical observers’ open-ended comments were also analyzed to identify examples of disrespect and abuse.
A total of 2164 labor and delivery observations were conducted at hospitals and health centers. Encouragingly, women overall were treated with dignity and in a supportive manner by providers, but many women experienced poor interactions with providers and were not well-informed about their care. Both physical and verbal abuse of women were observed during the study. The most frequently mentioned form of disrespect and abuse in the open-ended comments was abandonment and neglect.
Efforts to increase use of facility-based maternity care in low income countries are unlikely to achieve desired gains if there is no improvement in quality of care provided, especially elements of respectful care. This analysis identified insufficient communication and information sharing by providers as well as delays in care and abandonment of laboring women as deficiencies in respectful care. Failure to adopt a patient-centered approach and a lack of health system resources are contributing structural factors. Further research is needed to understand these barriers and develop effective interventions to promote respectful care in this context.