Reactogenicity and Immunogenicity of Vaginal CNgp140 (SG06RS02)

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.