A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of V920 Ebola Vaccine in Healthy Adults

Phase 1

• Conditions: Prevention of Ebola infection; MedDRA version: 19.1Level: LLTClassification code 10014074Term: Ebola virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001658-14-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-31
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1125

Inclusion Criteria

1. Be a healthy male or female between 18 and 65 years of age.
2. Provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
3. Be able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
4. Be able to complete all scheduled visits, comply with all study procedures, and return to the investigator site for assessment of adverse events of arthralgia/arthritis, rash and/or vesicular lesions (and provide additional study specimens, as applicable).
5. Meet one of the following categories:
a) The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to having had a vasectomy or due to an underlying medical condition).
b) The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women =45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
c) The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following
vaccination by complying with one of the following: (1) practice abstinence†
from heterosexual activity OR (2) use (or have their partner use) acceptable
contraception during heterosexual activity. Acceptable methods of contraception are‡:
Single method (one of the following is acceptable):
• non-hormonal intrauterine device (IUD)
• vasectomy of a female subject’s male partner
• contraceptive rod implanted under the skin
Combination method (requires use of two of the following):
• diaphragm with spermicide (cannot be used in conjunction with cervical
cap/spermicide)
• cervical cap with spermicide (nulliparous women only)
• contraceptive sponge (nulliparous women only)
• male condom or female condom (cannot be used together)
• hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or
progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or
subcutaneous contraceptive injection †Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs.
Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation
methods, etc.) and withdrawal are not acceptable methods of contraception.
‡If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

1. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.
2. Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.
3. Has been exposed to Ebola virus at any time prior to study entry.
4. Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.
5. Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.
6. Has known or suspected impairment of immunological function (e.g., HIV positive).
7. Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).
8. Has had a fever (=100.5ºF/38.0ºC) within 48 hours prior to study entry.
9. Has received systemic corticosteroids (equivalent of =2 mg/kg total daily dose of prednisone or =20 mg/d for persons weighing >10 kg) for =14 consecutive days and has not completed treatment at least 30 days prior to study entry.
10. Has received systemic corticosteroids exceeding physiologic replacement doses (~5 mg/d prednisone equivalent) within 14 days prior to study entry.
11. Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.
12. Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.
13. Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).
14. Has a history of malignancy =5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
15. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial.
16. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified