HIVIS 01: A phase I trial to assess the safety of different modes of administering plasmid DNA with HIV genes env, rev, gag, and RT, with Amendment 3, HIVIS 02: Assessment of the safety and immunogenicity of administering modified vaccinia Ankara (MVA), carrying HIV-1 genes env, gag, and pol in subjects who have previously received plasmid DNA with analogous HIV-1 genes in HIVIS 01

Not Applicable

Completed

• Conditions: HIV type 1; Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN32604572
• Lead Sponsor: Swedish Institute for Infectious Disease Control (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-10
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age: Men 18 to 67 years of age or women from one year after menopause (or from 18 with verified infertility) to 67 years of age
2. Negative antibody/antigen test for HIV infection
3. Willing to undergo a HIV testing
4. Residents in Stockholm at low risk of HIV and willing to remain so for the duration of the study
5. Low risk of HIV infection defined as:
5.1. No history of injecting drug use in the previous ten years.
5.2. No gonorrhoea, chlamydia or syphilis in the last six months.
5.3. No high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
5.4. No unprotected vaginal and/or anal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
6. Willing to undergo a genital infection screening if need arises
7. If heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
8. Be willing to practice safer sex for the duration of the study to avoid sexually transmitted infections
9. Good health as determined by medical history, physical examination, and clinical judgment
10. No grade 1 or higher routine laboratory parameters:
10.1. Haemoglobin (Hb) >10.5 g/dL
10.2. White blood cell count <13,000/mm^3
10.3. Neutrophils >1,500/mm^3
10.4. Lymphocytes >1.0
10.5. Platelets >120,000/mm^3
10.6. CD4 >400/mm^3
10.7. Glucose 2.5-7.0 mmol/L
10.8. Bilirubin <1.25 x upper limit of normal (ULN)
10.9. Aspartate aminotransferase (AST) <1.25 x UNL
10.10. Alanine aminotransferase (ALT) <1.25 x UNL
10.11. Alkaline phosphate <1.25 x UNL
10.12. Creatinine <1.0 x UNL
10.13. Complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or proteinuria = 1+, the volunteer is ineligible).
11. Availability for the duration of the study
12. Able to give fully informed consent at screening visits 1 and 2

Exclusion Criteria

1. Have active tuberculosis or other systemic infectious process by review of systems and physical examination and laboratory detection, such as laboratory detection of hepatitis B antigen or hepatitis C acute or active syphilis
2. Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, autoimmune disease, severe eczema.
3. Have history of psychiatric, medical and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial
4. History of grand-mal epilepsy, or currently taking anti-epileptics
5. Positive for anti-double strand DNA antibodies and/or ANA
6. Have received blood products or immunoglobulins in the past 3 months
7. Are receiving ongoing therapy with immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
8. Have used experimental therapeutic agents within 30 days of study entry
9. Have received any live, attenuated vaccine within 60 days of study entry (NOTE: Medically indicated subunit or killed vaccines [e.g., hepatitis A or hepatitis B] are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions)
10. Have previously received an HIV vaccine
11. History of severe local or general reaction to vaccination defined as:
11.1. Local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
11.2. General: fever >= 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 72 hours
12. Are study site employees who are involved in the protocol and may have direct access to the immunogenicity results
13. Unlikely to comply with protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified