HIV type 1 Infections and Infestations Human immunodeficiency virus [HIV] disease
Conditions
Interventions
The immunological laboratory was blinded during the study. The clinic staff and participants were not blinded, since this was a safety study with different modes of administration without placebo.
P
Sponsors
Swedish Institute for Infectious Disease Control (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety: 1.1. Samples for routine biochemistry and haematology (see inclusion criteria) were obtained at screening, before and 2 weeks after each immunization, and 3 month after the last DNA and MVA immunization 1.2. Creatinine phosphokinase and antinuclear antibodies were determined at baseline and after the last DNA injection 1.3. 12-lead electrocardiograms were performed before and 2 weeks after the MVA injection 1.4. Clinical adverse reactions and vital signs at 10 and 30 minutes, in addition a contact was made by telephone 1-3 days after each injection 1.5. A 7-day diary card (including standardized measurements of body temperature) was filled in and presented at the visit 2 weeks after each injection, when direct questions were asked on the basis of the diary card 2. Specific reactivity to HIV-1 peptides in IFN-gamma Enzyme-linked immunosorbent spot (ELISpot), performed on fresh Peripheral Blood Mononuclear Cell (PBMC) before the first DNA and the MVA immunization and 2 weeks after the last DNA and MVA immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were performed on fresh Peripheral Blood Mononuclear Cell (PBMC) before the first DNA and the MVA immunization and 2 weeks after the last DNA and MVA immunization: 1. Specific reactivity to HIV-1 peptides in IL-2 ELISpot 2. Lymphoproliferation to inactivated whole HIV-1 virions | — |
Countries
Sweden
Outcome results
None listed