African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola

This is an interventional prevention trial for Ebola Read More

Inclusion Criteria:

• HIV-infected adult or adolescent male or non-pregnant, non-breastfeeding female, ages 13 to 65 (inclusive) at the time of screening;
• On antiretroviral therapy with an undetectable viral load (< 40 c/ml);
• CD4 T cell counts ≥ 200 cells/mm3;
• Written informed consent (subject or parent) and assent (adolescent), after reading the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee
• Free of clinically significant health problems that could affect the safety of the participant, as determined by the Investigator by pertinent medical history and clinical examination prior to entry into the study;
• Available, able, and willing to participate for all study visits and procedures;

• Males and females who are willing to practice abstinence from sexual intercourse, or are willing to use effective methods of contraception, from at least 30 days prior to vaccination until 2 months after vaccination.

  1. If the female partner is NOT of childbearing potential, the couple will only be required to use condoms, without other adjunctive contraception.
  2. For this study, a woman is considered of childbearing potential unless postmenopausal (≥ 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)
  3. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label for example:

  i. Male condoms PLUS: ii. Oral contraceptives, either combined or progestogen alone iii. injectable progestogen iv. implants of etenogestrel or levonorgestrel v. oestrogenic vaginal ring vi. percutaneous contraceptive patches vii. intrauterine device or intrauterine system

• Be willing to minimize blood and body fluid exposure of others for 6 weeks after vaccination

  1. Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
  2. Avoiding the sharing of needles, razors, or toothbrushes
  3. Avoiding open-mouth kissing

Exclusion Criteria:

• History of prior infection with a filovirus or prior participation in a filovirus vaccine trial;
• History of prior infection with VSV or receipt of a VSV-vectored vaccine;
• Is a healthcare worker who has direct contact with patients
• Presence of any febrile illness or any known or suspected acute illness on the day of any first immunization (subject may be rescheduled);
• Clinical manifestations of systemic diseases considered by the investigator to impact safety or immunogenicity
• Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months;
• Receipt of any investigational drug within 12 months of vaccination;
• Receipt of any live virus vaccine within 42 days prior to study entry or any other (non-live virus) vaccine within 14 days prior to study entry.
• History of sensitivity to any component of study vaccines per investigator brochure or package insert;
• Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol: ALT, AST, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose (Appendix 2). To exclude transient abnormalities, the investigator may repeat a test up to twice, and if the repeat test is normal, subject may be enrolled;
• Have an active malignancy or history of metastatic or hematologic malignancy except non-melanoma skin cancers;
• Suspected or known alcohol and/or illicit drug abuse within the past 5 years;
• Moderate or severe illness and/or fever >101°F (38.3ºC) within one week prior to vaccination;
• Pregnant or breastfeeding female, or female who intends to become pregnant during the study period;
• Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period;
• Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.