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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0