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The Aflunov „bird flu“ vaccine that had to be withdrawn from the market in 2008 after it appears to have caused the death of a number of homeless people following medical trials close to Krakow, Poland, in 2008 contained the adjuvant, squalene, and seems to have been repackaged by Novartis as Celtura for use as a „swine flu“ jab.

Celtura is due to be used in Germany and Switzerland only.

Three Polish doctors and six nurses are facing criminal prosecution after they gave 350 homeless people in Poland what appears to be a vaccine made by Novartis called Aflunov or Fluad H5N1 vaccine.

The homeless people took the vaccine for about 2 euros under the impression it was a normal seasonal flu vaccine.

A clinical trials database lists the clinical trials for Novartis’ Fluad H5N1/Aflunov as taking place at the Centrum BadaÅ„ Farmakologii Klinicznej monipol, Kraków, Poland, 30-969.

Some of the trials due carried out on 4000 people were apparently conducted at a homeless person’s home where large numbers of people died.

http://clinicaltrials.gov/ct2/show/NCT00434733

http://www.telegraph.co.uk/news/worldnews/europe/poland/2235676/Homeless-people-die-after-bird-flu-vaccine-trial-in-Poland.html

Crucially, Aflunov is also listed under the clinical trials base as the vaccine being tested by the University Hospitals, Leicester in July 2009.

http://clinicaltrials.gov/ct2/show/NCT00814385?term=aflunov&rank=1

The principal investigator is Karl G. Nicholson, who published a positive study on Novartis’s Celtura with Dr Iain Stephenson in the New England Journal of Medicine this September.

http://content.nejm.org/cgi/content/short/NEJMoa0907650v1

Celtura is due to be given to people in Germany and Switzerland under special national licencing arrangements with the German Paul Ehrlich Institute and the Swiss Swissmedic organisation.

An April 2009 press release from Novartis shows that Aflunov was resurrected after it had to be withdrawn from the market in June 2008 and Novartis execs proposed it had potential to to treat the „swine flu“.

http://insciences.org/article.php?article_id=4665

Has Novartis repacked ist Aflunov as Celturà? Oddly, there is almost no information available on Celtura even though it was recommended this month for use in Germany by the Paul Ehrlich Institute.

Aflunov/Fluad H5N1 contains the adjuvant MF59, squalene.

The MF59 adjuvant is also a component in both the „swine flu“ jabs from Novartis, Focetria and Celtura (MF59C.1).

Aflunov had to be withdrawn from the market by Novartis in June 2008 following a complaint by the„Committee for Medicinal Products for Human Use" (CHMP):

“The CHMP was concerned over the way the main clinical study was carried out. An inspection of some of the study sites showed that the study had not been conducted in compliance with 'good clinical practice' (GCP). Consequently, the study results could not be considered reliable and could not be used for the evaluation of the vaccine. As a result, the size of the clinical database for the assessment of the vaccine's safety was not sufficient to fulfil the requirements of the EMEA's guidelines on prepandemic vaccines.
Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov,” says the official report.

Michael Pfeiderer from the Paul Ehrlich Institute, the government body responsible for approving drugs in Germany, had said in a report in a medical newspaper that he expected Aflunov to receive its final approval for marketing in the autumn of 2008 - shortly before it killed people in an incident uncovered by the Polish police.

http://www.pharmazeutische-zeitung.de/index.php?id=2754

According to a Novartis document from 11 September 2007 (Novartis Vaccines & Diagnostics Growth and Innovation), Aflunov submitted to the EMEA on 6th November, 2006, and had passed all three clinical trials and was about to be registered.

http://www.novartis.ch/downloads/investors/events/broker-conferences/2007_09_Novartis_for_BS.pdf

The fact that the lethal Aflunov contained squalene is bound to raise fears about the use for the first time of squalene in the swine flu jab.

The vaccine adjuvant, MF59, is not licensed in the USA or UK.

MF59 contains SQUALENE, which causes autoimmune diseases.

US and UK  injected with an anthrax vaccine contanining MF59 reported a range of autoimmune and other diseases.

The squalene adjuvant ASO3 is to be used in the pandemrix vaccine from Glaxo Smith Kline.

Vaccines containing MF59 and ASO3 do not have the Emergency Use Authorizations issued as yet, but this could change.

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Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

This study has been completed.

