Results from US Government-Sponsored Phase 1 Trial of VSV Vaccine Reported
?An early-stage clinical trial of an experimental Ebola vaccine conducted at the National Institutes of Health (NIH) and the Walter Reed Army Institute of Research (WRAIR) found that the vaccine, called VSV-ZEBOV, was safe and elicited robust antibody responses in all 40 of the healthy adults who received it. The most common side effects were injection site pain and transient fever that appeared and resolved within 12 to 36 hours after vaccination. A report describing preliminary results of the NIH-WRAIR study appears online today in The New England Journal of Medicine. The VSV-ZEBOV candidate is one of two experimental Ebola vaccines now being tested in the phase 2/3 PREVAIL clinical trial that is enrolling volunteers in Liberia.
“The ongoing Ebola outbreak in West Africa is unprecedented in scope and duration,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. “The outbreak is slowly coming under control, thanks to extraordinary and multi-faceted efforts in the affected nations. However, there still are no licensed specific therapies or vaccines for Ebola. Until a safe and effective vaccine is available, the world will continue to be under-prepared for the next Ebola outbreak.”
Scientists at the Public Health Agency of Canada developed the candidate vaccine. It was licensed to NewLink Genetics Corp. of Ames, Iowa, a company collaborating with Merck & Co. Inc., of Kenilworth, New Jersey, which is responsible for advancing this vaccine towards regulatory approval. The investigational vaccine is based on a genetically modified and attenuated vesicular stomatitis virus (VSV), a virus that mainly affects cattle. In the investigational vaccine, a gene for a VSV protein is replaced with a gene segment from a key protein in the Zaire species of Ebola virus. The vaccine does not contain the whole Ebola virus and therefore cannot infect vaccinated persons with Ebola.
The new report summarizes results of the first 52 volunteers enrolled in the study: 26 at the NIH Clinical Center in Bethesda, Maryland, and 26 at the WRAIR clinic in Silver Spring, Maryland. Six volunteers at each site received a placebo injection of saline solution, and the remaining 40 received the experimental vaccine at either one of two different dosages (2 x107 or 3 x106 in 20 volunteers at each site). The NIH trial was led by NIAID investigators Richard T. Davey, Jr., M.D., and John H. Beigel, M.D., while Jason A. Regules, M.D., and Stephen J. Thomas, M.D., headed the trial at WRAIR.
The candidate vaccine’s ability to stimulate immune responses was assessed by sampling the volunteers’ blood at multiple time points following injection. (The blood sampling schedule differed between the two trial sites.) Of those volunteers tested at 14 days after injection, 93 percent (26 out of 28) of whose who had received vaccine developed antibodies against Zaire species of Ebola virus. Antibodies were detected in the remaining 14 volunteers who had received vaccine by 28 days after injection. Antibody responses were approximately three-fold greater in those who received the higher vaccine dose. This information was available to the designers of the PREVAIL trial and was used to guide the decision to use VSV-ZEBOV at the higher dosage level in that trial.
“The prompt, dose-dependent production of high levels of antibodies following a single injection and the overall favorable safety profile of this vaccine make VSV-ZEBOV a promising candidate that might be particularly useful in outbreak interventions,” said Dr. Davey.
Read more: Experimental Ebola Vaccine Safe, Prompts Immune Response
The Latest on: Ebola Vaccine
[google_news title=”” keyword=”Ebola Vaccine” num_posts=”10″ blurb_length=”0″ show_thumb=”left”]
via Google News
The Latest on: Ebola Vaccine
- Was COVID Vaccine Recalled Over Health Danger Fears? What We Knowon May 9, 2024 at 5:26 am
AstraZeneca, which is withdrawing its COVID-19 vaccine, says independent estimates show that it saved over 6.5 million lives in the first year of its use.
- New mRNA vaccine for deadly brain cancer triggers a strong immune responseon May 9, 2024 at 4:00 am
COVID-19 vaccine development paves way to a new class of cancer immunotherapy. For the first time, scientists have tested a messenger RNA (mRNA) vaccine in a patient with a deadly form of brain cancer ...
- Travel Vaccines Market Forecast: Expected Growth Rates and Key Trends for 2032.on May 8, 2024 at 11:21 pm
The global travel vaccines market size was US$ 6.1 billion in 2021. The global travel vaccines market is forecast to grow to US$ 12.1 billion by 2030 by registering a compound annual growth rate (CAGR ...
- Urgent considerations for booster vaccination strategies against Ebola virus diseaseon May 8, 2024 at 4:30 pm
With two endorsed and prophylactic vaccines against Zaire ebolavirus (referred to hereafter as EBOV), the number of individuals vaccinated against EBOV worldwide is estimated to range between 500 000 ...
- Over 50mln lives saved in Africa through expanded immunisation programme — WHOon April 25, 2024 at 4:28 am
An estimated 51.2 million lives have been saved through vaccines in the African region over the past 50 years. For every infant life saved over that period, close to 60 years of life are lived, a new ...
- What is the flu virus likely to cause the next pandemic?on April 23, 2024 at 6:35 am
A new survey of 187 scientists set to be published at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) congress in Barcelona says that the flu virus, also known as ...
- The Evolving History of Influenza Viruses and Influenza Vaccineson April 17, 2024 at 5:00 pm
The year of isolation (four-digit year for viruses isolated in 2000 or later; two-digit year for viruses isolated during the 1900s); The subtype [16 possible hemagglutinin and 9 possible ...
- Conference Report - I. Investigating New Vaccines: Ebola and HIVon April 10, 2024 at 5:00 pm
2 characteristics that sustain its potential as immunization vector for HIV vaccines. An E1 deletion-mutant of Ad35 [9] was generated and compared with Ad5 in the immunization against the gag ...
- What Britain can learn from India’s ‘Vaccine Prince’on March 10, 2024 at 1:30 am
Last year alone, it produced more than 1.9 billion vaccines – delivering shots for deadly diseases including Ebola, malaria and measles to some 170 countries. But it was the pandemic – when ...
- Here’s Why Vaccines Are So Crucialon August 16, 2020 at 9:49 am
In Bangladesh, for example, it could push the GSK pneumococcal vaccine cost from 60 cents to $9.15 per child. That still looks like a bargain to an American doctor paying more than 50 times that much.
via Bing News