A Phase II Clinical Trial to Evaluate the Recombinant Human Type 5 Adenovirus Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV)

A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201509001259869

Enrollment

500

Registered

2015-09-10

Start date

2015-10-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola Ebola Virus Disease

Interventions

Ad5-EBOV

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 50 years 2. Able to understand the content of informed consent and signed the informed consent 3. Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months). 4. Negative in HIV diagnostic blood test on the day of enrollment 5. Axillaty temperature ?37.0°C on the day of enrollment 6. Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment 7. General good health as established by medical history and physical examination.

Exclusion criteria

Exclusion criteria: 1. Infected by Ebola virus (inquiry) 2. Vaccination with other Ebola vaccine (inquiry) 3. HIV infection or other serious immunodeficiency disease (inquiry) 4. Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol 5. Family history of brain or mental disease 6.Woman who is pregnant or breast-feeding 7. Any acute fever disease or infections in last 7 days 8. Major congenital defects or not well-controlled chronic illness 9. Asplenia or functional asplenia 10. Platelet disorder or other bleeding disorder 11. Faint at the sight of blood or needles. 12. Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months 13. Prior administration of other research medicines in last 1 month 14. Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives

Design outcomes

Primary

Measure	Time frame
Safety: Occurrence of solicited adverse reactions within 7 days after vaccination;Immunogenicity: ELISA antigen-specific assays for antibody responses	—

Secondary

Measure	Time frame
Safety: Occurrence of unsolicited adverse reactions;Safety: Occurrence of serious adverse reactions during whole follow-up period;Safety: Infection rate of HIV during the whole follow-up period;Immunogenicity: Neutralizing antibody tiers response to human Ad5	—

Countries

Sierra Leone

Contacts

Public ContactEdward Kargbo

Communications Director- Ad5-EBOV

pdthealth@gmail.com+232-7939999

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026