Clinical trial: Reactogenicity and Immunogenicity of Vaginal CNgp140 (NCT00637962)

Eligibility criteria:
Inclusion Criteria:

          -  They are adult female volunteers, 18 to 45 years of age, who have signed an informed
             consent form following a detailed written explanation of participation in the
             protocol.

          -  They are volunteers who are in good health as determined by medical history, physical
             examination and clinical judgement.

          -  They are available for the duration of the study.

          -  They are women who, if capable of becoming pregnant during the study, have agreed to
             have a pregnancy test immediately before immunisation, and to use appropriate
             contraception methods during the whole study period. Appropriate contraception shall
             include physician-prescribed oral hormonal agents, barrier contraceptives, regular and
             consistent use of condoms without spermicidal agents, or intrauterine devices only.
             Progesterone-only contraceptives are not suitable due to the lack of a regular
             menstrual cycle.

          -  They have agreed not to undertake any vaginal practices other than receptive
             intercourse with a male or use of sanitary tampons during menses. Use of condoms
             without spermicidal agents is encouraged.

          -  They have not donated blood during 3 months prior to study entry and agree to not
             donate for 3 months after the end of their participation in the study.

        Exclusion Criteria:

          -  They have hypersensitivity to any component of the vaccine used in this study.

          -  They are found to be HIV antibody or HIV proviral DNA positive at the time of initial
             screening.

          -  They have a known or suspected history of cervico-vaginal disease, malignancy or
             abnormality discovered at time of screening.

          -  They present in the samples obtained at the screening visit:

          -  a clinically significant amount of protein or haemoglobin in the urine sample,
             determined by urine dipstick.

          -  a clinically significant abnormality in the haematological or biochemical assays.

          -  Positive tests for Hepatitis B and/or C infection An abnormal value will be defined by
             the ranges quoted by The Doctors Laboratory for the Vaccine Institute site and
             Pathology Department, York Hospital for the York site.

          -  They have a known or suspected impairment of lung, heart, liver, kidney, diseases,
             blood disorders or immune dysfunction.

          -  They are receiving immunosuppressive therapy (including systemic steroids).

          -  They are receiving any medications via vaginal route.

          -  They have any acute infections (including fever greater than or equal to 38°C) or any
             chronic disease.

          -  They present a current problem with substance abuse or with a history of substance
             abuse which, in the opinion of the investigator, might interfere with participation in
             the study.

          -  They have any condition which, in the opinion of the investigator, might interfere
             with the evaluation of the study objectives.

          -  They have received an investigational agent within 3 months prior to study entry.

          -  They cannot speak fluent English, or are planning to leave the area of the study site
             prior to the end of the study period, or are likely not to complete the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment