Apparently a Single Jab Will Do Ya


Good news for a change for adults that is, kids might be a different story...

Although we'll be getting a further release of information tomorrow from the NIH, Dr. Anthony Fauci has signaled that US clinical trial data on the novel H1N1 vaccine matches that which was released earler today by Australia's CSL Ltd., which indicates that a single 15 microgram unadjuvanted shot produces good immune responses in adults over and under the age of 50.

Piling on the good news is that antibody titers reach protective levels in just 8 to 10 days after immunization, which is considerably sooner than had been expected.

All of this significantly loosens up tight vaccine supplies and lessens some of the logistics involved in getting the vaccine out into the arms of the population.

More at:

indigo girl

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Single dose of 2009 H1N1 vaccine immunogenic in adults

An Australian group has reported results of a clinical trial to determine the safety and immunogenicity of a 2009 pandemic H1N1 influenza virus vaccine. Twenty-one days after the first of two scheduled doses, the vaccine proved to be immunogenic in adults. This is good news, as many had believed that two doses of the vaccine would be needed to achieve adequate protective immune responses.

A total of 240 individuals were enrolled in the trial and given 15 or 30 microgram doses of an inactivated, H1N1 vaccine propagated in eggs by CSL Biotherapies, Parkville, Australia. Anti-influenza antibody titers were measured at enrollment and 21 days after each vaccination, by hemaggultination-inhibition (HI) and microneutralization assays.

A single 15-µg or 30-µg dose of the H1N1 vaccine produced a robust immune response in most subjects. Day 21 titers of 1:40 or more on HI assay were observed in 96.7% of those who received the 15 µg dose and in 93.3% of those who received the 30 µg dose. In total, 74.2% of subjects showed a significant seroconversion or increase in HI titer. Protection of humans against seasonal influenza is generally believed to require a HI titer of 1:40 or more.

Some of the side effects of immunization included injection-site tenderness, pain, swelling, and headache.

Whether similar results will be obtained in children, and using vaccine manufactured by other companies remains to be determined.

The ability of one dose of adjuvant-free H1N1 vaccine to induce a strong immune response has two important benefits. One is that twice as many individuals can be immunized than if two doses were required. And a return visit for a second dose of pandemic H1N1 vaccine won't be needed.


188 Posts

This at least is some good news. :wink2:

indigo girl

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Swine Flu Vaccine Works in One Shot, Doubling Supply (Update1)

Swine flu, also known as H1N1, has become the world's fastest-moving influenza pandemic, sweeping across 177 countries in the four months since it was first identified, according to the U.S. Centers for Disease Control and Prevention based in Atlanta. More than 1 million people have already contracted the virus in New York alone, according to estimates by the city's health department.

Five U.S.-sponsored trials were initiated July 22 to test safety and proper dosing of a pandemic vaccine. The results of the first U.S. study and that conducted by CSL suggest one dose of the formula used by drugmakers should offer H1N1 protection similar to the seasonal flu shot. Paris-based Sanofi Aventis SA, London-based GlaxoSmithKline Plc, and Basel, Switzerland-based Novartis AG are among the other companies making the vaccine.

"This vaccine could substantially reduce the spread and impact of the pandemic virus," Anne Kelso, director of the World Health Organization's collaborating center in Melbourne, said today in an e-mail. "The data are also consistent with the trial results recently reported by China for a similar type of vaccine, so we can be hopeful that many countries will have access to effective pandemic vaccines over the coming months."

CSL's Results

CSL's study, published yesterday by the New England Journal of Medicine, found that 21 days after a first shot was given, more than 95 percent of the 240 patients had levels of protective antibodies sufficient to fight off the flu.

The shot contained 15 micrograms of antigen, the same level as for seasonal flu vaccines. It had similar side effects to regular flu shots, the most common being headache and pain at the injection site, CSL said.

The company is producing about 19 percent of the U.S. stockpile and is Australia's sole supplier of pandemic shot, called Panvax H1N1. CSL has agreed to provide 21 million doses of the vaccine to Australia and 36 million doses to the U.S., Perreault said. The U.S., which contracts with five companies, anticipates 45 million doses of its 195 million shots will be available for use by mid-October.

"We'll certainly be able to meet all of the commitments that we've already made in the appropriate time frames, both to the U.S. and to the Australian governments," Rachel David, a CSL spokeswoman, said on a conference call today.

The vaccines in both studies didn't use ingredients called adjuvants included by some countries in formulations to boost effectiveness. No serious side effects were reported, though the trials are too small to detect rare conditions. The shots are being studied further and will be closely monitored once vaccination campaigns begin, according to U.S. officials.

"This is great news," Malik Peiris, professor of microbiology at Hong Kong University, said in an e-mail. "It remains to be investigated whether even lower doses can be used with reasonable levels of immunity, and if so, it means the available vaccine stock will stretch even further."

Other Tests

Novartis reported Sept. 3 that a single dose of its vaccine, which included an adjuvant, safely provoked a strong immune response in a trial of 100 healthy volunteers.

Sinovac Biotech Ltd., the first company to win Chinese government approval for a swine flu shot, said Aug. 18 its vaccine was safe and effective after a single shot.

Both studies focused on adults, and more tests will be needed to determine whether one shot will be sufficient in children, who have less natural immunity developed from previous exposures to seasonal flu, Fauci said.

Children usually need two doses of seasonal flu vaccine, CSL's David said. The company expects results from studies in children in Australia and the U.S. in October, she said.

"In our current global situation, in which demand for influenza vaccine greatly exceeds supply, dose-sparing strategies are needed," Kathleen Neuzil, an infectious disease specialist at the University of Washington in Seattle, said in an editorial that accompanied the journal study.

A separate shot will still be needed for protection against seasonal flu.

Katnip, RN

2,904 Posts

So the available supply of H1N1 vaccine has effectively doubled. Good news.


373 Posts

Specializes in Acute post op ortho. Has 32 years experience.

While you guys run out & get that shot full of mercury, squalene & God knows what else, I'm gonna sit back & watch to see how you fair.

I certainly hope it goes better than it did in 1976.

Cause that would suck.

allnurses Guide

herring_RN, ASN, BSN

3,651 Posts

Specializes in Critical care, tele, Medical-Surgical. Has 51 years experience.

Not planning on getting an injection of Novartis vaccine because it includes an adjuvant.


373 Posts

Specializes in Acute post op ortho. Has 32 years experience.

Take grape seed extract & wild oregano oil, & eat healthy.

I started my family on grape seed extract & wild oregano oil 7 years ago & we haven't been sick since. When I say "haven't been sick" I mean perfect school attendance for 7 years not sick.

indigo girl

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Not planning on getting an injection of Novartis vaccine because it includes an adjuvant.

As it now stands, adjuvants have not been approved for use in the US for any of the flu vaccines.


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Specializes in Derm/Wound Care/OP Surgery/LTC. Has 10 years experience.

Just wondering...if you get a regular flu shot...can you also get the H1N1 shot as well? Is it contraindicated? I can't find anything about it online.

twinmommy+2, ADN, BSN, MSN

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Specializes in ED. Has 18 years experience.

Its my understanding that you can have them both as long as you have a specified time period in between both of them.

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