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

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2015-001658-14-ES
• Date of registration: 31/07/2015
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
• Public title: A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of V920 Ebola Vaccine in Healthy Adults
• Scientific title: A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lot Doses and a High Dose of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults - V920 Consistency Lots and High Dose Lot Safety and Immunogenicity Trial
• Date of first enrolment: 03/09/2015
• Target sample size: 1125
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001658-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Denmark, Spain, United Kingdom, United States

Contacts

• Name: Investigación Clínica
• Affiliation: Merck Sharp & Dohme de España S.A.

• Name: Investigación Clínica
• Affiliation: Merck Sharp & Dohme de España S.A.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Prevention of Ebola infection
MedDRA version: 19.1 Level: LLT Classification code 10014074 Term: Ebola virus infection System Organ Class: 100000004862

Intervention(s)

Product Name: V920 rVSV-ZEBOV-GP Consistency Lot A
Product Code: V920-012
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: V920-012
Other descriptive name: V920-012
Concentration unit: PFU plaque forming unit
Concentration type: not less then
Concentration number: 50000000-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use

Product Name: V920 rVSV-ZEBOV-GP Consistency Lot B
Product Code: V920-012
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: V920-012
Other descriptive name: V920-012
Concentration unit: PFU plaque forming unit
Concentration type: not less then
Concentration number: 50000000-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use

Product Name: V920 rVSV-ZEBOV-GP Consistency Lot C
Product Code: V920-012
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: V920-012
Other descriptive name: V920-012
Concentration unit: PFU plaque forming unit
Concentration type: not less then
Concentration number: 50000000-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use

Product Name: V920 rVSV-ZEBOV-GP (High Dose)
Product Code: V920-012
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: V920-012
Other descriptive name: V920-012
Concentration unit: PFU plaque forming unit
Concentration type: not less then
Concentration number: 100000000-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Primary end point(s): -(GMT) of anti-ZEBOV glycoprotein antibody measured by ELISA (GP-ELISA)
-Detailed safety

Main Objective: 1-To determine whether vaccination with V920 from three separate consistency lots results in equivalent immunogenicity.
2- To determine the safety and tolerability of V920 from three Consistency Lot
groups (A, B, and C each separately and combined) and the High Dose group through 42 days postvaccination.

Timepoint(s) of evaluation of this end point: -GMT of anti-ZEBOV glycoprotein antibody measured by GP-ELISA at Day 28 postvaccination.
-Detailed safety from Day 1 to 42 postvaccination.

Secondary Objective: 1-To estimate the anti-ZEBOV GP-ELISA GMTs measured at 28 days
postvaccination in the three Consistency Lot groups (Lots A, B, and C combined) and the High Dose group.
2- To estimate the GMTs of neutralizing antibodies measured by plaque
reduction neutralization test (PRNT) at 28 days postvaccination in the three Consistency Lot groups (A, B, and C combined) and the High Dose group.
3- To determine whether vaccination with V920 from three separate
consistency lots results in equivalent immunogenicity.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: -Geometric mean titer (GMT) of anti-ZEBOV glycoprotein antibody measured by GP-ELISA at 28 days postvaccination.
-GMTs of neutralizing antibodies measured by plaque reduction neutralization test (PRNT) at 28 days postvaccination.
-All SAEs from Day 43 through Month 6 postvaccination.

Secondary end point(s): -Geometric mean titer (GMT) of anti-ZEBOV glycoprotein antibody
measured by ELISA (GP-ELISA)
-GMTs of neutralizing antibodies measured by plaque reduction neutralization test (PRNT)
-SAEs

Secondary ID(s)

V920-012

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.