First Received: February 12, 2007   Last Updated: April 23, 2008 History of Changes

Purpose

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

• Adverse event rate

Secondary Outcome Measures:

• Seroconversion and seroprotection after two doses of H5N1 vaccine

Eligibility

Criteria

Inclusion Criteria:

• Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

• Receipt of another investigational agent within 4 weeks
• Receipt of influenza vaccination for current season 2006/2007.
• any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
• fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
• Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
• Surgery planned during the study period
• Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
• Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
• History of (or current) drug or alcohol abuse
• Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434733

Locations

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

More Information

No publications provided

Keywords provided by Novartis:

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on October 14, 2009

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Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04

This study is currently recruiting participants.

Verified by University Hospitals, Leicester, July 2009

First Received: December 23, 2008   Last Updated: July 20, 2009 History of Changes

Purpose

This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: MF 59

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:

• Geometric mean antibody titres to influenza H5N1 by neutralising antibody, HI and SRH [ Time Frame: pre vaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks, 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• local and systemic reactogenicity [ Time Frame: within 7 days of each vaccination ] [ Designated as safety issue: Yes ]
• Seroprotective and seroconversion responses to H5N1 by neutralising antibody, HI and SRH [ Time Frame: Prevaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks and 56 weeks ] [ Designated as safety issue: No ]

Detailed Description:

OBJECTIVES:

Immunogenicity objectives

1. To evaluate the magnitude of the antibody responses to one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine, each dose containing 7.5μg of H5N1 haemagglutinin, in immunologically naïve subjects;
2. To examine the kinetics of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75 or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
3. To evaluate the magnitude of the antibody responses to one 0.5mL 'booster' intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75μg or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
4. To evaluate the breadth of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above), with respect to a representative range of antigenically distinct H5N1 viruses (wild-type and attenuated); and
5. To evaluate the persistence of the antibody responses induced by 'priming' (see 1., above), and 'booster' vaccination regimens (see 2., and 3., above).

Safety objective

1. To evaluate the safety of the administration of one or two 'priming' 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (each dose containing 7.5μg of H5N1 haemagglutinin), in immunologically naïve subjects, followed by one 3.75μg or 7.5μg 'booster' dose of antigenically drifted MF59-adjuvanted H5N1 vaccine, or non-adjuvanted antigenically drifted H5N1 vaccine.

Eligibility

Criteria

Inclusion Criteria:

1. Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;

2. Are in good health or have one or more stable (See footnote) medical conditions, as determined by:

1. 1. Medical history,
   2. Physical examination,
   3. Clinical judgment of the medical investigator;
2. Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
3. Subjects who experienced fever (defined as axillary temperature >38oC) within 3 days prior to Visit 1;
4. Subjects who are pregnant or breastfeeding;
5. Females of childbearing potential who refuse to use an acceptable method of birth control for a period of 56 days before and after each vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), monogamous relationship with vasectomised partner who has been vasectomised for 6 months or more prior to the subject's study entry, or abstain from heterosexual intercourse (e.g., through sexual orientation or religious or other beliefs about premarital intercourse);

7. Subjects with any serious disease, including:

1. 1. cancer,
   2. acute or progressive hepatic disease,
   3. acute or progressive renal disease,
   4. chronic pulmonary disease requiring home oxygen therapy,
   5. active neurological disorder,
   6. autoimmune disease (including rheumatoid arthritis);
2. Subjects for whom surgery is planned during the study period;
3. Subjects with a bleeding diathesis;
4. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin, or any other component of the study vaccine;
5. Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine;

12. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:

1. 1. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or cancer chemotherapy) (long-term, inhaled steroids for asthma management is acceptable),
   2. receipt of immunostimulants or interferon,
   3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5 (Day 382), or planned during the full length of the study,
   4. high risk from developing an immunocompromising disease;
2. Actual or planned receipt of another vaccine during the period 3 weeks before to 3 weeks after vaccination on Days 1, 22, and 382;
3. Subjects with a history of (or current) drug or alcohol abuse (20g/day for females; 30g/day for males) that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
4. Subjects who are unable to lead an independent life either physically or mentally;
5. Have participated in a previous study of H5 avian influenza vaccine;
6. Have been previously vaccinated with a vaccine containing MF59 or similar adjuvant;
7. Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814385

Contacts

Locations

Sponsors and Collaborators

University Hospitals, Leicester

Medical Research Council

Novartis

Health Protection Agency

National Institute of Biological Standards and Control

Investigators

More Information

No publications provided

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on October 14, 2009

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