Vaccines And Clinical Trials
Clinical trials are key to learning more about both cancer prevention vaccines and cancer treatment vaccines. Researchers are testing vaccines for many types of cancer, including:
Bladder cancer. Researchers are testing how well a vaccine made from a virus altered with the HER2 antigen works. These antigens or molecules live on the surface of some bladder cancer tumors. The virus may help teach the immune system to find and destroy these tumor cells. Researchers also want to know which works better: standard bladder cancer treatment or standard treatment with a vaccine.
Brain tumors. There are many studies testing treatment vaccines aimed at certain molecules on the surface of brain tumor cells. Some focus on newly found brain cancer. Others focus on cancer that has come back, or recurred. Many of the studies include children and teens.
Breast cancer. Many studies are testing treatment vaccines for breast cancer, given alone or with other treatments. Other researchers are working to get vaccines that prevent breast cancer into clinical trials.
Cervical cancer. As explained above, the FDA approved HPV vaccines that prevent cervical cancer. Research continues on vaccines that help treat each stage of cervical cancer.
Colorectal cancer. Researchers are making treatment vaccines that tell the body to attack cells with antigens thought to cause colorectal cancer. These antigens include carcinoembryonic antigen , MUC1, guanylyl cyclase C, and NY-ESO-1.
Concerns Over Mrna Vaccine
According to Dr. Kenyon, misinformation surrounding mRNA vaccines stems from a concern that the vaccine infects people with the virus.
Nobody is getting infected with a COVID-19 vaccine. It is only the surface protein that would be replicated because we have given you the messenger RNA. It is not the entire virus, he explained.
One misconception is that an mRNA vaccine would not be useful when the virus mutates.
A July 2020 study that appears in Frontiers in Microbiology confirms that the virus mutates. After analyzing 48,635 samples of SARS-CoV-2, the researchers identified an average of 7.23 mutations per sample.
While mutations are a certainty, Dr. Sun said that this should not be a cause for alarm.
There has been an estimated 250,000 variants or strains of SARS-CoV-2 sequenced in the lab. For the most part, the virus has a low mutation rate compared to the mutation rate of the influenza virus , Dr. Sun explained. The spike protein is important for the ability of the virus to infect humans cells. I think it would not mutate enough for the vaccines to be ineffective.
Another concern is whether natural immunity would be more effective than a vaccine. However, a CDC study from November 2021 found that COVID-19 mRNA vaccines are about five times more effective in preventing hospitalization than a previous infection.
Dr. Kenyon said that before any clinical trial can start, a data monitoring and safety board must approve a study protocol.
The Asian Flu Pandemic Hits
This was the second major influenza pandemic of the 20th century, killing about 2 million worldwide, including almost 70,000 in the United States. It was caused by a virus known as influenza A subtype H2N2 , a mixed strain many scientists believe originated from a combination of bird and human flu viruses.
Influenza strains are characterized by two proteins on the outer surface of the virus: hemagglutinin and neuraminidase . There are 14 versions of the H protein and nine versions of the N protein, according to the American Council on Science and Health.
The virus was first identified in Guizhou, China, in 1956. It spread to Singapore by February 1957, Hong Kong by that April and the U.S. by June. A vaccine was developed to contain the outbreak in 1957, but the strain would later evolve via antigenic shift into H3N2, causing a milder pandemic between 1968 and 1969.
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Work Begins On A Universal Flu Vaccine
Johnson & Johnson announced that it will begin work on the development of a new universal flu vaccine designed to fight all types of the virus, using molecules called mini-HA antigens that contain parts of the flu virus that appear within a wide variety of viruses. The goal: provide longer-lasting protection than the regular seasonal flu shot.
The catalyst for this was a 2008 discovery by Crucell that human antibody CR6261 could protect against a broad spectrum of influenza viruses. It was then that researchers realized humans are capable of producing antibodies against the part of the influenza virus that doesn’t changean idea that was not accepted before this time.
Current flu vaccines have to be changed year to year, and even then, they only reduce the risk of developing the flu by 40 to 60%, explains Ted KwaksTed Kwaks, Ph.D.,Director for Project Management and External Innovation, Viral Vaccines Discovery, Janssen Pharmaceuticals, Ph.D., Director for Project Management and External Innovation, Viral Vaccines Discovery, , part of the Johnson & Johnson family of companies. The theory is that, ultimately, well put these antigens into a vaccine that will provide protection against virtually all flu strains.
Years Of Advance Research
The research that helped to develop vaccines against the new coronavirus didnt start in January. For years, researchers had been paying attention to related coronaviruses, which cause SARS and MERS , and some had been working on new kinds of vaccine an effort that has now paid off spectacularly.
Vials of Sinovac Biotechs COVID-19 vaccine on a production line in Beijing.Credit: Kevin Frayer/Getty
Conventional vaccines contain viral proteins or disabled forms of the virus itself, which stimulate the bodys immune defences against infection by a live virus. But the first two COVID-19 vaccines for which efficacy was announced in large-scale clinical trials used just a string of mRNA inside a lipid coat. The mRNA encodes a key protein of SARS-CoV-2 once the mRNA gets inside our cells, our bodies produce this protein. That acts as the antigen the foreign molecule that triggers an immune response. The vaccines made by Pfizer and BioNTech and by the US pharmaceutical company Moderna both use mRNA that encodes the spike protein, which docks to human cell membranes and allows the coronavirus to invade the cell.
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Vaccine Development Testing And Regulation
Paul Offit, MD, describes the general process of making a vaccine.The College of Physicians of Philadelphia
Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.
The current system for developing, testing, and regulating vaccines developed during the 20th century as the groups involved standardized their procedures and regulations.
The Specter Of The Spanish Flu
Ford was only 5 years old during the Spanish flu pandemic, but the devastating outbreak loomed large in the cultural memory, as did the especially deadly pandemics of seasonal influenza during the winters of 1957-1958 and 1968-1969, when schemes to immunize the U.S. population failed.
The matter rapidly moved from the federal health agencies to the White House, driven by David Mathews, the secretary of health, education and welfare, Theodore Cooper, assistant secretary for health, and CDC Director David Sencer, each of whom favored an aggressive response.
Six weeks after Lewis died at Fort Dix, Mathews wrote the White House Office of Management and Budget director, James Lynn, with dire warnings about a looming swine flu outbreak.
There is evidence there will be a major flu epidemic this coming fall. The indication is that we will see a return of the 1918 flu virus that is the most virulent form of flu, Mathews wrote on March 15. In 1918, a half million people died. The projections are that this virus will kill one million Americans in 1976.
One million deaths would amount to nearly 60 times the fatalities caused by the seasonal flu each year at the time.
Health officials led by the HEWs Cooper provided Mathews and Ford with a range of options that included a national vaccination program, doing nothing at all and several alternatives in between. But the language in that from the HEW strongly suggested that the Ford administration do something big and fast.
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Are There Vaccines That Treat Cancer
There are vaccines that treat existing cancer, called treatment vaccines or therapeutic vaccines. These vaccines are a type of cancer treatment called immunotherapy. They work to boost the body’s immune system to fight cancer. Doctors give treatment vaccines to people who already have cancer. Different treatment vaccines work in different ways. They can:
Keep the cancer from coming back
Destroy any cancer cells still in the body after treatments end
Stop a tumor from growing or spreading
What Are The Challenges Of Using Treatment Vaccines
Making treatment vaccines that work is a challenge because:
Cancer cells suppress the immune system. This is how cancer is able to begin and grow in the first place. Researchers are using adjuvants in vaccines to try to fix this problem. An adjuvant is a substance added to a vaccine to improve the body’s immune response.
Cancer cells start from a person’s own healthy cells. As a result, the cancer cells may not “look” harmful to the immune system. The immune system may ignore the cells instead of finding and fighting them.
Larger or more advanced tumors are hard to get rid of using only a vaccine. This is 1 reason why doctors often give a cancer vaccine along with other treatment.
People who are sick or older can have weak immune systems. Their bodies may not be able to produce a strong immune response after they receive a vaccine. That limits how well a vaccine works. Also, some cancer treatments may weaken a person’s immune system. This limits how well the body can respond to a vaccine.
For these reasons, some researchers think cancer treatment vaccines may work better for smaller tumors or cancer in its early stages.
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Questions To Ask Your Health Care Team
If you want to learn more about joining a cancer treatment vaccine clinical trial, talk with your health care team. You may want to ask these questions:
Is there a clinical trial testing a vaccine for my type and stage of cancer?
Where is the clinical trial located?
What is the vaccine and how does it work?
How is the vaccine made? Will I need blood cells or tumor tissue removed to make the vaccine? How will you remove it?
How will I receive the vaccine and how often?
How long will I need the vaccine?
What side effects could occur?
Can I receive the vaccine with other treatments such as radiation therapy or chemotherapy?
What are the other treatment options for this cancer?
The Sixties: Split Vaccines
New inactivated compounds were tested for safety and efficacy during seasonal epidemics in the 1960s, in particular two new formulations were created: split and subunit vaccines. The 1968 pandemic led to the development of trivalent inactivated vaccines against influenza viruses moreover the development of new split or subunit vaccines led to a decrease of adverse reactions in children. These vaccines were split using ether and/or detergent, and haemagglutinin and neuraminidase were, in the case of subunit vaccines, purified and enriched .
In the same period, the first flu vaccines were licensed in Europe, while in the US annual influenza vaccination was recommended for individuals at major risk of influenza complications.
In 1968, the new virus strain H3N2 appeared, completely replacing the previous type A strain , and led to another global pandemic with high morbidity and mortality . In the same year, a new type of vaccine, the split vaccine, was authorized in the US after several clinical studies had demonstrated that it was less reactogenic than whole virus vaccines, especially in the early years of life .
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Quadrivalent Vaccines For Seasonal Flu
A quadrivalent flu vaccine administered by nasal mist was approved by the FDA in March 2012. Fluarix Quadrivalent was approved by the FDA in December 2012.
