Archive for November, 2014

How are vaccines developed?

Wednesday, November 12th, 2014 (last updated)

Before a vaccine is developed it undergoes rigorous testing. Vaccines are subject to even tougher standards than medicines – more people are included in clinical trials and safety standards are very high.

A new vaccine is first tested in a very small group of people to rule out major safety problems and helps doctors work out the right dose.

Next it is tested in a larger group to check that the vaccine works consistently, and scientists watch for any side effects.

Then the vaccine is tested in tens of thousands of healthy volunteers. This shows whether the vaccine protects against natural infection and gives a better chance of discovering rare problems not seen in smaller studies.

But it doesn’t end there. If the vaccine passes all of these tests and is approved by regulators it is continuously monitored.

The vaccines available to use today have been given to millions of people, preventing illness and saving lives.

Source:
Vaccines Today

Vaxart’s Tablet Vaccine for H1N1 Influenza Generates Protective Immunity Equivalent to Injectable in Phase I Clinical Study

Monday, November 10th, 2014 (last updated)

Vaxart, Inc., a privately held, clinical-stage company developing recombinant vaccines that are administered by tablet rather than by injection, today announced clinical results demonstrating that its H1N1 tablet vaccine generates protective immunity comparable to currently licensed influenza vaccines, as measured by hemagglutinin inhibition assay (HAI), the established correlate of protection. Vaxart’s founder and chief scientific officer, Sean Tucker, PhD, discussed the data in a presentation today at the 15th Annual World Vaccine Congress in Brussels.

vaccine tablet

“A tablet vaccine for flu could significantly change the way we administer vaccines,” said John J. Treanor, MD, Chief of Infectious Diseases at the University of Rochester Medical Center. “Every year, more than 100 million Americans visit their pharmacy, clinic or private practitioner to receive a flu shot. In contrast, a tablet vaccine could be brought directly to the user, such as in the workplace or at school, and avoids the need to worry about needles. A tablet vaccine might also be manufactured and distributed faster than current injectable vaccines, a factor that could be critical when responding to a pandemic or outbreak. These results look very promising and I am eager to hear more about the continued progress of Vaxart’s programs.”

The data were generated in a phase 1 clinical study of Vaxart’s tablet vaccine candidate for H1N1 seasonal influenza. The randomized, double-blind, placebo-controlled study enrolled 24 healthy volunteers of ages 18-49, who received either placebo or vaccine in tablet form in a single administration.

In the study, 75 percent of subjects (9 of 12) taking the Vaxart H1N1 tablet vaccine fully seroconverted as measured by HAI, a response rate equivalent to those reported for licensed injectable vaccines. HAI geometric mean titers increased 7.7-fold, also within the range of injectable vaccines. None of the subjects receiving placebo (0 of 12) seroconverted. HAI titers are an important standard for determining protective immunity used by industry and the U.S. Food and Drug Administration (FDA).

In addition, the Vaxart H1N1 tablet vaccine induced four-fold increases in neutralizing antibody titers in 92 percent of subjects (11 of 12) as measured by microneutralization (MN) titers, an increasingly recognized marker of protective immunity, versus 0 percent (0 of 12) in the placebo group. MN geometric mean titers rose 23-fold, exceeding rate increases reported for most injectable vaccines. The vaccine also generated strong mucosal and cellular immune responses in 92 percent of subjects, suggesting the Vaxart tablet vaccine could offer broader protection than currently licensed influenza vaccines.

The vaccine exhibited an excellent clinical safety profile, with only mild adverse events that were distributed evenly between the placebo and vaccine groups.

“Our tablet flu vaccine generated broad immune responses in more than 90 percent of recipients, while a remarkable 75 percent seroconverted by HAI, the accepted correlate for protective immunity”, said Vaxart CEO Wouter Latour, MD. “We are seeing a safety-immunogenicity profile that could compete with that of any of the currently marketed vaccines, even without taking into account the convenience and logistical advantages of our room-temperature stable and user-friendly tablet. In addition, our tablet vaccine could significantly increase vaccination rates, currently at about 45 percent of the U.S. population.”

Dr. Tucker discussed the Vaxart data in his presentation, “High titer neutralizing antibody and potent cellular immune responses to influenza in humans after oral immunization with recombinant adenovirus expressing HA.” He further commented, “In addition to the robust HAI and MN responses, our tablet vaccine generated strong mucosal and T cell responses in virtually all recipients (11 of 12). This suggests that the platform technology could be exploited across a wide range of vaccine indications. Accordingly, we are accelerating our non-flu programs and expect to enter the clinic with at least two new indications in 2015.”

