Early-Stage Respiratory Syncytial Virus (RSV) Vaccine Trial Begins

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has launched a clinical trial of an investigational vaccine designed to protect against respiratory syncytial virus (RSV).

This scanning electron micrograph image depicts RSV particles, colored blue.

The Phase 1 study will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine and its ability to induce an immune response. The study is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs).

RSV, a common virus, typically causes mild, cold-like symptoms that resolve within two weeks. However, the virus can cause severe symptoms, especially among infants and young children. Each year, an estimated 57,000 children under the age of five years are hospitalized in the United States due to RSV infection, according to the Centers for Disease Control and Prevention (CDC). Globally, RSV is estimated to cause up to 200,000 deaths annually, according to the World Health Organization. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia among children under the age of 1 year. Almost all children in the United States are infected with RSV at least once by the age of 2, and most will experience repeated infections over their lifetimes.

Additionally, people 65 years or older, adults with chronic heart or lung disease, and individuals with weakened immune systems are at increased risk of severe RSV infection. Each year in the United States, RSV leads to an average of 14,000 deaths among adults older than 65 years, according to the CDC. Currently, no specific treatments or vaccines are available for RSV.

“RSV infection is a significant cause of illness and disease among the most vulnerable populations,” said NIAID Director Anthony S. Fauci, M.D. “A vaccine to prevent disease from this pervasive and sometimes deadly virus is urgently needed.”

Led by principal investigator David Bernstein, M.D., of the Cincinnati Children’s Hospital Medical Center, the study is testing an experimental vaccine called SeVRSV. The vaccine candidate was developed by researchers at St. Jude Children’s Research Hospital and manufactured by Children’s GMP LLC, of St. Jude Children’s Research Hospital in Memphis, Tennessee. SeVRSV contains a modified mouse virus (Sendai virus) designed to carry RSV genetic material that will express RSV fusion protein in the vaccine recipient to stimulate RSV-specific antibodies and T-cells. The Sendai virus vaccine platform has been well-tolerated to date in human clinical trials of vaccines for other infectious diseases, including HIV. SeVRSV performed well in previous preclinical and animal studies.

The study will enroll up to 25 healthy, non-pregnant volunteers between 18 and 45 years. After receiving an initial screening exam, at least 16 volunteers will be given a single intranasal dose of the experimental vaccine (0.22 milliliters in each nostril) and four or more will receive a placebo, in the form of saline nose drops. After vaccination, all volunteers will be observed for at least 30 minutes.

Afterwards, volunteers will report for five clinic visits over 29 days. During these visits, volunteers will be examined for any adverse reactions, and blood samples and nasal washes will be collected to check for RSV-specific antibodies. The volunteers will return at two and six months after vaccination.

Donors pledge over US$15 million to WHO’s Contingency Fund for Emergencies

Donors have pledged an additional US$15.3 million to support quick action by the World Health Organization to tackle disease outbreaks and humanitarian health crises through its emergency response fund in 2018, the Contingency Fund for Emergencies (CFE).

   Canada, Denmark, Estonia, Germany, the Republic of Korea, Kuwait, Luxembourg, Malta, Netherlands, Norway, and the United Kingdom of Great Britain and Northern Ireland announced contributions ranging from US$20,000 to US$5.6 million at a conference hosted at WHO headquarters in Geneva, Switzerland on Monday (March 26) – increasing CFE funding levels to US$23 million.

This will enable the rapid financing of health response operations in the coming months – filling that critical gap between the moment the need for an emergency response is identified and the point at which funds from other sources can be released. WHO will seek to secure further donor commitments to achieve its US$100 million funding target for the 2018/2019 biennium.

First-time pledges were made by Denmark, Kuwait, Luxembourg, Malta and Norway. The UK has increased its overall commitment to the fund from US$10.5 million to US$16 million, making it the second largest donor after Germany.

“For the UK, the CFE is an extraordinarily good investment. We are convinced it has a vital and unique role to play in the global effort to prevent and mitigate health emergencies. Today we pledge an additional £4 million (US$5.6 million) for the Contingency Fund and pledge to work with WHO to better profile to a wider audience the huge value it brings. The G7 and the G20 share the UK’s desire for an adequately funded CFE. We urge our fellow Member States and donors to heed WHO’s call and to step forward to provide financial support for the Contingency Fund for Emergencies,” said Alistair Burt, UK Minister of State for International Development.

