HIVIS07: A phase I trial to assess the safety and immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate administered together with dermal electroporation among volunteers in Stockholm, Swede

Phase 1

Completed

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

• Registration Number: ISRCTN60284968
• Lead Sponsor: Swedish Institute for Infectious Disease Control (SMI) (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-06
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Men and women 18 to 40 years of age
2. Negative antibody/antigen test for HIV infection
3. Willing to undergo 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 during 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
6. Willing to undergo a genital infection screening if need arises
7. Participants will agree to practice effective contraception from study entry until 4 months after the last immunization
8. 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. Hb >10.5g/dL
10.2. White blood cell count <13.000/mm3
10.3. Neutrophils >1500/mm3
10.4. Lymphocytes >1.0
10.5. Platelets >120.000/mm3
10.6. CD4 >400/mm3
10.7. Glucose 2.5-7.0 mmol/L
10.8. Bilirubin <1.25xULN
10.9. Aspartate Aminostransferase (AST) <1.25xUNL
10.10. Alanine Aminotransferase (ALT) <1,25xUNL
10.11. Alkaline Phosphatase (ALP) <1.25xUNL
10.12. Creatinine <1.0xUNL
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, such as laboratory detection of tuberculosis bacteria, Hepatitis antigen, acute 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. Have received blood products or immunoglobulin in the past 3 months
6. Are receiving ongoing therapy with immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy
7. Have used experimental therapeutic agents within 30 days of study entry
8. Have ECG deviations that indicate heart disease or would make interpretation of vaccine induced effect difficult
9. Have received any live, attenuated vaccine within 60 days of study entry (NOTE: Medically indicated subunit or killed vaccines [e.g., Hepatitis or influenza] 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 >= 39.5oC 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 access to the immunogenicity results
13. Unlikely to comply with protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified