Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects

Inclusion Criteria:

1. Female, aged between 18 and 45 years, extremes included
2. Having regular menstrual cycles (24 to 30 days). Women that got sterilized by bilateral tubal ligation are allowed, as long as they have regular cycles
3. Non-smoking or smoking (no more than 10 cigarettes or 2 cigars or 2 pipes per day, for at least 3 months prior to selection)
4. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included. BMI is calculated as the weight (in kg) divided by the square of height (in m)
5. Informed Consent Form (ICF) signed voluntarily before first trial-related activity
6. Able to comply with all protocol requirements
7. Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, a gynecological examination, medical history, electrocardiogram, vital signs and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening
8. If the subject is of childbearing potential, agrees to use adequate contraception (oral contraceptives or double barrier method, as described in section 5.2.4, point 7 of the protocol) and not become pregnant for the duration of the study.

Exclusion Criteria:

1. Male
2. Female subject without regular menstrual cycle (24-30 days)
3. History of total hysterectomy
4. Female subject of childbearing potential without use of effective birth control method(s), or not willing to continue practicing these birth control method(s) for the duration of the trial
5. Spermicides or other chemicals as used in contraceptive barrier methods (i.e., a male or female condom, diaphragm, cervical cap or intra-uterine device);
6. A positive pregnancy test or breast feeding at screening
7. A positive HIV-1 or HIV-2 test at trial screening
8. Having vaginitis as observed by local inspection and vaginal swab
9. Recurrent vaginal infections or sexually transmitted diseases within one year prior to vaccination
10. A positive test for Hepatitis A (confirmed by hepatitis A antibody IgM), hepatitis B (confirmed by hepatitis B surface antigen), or hepatitis C (confirmed by hepatitis C virus antibody) infection at trial screening
11. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drugs which in the investigator's opinion would compromise subject safety or compliance with trial procedures
12. Currently active or underlying diabetes, gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, auto-immune disease(s), inheritable immune deficiency(s), infectious disease(s), nasal disorders (i.e. rhinitis, chronic nose bleeds, chronic sinusitis, polyps, chronic cold sores), dental or mouth infections, or rectal problems (fistals, hemorrhoids)
13. History of allergic disease (i.e. egg, milk, dairy products) or reaction likely to be exacerbated by any component of the vaccine to be administered in this trial, and severe allergic disease(s)
14. Contraindication to i.m. injections, history of bleeding disorder or use of anticoagulant therapy within 4 weeks prior to the first study vaccination

15. Having received any of the following substances:

    • Nasal or inhalation corticosteroids within 2 weeks prior to first vaccination
    • Vaginal and/or rectal treatment within 3 days prior to first mucosal sampling
    • HIV vaccine in a prior clinical trial
    • Immunosuppressive medications within 6 months prior to first vaccination
    • Blood products within 120 days prior to the first vaccination
    • Immunoglobulin within 60 days prior to the first vaccination
    • Any investigational or non-registered drug or vaccine within 30 days preceding the first vaccination
    • Any planned vaccination during the study period and safety follow-up
    • Allergy treatment with antigen injections, within 14 days prior to the first study vaccination
    • Current anti-tuberculosis preventive therapy or treatment
16. Serious adverse reactions to vaccines such as, but not limited to, anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain or a history of anaphylactic reactions
17. Donation of blood or plasma within the 30 days preceding the first vaccination
18. Acute disease at the time of enrollment.