The CFE’s ability to release funds within 24 hours sets it apart from complementary financing mechanisms that have different funding criteria and slower disbursement cycles. While other funding mechanisms allow for the scale up of response operations, none are designed to deliver an immediate and early response. The CFE has demonstrated that a small investment can save lives and dramatically reduce the direct costs of controlling outbreaks and responding to emergencies.

“Without the CFE, recent outbreaks of Ebola in DRC, Marburg virus Disease in Uganda and pneumonic plague in Madagascar could have gotten out of control. By acting decisively and quickly, we can stop disease outbreaks and save thousands of lives for a fraction of the cost of a late response. The CFE has proven its value as a global public good that should be underwritten by long term investment,” said Dr Peter Salama, WHO Deputy Director General for Emergency Preparedness and Response.

Since 2015, the CFE has enabled WHO, national authorities and health partners to get quick starts on more than 50 disease outbreaks, humanitarian crises and natural disasters, allocating more than US$46 million. It has supported the rapid deployment of experts; better disease detection and reporting; the delivery of essential medicines, supplies and personal protective equipment; the strengthening of surveillance and vaccination; improved access to water, sanitation and health services; community engagement; and more.

Madagascar’s health minister Dr Lalatiana Andriamanarivo called for increased support for the CFE, saying it was instrumental to containing an unprecedented outbreak of pneumonic plague that rapidly spread across the island nation in 2017.

“We call on our international partners to support the Contingency Fund for Emergencies to enable WHO to respond to outbreaks everywhere across the world, and to reinforce national capacities to manage health emergencies in the future,” said Dr Andriamanarivo.

In 2017, the CFE provided nearly US$21 million for operations in 23 countries, with most allocations released within 24 hours. Over half (56%) of allocations funded responses in the WHO Africa region, with 28% going to responses in countries in the WHO Eastern Mediterranean Region and 11% to the South East Asia Region.

NIH experts call for transformative research approach to end tuberculosis

A more intensive biomedical research approach is necessary to control and ultimately eliminate tuberculosis (TB), according to a perspective published in the March 2018 issue of The American Journal of Tropical Medicine and Hygiene. 

Scanning electron micrograph of Mycobacterium tuberculosis bacteria, which cause TB.

In the article, authors Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and Robert W. Eisinger, Ph.D., special assistant for scientific projects at NIAID, discuss the need to modernize TB research by applying new diagnostic, therapeutic, and vaccine approaches. The perspective is based on a lecture delivered by Dr. Fauci on Nov. 17, 2017 in Moscow at the first World Health Organization Global Ministerial Conference, “Ending TB in the Sustainable Development Era: A Multisectoral Response.”

TB, a bacterial infection that typically infects the lungs, is one of the oldest known human diseases and the leading infectious cause of death worldwide. The authors recall the significant HIV/AIDS research advances made in the nearly 37 years since AIDS was first recognized, and encourage the scientific community to strive for comparable TB milestones.

Specifically, the authors call for systems biology approaches (using large data sets and modeling to understand complex biological systems) to fill critical knowledge gaps in understanding how Mycobacterium tuberculosis (Mtb) infection causes disease. Such research could help explain why some people infected with Mtb have latent infections and show no signs of disease while others, especially those co-infected with HIV, become sick. The perspective also underscores the need for improved diagnostic tests, including those that can detect Mtb in various specimens as well as rapid, inexpensive tests that can detect drug-resistant TB.

Lengthy and complex treatment regimens and an increasing number of multi-drug-resistant TB infections make the disease increasingly difficult to cure. The authors note that the ultimate treatment goal should be drug combinations administered for shorter time periods that can cure people infected with any strain of Mtb. Another research goal is a safe and more broadly effective vaccine, which remains one of the most difficult challenges, according to Drs. Fauci and Eisinger. However, they explain, a vaccine and other significant advances are possible with an innovative and aggressive biomedical research program and rapid translation of results into global control strategies.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

World Bank and WHO: Half the world lacks access to essential health services

At least half of the world’s population cannot obtain essential health services, according to a new report from the World Bank and the World Health Organization.

And each year, large numbers of households are being pushed into poverty because they must pay for health care out of their own pockets.

