A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSV¿G-ZEBOV) Ebola Virus Vaccine Candidate.

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201411000919191
• Date of registration: 28/10/2014
• Prospective Registration: Yes
• Primary sponsor: Universitaetsklinikum Tuebingen
• Public title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSV¿G-ZEBOV) Ebola Virus Vaccine Candidate.
• Scientific title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC1001 (VSV¿G-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Volunteers in Lambaréné, Gabon.
• Date of first enrolment: 01/11/2014
• Target sample size: 60
• Recruitment status: Other
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=919
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Group randomisation,Sealed opaque envelopes
• Phase: Phase-1

Countries of recruitment

Gabon

Contacts

• Name: Jessica Brosnahan
• Affiliation: Project Manager

• Name: Jessica Brosnahan
• Affiliation: Project Manager

Key inclusion & exclusion criteria

Inclusion criteria: Healthy male or non-pregnant, non-lactating female, ages 6 to 50 (inclusive) at the time of screening

Have provided written informed consent prior to screening procedures

Free of clinically significant health problems, as determined 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

Negative pregnancy-test for female volunteers

Females, of childbearing potential, who are willing to use of the study effective methods of contraception during 30 days after vaccination.
- A woman is considered of childbearing potential unless post-menopausal (¿ one 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:
* Oral contraceptives, either combined or progestogen alone,
* injectable progestogen,
* implants of etenogestrel or levonorgestrel,
* oestrogenic vaginal ring
* percutaneous contraceptive patches,
* intrauterine device or intrauterine system,
* male partner sterilisation at least 6months prior to the female subject¿s entry into the study, and the relationship is monogamous,
* male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository).
* male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)

Be willing to minimize blood and body fluid exposure of others days after vaccination
- Be advised to use of effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse 30 days after vaccination
- Avoiding the sharing of needles, razors, or toothbrushes
- Avoiding open-mouth kissing

Exclusion criteria: History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions

Known allergy to the components of the BPSC1001 vaccine product

Ongoing participation in another clinical trial

Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines)

Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test (including sickle cell anemia)

Viral Serologies (HBsAg, anti-HCV Ab, anti-HIV)

Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes requiring medication

Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child

Have a known history of Guillain-Barré Syndrome

Have an active malignancy or history of metastatic or hematologic malignancy

Suspected or known alcohol and/or illicit drug abuse within the past 5 years

Moderate or severe illness and/or fever >38°C within 1 week prior to vaccination

Pregnant or lactating female, or female who intends to become pregnant 30 days after vaccination

Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period

History of blood donation within 30 days of enrollment or plans to donate within the study period

Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry
- For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
- Intranasal and topical steroids are allowed

Any other significant finding that in the opinion of the investigator would increase the risk to the individual.

Age minimum: 6 Year(s)
Age maximum: 50 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola

Ebola

Intervention(s)

BPSC1001 (VSVdG-ZEBOV)

BPSC1001 (VSV¿G-ZEBOV)

Primary Outcome(s)

Safety and tolerability

Secondary Outcome(s)

¿ Determination of B-cell and T-cell repertoire before and after vaccination

long term safety and immunogenicity

Reactogenicity

Immunogenicity

Source(s) of Monetary Support

Innovative Medicines Initiative 2 joint undertaking

Bill and Melinda Gates Foundation

German Federal Ministry of Education and Research

Wellcome Trust

Ethics review

Status: Approved
Approval date:
Contact:

National Ethics Committee of Gabon

Status: Approved
Approval date:
Contact:

World Health Organisation Research Ethics Review Committee

Status: Approved
Approval date: 22/10/2014
Contact:

Zentrum fuer Klinische Studien (ZKS), Tuebingen

Status: Approved
Approval date: 22/11/2016
Contact:

World Health Organisation Research Ethics Review Committee

Status: Approved
Approval date: 30/11/2016
Contact:

CERMEL Institutional Ethics Committee