Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:10/18/2017
Start Date:January 2015
End Date:June 2016

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Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2

This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be
randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.

Objectives:

- To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6
different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:

- Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)

- Proportion of subjects who are recurrence free at 6 and 12 months after the last
dose of vaccine

- Lesion rate (percent of days with genital lesions present) during the
post-vaccination follow-up period

- Antiviral use.

- To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.


Inclusion Criteria:

1. Subjects who received placebo in GEN-003-002 and completed the study through Day 71
per protocol, including the collection of at least 45 anogenital swabs during Days 43
to 71.

2. Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.

3. Willing and able to provide written informed consent.

4. Willing to perform and comply with all study procedures including attending clinic
visits as scheduled.

5. Men and women of childbearing potential, must be willing to practice a highly
effective method of contraception that may include, but is not limited to, abstinence,
monogamous relationship with vasectomized partner, vasectomy, licensed hormonal
methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28
days before and 90 days after receiving Study Drug.

Exclusion Criteria:

1. On suppressive antiviral medication within 7 days prior to the first dose of Study
Drug.

2. Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002
study.

3. History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related
erythema multiforme, or herpes meningitis or encephalitis.

4. Immunocompromised individuals, including those receiving immunosuppressive doses of
corticosteroids (more than 20 mg of prednisone given daily or on alternative days for
2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of
corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled
corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other
immunosuppressive agents.

5. Presence or history of autoimmune disease, regardless of current treatment.

6. Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C
infection (in the absence of a negative PCR result); positive hepatitis B surface
antigen (HBsAg) within 6 months prior to the first dose of Study Drug.

7. Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days
prior to the first dose of Study Drug.

8. Receipt of blood products within 90 days prior to the first dose of Study Drug.

9. Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days
prior to the first dose of Study Drug or planned vaccination within 30 days following
the last dose of Study Drug.

10. Pregnant or nursing women.

11. History of drug or alcohol abuse that, in the opinion of the Investigator, would
interfere with the patient's ability to comply with the requirements of the study.

12. Other active, uncontrolled co-morbidities that, in the opinion of the Investigator,
would make the subject unsuitable for the study or unable to comply with the study
requirements.

NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be
enrolled if there have been no changes to their medication within 60 days prior to the
first dose of Study Drug.
We found this trial at
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Austin, Texas 78745
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Boston, Massachusetts 02115
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1740 West Taylor Street
Chicago, Illinois 60612
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Houston, Texas 77030
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Portland, Oregon 97210
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San Diego, California 92108
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San Francisco, California 94115
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