Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiltern Pesquisa Clinica Ltda
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
For HIV-1 Infected Subjects:
Adults between 18-60 years old (inclusive)
Any sex or ethnicity
Confirmed Diagnosis of HIV-1 infection
CD4+ cells count \>200 per mm3 within 3 months prior to inclusion in the study
HIV-1 viral load below 200 copies/mL within 90 days prior to inclusion in the study
Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
2. Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
3. Intra-uterine device (IUD)
4. Monogamous relation with vasectomized partner (must have been vasectomized at least six months before the volunteer entered the study)
No changes in the antiviral therapy (including HAART) for the previous 4 weeks and/or change in the predicted antiviral therapy through study Day 43 (3 weeks after the second dose of the vaccine)
No use of immunomodulatory therapy, including cyclosporine, interleukins, interferons, or systemic glucocorticoids (including inhalatory) within 3 months before study inclusion
Subjects capable of respecting all the study procedures and available for all visits scheduled to the investigation site
Subjects capable of understanding the nature and risk of the study proposed and signing the consent form
The subjects may have other underlying diseases, such as, but not limited to, hypertension, diabetes, cardiac ischemic disease, or hypothyroidism, however their symptoms/signs must be currently under control with medical treatment according to the investigator's evaluation
For Healthy Adults:
Adults between 18-60 years old (inclusive)
Any sex and ethnicity
Subjects with good health as determined by medical history, physical evaluation, and investigator's clinical opinion
Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
2. Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole sexual intercourse
3. Intra-uterine device (IUD)
4. Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study)
Subjects capable of respecting all the study procedures and available for all the visits scheduled at the investigation site
Subjects capable of understanding the nature and risk of the study proposed and signing the consent form
There will be NO blood sample collection of healthy volunteers viewing the determination of their serological status regarding the HIV virus.
You may not be if
For HIV-1-Infected Subjects:
HIV-1 viral load above 500 copies/mL within 6 months prior to inclusion in the study
Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
Receipt of another vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
Any recent vaccine given within the last 21 days (inclusive)
History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
History of cancer, except for skin cancer, including Kaposi's Sarcoma, basal cell carcinoma, and non-invasive malignancy related to HPV
History of cognitive disorders
History of progressive or severe neurological disorders, including Guillain-Barré Syndrome
Pregnancy or breast-feeding
Use of immunomodulatory therapy, including cyclosporin, interleukins, and interferons, within 3 months prior to inclusion in the study
Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study
Projected life expectancy lower than 12 months
Receipt of any investigational product within 12 months prior to inclusion in the study
For Healthy Adults:
Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
Receipt of another vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
Any recent vaccine given within the last 21 days (inclusive)
History of allergic reaction to influenza vaccine in the past, or a current or previous allergy to egg or egg protein, kanamycin, and neomycin sulfate
Acute febrile disease (the vaccination may be delayed up to 3 days after symptoms resolution)
Pregnancy or breast-feeding
Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study
Receipt of any investigational product within 12 months prior to inclusion in the study
