Newcastle virus vaccine

The recent advances in the development of NDV-vectored vaccines or therapeutics for animals and humans are discussed. Perspectives to fill the gap of understanding concerning the mechanism of MDA interference in poultry and to improve the NDV vector vaccines are also proposed.

The virus can also be inhaled. As explained in Question 1 , NDV infects cells and then replicates itself, creating more copies of the virus that can then infect cells throughout the body. This process targets and kills cancer cells by damaging the cells' outer membranes.

Oncolysate vaccines are made using pieces of cancer cell membranes infected with NDV. Oncolysate-based vaccines are injected under or into the skin. Whole-cell vaccines are made using whole tumor cells infected with NDV. The tumor cells used in the vaccine are changed in the laboratory so that they cannot multiply or infect the patient. Whole-cell vaccines with NDV are given only by injection under the skin.

A number of preclinical studies have been done with NDV. Research in a laboratory or using animals is done to find out if a drug , procedure, or treatment is likely to be useful in humans.

These preclinical studies are done before any testing in humans is begun. The following has been learned from preclinical studies:. A few of these studies used human cells, but most used animal cells. Based on these and other laboratory findings, clinical trials research studies with people using NDV were begun. Some of the trials reported positive results and some did not.

Most of the studies enrolled only small numbers of patients who also received standard treatments. None of the trials published in English were randomized and few were controlled. Randomized clinical trials give the highest level of evidence. In randomized trials, volunteers are assigned randomly by chance to one of 2 or more groups that compare different factors related to the treatment.

In a controlled clinical trial, one group called the control group does not receive the new treatment being studied. The control group is then compared to the groups that receive the new treatment, to see if the new treatment works. Randomized controlled trials, enrolling larger numbers of people, are needed to confirm the results of studies done so far on the use of NDV to treat cancer.

Below are brief descriptions of these studies. Four clinical trials in the United States studied the use of NDV oncolysates in patients with metastatic melanoma.

Three of these studies, a phase I clinical trial and 2 phase II clinical trials , were by the same group of researchers. Some positive results were found in these studies.

The fourth trial was led by different researchers and showed no benefit. The same type of NDV was used to make the vaccines in all 4 studies, but the 2 groups of researchers used different methods to make them. Results from these studies need to be confirmed by randomized controlled trials that enroll larger numbers of people. One of the studies showed that people in the trial had longer disease-free survival when compared with published information on similar patients who were treated with surgery alone.

Because these studies were not controlled and the patients received other treatments, it is not clear if it was the treatment with NDV oncolysates that caused the responses reported. Most of the published clinical studies of whole-cell vaccines with NDV have been done in Germany. The largest reported trial was in China. Most of these studies involved patients with colorectal cancer , breast cancer , ovarian cancer , renal cell kidney cancer , or malignant glioma.

The same type of NDV was used to make the vaccines in all of the studies. Some of these studies found improved disease-free survival or improved overall survival in patients treated with whole-cell vaccines. The lack of control groups and other weaknesses in study design and reporting made it unclear if benefits were caused by the whole-cell vaccine or by something else.

Overall, the results showed that these vaccines may help the immune system kill more cancer cells during the vaccination program but may not provide long-term cancer immunity. The published findings include the following types of studies:.

According to the researchers, the MTH treatment was helpful for most of the patients in these studies. The number of patients in the studies was small, however, and the patients in the clinical trial were not randomly assigned. The patients also received other treatments.

For these reasons, it is not known if the patients were helped by the MTH or by something else. In this trial, 79 patients with advanced cancers that were not helped by conventional therapy were given PV by injection into a vein. Some patients had partial responses to the treatment, while others did not have any change in their condition. More studies are planned. One major concern is that repeated injections of NDV may cause a person's immune system to form antibodies against the virus.

These antibodies would prevent NDV from infecting and killing cancer cells. More research is needed to study this. While most studies of NDV in cancer treatment have been small and without control groups, there have been enough promising results to call for continued research.

The side effects caused by NDV exposure have been mild to moderate. As noted in Question 1 , NDV causes mild flu-like symptoms, conjunctivitis, and laryngitis in humans. Other side effects vary with how the virus is given.

Studies that combined treatment with NDV oncolysates or whole-cell vaccines with substances called cytokines reported flu-like symptoms, fever, and swelling. The side effects seen in these studies have been linked to the cytokine portion of the treatment. Use our clinical trial search to find NCI-supported cancer clinical trials that are accepting patients. You can search for trials based on the type of cancer, the age of the patient, and where the trials are being done.

General information about clinical trials is also available. The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries come in two versions. The health professional versions have detailed information written in technical language. The patient versions are written in easy-to-understand, nontechnical language.

Both versions have cancer information that is accurate and up to date and most versions are also available in Spanish. The PDQ summaries are based on an independent review of the medical literature. This PDQ cancer information summary has current information about the use of Newcastle disease virus in the treatment of people with cancer. It is meant to inform and help patients, families, and caregivers. It does not give formal guidelines or recommendations for making decisions about health care.

Editorial Boards write the PDQ cancer information summaries and keep them up to date. These Boards are made up of experts in cancer treatment and other specialties related to cancer.

The summaries are reviewed regularly and changes are made when there is new information. The date on each summary "Updated" is the date of the most recent change. The information in this patient summary was taken from the health professional version, which is reviewed regularly and updated as needed, by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board.

A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about the effects of a new treatment and how well it works. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become "standard.

The safety and tolerability profile assessed by the number of serious adverse events. The safety and tolerability profile assessed by the number of medically-attended adverse events MAAEs. Eligibility Criteria.

Inclusion Criteria: Willing and able to provide written informed consent prior to performing study procedures. Males and non-pregnant females who are between 18 to 59 years of age. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Only highly effective methods of contraception that have a low user dependency or a combination of highly effective methods that are user dependent may be used. In addition to male condom use, a highly effective method of contraception may be considered in WOCBP partners of male participants.

Participant understands and agrees to comply with planned study procedures. Provides consent for release of information for hospitalization records and other medically attended visits during the study. History of hypersensitivity to egg products. History of severe reactions to vaccinations. Potential for prior NDV exposures i. History of an immunocompromising medical condition such as primary immunodeficiencies, AIDS, or neutropenia. Current or recent use of immunosuppressive medications i. Pregnancy or actively breastfeeding.

Other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator. In the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of SARS-CoV-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle SARS-CoV This guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people.

Participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration. Participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger. Participants who have close or household high-risk contacts including but not limited to: Persons more than or equal to 65 years of age Children less than or equal to 5 years of age.

Post-hatch survival after vaccination with the rNDV-IL4R vaccines was dose-dependent, with an increase in survival as the dose decreased. This improved survival and the dose-dependency data suggest that novel attenuated in ovo rNDV-based vaccines that are able to penetrate maternal immunity to elicit a strong immune response as early as 14 days post-hatch, resulting in high or full protection from virulent challenge, show promise as a contributor to the control of Newcastle disease.

Keywords: Newcastle disease; cytokine; dose; in ovo vaccine; maternal immunity; recombinant. Abstract Newcastle disease ND is one of the most economically important poultry diseases.