Currently, 800 million people spend at least 10 percent of their household budgets on health expenses for themselves, a sick child or other family member. For almost 100 million people these expenses are high enough to push them into extreme poverty, forcing them to survive on just $1.90 or less a day. The findings, released today in Tracking Universal Health Coverage: 2017 Global Monitoring Report, have been simultaneously published in Lancet Global Health.

“It is completely unacceptable that half the world still lacks coverage for the most essential health services,” said Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “And it is unnecessary. A solution exists: universal health coverage (UHC) allows everyone to obtain the health services they need, when and where they need them, without facing financial hardship.”

“The report makes clear that if we are serious – not just about better health outcomes, but also about ending poverty – we must urgently scale up our efforts on universal health coverage,” said World Bank Group President Dr. Jim Yong Kim. “Investments in health, and more generally investments in people, are critical to build human capital and enable sustainable and inclusive economic growth. But the system is broken: we need a fundamental shift in the way we mobilize resources for health and human capital, especially at the country level. We are working on many fronts to help countries spend more and more effectively on people, and increase their progress towards universal health coverage.”

There is some good news: The report shows that the 21st century has seen an increase in the number of people able to obtain some key health services, such as immunization and family planning, as well as antiretroviral treatment for HIV and insecticide-treated bed nets to prevent malaria. In addition, fewer people are now being tipped into extreme poverty than at the turn of the century.

Progress, however, is very uneven.

There are wide gaps in the availability of services in Sub-Saharan Africa and Southern Asia. In other regions, basic health care services such as family planning and infant immunization are becoming more available, but lack of financial protection means increasing financial distress for families as they pay for these services out of their own pockets. This is even a challenge in more affluent regions such as Eastern Asia, Latin America and Europe, where a growing number of people are spending at least 10 percent of their household budgets on out-of-pocket health expenses. Inequalities in health services are seen not just between, but also within countries: national averages can mask low levels of health service coverage in disadvantaged population groups. For example, only 17 percent of mothers and children in the poorest fifth of households in low- and lower-middle income countries received at least six of seven basic maternal and child health interventions, compared to 74 percent for the wealthiest fifth of households.

The report is a key point of discussion at the global Universal Health Coverage Forum 2017, currently taking place in Tokyo, Japan. Convened by the Government of Japan, a leading supporter of UHC domestically and globally, the Forum is cosponsored by the Japan International Cooperation Agency (JICA), UHC2030, the leading global movement advocating for UHC, UNICEF, the World Bank, and WHO. Japanese Prime Minister Shinzo Abe, UN Secretary-General Antonio Guterres, World Bank President Kim, WHO Director-General Tedros and UNICEF Executive Director Anthony Lake will all be in attendance, in addition to heads of state and ministers from over 30 countries.

“Past experiences taught us that designing a robust health financing mechanism that protects each individual vulnerable person from financial hardship, as well as developing health care facilities and a workforce including doctors to provide necessary health services wherever people live, are critically important in achieving ‘Health for All,’” said Mr. Katsunobu Kato, Minister of Health, Labour and Welfare, Japan. “I firmly believe that these early-stage investments for UHC by the whole government were an important enabling factor in Japan’s rapid economic development later on.”

The Forum is the culmination of events in over 100 countries, which began on Dec. 12—Universal Health Coverage Day—to highlight the growing global momentum on UHC. It seeks to showcase the strong high-level political commitment to UHC at global and country levels, highlight the experiences of countries that have been pathfinders on UHC progress, and add to the knowledge base on how to strengthen health systems and effectively promote UHC.

The main high-level sessions of the Forum take place tomorrow, Dec. 14, and will also feature an all-day “innovation showcase,” highlighting innovations driving progress in health systems around the world, and a celebratory public event in the evening. A commitment to action, called the Tokyo Declaration on Universal Health Coverage, will be released during the Forum’s closing ceremony.

“Without health care, how can children reach their full potential?  And without a healthy, productive population, how can societies realize their aspirations?” said UNICEF Executive Director Anthony Lake. “Universal health coverage can help level the playing field for children today, in turn helping them break intergenerational cycles of poverty and poor health tomorrow.”

Building on the G7 Ise-Shima Summit and the TICAD VI in 2016, both of which stress the need for UHC, the Forum in Tokyo is seen as a milestone for accelerating progress towards the target of UHC by 2030, a key part of the Sustainable Development Goals. Countries will then gear up for the next global moment: a high-level meeting of the UN General Assembly on UHC in 2019.