In 2014, the Canadian National Advisory Committee on Immunization published a review of quadrivalent influenza vaccines.
Starting with the 2018-2019 influenza season most of the regular-dose egg-based flu shots and all the recombinant and cell-grown flu vaccines in the United States are quadrivalent. In the 2019â2020 influenza season all regular-dose flu shots and all recombinant influenza vaccine in the United States are quadrivalent.
In November 2019, the FDA approved Fluzone High-Dose Quadrivalent for use in the United States starting with the 2020-2021 influenza season.
In February 2020, the FDA approved Fluad Quadrivalent for use in the United States. In July 2020, the FDA approved both Fluad and Fluad Quadrivalent for use in the United States for the 2020â2021 influenza season.
Southern Hemisphere Influenza Season
The composition of virus vaccines for use in the 2018 Southern Hemisphere influenza season recommended by the World Health Organization on September 28, 2017, was:
- an A/Michigan/45/2015 pdm09-like virus
- an A/Singapore/INFIMH-16-0019/2016 -like virus
- a B/Phuket/3073/2013-like virus
The WHO recommended that quadrivalent vaccines containing two influenza B viruses should contain the above three viruses and a B/Brisbane/60/2008-like virus.
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The First Us Influenza Vaccine Is Approved
This whole-virus, inactivated influenza A and B vaccine was first tested in military recruits and college students before it received approval for military use in the United States. A year later, it was approved for civilian use, as well. At right, schoolchildren wait in line for immunization shots at a child health station in New York City, circa 1946.
There are four types of influenza virusA, B, C and Dbut only the A and B types are thought to cause viral epidemics in humans, according to the CDC.
Next Steps: Clinical Studies With Human Subjects
Phase I Vaccine Trials
This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded .
The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. In a small minority of Phase 1 vaccine trials, researchers may use the challenge model, attempting to infect participants with the pathogen after the experimental group has been vaccinated. The participants in these studies are carefully monitored and conditions are carefully controlled. In some cases, an attenuated, or modified, version of the pathogen is used for the challenge.
A promising Phase 1 trial will progress to the next stage.
Phase II Vaccine Trials
A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group.
The goals of Phase II testing are to study the candidate vaccines safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
Phase III Vaccine Trials
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The Russian Flu Pandemic Spreads
Technically considered the fourth pandemic of the 20th century , this outbreakwhich started in China and Russia but eventually spread worldwidemainly affected people under the age of 25.
Researchers would later theorize that an older H1N1 virus had mysteriously resurfaced, only impacting younger people who had never been exposed to it.
The First Flu Vaccine Is Introduced
Soviet scientist A.A. Smorodintseff made the first attempt to vaccinate people with a live influenza vaccine. Following in the footsteps of Louis Pasteurwho had made the first known attempt to vaccinate humans with a live, attenuated viral strain of rabies in 1885Smorodintseff passed the live flu virus about 30 times in eggs, so it lost its virulence. He reported that those injected with the modified virus developed a slight fever but were protected against reinfection.
The attenuated virus was then used for mass production of a vaccine that was largely administered to factory workers, who were susceptible to outbreaks due to close working conditions.
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What Are Potential Side Effects Or Reactions To Flu Vaccines And Flu Vaccine Safety
In general, all medications, including intramuscular and nasal-spray vaccines, have side effects and the potential for allergic reactions. For most medicines and vaccines, the side effects or reactions are infrequent and are minimal if they do occur. Consequently, the pros far outweigh the cons for vaccination. The seasonal and pandemic vaccines are no different. What is different about the side effects of flu vaccines is that the occasional side effects seen with all flu vaccines usually resemble the flu disease. About 5%-10% of people experience mild side effects, such as headache, nasal congestion, low-grade fever, sore throat, or muscle cramps. Some individuals may experience short-term dizziness, nausea, and/or soreness or a mild rash at the inoculation site as vaccination side effects. Although these are short-lived, some people think they contracted the flu from the vaccine. This is a myth. The intramuscular vaccines contain no live virus, so the vaccine cannot transmit the disease. Although the nasal-spray vaccines contain live virus, it contains weakened virus. The vast majority of attenuated viruses will not be able to cause influenza in people with normal immune systems and good health because the attenuated viruses replicate poorly or not at all in these people. These side effects are most likely to occur in children who have not been exposed to influenza virus in the past, but they can occur in some adults.
Vaccines For Adolescents: A New Generation Of Vaccines
Adolescents, like adults, were recommended to get tetanus boosters every 10 years most requiring their first booster dose around age 11. Other than this, however, most adolescents did not require additional vaccines unless they missed one in childhood. By 2005, vaccines specifically recommended for adolescents were only recommended for sub-groups based on where they lived or medical conditions that they had. However, a new group of vaccines became available in the latter part of the decade.
- New vaccines: Tdap, 2005, meningococcal conjugate , HPV , meningococcal serogroup B vaccine
- Additional recommendations for existing vaccines: HPV , intranasal influenza vaccine
- New versions of existing vaccines: HPV
- Discontinuation of vaccine: intranasal influenza vaccine
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