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Phase 2 N=523 Randomized Triple-blind Prevention

Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally

Smallpox

Enrolled (actual)
523
Serious AEs
0.8%
Results posted
Jan 2021
Primary outcome: Primary: Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus Following 2 Doses of IMVAMUNE® Liquid Administered Subcutaneously, ITT Population — 77.9; 46.7 titer

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 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus Following 2 Doses of IMVAMUNE® Liquid Administered Subcutaneously, ITT Population
77.9; 46.7
PRIMARY
GMT Based on Vaccinia-specific Individual Peak PRNT Following 2 Doses of IMVAMUNE® Lyophilized Versus Following 2 Doses of IMVAMUNE® Liquid Administered Subcutaneously, Per Protocol Population
87.8; 49.5
PRIMARY
GMT Based on Vaccinia-specific Individual Peak PRNT, Following 2 (Lower) Doses Liquid IMVAMUNE® Administered Intradermally Versus 2 (Higher) Doses of Liquid IMVAMUNE® Administered Subcutaneously, ITT Population
45.2; 46.7
PRIMARY
GMT Based on Vaccinia-specific Individual Peak PRNT, Following 2 (Lower) Doses Liquid IMVAMUNE® Administered Intradermally Versus 2 (Higher) Doses of Liquid IMVAMUNE® Administered Subcutaneously, Per Protocol Population
59.6; 49.5
PRIMARY
Number of Participants Reporting Serious Adverse Events Associated With IMVAMUNE® Vaccination
0; 0; 0
SECONDARY
Number of Participants Assessed With Grade 3 and 4 Laboratory Toxicities Associated With IMVAMUNE®.
0; 0; 0
SECONDARY
GMT Based on Vaccinia-specific Individual Peak ELISA Titers, Following 2 Doses (Lower) Liquid Formulation IMVAMUNE® Administered Intradermally Versus That Obtained Following 2 Doses IMVAMUNE® Liquid Formulation Administered Subcutaneously, ITT Population
554.0; 700.5
SECONDARY
GMT Based on Vaccinia-specific Individual Peak ELISA Titers, Following 2 Doses (Lower) Liquid Formulation IMVAMUNE® Administered Intradermally Versus That Obtained Following 2 Doses IMVAMUNE® Liquid Formulation Subcutaneously, Per Protocol Population
757.9; 769.3
SECONDARY
GMT Based on Vaccinia-specific Individual Peak ELISA Titers Following 2 Doses of IMVAMUNE® Lyophilized Formulation Versus That Obtained Following 2 Doses of IMVAMUNE® Liquid Formulation Subcutaneously, ITT Population.
893.5; 700.5
SECONDARY
GMT Based on Vaccinia-specific Individual Peak ELISA Titers Following 2 Doses of IMVAMUNE® Lyophilized Formulation Versus That Obtained Following 2 Doses of IMVAMUNE® Liquid Formulation Subcutaneously, Per Protocol Population.
1062.4; 769.3

Summary

Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be injected (given as a shot) just under the skin (subcutaneously) or injected between the layers of the skin (intradermally). The powder formulation is only injected just under the skin. Approximately 495 adults, age 18 older born after 1971, which have not had smallpox vaccine before, may participate in the study for about 7 months.

Eligibility Criteria

Inclusion Criteria

Inclusion criteria that must be met prior to the initial vaccination:

  • At least 18 years of age and born after 1971.
  • Read, signed, and dated informed consent document.
  • Available for follow-up for the planned duration of the study (6 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 pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to vaccination.
  • If the subject is female and of childbearing potential, she agrees to use acceptable contraception, and not become pregnant for 28 days following the last vaccination:
  • A woman is considered of childbearing potential unless post-menopausal (greater than or equal to 1 year) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy).
  • Acceptable contraception methods are restricted to effective devices [intrauterine devices (IUD)s, NuvaRing®] or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, abstinence from sexual intercourse with men (vaginal penetration by a penis, coitus), and monogamous relationship with a vasectomized partner.
  • Negative enzyme linked immunosorbent assay (ELISA) for human immunodeficiency virus (HIV).
  • Alanine aminotransferase (ALT) 140 mm Hg) or are on antihypertensive medication, and/or c. have a family history of coronary heart disease in male first-degree relative (father or brother) <55 years of age or a female first-degree relative (mother or sister) <65 years of age
  • High-dose steroid use for greater than 2 weeks duration within three months prior to vaccination and current use of immunosuppressive medication
  • Corticosteroid nasal sprays are permissible
  • Persons who are using a topical steroid can be enrolled after their therapy is completed
  • Inhaled steroids for asthma are not permissible
  • 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 study
  • Receipt of blood products or immunoglobulin within six months prior to vaccination
  • Donation of a unit of blood within 56 days prior to vaccination and prior to Visit 6
  • Acute febrile illness (greater than or equal to 100.4 degrees Fahrenheit) on the day of vaccination
  • Pregnant or lactating women
  • Eczema of any degree or history of eczema
  • Active atopic dermatitis, active exfoliative skin disorders/conditions, current Varicella zoster, 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 study objectives
  • Known allergy to IMVAMUNE® vaccine
  • Known allergy to egg or aminoglycoside (including gentamicin)
  • Study personnel

Exclusion criteria that apply prior to the second vaccination:

  • Continued inflammation (erythema and/or induration) graded as moderate or severe at the site of the initial vaccination
  • History of immunodeficiency
  • Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease, diabetes mellitus, or moderate to severe kidney impairment
  • Malignancy not including squamous cell skin cancer or basal cell skin cancer unless at the vaccination site or history of skin cancer at the vaccination site
  • Active autoimmune disease

a. Persons with vitiligo or thyroid disease (e.g., taking thyroid hormone replacement) are no

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00914732). 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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