Emily
Editor, Senior Moderator
http://content.nejm.org/cgi/content/full/NEJMoa0907650
Published at www.nejm.org September 10, 2009 (10.1056/NEJMoa0907650)
Trial of Influenza A (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine — Preliminary Report
"Methods We conducted a single-center study, involving 175 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 µg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-µg doses of MF59-adjuvanted vaccine, or 7.5 or 15 µg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose."
Appendix with details on an adverse effect:
http://content.nejm.org/cgi/data/NEJMoa0907650/DC1/1
Vaccine-related adverse reaction
A probable vaccine-related adverse reaction was reported. One female subject who received two
7.5μg MF59-adjuvanted vaccines on day 0 reported a purpuric rash over her lower limbs,
commencing on day 17 post-vaccination and spontaneously resolving within 72 hours. Further
questioning revealed that she had consulted her family practitioner 2-3 months earlier for recurrent,
self limiting intermittent rash over lower limbs in the 12 months prior to the study. Investigations,
at that time by her physician, included a complete blood count, urea and electrolytes, liver function
tests, and C-reactive protein, all of which were within normal values. An autoimmune profile
demonstrated positive antinuclear antibodies (1:1600) with positive extractable nuclear antigen
antibodies (anti-Ro and anti-La). Antibodies to double stranded DNA and rheumatoid factor were
negative. At the time of study enrollment, she was not taking any medication and study staff were
not aware of her prior medical history. Investigations initiated by the study investigators following
her rash included complete blood count, urea and electrolytes, liver function tests, bone profile,
immunoglobulins and C-reactive protein all of which were reported within normal values.
Antibodies to HIV, hepatitis B and C were negative. An autoimmune profile was unchanged from
those performed 2-3 months prior to enrolment and cryoglobulins were negative. She was referred
to rheumatology with a provisional diagnosis of an underlying connective tissue disease. No
treatment was given.
Those anti-bodies were found in a soldier who died after multiple military vaccines, including anthrax vaccine, the one alleged to have contained squalene.
http://www.anthrax.osd.mil/media/pdf/safetypanelQA.pdf
"Both panels concluded that vaccinations may have triggered an illness that ultimately led to the death in April 2003 of SPC [], a 22-year-old Army Reservist, who received several vaccinations at the time she was mobilized for deployment....
....What were the key findings that led to a conclusion of a link?
This soldier had an unusual pattern of antibodies called anti-Ro antibodies that have been associated with lupus in some patients with the disease.
These antibody tests have to be interpreted with care, because most people who test positive do not go on to develop symptoms of lupus. Those people simply carry the antibody around for years and it doesn’t cause a problem. A very small proportion of people who carry the antibody may experience some kind of “trigger” that sets in motion a lupus reaction. This lab finding leads some to conclude that the vaccines may have triggered her lupus; but as can be seen in Specialist [] case, she had received multiple vaccinations in the past without any problem."
Published at www.nejm.org September 10, 2009 (10.1056/NEJMoa0907650)
Trial of Influenza A (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine — Preliminary Report
"Methods We conducted a single-center study, involving 175 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 µg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-µg doses of MF59-adjuvanted vaccine, or 7.5 or 15 µg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose."
Appendix with details on an adverse effect:
http://content.nejm.org/cgi/data/NEJMoa0907650/DC1/1
Vaccine-related adverse reaction
A probable vaccine-related adverse reaction was reported. One female subject who received two
7.5μg MF59-adjuvanted vaccines on day 0 reported a purpuric rash over her lower limbs,
commencing on day 17 post-vaccination and spontaneously resolving within 72 hours. Further
questioning revealed that she had consulted her family practitioner 2-3 months earlier for recurrent,
self limiting intermittent rash over lower limbs in the 12 months prior to the study. Investigations,
at that time by her physician, included a complete blood count, urea and electrolytes, liver function
tests, and C-reactive protein, all of which were within normal values. An autoimmune profile
demonstrated positive antinuclear antibodies (1:1600) with positive extractable nuclear antigen
antibodies (anti-Ro and anti-La). Antibodies to double stranded DNA and rheumatoid factor were
negative. At the time of study enrollment, she was not taking any medication and study staff were
not aware of her prior medical history. Investigations initiated by the study investigators following
her rash included complete blood count, urea and electrolytes, liver function tests, bone profile,
immunoglobulins and C-reactive protein all of which were reported within normal values.
Antibodies to HIV, hepatitis B and C were negative. An autoimmune profile was unchanged from
those performed 2-3 months prior to enrolment and cryoglobulins were negative. She was referred
to rheumatology with a provisional diagnosis of an underlying connective tissue disease. No
treatment was given.
Those anti-bodies were found in a soldier who died after multiple military vaccines, including anthrax vaccine, the one alleged to have contained squalene.
http://www.anthrax.osd.mil/media/pdf/safetypanelQA.pdf
"Both panels concluded that vaccinations may have triggered an illness that ultimately led to the death in April 2003 of SPC [], a 22-year-old Army Reservist, who received several vaccinations at the time she was mobilized for deployment....
....What were the key findings that led to a conclusion of a link?
This soldier had an unusual pattern of antibodies called anti-Ro antibodies that have been associated with lupus in some patients with the disease.
These antibody tests have to be interpreted with care, because most people who test positive do not go on to develop symptoms of lupus. Those people simply carry the antibody around for years and it doesn’t cause a problem. A very small proportion of people who carry the antibody may experience some kind of “trigger” that sets in motion a lupus reaction. This lab finding leads some to conclude that the vaccines may have triggered her lupus; but as can be seen in Specialist [] case, she had received multiple vaccinations in the past without any problem."
Last edited: