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

NCT03031912 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CT1401-B
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled, multi-site, double-blind trial of V920 (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be conducted in conformance with Good Clinical Practices. The study will take place at 2 Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital) and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le Dantec, Dakar, Senegal). The Duration of Study: 365 days for each participant not including screening.

Conditions

Ebola

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Solicited Adverse Events Following V920 Vaccination

  The number of participants with general solicited local (at the injection site) and systemic adverse events following vaccination will be summarized. Local AES include: pain at injection site, redness at injection site, swelling at injection site Systemic AEs include: fever, arthritis, arthralgia, rash and blisters/vesicular lesions.

  From vaccine administration up to day 14 following vaccination

• Number of Participants With Solicited Adverse Events Following V920 Vaccination

  The number of participants with solicited systemic adverse events following vaccination that include arthralgia, blister, joint swelling, pyrexia and rash

  From vaccine administration up to 42 days postvaccination

• Number of Participants With Unsolicited Adverse Events Following V920 Vaccination

  The number of participants with unsolicited adverse events following vaccination. These include the following disorders: Blood and lymphatic system disorders, cardiac disorders, ear and labyrinth disorders, eye disorders, gastrointestinal disorders, general disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, nervous system disorders, psychiatric disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, skin and subcutaneous tissue disorders,vascular disorders.

  From vaccine administration up to day 42 postvaccination

• Number of Participants With Serious Adverse Events Following V920 Vaccination

  The number of participants with solicited vaccine-related serious adverse events following V920 vaccination.

  From vaccine administration up to day 365 following vaccination

• Geometric Mean Titers Induced by V920

  Geometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, along with two-sided 95% CIs, by exponentiating the corresponding log-transformed mean and two-sided 95% confidence limits. Cohorts 1-5.

  Day 28 postvaccination

• Geometric Mean Titers Induced by V920

  Geometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, along with two-sided 95% CIs, by exponentiating the corresponding log-transformed mean and two-sided 95% confidence limits Only Cohort 5 received 2 doses of vaccine.

  28 days after LAST (second) dose of vaccine

Study Arms (2)

Group 1: V920

ACTIVE COMPARATOR

Participants randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

Biological: V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine

Group 2: Placebo

PLACEBO COMPARATOR

Participants randomly assigned to receive placebo. Saline: Normal saline (0.9%) was chosen as an inert substance to serve as placebo control.

Other: Saline

Interventions

V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine BIOLOGICAL

The rVSVΔG-ZEBOV-GP vaccine is a live attenuated recombinant virus consisting of a single recombinant VSV isolate (11481 nt, strain Indiana) with the gene for the Zaire ebolavirus GP (ZEBOV GP), Kikwit strain replacing the gene for the VSV GP, which has been deleted. This results in a VSV backbone with the ZEBOV GP constituting the envelope of the virus.

Group 1: V920

Saline OTHER

Normal saline (0.9%) has been chosen as an inert substance to serve as placebo control.

Group 2: Placebo

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If the female partner is NOT of childbearing potential, the couple will only be required to use condoms, without other adjunctive contraception.
• 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)
• 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
• Use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
• Avoiding the sharing of needles, razors, or toothbrushes
• Avoiding open-mouth kissing

You may not qualify if:

• 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;

Sponsors & Collaborators

• Canadian Immunization Research Network: lead
• Merck Sharp & Dohme LLC: collaborator
• International Development Research Centre, Canada: collaborator
• Dalhousie University: collaborator
• Université de Montréal: collaborator
• Coalition for Epidemic Preparedness Innovations: collaborator
• University of Ottawa: collaborator
• Centre Muraz: collaborator
• Institute for Health Research - Epidemiological Surveillance and Training (IRESSEF): collaborator

Study Sites (1)

CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

Ebola Vaccines; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Joanne Langley - Coordinating Investigator
• Organization: CIRN

joanne.langley@dal.ca

902-470-8762

Study Officials

• Cecile Tremblay, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: COORDINATING Investigator

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 26, 2017
• Study Start: August 1, 2017
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)