Results tagged “clinical trials” from Vaccination News

As the first FDA-approved cancer vaccine, designed to protect against human papillomavirus, has moved from scientific discussion to social debate, other vaccine studies are continuing to make progress. While HPV vaccine efforts had the "benefit" of a viral source for the disease, other researchers are developing vaccines for cancers that are not virally based, in an effort to coax the immune system into attacking cancerous cells.

At the 2007 Annual Meeting of the American Association for Cancer Research, presentations on ongoing HPV trials and other new approaches to stimulating the immune system are injecting momentum into cancer vaccine research.

LAS GUARANAS, Dominican Republic - Leaving her tin-roofed brothel for the day, the 42-year-old prostitute journeys to the capital for an injection that might save not only her life, but possibly millions more around the world.

Jacinta Julia Adams Fernández, a mother of three, is one of 175 Dominican prostitutes lending their bodies to a trial of what New Jersey-based Merck & Co. hopes will prove to be a vaccine against the virus that causes AIDS.

Since turning to prostitution after a divorce 13 years ago, Adams has seen friends and co-workers die from the disease. Prostitution is illegal but widespread, largely ignored by the authorities.

A large-scale HIV vaccine trial has begun in South Africa.

The trial, the largest clinical trial to date, will see 3,000 HIV-negative men and women receive a vaccine containing copies of three HIV genes. Volunteers will not receive the full copy of the HIV virus, making it impossible to be infected in the trial.

Previous trials of the vaccine found it to be safe in stimulating cellular immune responses against HIV.

The first human trial of a DNA vaccine designed to prevent H5N1 avian influenza infection began late last month, when the vaccine was administered to the first volunteer at the National Institutes of Health (NIH) Clinical Center in Maryland in the US.

Scientists from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), one of the NIH Institutes, designed the vaccine.

The study will involve 45 volunteers between the ages of 18 and 60. Fifteen will receive placebo injections and 30 will receive three injections of the trial vaccine over 2 months and will be followed for 1 year. NIAID researchers will measure immune responses to the vaccine, assess its safety, and compare its potency to more traditional vaccine approaches.

COPENHAGEN, Jan 3 (Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.

Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.

BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.

Uganda has screened and vaccinated at least a quarter of the 50 babies needed for vaccine trial focused on prevention of HIV transmission from mother to child during breastfeeding.

The first baby in the vaccine trials was enrolled in October and by last week 14 of them had received either the vaccine or placebo saline solution (for control) while 16 have been screened to participate. 

The study is in its phase I, randomised double blind — where the researchers will not know which babies receive the vaccine or the placebo solution, while 40 babies will randomly receive the vaccine and 10 the placebo.

BRISBANE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Pink Sheets: VXGN.PK) announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.

BERN, Switzerland, Dec. 18, 2006 – Pevion Biotech announced the start of phase I clinical testing of its virosome-based hepatitis C virus (HCV) vaccine. The therapeutic HCV vaccine is based on Pevion Biotech`s proprietary PeviPROTM and PeviTERTM technologies and will be tested for its safety and immunogenicity.

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPROTM and PeviTERTM platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech’s HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTERTM) together with a supportive helper T cell response (PeviPROTM). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.

By Ed Susman SAN ANTONIO, TX -- December 15, 2006 -- A experimental breast cancer vaccine appeared to offer protection against recurrences but failed to achieve statistical significance after 2 years of treatment, doctors reported here at the 29th San Antonio Breast Cancer Symposium (SABCS).

"Recurrence rates reached 8.3% among the 101 women who received the vaccine and 16% among the 85 women who acted as controls in the trial," said Col. George Peoples, a surgeon at Brooke Army Medical Center, Fort Sam Houston, Texas.

Despite the nearly 50% reduction in recurrence, the small numbers of women in the trial resulted in a statistical value that is above the cutoff generally recognized as being significant.

Vienna (Austria), December 12, 2006 - Intercell AG (VSE, "ICLL") announced   today that it has completed a Phase II trial for its therapeutic Hepatitis C vaccine (IC41), where the vaccine was applied in combination with the standard Hepatitis C therapy (pegylated Interferon and Ribavirin - PegIFN- RBV) to patients infected with genotype 1. In the study, the vaccine  administration was bound to the schedule of the first patient trial  concluded in 2004 where route and frequency was still sub-optimal as  compared to the improved induction of pivotal T cells achieved in recently  concluded optimization trial.

In the current clinical trial, chronically infected Hepatitis C patients receiving standard therapy with PegIFN-RBV were enrolled in Germany, Austria and in the UK. 22 patients who had an early response at week 12 to standard therapy received vaccinations with IC41 as an add-on to standard therapy during the second half of their treatment (week 28 to 48). 

HOUSTON--(BUSINESS WIRE)--CytoGenix (OTCBB:CYGX) has demonstrated that a synDNA™ vaccine against human immunodeficiency virus (HIV) has activity in monkeys. The study, conducted by Drs. Yin Chen and Frédéric Kendirgi at CytoGenix in collaboration with Lauren Hirao and Dr. David Weiner of the University of Pennsylvania, demonstrated that rhesus monkeys injected with a synDNA™ HIV vaccine mounted a significant cellular immune response. The study involved monkeys treated with a synDNA™ vaccine targeting two key viral proteins (gag and env) with interleukin-15 as an adjuvant.