Source:
Vaxart

First moments for Pampers/UNICEF: “one pack = one life saving vaccine”

Saturday, November 8th, 2014 (last updated)

Source:
Happy Healthy Mumma

Russian HIV vaccine heading for phase II trials

Friday, November 7th, 2014 (last updated)

HIV vaccine

A candidate HIV vaccine developed in Russia is on the brink of starting phase II trials but could be stymied by a lack of funding, according to the researchers behind the project.

Valery Mikheyev of the Russian State Center of Virology and Biotechnology (Vector) based in Novosibirsk told a press briefing this week that the $5m-$7.5m in funding for the trial of CombiHIVvac still needs to be approved by the government, reports the RIA Novosti news agency.

The vaccine – which is synthetic and based on several DNA and protein HIV antigens or epitopes – is one of three candidates being developed by Russia’s state-funded scientific research institutions and has already cleared phase I trials started by Vector in 2010.

In preclinical studies, it was shown to induce an antibody and cytotoxic T lymphocyte (CTL) responses in mice, with antibodies that were deemed to be highly specific and are able to neutralise HIV-1 in vitro.

Mikheyev told reporters that the phase II trials planned for CombiHIVvac could take around two years to complete, provided funding can be found. It is “Russia’s only vaccine against AIDS to reach the second phase of clinical trials,” he added.

Efforts to develop an effective vaccine against HIV have so far proved fruitless, with a phase III programme for VaxGen’s AIDSVAX candidate ending in failure in 2004 and another study (NVTN 505) of a so-called ‘prime-boost’ vaccination approach dropped due to lack of efficacy in 2013.

To date, the only candidate showing any promise is RV144, which exhibited a modest level of protection in a Thai study reported in 2009 but needs additional research before it could be considered a vaccine candidate suitable for licensing.

The International AIDS Vaccine Initiative (IAVI) is supporting work on eight vaccines in total, but so far none have progressed beyond early-stage clinical testing.

Researchers are now studying the molecular structures of antibodies shown to have potent HIV-1-neutralising effects in a bid to reverse-engineer vaccines that might elicit similarly effective responses.

Source:
PMLive

HPV Vaccine does not cause multiple sclerosis

Thursday, November 6th, 2014 (last updated)

Vaccines have been associated with autism and various other conditions and diseases. Most recently, the hepatitis B (HepB) and human papillomavirus (HPV) vaccine has been linked to increased risk of multiple sclerosis (MS) and other acquired central nervous system demyelinating syndromes (CNS ADS).

HPV

A study to seek answers found no long-term association of vaccines with disease and short-term increased risk in younger patients was likely resulted from existing disease, write authors Annette Langer-Gould, M.D., Ph.D., of Kaiser Permanente, Southern California, Pasadena, and colleagues.

Claims that vaccinations could prompt a small increase in the risk of MS and CNS ADS are controversial. Most studies showed no effect while ones that claimed to find a link were plagues by poor methodology, a small numbers of cases. and other factors.

The authors examined the relationship between vaccines and MS or other CNS ADS by using data from Kaiser Permanente Southern California members. The authors identified 780 cases of CNS ADS and 3,885 control group patients; 92 cases and 459 control patients were females between the ages of 9 to 26 years, which is the indicated age range for HPV vaccination.

There were no associations between HepB vaccinations, HPV vaccination or any vaccination and the risk of MS or CNS ADS up to three years later. Vaccination of any type was associated with increased risk of a CNS ADS onset within the first 30 days after vaccination only in patients younger than 50 years but this association disappeared after 30 days.

The authors said this may suggest that vaccines (like infections) may accelerate the transition from sub-clinical to overt autoimmunity in patients with preexisting disease. The authors say their results for HPV vaccinations are inconclusive because of the small number of cases and few previous studies in the topic.

“Our data do not support a causal link between current vaccines and the risk of MS or other CNS ADS. Our findings do not warrant any change in vaccine policy.”

Source:
JAMA

Kids & Flu Vaccine: Celebrity Parents, Bloggers Speak Out

Wednesday, November 5th, 2014 (last updated)

Source:
Ontario Health

Learn about how Pertussis vaccines work

Monday, November 3rd, 2014 (last updated)

Source:
Khanacademy

Know the facts about vaccines now, so once your baby is born you can help provide them with a healthy start.

Sunday, November 2nd, 2014 (last updated)

There may be a lot of controversy out there, but you may be surprised by how other parents feel about vaccination.

vaccination

Source:
ImmYounity (www.vaccines.com)