None listed
Conditions
Interventions
Intervention1: ADVAX 4 mg, TBC-M4 5 x 10 6 pfuu: 1 ml im, 0.5 ml im
Control Intervention1: Placebos: ADVAX placebo- 1 ml im, TBC-M4 placebo- 0.5 ml im
Sponsors
International AIDS Vaccine Initiative (IAVI)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy males and females as assessed by a medical history, physical examination and laboratory test 2. Age at least 18 years on the day of screening and have not yet reached his/ her 51st birthday on the day of first vaccination 3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 18 months, see schedule of procedures). 4. In the opinion of the Principal Investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed. 5. Willing to undergo HIV testing, HIV counseling and receive HIV test results 6. If sexually active female, using an effective method of contraception (combined oral contraceptive pill; injectable contraceptive; intra-uterine device; condoms; anatomical sterility in self or partner) from screening until four months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the schedule of procedures (Appendix A). 7. If sexually active male, willing to use an effective method of contraception (such as condoms) from enrolment until four months after last vaccination. 8. Willing to forgo donations of blood, sperm, eggs, bone marrow or organs during the study and for those who test HIV positive after vaccination, till the anti-HIV antibody titers become undetectable.
Exclusion criteria
Exclusion criteria: 1. Confirmed HIV-1 or HIV-2 infection 2. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical steroids is permitted), immunosuppressive, antiviral, anticancer, anti-tuberculosis, or other medications considered significant by the investigator within the previous 6 months. 3. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study. 4. Any of the following abnormal laboratory parameters listed below: &#61607; Hematology o Hemoglobin <11.0 g/dL o Absolute Neutrophil Count (ANC): &#8804; 1000/mm3 o Absolute Lymphocyte Count (ALC): &#8804; 600/mm3 o Absolute Eosinophil Count (AEC): &#61619; 1500/mm3 o Platelets: decreased &#8804; 100,000/ mm3 &#61607; Chemistry o Creatinine: > 1. 1 x ULN o AST: >1.25 x ULN o ALT: >1.25 x ULN o Serum albumin <3 g/dL o Fasting blood glucose > 110 mg/ dL o Glycosylated hemoglobin A1C: > 7% &#61607; Urinalysis: 3+ confirmed by urine dipstick o Protein o Blood (not due to menses) o Leukocytes &#61607; Stool examination evidencing helminthiasis infection &#61607; Cardiac troponin I: > Upper Normal Limit 5. Reported high-risk behaviour for HIV infection, defined as within 6 months before vaccination, the volunteer has: ? Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e. no continuing established relationship) ? Engaged in sex work for money, drugs or shelter ? Used injection drugs ? Acquired a sexually transmitted disease (STD) e.g., gonorrhoea, chlamydia, syphilis, Trichomonas vaginalis, Herpes genitalis. ? Had a high-risk partner 6. If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating 7. Presence of double stranded DNA antibodies. 8. Receipt of live attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or other vaccine within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product. Prior receipt of smallpox vaccination should be documented, but will not be an exclusion criterion. 9. Receipt of blood transfusion or blood-derived products within the previous 6 months 10. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study 11. Former or ongoing participation in another AIDS vaccine clinical trial 12. History of severe local or systemic reactogenicity events to vaccines or history of severe allergic reactions 13. Confirmed diagnosis of hepatitis B or hepatitis C (HB surface antigen, HCV antibodies) or active syphilis or active tuberculosis. 14. History of severe neurological and/ or psychiatric disorder, or substance abuse. 15. ECG with clinically significant findings or features that would interfere with the assessment of myopericarditis including but not limited to: ? conduction disturbance (atrio-ventricular or intra-ventricular condition, left or right bundle branch block, AV block of any degree, or QTc prolongation) ? repolarization (ST segment or T wave) abnormality ? significant atrial or ventricular arrhythmia ? frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2 premature v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of intramuscularly administered ADVAX DNA HIV vaccine, followed by TBC-M4 a, compared with TBC-M4 administered intramuscularlyTimepoint: ADVAX DNA HIV vaccine at time 0 and 1 month, followed by TBC-M4 at months 3 and 6, compared with TBC-M4 administered intramuscularly at 0, 1, and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity of intramuscularly administered ADVAX DNA HIV vaccine, followed by TBC-M4 , compared with TBC-M4 . Timepoint: ADVAX DNA HIV vaccine at time 0 and 1 month, followed by TBC-M4 at months 3 and 6, compared with TBC-M4 administered intramuscularly at 0, 1, and 6 months. | — |
Countries
India
Contacts
Public ContactSanjay Mehendale (NARI), V.D. Ramanathan (TRC)
NARI, TRC (PI's of trial)
Outcome results
None listed