"This observation, the first evidence of activity for a synDNA™ vaccine in non-human primates, is encouraging in that it shows that the synDNA™ vaccine is as effective as the DNA plasmid-based vaccine expressing the same antigen. The advantages of using DNA vaccines can be significantly extended using synDNA™ constructs and warrants further study to determine if the response is sufficient to protect against HIV infection,” stated David B. Weiner, Ph.D., an expert in DNA vaccination and a Professor of Pathology and Laboratory Medicine at the University of Pennsylvania School of Medicine.

South Africa's first large-scale HIV vaccine efficacy trial will start next year at five clinical sites around the country.

Representatives from the HIV Vaccine Trials Network and the SA Aids Vaccine Initiative remained tight-lipped on details of the number of subjects and the locations of the trial sites, saying an announcement would be made in January.

But principal investigator at the Desmond Tutu HIV Centre at UCT, Linda-Gail Bekker, said the trials would test the efficacy of a subtype B HIV vaccine on South Africa's predominantly subtype C sufferers.

Each HIV-infected region of the world tends to have a predominant genetic subtype of the virus.

LONDON, Dec 7 (Reuters) - Biotech group Allergy Therapeutics Plc <AGY.L> said on Thursday a Phase IIa study of its orally delivered hay fever vaccine showed it to be safe and effective.

The company said it was now confident that it can go ahead and develop the vaccine, which could be the first ever oral alternative to existing injectable treatments.

"These results provide the first indication that we have the technology to deliver a painless, injection-free potentially curative allergy treatment," Chief Executive Keith Carter said.

Analysts at Bridgewell -- which has a buy rating on the stock -- said that the statement was "good news that could uniquely position the drug against its competitors".

© Reuters 2006

Dynavax Technologies Corporation (Nasdaq: DVAX) announced today positive results from a Phase 2 trial comparing two different vaccination schedules of HEPLISAV, its hepatitis B virus (HBV) vaccine. The primary endpoint is comparative seroprotection after the second dose.

The data was reported today in a poster at the Canadian Immunization Conference in Winnipeg, Manitoba, Canada by Dr. Scott A. Halperin, Professor of Pediatrics and Microbiology and Immunology at Dalhousie University and Head of Pediatric Infectious Disease at the Halifax-based IWK Health Center.

A small Australian biotech company has secured the help of the world's leading miners to fund clinical trials of its Aids vaccine in South Africa.

In the first programme of its kind, Virax, which is listed on the Australian stock exchange and plans to float on Aim next year, has set up a non-profit organisation for corporate donors with operations and interests in South Africa and other neighbouring countries, and whose workforces are affected by the disease.

Eight companies including Rio Tinto and BHP Billiton will fund the trials, expected to cost between $5m and $6m.

There are more than six million people with HIV/Aids in the country. The incidence of the disease varies - in KwaZulu-Natal, for example, up to 35% of the population is HIV positive, and 41% of those in the penal system have the virus.

SAN FRANCISCO (MarketWatch) -- Dynavax Technologies Corp. shares soared as much as 44% Wednesday to reach their highest level ever after the company said its experimental hepatitis B vaccine protected all of the patients it tested in a late-stage clinical trial.

Shares of the Berkeley, Calif.-based drugmaker (DVAX) were changing hands for $9.96 in afternoon trading, up $2.56 and off an earlier high of $10.66.

Dynavax said that after three doses, its Heplisav vaccine protected 100% of a "difficult-to-immunize" population of adults aged 40 to 70 years compared with GlaxoSmithKline PLC's (GSK) Engerix-B vaccine, which was found to protect 73.1% of such people. In those ranging from 56 to 70 years of age, Heplisav's rate of protection was similarily 100% vs. a 56.1% rate for Engerix-B.

PHILADELPHIA, Nov. 29 (UPI) -- U.S. firm AVAX Technologies said Wednesday it is cleared to launch a phase 3 study of its metastatic melanoma vaccine, M-Vax.

The trial will enroll as many as 387 patients with stage IV melanoma at sites in the United States, Europe and Australia. Patients will be randomized in a 2-1 ratio to receive either M-Vax or placebo.

The study will measure best overall anti-tumor response rate and the percentage of patients surviving two years, AVAX said.

A novel vaccine designed to treat ragweed allergy significantly improved nasal symptoms for at least 2 years, according to a study presented here at the 52nd annual scientific meeting of the American College of Allergy, Asthma and Immunology. In addition, patients given the vaccine showed similar trends in symptom relief, regardless of how severely allergic they were to ragweed at baseline.

"We're very excited about this," said Eduardo Martins, MD, vice-president for clinical development at Dynavax Technologies, the San Francisco-based company developing the Tolamba ragweed allergy vaccine. "There have been 14 research trials to date with different dosages, and although they've been small, trial after trial, we've had consistently good results like this for patients across the board."

This randomized placebo-controlled study — the largest to date on this ragweed vaccine — included 462 people aged 18 to 55 years with confirmed ragweed allergy. One group received 6 weekly injections of the vaccine in incremental doses; the other group received injected placebo. Patients were then followed for 2 allergy seasons and asked to electronically report their daily hayfever symptoms, medication use, and related factors.

A vaccine which uses the body's immune system to attack an aggressive form of kidney cancer has completely eradicated one patient's tumour.

The TroVax vaccine, made by Oxford Biomedica, has been given to 150 patients so far in clinical trials.

Another two patients have seen their tumours shrink, and a further 15 have been stable for at least three months.

UK cancer experts said the data, presented at a conference in Prague, showed TroVax was effective.