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Phase 2 N=435 Randomized Prevention

Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®

Smallpox

Enrolled (actual)
435
Serious AEs
1.2%
Results posted
Dec 2015
Primary outcome: Primary: Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination — 138.0; 55.1; 75.9; 103.5 titers

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
MVA Smallpox Vaccine (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Apr 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination
138.0; 55.1; 75.9; 103.5
PRIMARY
Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration
28; 36; 26; 33; 6; 10 0.4782
SECONDARY
Geometric Mean Peak ELISA Titer After Second Vaccination
1259.8; 741.4; 1021.0; 1351.8
SECONDARY
Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE
1; 0; 1; 0

Summary

Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure. This study will be a Phase II to evaluate three different immunization schedules and two different modes of delivery. The study will look at condensed schedules. Study will randomize subjects to one of four arms.

Eligibility Criteria

Inclusion Criteria

  • 18 to 40 years of age, inclusive.
  • Read, signed, and dated informed consent document.
  • Available for follow-up for the planned duration of the study (six months after last immunization).
  • Acceptable medical history by screening evaluation and limited physical assessment.
  • If the subject is female and of childbearing potential, negative serum or urine pregnancy test at screening and within 24 hours prior to vaccination.
  • If the subject is female and of childbearing potential*, she agrees to practice abstinence** or use acceptable contraception*** through 56 days after the last vaccination in order to avoid pregnancy:
  • a woman is considered of childbearing potential unless post-menopausal (>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)

**No sexual intercourse with men (vaginal penetration by a penis, coitus)

***Acceptable contraception methods are restricted to effective devices (IUDs, NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to study entry, or successful Essure placement with documented confirmation test at least 3 months after the procedure, and any other FDA-approved contraceptive method

  • Negative test for HIV.
  • Alanine Aminotransferase (ALT) 3,800 and /=120,000/mm^3
  • Body mass index >/=18.5- /= 150mmHg or diastolic blood pressure >/= 100mmHg.
  • Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's (NCEP) risk assessment tool*

*NOTE that this criterion applies only to subjects 20 years of age and older AND only if at least one of the following apply:

  • have smoked a cigarette in the past month, and/or
  • have hypertension (defined as systolic blood pressure >140 mm Hg) or are on antihypertensive medication, and/or
  • have a family history of coronary heart disease in male first-degree relative (father or brother) 5 mg prednisone or equivalent is considered high dose and immunosuppressive
  • Corticosteroid nasal sprays for allergic rhinitis are permissible
  • Persons who are using a topical steroid for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed
  • Inhaled steroids for asthma are not permissible
  • Oral/parenteral corticosteroids given for non-chronic conditions not expected to recur are permissible if the length of therapy was </= 14 days with completion at least 30 days prior to enrollment.
  • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol.
  • Any history of illegal injection drug use.
  • Receipt or planned receipt of inactivated vaccine from 14 days prior to the first vaccination through 14 days post second vaccination.
  • Receipt or planned receipt of any other live attenuated vaccine within 30 days prior to the first vaccination through 30 days post second vaccination.
  • Use of any other experimental agent within 30 days prior to vaccination and for the duration of the subject's participation in the study.
  • Receipt of blood products or immunoglobulin, including Rhogam, within six months prior to vaccination.
  • Donation of a unit of blood within 56 days prior to vaccination or planned donation prior to 28-days following the last vaccination.
  • Pregnant or breastfeeding women.
  • Active exfoliative skin disorders/conditions, current varicella zoster virus infection, or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn greater than 2×2 cm.
  • Any condition that, in the opinion of the investigator, might interfere with assessing the study objectives.
  • Known allergy to egg, aminoglycoside (including gentamicin) or c
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01827371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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